Pack Articles Directory Cameroon: September 2016

Friday, September 30, 2016

Femerital

Femerital may be available in the countries listed below.

Ingredient matches for Femerital

Paracetamol

Paracetamol is reported as an ingredient of Femerital in the following countries:

Netherlands

International Drug Name Search

Levothyroxine Tablets BP 100 micrograms

1. Name Of The Medicinal Product

LEVOTHYROXINE TABLETS BP 100 micrograms

2. Qualitative And Quantitative Composition

Each tablet contains 100 micrograms anhydrous Levothyroxine Sodium.

3. Pharmaceutical Form

White uncoated tablets.

White, circular, shallow convex uncoated tablets impressed “C” on one face and the identifying letters “TC” on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

1) Hypothyroidism.

4.2 Posology And Method Of Administration

Posology

It is recommended that the tablets should be administered before meals.

Adults: Initially 50-100 micrograms daily, then adjusted at 3-4 week intervals by 50 microgram increments until normal metabolism is steadily maintained. This may require doses of up to 150-300 micrograms daily.

Patients over 50 years: It is not advisable to exceed 50 micrograms a day initially, and where there is cardiac disease, 25 micrograms daily, or 50 micrograms on alternate days is more suitable. In this condition the daily dosage may be increased by 25 microgram increments at intervals of maybe 4 weeks.

In younger patients, and in the absence of heart disease, a serum levothyroxine (T4) level of approximately 70-160 nanomoles/litre or a serum thyrotrophin level of less than 5 milli-units/litre should be aimed at. In those aged over 50, and/or in the presence of heart disease, clinical response is probably a more acceptable criterion of dosage than serum levels.

A pre-therapy ECG is valuable, as changes induced by hypothyroidism may be confused with ECG evidence of ischaemia. If too rapid an increase of metabolism is produced, dosage should be reduced or withheld for a day or two, then recommenced at a lower level.

Paediatric patients: The maintenance dose is generally 100 to 150micrograms per m² body surface area. For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values.

For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50micrograms per day. The dose should be increased gradually every 2 to 4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached. Infants should be given the total daily dose at least half an hour before the first meal of the day.

Juvenile myxoedema: A suitable starting dose is 25micrograms levothyroxine daily, with increments of 25micrograms every 2-4 weeks until mild toxic symptoms appear. Dosage should then be slightly reduced. The starting dose for children older than one year may be 2.5-5micrograms/kg bodyweight daily.

When applicable:

Tablets are to be disintegrated in some water (10 to 15ml) and the resultant suspension, which must be prepared freshly as required, is to be administered with some more liquid (5 to 10ml).

Method of Administration

For oral administration.

4.3 Contraindications

• Hypersensitivity to levothyroxine or any other ingredients in the tablets.

• Thyrotoxicosis.

• Patients with adrenal insufficiency without adequate corticosteroid cover.

4.4 Special Warnings And Precautions For Use

Levothyroxine should be administered with caution where there are symptoms of myocardial insufficiency, ECG evidence of myocardial infarction and hypertension. A pre-therapy ECG is valuable as changes induced by hypothyroidism may be confused with evidence of ischaemia.

Thyroid replacement therapy should be introduced gradually in elderly patients, and those with severe long standing hypothyroidism.

Patients with adrenal insufficiency or other causes predisposing to it such as panhypopituitarism may react unfavourably to levothyroxine treatment so it is advisable to initiate corticosteroid therapy before giving levothyroxine. Caution should also be exercised when administering levothyroxine to diabetics (mellitus or insipidus) or digitalised patients.

Subclinical hyperthyroidism may be associated with bone loss. To minimise the risk of osteoporosis, dosage of levothyroxine sodium should be titrated to the lowest possible effective level.

Parents of children receiving a thyroid agent should be advised that partial loss of hair may occur during the first few months of therapy, but this effect is usually transient and subsequent regrowth usually occurs.

Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are co-administered (see section 4.5). Patients taking levothyroxine should consult a doctor before starting treatment with orlistat, as orlistat and levothyroxine may need to be taken at different times and the dose of levothyroxine may need to be adjusted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

• A possible interaction occurs with hypoglycaemic agents, hence diabetic patients should be monitored for increased requirements of insulin or oral hypoglycaemic agents.

• If levothyroxine therapy is initiated in digitalised patients, the dose of digitalis may require adjustment. Hyperthyroid patients may need their digoxin dosage gradually increased as treatment proceeds because initially patients are relatively sensitive to digoxin.

• Levothyroxine may enhance the effects of anticoagulants (e.g. warfarin, dicoumarol, acenocoumarol and phenindione) and it may be necessary to reduce the dose of anticoagulant if excessive hypoprothrombinaemia and bleeding are to be avoided.

• Levothyroxine increases receptor sensitivity to catecholamines thus accelerating the response to tricyclic antidepressants (e.g. amitriptyline).

• The effects of sympathomimetic agents (e.g. adrenaline(epinephrine)) are also enhanced.

• The absorption of levthyroxine is reduced by sucralfate, sodium polystyrene sulphonate or colestyramine binding within the gut. Cimetidine, aluminium hydroxide, calcium carbonate and ferrous sulphate also reduce absorption of levothyroxine from the G.I. tract. Dosages should be separated by an interval of several hours.

• Concurrent use of carbamazepine, phenytoin, phenobarbital, primidone or rifampicin have been found to increase levothyroxine metabolism.

• Isolated reports of marked hypertension and tachycardia has been reported with concurrent ketamine administration.

• Lovastatin has been reported to cause one case each of hypothyroidism and hyperthyroidism in two patients taking levothyroxine.

• False low total plasma concentrations have been observed with concurrent anti-inflammatory treatment such as phenylbutazone or acetylsalicylic acid and levothyroxine therapy.

• Levothyroxine accelerates the metabolism of propranolol.

• Oestrogen, oestrogen containing products and oral contraceptives may increase the requirement of thyroid therapy dosage. Conversely, androgens and corticosteroids may decrease serum concentrations of Levothyroxine-binding globulins.

• Amiodarone may reduce the effects of thyroid hormones used in the treatment of hypothyroidism.

• Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur when levothyroxine is taken concomitantly with orlistat.

• In an interaction study in healthy volunteers, colesevelam reduced the AUC and C_max of levothyroxine when administered either concomitantly or after one hour.

• No interaction was observed when colesevelam was administered at least four hours after levothyroxine.

• A number of drugs may affect thyroid function tests and this should be borne in mind when monitoring a patient on levothyroxine therapy.

4.6 Pregnancy And Lactation

Pregnancy

Women on a maintenance dose for hypothyroidism, who become pregnant, must be monitored closely. Levothyroxine sodium does not readily cross the placenta in the second and third trimester but may do so in the first. Levothyroxine sodium is not known to have either carcinogenic or teratogenic effects.

Lactation

Minimal concentrations of levothyroxine are excreted in breast milk and may cause hypothyroidism in a newborn baby. It is considered that there is insufficient thyroid hormone in breast milk to meet the needs of a suckling infant with a non-functioning thyroid gland.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Hypersensitivity reactions including rash, pruritus and oedema have also been reported.

The following side effects are usually due to excessive dosage and correspond to symptoms of hyperthyroidism. These reactions usually disappear after dose reduction or withdrawal of treatment. They include:

Effects on the heart: arrhythmias, anginal pain, tachycardia, palpitations.

Effects on the central nervous system (CNS): headache, restlessness, excitability, flushing, sweating, insomnia, tremor, fever, heat intolerance.

Effects on the gastrointestinal (G.I.) tract: diarrhoea, excessive weight loss, vomiting.

Musculoskeletal Effects: muscle cramps, muscle weakness.

Thyroid crises have occasionally been reported following massive or chronic intoxication and cardiac arrhythmias, heart failure, coma and death have occurred.

4.9 Overdose

Symptoms of mild to moderate overdose: fever, angina, tachycardia, arrhythmias, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea. Reduction of dose or withdrawal of therapy reverses mild overdose effects.

Symptoms of severe overdose: this may resemble thyroid crisis with collapse and coma.

Signs and symptoms of hyperthyroidism may be delayed for up to 5 days due to the gradual peripheral conversion of levothyroxine to triiodothyronine. Overdosage following recent ingestion of tablets can be treated using gastric lavage/emesis.

Propranolol and other supportive measures are used to maintain the circulation. Antithyroid drugs such as propylthiouracil and lithium are unlikely to be of benefit to prevent thyrotoxic crisis due to delayed absorption/onset of action.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Levothyroxine sodium is employed in the treatment of thyroid deficiency states.

5.2 Pharmacokinetic Properties

Levothyroxine sodium is incompletely and variably absorbed from the GI tract; it is almost completely bound to plasma proteins and has a half-life in the circulation of about a week in healthy persons and slightly longer during pregnancy and in patients with myxoedema.

Levothyroxine is excreted in the urine as free drug, deiodinated metabolites, and conjugates. Some levothyroxine is excreted in the faeces.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains:

Lactose

Magnesium stearate

Maize starch

Pregelatinised maize starch

Stearic acid

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture (polypropylene containers, polyethylene containers and amber glass bottles).

Two years from date of manufacture (Blisters)

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Blister packs:

Do not store above 25°C.

Store in the original package.

Keep container in the outer carton.

Polypropylene containers, polyethylene containers and amber glass bottles:

Do not store above 25ºC.

Store in the original container.

Keep the container tightly closed.

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 7s, 14s, 28s, 56s, 84s, 100s, 250s, 500s, 1000s.

The product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 25,000

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

Barnstaple

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/0105

9. Date Of First Authorisation/Renewal Of The Authorisation

8 June 1978

4 August 1997, 4 August 2002

10. Date Of Revision Of The Text

27.05.2011

11 DOSIMETRY (IF APPLICABLE)

Not applicable.

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not applicable.

Cefazolin Hexal

Cefazolin Hexal may be available in the countries listed below.

Ingredient matches for Cefazolin Hexal

Cefazolin

Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Cefazolin Hexal in the following countries:

Germany

International Drug Name Search

Gastrointestinal Obstruction Medications

There are currently no drugs listed for "Gastrointestinal Obstruction".

Definition of Gastrointestinal Obstruction: A block or clog in the stomach and/or intestines.

Learn more about Gastrointestinal Obstruction

Micromedex Care Notes:

Diabetic Gastroparesis
Pyloric Stenosis

Medical Encyclopedia:

Gastroparesis
Pyloric stenosis

Drug List:

Diactin

Diactin may be available in the countries listed below.

Ingredient matches for Diactin

Glipizide

Glipizide is reported as an ingredient of Diactin in the following countries:

Bangladesh

Myanmar

International Drug Name Search

Thursday, September 29, 2016

Abinol

Abinol may be available in the countries listed below.

Ingredient matches for Abinol

Lorazepam

Lorazepam is reported as an ingredient of Abinol in the following countries:

Chile

International Drug Name Search

Lemsip Max Daytime Cold & Flu Relief

1. Name Of The Medicinal Product

Lemsip Max Daytime Cold & Flu Relief

2. Qualitative And Quantitative Composition

Active Ingredient	mg/Capsule	Specification
Paracetamol	500	Ph Eur
Caffeine	25	Ph Eur
Phenylephrine hydrochloride	6.1	Ph Eur

For excipients see 6.1.

3. Pharmaceutical Form

Red/yellow hard gelatine capsules.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms associated with the common cold and influenza, including relief of aches and pains, sore throat, headache, fatigue and drowsiness, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Swallow whole with water. Do not chew.

Adults and children over 12 years of age: Two capsules every 4 hours to a maximum of four doses in any 24 hours, or up to a maximum of three doses in any 24 hours if a night-time paracetamol-containing product is taken before bedtime.

Particularly appropriate for day-time use.

Do not exceed eight capsules in any 24 hours.

Not recommended for children under 12 years of age.

4.3 Contraindications

Paracetamol: Hypersensitivity to paracetamol or any of the other constituents.

Caffeine: Should be given with care to patients with a history of peptic ulcer.

Phenylephrine hydrochloride: Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Use with caution in patients with Raynaud's Phenomenon and diabetes mellitus.

Phenylephrine

Phenylephrine should be used with care in patients with cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Medicinal products which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose.

Phenylephrine hydrochloride

Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see section 4.3).

Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The risk of hypertension and other cardiovascular side effects may be increased (see section 4.3).

Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects with phenylephrine (see section 4.3).

Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.

Caffeine

Caffeine undergoes extensive metabolism by hepatic microsomal cytochrome P450, factors known to alter the activity of this enzyme system may influence caffeine clearance. Thus, caffeine elimination is enhanced in cigarette smokers and inhibited by cimetidine, disulfiram, and oral contraceptive steroids.

4.6 Pregnancy And Lactation

Paracetamol

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.

Caffeine

Taken during pregnancy it appears that the half-life of caffeine is prolonged. This is a possible contributing factor in hyperemesis gravidarum.

Phenylephrine hydrochloride

The safety of this medicine during pregnancy and lactaction has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia. In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Lemsip Max Daytime Cold & Flu Relief has no or negligible influence on ability to drive or use machinery.

4.8 Undesirable Effects

Paracetamol

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Acute pancreatitis after ingestion of above normal amounts.

Phenylephrine hydrochloride

High blood pressure with headache and vomiting, probably only in overdose. Rarely, palpitations. Also, rare reports of allergic reactions and occasionally urinary retention in males.

Caffeine

The most commonly reported adverse events following dosing with caffeine are GI irritation and CNS stimulation. Adverse CNS effects include insomnia, restlessness, nervousness and mild delirium; adverse GI effects include nausea, vomiting and gastric irritation.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g of more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient:

(a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

(b) Regularly consumes ethanol in excess of recommended amounts.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines. See BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

Caffeine

Symptoms - emesis and convulsions may occur. No specific antidote. However, treatment is usually fluid therapy. Fatal poisoning is rare. If symptoms become apparent or overdose is suspected, consult a doctor immediately.

Phenylephrine hydrochloride

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor blocking agent.

Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, mydriasis, acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, allergic dermatitis), dysuria, urinary retention (most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy).

Additional symptoms may include, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking medicinal products such as phentolamine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Caffeine: Caffeine is a central nervous system stimulant. It inhibits the enzyme phosphodiesterase and has an antagonistic effect at central adenosine receptors. Its action on the central nervous system is mainly on the higher centres and it produces a condition of wakefulness and increased mental activity.

Phenylephrine hydrochloride: Phenylephrine is a post-synaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic Properties

Paracetamol: Paracetamol is absorbed rapidly and completely from the small intestine, producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Caffeine: Caffeine is absorbed readily after oral, rectal or parenteral administration, but absorption from the gastrointestinal tract may be erratic. There is little evidence of accumulation in any particular tissue. Caffeine passes readily into the central nervous system and into saliva. Concentrations have also been detected in breast milk. It is metabolised almost completely and is excreted in the urine as 1-methyluric acid, 1-methylxanthine and other metabolites with only about 1% unchanged.

Phenylephrine hydrochloride: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Starch

croscarmellose sodium

sodium lauryl sulphate

magnesium stearate

talc

gelatine

titanium dioxide (E171)

quinoline yellow (E104)

patent blue V (E131)

erythrosin (E127)

shellac

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store up to 25°C.

6.5 Nature And Contents Of Container

250 micron opaque uPVC blister with a foil/paper laminate, 35gsm paper/9 micron soft-temper foil and heat-seal coated, contained in an outer cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

The capsules are to be taken orally, with water if preferred, and swallowed without being chewed.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS,

East Yorkshire.

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0148

9. Date Of First Authorisation/Renewal Of The Authorisation

26^th November 2004

10. Date Of Revision Of The Text

10/08/2011

Wednesday, September 28, 2016

Concept DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Concept DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Concept DHA resources

Concept DHA Use in Pregnancy & Breastfeeding
Concept DHA Drug Interactions
Concept DHA Support Group
1 Review for Concept DHA - Add your own review/rating

Concept DHA Prescribing Information (FDA)

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Concept DHA with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

Rulicin

Rulicin may be available in the countries listed below.

Ingredient matches for Rulicin

Roxithromycin

Roxithromycin is reported as an ingredient of Rulicin in the following countries:

Japan

International Drug Name Search

Nialip

Nialip may be available in the countries listed below.

Ingredient matches for Nialip

Nicotinic Acid

Nicotinic Acid is reported as an ingredient of Nialip in the following countries:

India

International Drug Name Search

Tuesday, September 27, 2016

vitamin d and related compounds Oral, Parenteral

Commonly used brand name(s)

In the U.S.

Calciferol

Delta D3

DHT Intensol

Drisdol

Hectorol

Rocaltrol

Vitamin D

Zemplar

In Canada

D-Vi-Sol

Radiostol Forte

Available Dosage Forms:

Capsule, Liquid Filled

Capsule

Solution

Tablet

Liquid

Tablet, Chewable

Uses For vitamin d and related compounds

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are available in the foods that you eat. Vitamin D is necessary for strong bones and teeth.

Lack of vitamin D may lead to a condition called rickets, especially in children, in which bones and teeth are weak. In adults it may cause a condition called osteomalacia, in which calcium is lost from bones so that they become weak. Your doctor may treat these problems by prescribing vitamin D for you. Vitamin D is also sometimes used to treat other diseases in which calcium is not used properly by the body.

Ergocalciferol is the form of vitamin D used in vitamin supplements.

Some conditions may increase your need for vitamin D. These include:

Alcoholism

Intestine diseases

Kidney disease

Liver disease

Overactivity of the parathyroid glands with kidney failure

Pancreas disease

Surgical removal of stomach

In addition, individuals and breast-fed infants who lack exposure to sunlight, as well as dark-skinned individuals, may be more likely to have a vitamin D deficiency. Increased need for vitamin D should be determined by your health care professional.

Alfacalcidol, calcifediol, calcitriol, and dihydrotachysterol are forms of vitamin D used to treat hypocalcemia (not enough calcium in the blood). Alfacalcidol, calcifediol, and calcitriol are also used to treat certain types of bone disease that may occur with kidney disease in patients who are undergoing kidney dialysis.

Claims that vitamin D is effective for treatment of arthritis and prevention of nearsightedness or nerve problems have not been proven. Some psoriasis patients may benefit from vitamin D supplements; however, controlled studies have not been performed.

Injectable vitamin D is given by or under the supervision of a health care professional. Some strengths of ergocalciferol and all strengths of alfacalcidol, calcifediol, calcitriol, and dihydrotachysterol are available only with your doctor's prescription. Other strengths of ergocalciferol are available without a prescription. However, it may be a good idea to check with your health care professional before taking vitamin D on your own. Taking large amounts over long periods may cause serious unwanted effects.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin D is found naturally only in fish and fish-liver oils. However, it is also found in milk (vitamin D–fortified). Cooking does not affect the vitamin D in foods. Vitamin D is sometimes called the "sunshine vitamin" since it is made in your skin when you are exposed to sunlight. If you eat a balanced diet and get outside in the sunshine at least 1.5 to 2 hours a week, you should be getting all the vitamin D you need.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, fat is needed so that vitamin D can be absorbed into the body.

The daily amount of vitamin D needed is defined in several different ways.

For U.S.—

Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—

Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

In the past, the RDA and RNI for vitamin D have been expressed in Units (U). This term has been replaced by micrograms (mcg) of vitamin D.

Normal daily recommended intakes in mcg and Units are generally defined as follows:

Persons	U.S.		Canada
Persons	mcg	Units	mcg	Units
Infants and children birth to 3 years of age	7.5-10	300-400	5–10	200–400
Children 4 to 6 years of age	10	400	5	200
Children 7 to 10 years of age	10	400	2.5–5	100–200
Adolescents and adults	5–10	200–400	2.5–5	100–200
Pregnant and breast-feeding females	10	400	5–7.5	200–300

Remember:

The total amount of each vitamin that you get every day includes what you get from the foods that you eat and what you may take as a supplement.

Your total amount should not be greater than the RDA or RNI, unless ordered by your doctor. Taking too much vitamin D over a period of time may cause harmful effects

Before Using vitamin d and related compounds

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. Some studies have shown that infants who are totally breast-fed, especially with dark-skinned mothers, and have little exposure to sunlight may be at risk of vitamin D deficiency. Your health care professional may prescribe a vitamin/mineral supplement that contains vitamin D. Some infants may be sensitive to even small amounts of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol. Also, children may show slowed growth when receiving large doses of alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol for a long time.

Studies on doxercalciferol or paricalcitol have been done only in adult patients, and there is no specific information comparing the use of doxercalciferol or paricalcitol in children with use in other age groups.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Studies have shown that older adults may have lower blood levels of vitamin D than younger adults, especially those who have little exposure to sunlight. Your health care professional may recommend that you take a vitamin supplement that contains vitamin D.

Pregnancy

It is especially important that you are receiving enough vitamin D when you become pregnant and that you continue to receive the right amounts of vitamins throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother.

You may need vitamin D supplements if you are a strict vegetarian (vegan-vegetarian) and/or have little exposure to sunlight and do not drink vitamin D-fortified milk.

Taking too much alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, or ergocalciferol can also be harmful to the fetus. Taking more than your health care professional has recommended can cause your baby to be more sensitive than usual to its effects, can cause problems with a gland called the parathyroid, and can cause a defect in the baby's heart.

Doxercalciferol or paricalcitol have not been studied in pregnant women. However, studies in animals have shown that paricalcitol causes problems in newborns. Before taking vitamin d and related compounds, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast Feeding

It is especially important that you receive the right amounts of vitamins so that your baby will also get the vitamins needed to grow properly. Infants who are totally breast-fed and have little exposure to the sun may require vitamin D supplementation. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Only small amounts of alfacalcidol, calcifediol, calcitriol, or dihydrotachysterol pass into breast milk and these amounts have not been reported to cause problems in nursing babies.

It is not known whether doxercalciferol or paricalcitol passes into breast milk. Be sure you have discussed the risks and benefits of the supplement with your doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of vitamin d and related compounds

For use as a dietary supplement:

Do not take more than the recommended daily amount. Vitamin D is stored in the body, and taking too much over a period of time can cause poisoning and even death.

If you have any questions about this, check with your health care professional.

For individuals taking the oral liquid form of this dietary supplement:

This preparation should be taken by mouth even though it comes in a dropper bottle.

This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

While you are taking alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, doxercalciferol or paricalcitol , your health care professional may want you to follow a special diet or take a calcium supplement. Be sure to follow instructions carefully. If you are already taking a calcium supplement or any medicine containing calcium, make sure your health care professional knows.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For alfacalcidol

To treat bone disease in kidney patients undergoing kidney dialysis:
- For oral dosage form (capsules):
  - Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
- For oral dosage form (drops):
  - Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
- For oral dosage form (solution):
  - Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
- For parenteral dosage form (injection):
  - Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 12 mcg a week.

To treat diseases in which calcium is not used properly by the body:
- For oral dosage form (capsules):
  - Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
- For oral dosage form (drops):
  - Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
- For oral dosage form (solution):
  - Adults and teenagers—At first, 0.25 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.

For calcifediol

To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
- For oral dosage form (capsules):
  - Adults, teenagers, and children over 10 years of age—At first, 300 to 350 micrograms (mcg) a week, taken in divided doses either once a day or every other day. Your doctor may change your dose if needed.
  - Children 2 to 10 years of age—50 mcg a day.
  - Children up to 2 years of age—20 to 50 mcg a day.

To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
- For oral dosage forms (capsules and solution):
  - Adults, teenagers, and children—At first, 0.25 micrograms (mcg) a day. Your doctor may change your dose if needed.
- For parenteral dosage forms (injection):
  - Adults and teenagers—At first, 0.5 mcg injected into a vein three times a week. Your doctor may change your dose if needed.
  - Children—Use and dose must be determined by your doctor.

For dihydrotachysterol

To treat diseases in which calcium is not used properly by the body:
- For oral dosage forms (capsules, solution, or tablets):
  - Adults and teenagers—At first, 100 micrograms (mcg) to 2.5 milligrams (mg) a day. Your doctor may change your dose if needed.
  - Children—At first, 1 to 5 mg a day. Your doctor may change your dose if needed.

For doxercalciferol

To treat an overactive parathyroid gland in patients with kidney failure:
- For oral dosage form (capsules):
  - Adults—10 micrograms (mcg) three times weekly at dialysis. The doctor may change your dose if needed.
  - Children—Use and dose must be determined by your doctor.

For ergocalciferol

The amount of vitamin D to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of vitamin D.

To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
- For oral dosage form (capsules):
  - For the U.S.
  - Adults and teenagers—5 to 10 micrograms (mcg) (200 to 400 Units) per day.
  - Pregnant and breast-feeding females—10 mcg (400 Units) per day.
  - Children 4 to 10 years of age—10 mcg (400 Units) per day.
  - Children birth to 3 years of age—7.5 to 10 mcg (300 to 400 Units) per day.
  - For Canada
  - Adults and teenagers—2.5 to 5 mcg (100 to 200 Units) per day.
  - Pregnant and breast-feeding females—5 to 7.5 mcg (200 to 300 Units) per day.
  - Children 7 to 10 years of age—2.5 to 5 mcg (100 to 200 Units) per day.
  - Children 4 to 6 years of age—5 mcg (200 Units) per day.
  - Children birth to 3 years of age—5 to 10 mcg (200 to 400 Units) per day.

To treat deficiency:
- Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.

To treat diseases in which calcium and phosphate are not used properly by the body:
- Adults and teenagers—At first, 1000 to 500,000 Units a day. The doctor may change your dose if needed.
- Children—At first, 1000 to 200,000 Units a day. The doctor may change your dose if needed.

For paricalcitol

To treat an overactive parathyroid gland in patients with kidney failure:
- For oral dosage form (capsules):
  - Adults—1 to 2 micrograms (mcg) one time per day or 2 to 4 mcg three times a week (not more often than every other day). The doctor may change your dose if needed.
  - Children—Use and dose must be determined by your doctor.
- For parenteral dosage form (injection):
  - Adults—0.04 to 0.1 micrograms (mcg) per kg no more than every other day during dialysis. The doctor may change your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

For use as a dietary supplement: If you miss taking a dietary supplement for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this dietary supplement, try to remember to take it as directed every day.

If you are taking vitamin d and related compounds for a reason other than as a dietary supplement and you miss a dose and your dosing schedule is:

One dose every other day—Take the missed dose as soon as possible if you remember it on the day it should be taken. However, if you do not remember the missed dose until the next day, take it at that time. Then skip a day and start your dosing schedule again. Do not double doses

One dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

More than one dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your health care professional.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using vitamin d and related compounds

For individuals taking vitamin D without a prescription:

Vitamin D is stored in the body; therefore, when you take more than the body needs, it will build up in the body. This may lead to poisoning. Problems are more likely to occur in:
- Adults taking 20,000 to 80,000 Units a day and more for several weeks or months.
- Children taking 2,000 to 4,000 Units a day for several months.

If you are taking vitamin d and related compounds for a reason other than as a dietary supplement, your doctor should check your progress at regular visits to make sure that it does not cause unwanted effects.

Do not take any nonprescription (over-the-counter [OTC]) medicine or dietary supplement that contains calcium, phosphorus, or vitamin D while you are taking any of these dietary supplements unless you have been told to do so by your health care professional. The extra calcium, phosphorus, or vitamin D may increase the chance of side effects.

Do not take antacids or other medicines containing magnesium while you are taking any of these medicines. Taking these medicines together may cause unwanted effects.

vitamin d and related compounds Side Effects

Along with its needed effects, a dietary supplement may cause some unwanted effects. Alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, and ergocalciferol do not usually cause any side effects when taken as directed. However, taking large amounts over a period of time may cause some unwanted effects that can be serious.

Check with your doctor immediately if any of the following side effects occur:

Late symptoms of severe overdose

High blood pressure

high fever

irregular heartbeat

stomach pain (severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Early symptoms of overdose

Bone pain

constipation (especially in children or adolescents)

diarrhea

drowsiness

dryness of mouth

headache (continuing)

increased thirst

increase in frequency of urination, especially at night, or in amount of urine

irregular heartbeat

itching skin

loss of appetite

metallic taste

muscle pain

nausea or vomiting (especially in children or adolescents)

unusual tiredness or weakness

Late symptoms of overdose

Bone pain

calcium deposits (hard lumps) in tissues outside of the bone

cloudy urine

drowsiness

increased sensitivity of eyes to light or irritation of eyes

itching of skin

loss of appetite

loss of sex drive

mood or mental changes

muscle pain

nausea or vomiting

protein in the urine

redness or discharge of the eye, eyelid, or lining of the eyelid

runny nose

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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HIVID

Generic Name: Zalcitabine
Class: Nucleoside and Nucleotide Reverse Transcriptase Inhibitors
VA Class: AM800
CAS Number: 7481-89-2

Severe peripheral neuropathy reported.¹ Caution in patients with neuropathy.¹ (See Peripheral Neuropathy under Cautions.)

Pancreatitis reported rarely.¹ If pancreatitis suspected, temporarily interrupt therapy until diagnosis is excluded.¹ (See Pancreatitis under Cautions.)

Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals.¹ (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

Hepatic failure and death reported rarely; possibly related to underlying hepatitis B virus (HBV) infection and zalcitabine therapy.¹

Introduction

Antiretroviral; nucleoside reverse transcriptase inhibitor (NRTI).⁴ ⁸ ⁹ ¹¹ ¹³ ¹⁴ ¹⁵ ¹⁸ ²³ ²⁷ ²⁸ ²⁹ ³⁸ ⁶² ⁸⁵ ⁸⁹

Uses for HIVID

Treatment of HIV Infection

Treatment of HIV infection in conjunction with other antiretrovirals.¹ ¹⁴¹ ¹⁶⁹ ¹⁷¹

HIVID Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.¹ ¹⁴¹ ¹⁶⁹

Dosage

Must be used in conjunction with other antiretrovirals.¹

Modification of zalcitabine dosage may be necessary in patients who develop peripheral neuropathy.¹

Pediatric Patients

Treatment of HIV Infection

Oral

Children <13 years of age†: 0.01 mg/kg every 8 hours under investigation.¹⁴¹ Dosage recommendations not available for neonates and infants.¹⁴¹

Children ≥13 years of age: 0.75 mg every 8 hours.¹ ¹⁴¹

Adults

Treatment of HIV Infection

Oral

0.75 mg every 8 hours.¹ ¹⁶⁹

If reintroduced following a temporary interruption due to peripheral neuropathy, 0.375 mg every 8 hours.¹

Special Populations

Renal Impairment

Treatment of HIV Infection

Oral

Cl_cr 10–40 mL/minute: 0.75 mg every 12 hours.¹ ¹⁶⁹

Cl_cr <10 mL/minute: 0.75 mg every 24 hours.¹ ¹⁶⁹

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for HIVID

Contraindications

Known hypersensitivity to zalcitabine.¹

Warnings/Precautions

Warnings

Clinically important adverse effects reported, some potentially fatal.¹ Patients with decreased CD4⁺ T-cell counts appear to have an increased incidence of adverse effects.¹

Peripheral Neuropathy

Moderate to severe peripheral neuropathy reported; ¹ ⁶⁵ ⁷⁴ ⁸⁶ occurs more frequently in patients with advanced HIV infection.¹

Zalcitabine-related peripheral neuropathy manifests initially as numbness and burning dysesthesia involving the distal extremities.¹ ² ⁶⁵ ⁷⁴ ⁸² ⁸⁵ ⁸⁹ ¹⁰² If drug is not discontinued, sharp shooting pains or severe continuous burning pain may occur and can progress to severe pain requiring opiate analgesics and is potentially irreversible.¹ ⁶⁵ ⁸² ⁸⁹

If zalcitabine is discontinued promptly, neuropathy usually is slowly reversible.¹ ²⁹ ⁶⁵ ⁷⁰ ⁷⁴ ⁸⁵ ⁸⁹ Symptoms may initially progress following discontinuation.¹

Use with extreme caution in patients with preexisting peripheral neuropathy; avoid in patients with moderate to severe peripheral neuropathy.¹

Use with caution in individuals at risk of developing peripheral neuropathy, including those with low CD4⁺ T-cell counts (<50 cells/mm³), diabetes, weight loss, and/or those receiving other drugs that have the potential to cause peripheral neuropathy.¹ (See Drugs Associated with Peripheral Neuropathy under Interactions.) Careful monitoring recommended.¹

Discontinue promptly if signs or symptoms of peripheral neuropathy occur (i.e., moderate discomfort from numbness, tingling, burning or pain of the extremities progresses, any related symptoms accompanied by objective findings).¹

Can be reintroduced at a lower dose if all findings have improved to mild symptoms.¹ Permanently discontinue for severe discomfort related to peripheral neuropathy or moderate discomfort that progresses.¹

Pancreatitis

Pancreatitis, sometimes fatal, reported rarely.¹ ⁸⁶ ⁸⁸

Closely monitor patients with a history of pancreatitis or known risk factors for pancreatitis.¹

Monitor serum amylase and triglyceride concentrations in patients with a prior history of pancreatitis, increased serum amylase concentrations, or alcohol abuse or in those receiving parenteral nutrition.¹ ⁸⁸

Discontinue immediately if clinical signs or symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory tests (hyperamylasemia associated with dysglycemia, rising triglyceride concentration, decreasing serum calcium) suggestive of pancreatitis occur.¹ ⁸⁸

The drug should not be reinitiated until the diagnosis of pancreatitis is excluded and should be discontinued permanently if pancreatitis is diagnosed.¹ ⁸⁸

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving zalcitabine.¹ Reported most frequently in women; obesity and long-term NRTI therapy also may be risk factors.¹ Has been reported in patients with no known risk factors.¹

Hepatic failure and death reported rarely; possibly related to underlying HBV infection and zalcitabine therapy.¹

Use with caution in patients with known risk factors for liver disease.¹

Interrupt therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).¹

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (anaphylactoid reaction, anaphylactic reaction, urticaria without other signs of anaphylaxis) reported.¹ ¹³⁸

Major Toxicities

GI Effects

Severe oral ulcers reported.¹

Esophageal ulcers reported infrequently.¹ Consider temporarily discontinuing zalcitabine if esophageal ulcers do not respond to specific treatment for opportunistic pathogens.¹

Cardiac Effects

Cardiomyopathy, CHF, and severe left ventricular hypokinesis reported rarely.¹ ⁷¹

Use with caution in patients with baseline cardiomyopathy or history of CHF.¹

General Precautions

Lymphoma

Lymphoma reported; causative effect not established.¹

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.^a

Specific Populations

Pregnancy

Category C.¹ Antiretroviral Pregnancy Registry at 800-258-4263.¹

Because of lack of data and concerns regarding teratogenicity in animals, experts recommend the drug not be used in pregnant women unless other alternatives are unavailable.¹⁶⁹ ¹⁷⁵

Lactation

Not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.¹

Pediatric Use

Safety and efficacy not established in pediatric patients <13 years of age.¹ ¹⁴¹

Has been used in children 6 months to 13 years of age† without unusual adverse effects.⁵ ³¹ ³² ³³ ³⁴ ³⁵ ⁸² ¹³⁹ ¹⁷³ ¹⁷⁴

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.¹

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Substantially eliminated by the kidneys; geriatric patients more likely to have decreased renal function; monitor renal function and adjust dosage accordingly.¹ ¹⁸

Hepatic Impairment

Caution in patients with preexisting hepatic impairment, increased serum liver enzyme concentrations, or history of alcohol abuse or hepatitis.¹ Temporarily interrupt therapy if clinical or laboratory findings suggestive of pronounced hepatotoxicity occur.¹

Use with caution in patients with known risk factors for liver disease.¹

Renal Impairment

Dosage adjustment needed.¹ Greater risk of toxicity in patients with renal impairment (Cl_cr <55 mL/minute).¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Peripheral neuropathy, abnormal hepatic function, fatigue.¹

Interactions for HIVID

Drugs Associated with Peripheral Neuropathy

Concomitant use with other drugs associated with peripheral neuropathy (e.g., chloramphenicol, cisplatin, dapsone, didanosine, disulfiram, ethionamide, glutethimide, gold compounds, hydralazine, iodoquinol, isoniazid, metronidazole, nitrofurantoin, phenytoin, stavudine, vincristine) increases risk of peripheral neuropathy and should be avoided if possible.¹ ² ⁸⁶

Specific Drugs

Drug	Interaction	Comments
Abacavir	In vitro evidence of additive or synergistic antiretroviral effects¹ ²⁶ ⁵⁵ ⁸⁹ ¹²⁷ ¹³⁰
Aminoglycosides	Increased risk of peripheral neuropathy¹	Monitor closely; dosage adjustment needed if substantial change in renal function¹
Amphotericin B	Increased risk of peripheral neuropathy¹	Monitor closely; dosage adjustment needed if substantial change in renal function¹
Antacids (magnesium- and aluminum-containing)	Decreased zalcitabine absorption¹	Simultaneous ingestion should be avoided¹
Didanosine	Increased risk of peripheral neuropathy¹⁶⁹ ¹⁷¹ ¹⁷²	Concomitant use not recommended¹⁶⁹ ¹⁷¹ ¹⁷²
Drugs associated with pancreatic toxicity (pentamidine)	Increased risk of pancreatitis¹ ⁸⁶	Discontinue didanosine temporarily if parenteral pentamidine used for treatment of Pneumocystis carinii¹ ⁸⁸
Doxorubicin	Doxorubicin inhibits intracellular phosphorylation of zalcitabine¹	Clinical importance unknown¹
Emtricitabine	In vitro evidence of additive or synergistic antiretroviral effects^b
Foscarnet	Increased risk of peripheral neuropathy¹	Monitor closely; dosage adjustment needed if substantial change in renal function¹
Histamine H₂-receptor antagonists (cimetidine)	Increased zalcitabine AUC with cimetidine¹	If used with cimetidine, monitor for zalcitabine adverse effects; decrease zalcitabine dosage if necessary¹
Lamivudine	May inhibit intracellular phosphorylation of one another¹	Concomitant use not recommended¹ ¹⁶⁹
Loperamide	Pharmacokinetic interactions unlikely¹
Metoclopramide	Slight decrease (10%) in zalcitabine bioavailability¹
Probenecid	Increased zalcitabine AUC¹	Monitor for zalcitabine adverse effects; decrease zalcitabine dosage if necessary¹
Ribavirin	Ribavirin inhibits intracellular phosphorylation of zalcitabine¹	Clinical importance unknown; caution if used concomitantly¹
Saquinavir	Pharmacokinetic interactions unlikely¹ ¹³¹ In vitro evidence of additive or synergistic antiretroviral effects¹
Stavudine	Additive toxicities (peripheral neuropathy)¹⁶⁹ In vitro evidence of additive or synergistic antiretroviral effects¹ ²⁶ ⁵⁵ ⁸⁹ ¹³⁰	Concomitant use not recommended¹⁶⁹
Zidovudine	Pharmacokinetic interactions unlikely¹ ⁷ ⁸⁹ In vitro evidence of additive or synergistic antiretroviral effects¹ ²⁶ ⁵⁵ ⁸⁹ ¹²⁷ ¹³⁰	Concomitant use not recommended in initial regimens because of inferior antiretroviral activity and higher rate of adverse effects compared with other dual NRTI alternatives¹⁶⁹

HIVID Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed; peak plasma concentrations achieved in 0.5–2 hours.¹ ³⁷ ³⁸ ⁸² ⁸⁴ ⁸⁹ Bioavailability is 70–88% (range: 23–127%).¹ ² ³⁷ ³⁸ ⁶² ⁷⁷ ⁸² ⁸⁴ ⁸⁹

Food

Food may decrease the rate and extent of absorption.¹ ⁶² ⁸⁹

Special Populations

Plasma concentrations increased in patients with renal impairment.¹ ⁸⁹

Oral bioavailability lower in children than adults; bioavailability is 54% (range: 29–100%) in children.¹ ³⁵

Distribution

Extent

Not well characterized.¹

Distributed into CSF in low concentrations.¹ ² ³⁷ ⁸² ⁸⁹

Not known whether zalcitabine crosses the placenta or is distributed into milk.¹

Plasma Protein Binding

<4%.¹

Elimination

Metabolism

Not metabolized substantially in the liver.¹

Intracellularly, zalcitabine is phosphorylated and converted by cellular enzymes to the active metabolite, dideoxycytidine 5′-triphosphate.¹ ²³ ²⁹ ³⁸

Elimination Route

Principally eliminated in urine as unchanged drug.¹ ² ³⁵ ³⁷ ³⁸ ⁸² ⁸⁹

Not known whether removed by hemodialysis or peritoneal dialysis.¹

Half-life

1.2–2 hours (range: 0.5–3 hours).¹ ² ³⁷ ⁸² ⁸⁴

Children 6 months to 13 years of age: 0.2–1.9 hours.³⁵

Special Populations

Half-life prolonged in patients with renal impairment; half-life of 8.5 hours reported in patients with Cl_cr <55 mL/minute.¹ ⁸⁹

Stability

Storage

Oral

Tablets

15–30°C; tightly closed bottles.¹

Actions and SpectrumActions

Analog of 2′-deoxycytidine.¹ ¹³ ¹⁴ ¹⁵ ¹⁸ ²³ ²⁸ ²⁹ ³⁸ ⁶² ⁸⁹

Pharmacologically related to other NRTIs (e.g., abacavir, didanosine, emtricitabine, lamivudine, stavudine, zidovudine); differs structurally from these drugs; also differs pharmacologically and structurally from other currently available antiretrovirals.¹

Active in vitro against HIV-1³⁰ ³⁹ ⁴¹ ⁴³ ⁴⁸ ⁵⁴ ⁷⁹ ⁸⁰ ⁸¹ ⁸⁹ ¹⁰⁵ and HIV-2.³⁰ ⁴¹ ⁵⁴ ⁸⁹

Inhibits replication of HIV by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).¹ ⁸ ⁹ ¹³ ¹⁴ ¹⁵ ¹⁸ ²³ ²⁷ ²⁸ ²⁹ ³⁸ ⁷⁹ ⁸² ⁸⁵ ⁸⁹

Strains of HIV-1 with reduced susceptibility to zalcitabine have been produced in vitro and have emerged during therapy with the drug.¹ ⁷⁷ ¹²³

Strains of HIV resistant to zalcitabine may be cross-resistant to some other NRTIs.³⁰ ⁵⁶ ⁵⁷ ⁵⁸ ⁶⁴ ⁷⁷ ⁸⁹ ⁹⁵ ⁹⁶

Cross-resistance between zalcitabine and HIV protease inhibitors (PIs) is highly unlikely since the drugs have different target enzymes.¹ Cross-resistance between didanosine and nonnucleoside reverse transcriptase inhibitors (NNRTIs) is considered to be low since the drugs bind at different sites on reverse transcriptase and have different mechanisms of action.¹⁷²

Advice to Patients

Critical nature of compliance with HIV therapy.¹ Importance of using zalcitabine in conjunction with other antiretrovirals—not for monotherapy.¹

Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

Patients should be advised that peripheral neuropathy is the major toxicity associated with zalcitabine therapy.¹ They should be advised to report early symptoms of peripheral neuropathy (numbness, tingling, burning) to their clinician.¹ Dosage modification may be necessary; importance of following clinician’s instructions regarding dosage adjustment.¹

Patients should be advised of the early symptoms of pancreatitis (nausea, vomiting, abdominal pain) and hepatic toxicity and that the development of manifestations of these conditions should be reported promptly to their clinician.¹

Redistribution/accumulation of body fat may occur, with as yet unknown long-term health effects.¹

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of advising patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Zalcitabine
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	0.375 mg	HIVID	Roche
		0.75 mg	HIVID	Roche

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Hivid 0.375MG Tablets (ROCHE): 90/$189.99 or 270/$529.96

Hivid 0.75MG Tablets (ROCHE): 90/$225.99 or 270/$645.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Roche Laboratories. HIVID (zalcitabine) tablets prescribing information. Nutley, NJ; 2002 Sept.

2. Yarchoan R, Perno CF, Thomas RV et al. Phase I studies of 2′,3′-dideoxycytidine in severe human immunodeficiency virus infection as a single agent and alternating with zidovudine (AZT). Lancet. 1988; 1:76-81. [IDIS 237856] [PubMed 2891981]

3. Broder S, Yarchoan R. Dideoxycytidine: current clinical experience and future prospects. Am J Med. 1990; 88(Suppl 5B):31-3S. [PubMed 2294763]

4. Meng TC, Fischl MA, Richman DD. AIDS clinical trials groups: phase I/II study of combination 2′,3′-dideoxycytidine and zidovudine in patients with acquired immunodeficiency syndrome (AIDS) and advanced AIDS-related complex. Am J Med. 1990; 88(Suppl 5B):27-30S. [IDIS 262507] [PubMed 2294762]

5. Pizzo PA. Considerations for the evaluation of antiretroviral agents in infants and children infected with human immunodeficiency virus: a perspective from the National Cancer Institute. Rev Infect Dis. 1990; 12(Suppl 5):S561-9.

6. Fauci AS. Combination therapy for HIV infection: getting closer. Ann Intern Med. 1992; 116:85-6. [IDIS 289405] [PubMed 1309202]

7. Meng TC, Fischl MA, Boota AM et al. Combination therapy with zidovudine and dideoxycytidine in patients with advanced human immunodeficiency virus infection: a phase I/II study. Ann Intern Med. 1992; 116:13-20. [IDIS 289400] [PubMed 1345755]

8. Hirsch MS. Chemotherapy of human immunodeficiency virus infections: current practice and future prospects. J Infect Dis. 1990; 161:845-57. [IDIS 304872] [PubMed 1691243]

9. Broder S, Mitsuya H, Yarchoan R et al. Antiretroviral therapy in AIDS. Ann Intern Med. 1990; 113:604-18. [IDIS 272457] [PubMed 1698042]

10. Skowron G, Merigan TC. Alternating and intermittent regimens of zidovudine (3′-azido-3′-deoxythymidine) and dideoxycytidine (2′,3′-dideoxycytidine) in the treatment of patients with acquired immunodeficiency syndrome (AIDS) and AIDS-related complex. Am J Med. 1990; 88(Suppl 5B):20-3S.

11. Clumeck N, Hermans P. Antiviral drugs other than zidovudine and immunomodulating therapies in human immunodeficiency virus infection. Am J Med. 1988; 85(Suppl 2A):165-72. [IDIS 247150] [PubMed 2457313]

12. Ostrow D, Grant I, Atkinson H. Assessment and management of the AIDS patient with neuropsychiatric disturbances. J Clin Psychiatry. 1988; 49(Suppl):14-22. [IDIS 242263] [PubMed 3286625]

13. Kim CH, Marquez VE, Broder S et al. Potential anti-AIDS drugs: 2′,3′-dideoxycytidine analogues. J Med Chem. 1987; 30:862-6. [PubMed 3033243]

14. Mitsuya H, Broder S. Strategies for antiviral therapy in AIDS. Nature. 1987; 325:773-8. [PubMed 2434858]

15. Yarchoan R, Broder S. Development of antiretroviral therapy for the acquired immunodeficiency syndrome and related disorders. N Engl J Med. 1987; 316:557-64. [IDIS 225773] [PubMed 3543683]

16. DeVita VT Jr, Broder S, Fauci AS et al. Developmental therapeutics and the acquired immunodeficiency syndrome. Ann Intern Med. 1987; 106:568-81. [IDIS 227982] [PubMed 2435201]

17. Stein DS, Korvick JA, Vermund SH. CD4⁺ lymphocyte cell enumeration for prediction of clinical course of human immunodeficiency virus disease: a review. J Infect Dis. 1992; 165:352-63. [IDIS 291340] [PubMed 1346152]

18. Sachs MK. Antiretroviral chemotherapy of human immunodeficiency virus infections other than with azidothymidine. Arch Intern Med. 1992; 152:485-501. [IDIS 292782] [PubMed 1546911]

19. Groopman JE, Molina JM. Nucleoside therapy for HIV infection: some answers, many questions. N Engl J Med. 1992; 327:639-41. [IDIS 300874] [PubMed 1640958]

20. Corey L, Fleming TR. Treatment of HIV infection: progress in perspective. N Engl J Med. 1992; 326:484-6. [IDIS 291002] [PubMed 1732776]

21. Connolly KJ, Hammer SM. Antiretroviral therapy: strategies beyond single-agent reverse transcriptase inhibition. Antimicrob Agents Chemother. 1992; 36:509-20. [IDIS 292608] [PubMed 1377897]

22. Goldsmith MF. Therapeutic options expand, take new directions. JAMA. 1991; 266:761-3. [PubMed 1650846]

23. Yarchoan R, Pluda JM, Perno CF et al. Anti-retroviral therapy of human immunodeficiency virus infection: current strategies and challenges for the future. Blood. 1991; 78:859-84. [IDIS 287390] [PubMed 1714326]

24. Groopman JE. Treatment of AIDS with combinations of antiretroviral agents: a summary. Am J Med. 1991; 90(Suppl 4A):27-30S.

25. Merigan TC. Treatment of AIDS with combinations of antiretroviral agents. Am J Med. 1991; 90(Suppl 4A):8-17.

26. Spector SA, Ripley D, Hsia K. Human immunodeficiency virus inhibition is prolonged by 3′-azido-3′-deoxythymidine alternating with 2′,3′-dideoxycytidine compared with 3′-azido-3′-deoxythymidine alone. Antimicrob Agents Chemother. 1989; 33:920-3. [PubMed 2548440]

27. Yarchoan R, Mitsuya H, Broder S. Clinical and basic advances in the antiretroviral therapy of human immunodeficiency virus infection. Am J Med. 1989; 87:191-200. [IDIS 261900] [PubMed 2474251]

28. Yarchoan R, Broder S. Anti-retroviral therapy of AIDS and related disorders: general principles and specific development of dideoxynucleosides. Pharmacol Ther. 1989; 40:329-48. [PubMed 2646649]

29. Yarchoan R, Mitsuya H, Myers CE et al. Clinical pharmacology of 3′-azido-2′,3′-dideoxythymidine (zidovudine) and related dideoxynucleosides. N Engl J Med. 1989; 321:726-38. [IDIS 258616] [PubMed 2671731]

30. Larder BA, Chesebro B, Richman DD. Susceptibilities of zidovudine-susceptible and -resistant human immunodeficiency virus isolates to antiviral agents determined by using a quantitative plaque reduction assay. Antimicrob Agents Chemother. 1990; 34:436-41. [PubMed 2334156]

31. Connor E. Antiretroviral treatment for children with human immunodeficiency virus infection. Pediatrics. 1991; 88:389-92. [IDIS 286587] [PubMed 1907364]

32. Krasinski K. Retroviral therapy and clinical trials for HIV- infected children. J Pediatr. 1991; 119(Suppl):S63-8. [IDIS 285417] [PubMed 2061762]

33. Bozzette SA, Richman DD. Salvage therapy for zidovudine-intolerant HIV-infected patients with alternating and intermittent regimens of zidovudine and dideoxycytidine. Am J Med. 1990; 88(Suppl 5B):24-6S.

34. Pizzo PA. Treatment of human immunodeficiency virus-infected infants and young children with dideoxynucleosides. Am J Med. 1990; 88(Suppl 5B):16-9S.

35. Pizzo PA, Butler K, Balis F et al. Dideoxycytidine alone and in an alternating schedule with zidovudine in children with symptomatic human immunodeficiency virus infection. J Pediatr. 1990; 117:799-808. [IDIS 274974] [PubMed 2172501]

36. Frijus-Plessen N, Michaelis HC, Foth H et al. Determination of 3′-azido-3′-deoxythymidine, 2′,3′-dideoxycytidine, 3′-fluoro-3′-deoxythymidine and 2′,3′-dideoxyinosine in biological samples by high-performance liquid chromatography. J Chromatogr. 1990; 534:101-7. [PubMed 1965595]

37. Klecker RW, Collins JM, Yarchoan RC et al. Pharmacokinetics of 2′,3′-dideoxycytidine in patients with AIDS and related disorders. J Clin Pharmacol. 1988; 28:837-42. [IDIS 247164] [PubMed 2852679]

38. Broder S. Pharmacodynamics of 2′,3′-dideoxycytidine: an inhibitor of human immunodeficiency virus. Am J Med. 1990; 88(Suppl 5B):2-7S.

39. Polas PJ, Swenson CL, Sams R et al. In vitro and in vivo evidence that the antiviral activity of 2′,3′- dideoxycytidine is target cell dependent in a feline retrovirus animal model. Antimicrob Agents Chemother. 1990; 34:1414-21. [PubMed 2167039]

40. Bhalla KN, Gongrong L, Grant S et al. The effect in vitro of 2′-deoxycytidine on the metabolism and cytotoxicity of 2′,3′-dideoxycytidine. AIDS. 1990; 4:427-31. [PubMed 2115341]

41. Hayashi S, Fine RL, Chou TC et al. In vitro inhibition of the infectivity and replication of human immunodeficiency virus type 1 by combination of antiretroviral 2′,3′-dideoxynucleosides and virus-binding inhibitors. Antimicrob Agents Chemother. 1990; 34:82-8. [PubMed 1691616]

42. Roilides E, Venzon D, Pizzo PA et al. Effects of antiretroviral dideoxynucleosides on polymorphonuclear leukocyte function. Antimicrob Agents Chemother. 1990; 34:1672-7. [PubMed 2178334]

43. Richman DD. Susceptibility to nucleoside analogues of zidovudine-resistant isolates of human immunodeficiency virus. Am J Med. 1990; 88(Suppl 5B):8-10S.

44. Johnson M, Caiazzo T, Molina JM et al. Inhibition of bone marrow myelopoiesis and erythropoiesis in vitro by anti- retroviral nucleoside derivatives. Br J Haematol. 1988; 70:137-41. [PubMed 2847772]

45. Vogt MW, Durno AG, Chou TC et al. Synergistic interaction of 2′,3′-dideoxycytidine and recombinant interferon-α-A on replication of human immunodeficiency virus type 1. J Infect Dis. 1988; 158:378-85. [PubMed 2841378]

46. Ganser A, Greher J, Vlkers B et al. N Engl J Med. 1988; 318:250-1. Letter.

47. Hao Z, Cooney DA, Hartman NR et al. Factors determining the activity of 2′,3′-dideoxynucleosides in suppressing human immunodeficiency virus in vitro. Mol Pharmacol. 1988; 34:431-5. [PubMed 2459590]

48. Perno CF, Yarchoan R, Cooney DA et al. Inhibition of human immunodeficiency virus (HIV-1/HTLV-IIIBa-L) replication in fresh and cultured human peripheral blood monocytes/macrophages by azidothymidine and related 2′,3′-dideoxynucleosides. J Exp Med. 1988; 168:1111-25. [PubMed 2844951]

49. Szebeni J, Wahl SM, Popovic M et al. Dipyridamole potentiates the inhibition by 3′-azido-3′-deoxythymidine and other dideoxynucleosides of human immunodeficiency virus replication in monocyte-macrophages. Proc Natl Acad Sci USA. 1989; 86:3842-6. [PubMed 2542948]

50. Baba M, Pauwels R, Balzarini J et al. Ribavirin antagonizes inhibitory effects of pyrimidine 2′,3′-dideoxynucleosides but enhances inhibitory effects of purine 2′,3′-dideoxynucleosides on replication of human immunodeficiency virus in vitro. Antimicrob Agents Chemother. 1987; 31:1613-7. [PubMed 3435108]

51. Hamamoto Y, Nakashima H, Matsui T et al. Inhibitory effect of 2′,3′-didehydro-2′,3′-dideoxynucleosides on infectivity, cytopathic effects, and replication of human immunodeficiency virus. Antimicrob Agents Chemother. 1987; 31:907-10. [PubMed 3039911]

52. Starnes MC, Cheng YC. Cellular metabolism of 2′,3′- dideoxycytidine, a compound active against human immunodeficiency virus in vitro. J Biol Chem. 1987; 262:988-91. [PubMed 2433280]

53. Mitsuya H, Jarrett RF, Matsukura M et al. Long-term inhibition of human T-lymphotropic virus type III/lymphadenopathy-associated virus (human immunodeficiency virus) DNA synthesis and RNA expression in T cells protected by 2′,3′-dideoxynucleosides in vitro. Proc Natl Acad Sci USA. 1987;84:2033-7.

54. Richman DD. Dideoxynucleosides are less inhibitory in vitro against human immunodeficiency virus type 2 (HIV-2) than against HIV-1. Antimicrob Agents Chemother. 1987; 31:1879-81. [IDIS 253321] [PubMed 3501941]

55. Eron JJ, Johnson VA, Merrill DP et al. Synergistic inhibition of replication of human immunodeficiency virus type 1, including that of a zidovudine-resistant isolate, by zidovudine and 2′,3′-dideoxycytidine in vitro. Antimicrob Agents Chemother. 1992; 36:1559-62. [IDIS 298971] [PubMed 1324648]

56. Fitzgibbon JE, Howell RM, Haberzettl CA et al. Human immunodeficiency virus type 1 pol gene mutations which cause decreased susceptibility to 2′,3′-dideoxycytidine. Antimicrob Agents Chemother. 1992; 36:153-7. [PubMed 1317143]

57. St. Clair MH, Martin JL, Tudor-Williams G et al. Resistance to ddI and sensitivity to AZT induced by a mutation in HIV-1 reverse transcriptase. Science. 1991; 253:1557-9. [PubMed 1716788]

58. Rooke R, Parniak MA, Tremblay M et al. Biological comparison of wild-type and zidovudine-resistant isolates of human immunodeficiency virus type 1 from the same subjects: susceptibility and resistance to other drugs. Antimicrob Agents Chemother. 1991; 35:988-91. [PubMed 1649576]

59. Yokota T, Mochizuki S, Konno K et al. Inhibitory effects of selected antiviral compounds on human hepatitis B virus DNA synthesis. Antimicrob Agents Chemother. 1991; 35:394-7. [PubMed 2024975]

60. Patel SS, Szebeni J, Wahl LM et al. Differential inhibition of 2′-deoxycytidine salvage as a possible mechanism for potentiation of the anti-human immunodeficiency virus activity of 2′,3′-dideoxycytidine by dipyridamole. Antimicrob Agents Chemother. 1991; 35:1250-3. [PubMed 1656858]

61. Chen CH, Cheng YC. Delayed cytotoxicity and selective loss of mitochondrial DNA in cells treated with the anti-human immunodeficiency virus compound 2′,3′-dideoxycytidine. J Biol Chem. 1989; 264:11934-7. [PubMed 2745424]

62. Jeffries DJ. The antiviral activity of dideoxycytidine. J Antimicrob Chemother. 1989; 23(Suppl A):29-34. [PubMed 2541126]

63. Kassianides C, Hoofnagle JH, Miller RH et al. Inhibition of duck hepatitis B virus replication by 2′,3PR/-dideoxycytidine: a potent inhibitor of reverse transcriptase. Gastroenterology. 1989; 97:1275-80. [PubMed 2477299]

64. Larder BA, Darby G, Richman DD. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science. 1989; 243:1731-4. [IDIS 252715] [PubMed 2467383]

65. Merigan TC, Skowron G, Bozzette SA et al. Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections: a phase I and II study. Ann Intern Med. 1989; 110:189-94. [IDIS 250279] [PubMed 2536257]

66. LeLacheur SF, Simon GL. Exacerbation of dideoxycytidine-induced neuropathy with dideoxyinosine. J Acquir Immune Defic Syndr. 1991; 4:538-9. [PubMed 1849990]

67. Pluda JM, Yarchoan R, Jaffe ES et al. Development of non-Hodgkin lymphoma in a cohort of patients with severe human immunodeficiency virus (HIV) infection on long-term antiretroviral therapy. Ann Intern Med. 1990; 113:276-82. [IDIS 270487] [PubMed 1973886]

68. Powderly WG, Klebert MK, Clifford DB. Ototoxicity associated dideoxycytidine. Lancet. 1990; 335:1106. [IDIS 266077] [PubMed 1970411]

69. Merigan TC, Skowron G. Safety and tolerance of dideoxycytidine as a single agents: results of early-phase studies in patients with acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex. Am J Med. 1990; 88(Suppl 5B):11-5S.

70. Dubinsky RM, Dalakas M, Yarchoan R et al. Follow-up of neuropathy from 2′,3′-dideoxycytidine. Lancet. 1988; 1:832. [IDIS 240697] [PubMed 2895352]

71. Herskowitz A, Willoughby SB, Baughman KL et al. Cardiomyopathy associated with antiretroviral therapy in patients with HIV infection: a report of six cases. A