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Zoral 200/400


COMPOSITION

Acyclovir USP 200 mg/400 mg per tablet

PRODUCT DESCRIPTION

200 mg: Light blue, hexagonal and convex tablet, 10mm diameter with score-line and "DHA" logo.
400 mg: Light pink, round and convex tablet, 12mm diameter with cross score-line and without logo.

 

PHARMACOLOGY

Acyclovir is active against herpes simplex virus types 1 and 2 (HSV-1 & 2) and against varicella zoster virus. This activity is due to intracellular conversion of acyclovir by viral thymidine kinase to monophosphate with subsequent conversion to diphosphate and to the active tiphosphate. This active trlphosphate is a potent inhibitor of HSV-1 & 2 DNA polymerase enzyme and
a DNA chain terminator. This process is highly selective for infected cells.

PHARMACOKINETICS

Acyclovir is only partially absorbed from the gut. Mean steady state peak plasma concentrations following doses of 200mg administered 4 hourly were 3.1Ámol and equivalent trough plasma levels were 1.8Ámol. Corresponding levels following doses of 400 and 800mg administered 4-hourly were 5.3Ámol and 8Ámol, respectively, and equivalent levels were 2.7Ámol and 4Ámol.

Plasma Acyclovir levels dropped approximately 60% during dialysis.

INDICATIONS

Herpes simplex infections of the skin and mucous membranes. Treatment of herpes zoster (shingles) and varicella (chicken-pox) infections.


DOSAGE
Adults: Herpes simplex: Treatment: 200 mg, 5 times daily for 5 days. Treatment may be extended in severe cases. Prophylaxis: 200 mg, 4 times daily. Herpes zoster and varicella: Treatment: 800 mg, 5 times daily for 7 days. Doses to be taken with or without food.

 

Immune-compromised patients: Suppression of herpes simplex: 200 mg 4 times daily at approximately 6-hourly intervals or 400 mg twice daily at approximately 12-hourly, intervals. Dosage may be titrated down to 200 mg twice or 3 times daily. Therapy should
be interrupted periodically at intervals of 6-12 months in order to observe possible changes in natural history of the disease.

 

Prophylaxis of herpes simplex infections: 200 mg 4 times daily at approximately 6-hourly intervals. Dosage may be doubled in severely immune-compromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut.

 

Treatment of varicella and herpes zoster infections: 800 mg 5 times daily at approximately 4-hourly intervals, omitting the night-time dose. Treatment should continue for 7 days.

Children: For treatment of herpes simplex infections and for prophylaxis of herpes simplex infections in the immune compromised, children above 2 years should be given adult dosages and children below 2 years should be given half of the adult dose.

 

For treatment of varicella infections: Children above 6 years: 800 mg 4 times daily; 2-6 years: 400 mg 4 times daily; Below 2 years: 200 mg 4 times daily; Dosing may be calculated as 20 mg Zoral/kg body weight (not to exceed 800 mg) 4 times daily. Treatment should continue for 5 days.

Elderly: Adequate hydration of elderly patients taking high oral doses of Zoral should be maintained.

 

Renal Impairment
For patients with renal impairment the following dosing regimen should be followed:

Creatinine clearance (mL/min)

Dosage

Less than 10

200 mg twice daily at approximately 12-hourly intervals for herpes simplex infections.

800 mg twice daily at approximately 12-hourly intervals for varicella and herpes zoster infections.

10-25

800 mg 3 or 4 times daily at approximately 6-8 hours

intervals for varicella and herpes zoster infections.


ADVERSE EFFECTS

Occasional adverse effects include increased values for liver enzymes, haematological and encephalopathic change. There have been reports of skin rashes and gastro-intestinal effects with acyclovir given by month, but it is usually well tolerated.

PRECAUTIONS

Acyclovir should be administered with caution to patients with renal impairment and doses should be adjusted according to creatinine clearance.


USE IN PREGNANCY

Should be used only if potential benefits outweigh the risks.

INCOMPATIBILITIES

Not known.

CONTRA-INDICATIONS

Contraindicated in patients known to be hypersensitive to Acyclovir.

DRUG INTERACTION

Increased mean half-line and plasma concentration with probanecid. Other drugs affecting renal physiology could influence the pharmacokinetics of Acyclovir.

PACKING

Blister pack (strip of 10's). 200 mg: 10 x 10's and 10 x 10 x 10's, 400 mg: 7 x 10's and 10 x 10 x 10's.

 

STORAGE

Keep in a cool, dry place. Below 25░C.

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