INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CYCLIVEX 200 mg TABLETS
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CYCLIVEX 200 mg TABLETS

COMPOSITION:
Each tablet contains: Acyclovir 200 mg as active ingredient

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 - Antiviral agents

PHARMACOLOGICAL ACTION:
Acyclovir is active in vitro against Herpes simplex virus (HSV) types I and II and varicella-zoster virus.
This activity is due to intracellular conversion of acyclovir to acyclovir triphosphate by viral thymidine kinase. Acyclovir triphosphate inhibits viral DNA synthesis and replication.

INDICATIONS:
- Treatment of initial and recurrent Herpes simplex infections of the skin and mucous membranes including initial and recurrent genital Herpes simplex infections.
- Suppression of recurrent genital Herpes simplex infections in immunocompetent patients.
- Prophylaxis of Herpes simplex infections in immuno-compromised patients.
- Treatment of Herpes zoster infections if the lesions are not older than 72 hours.
- Treatment of Varicella zoster (chickenpox) within 24 hours after appearance of the typical chickenpox rash.

CONTRA-INDICATIONS:
Acyclovir tablets are contra-indicated in patients known to be hypersensitive to acyclovir. The safety of acyclovir in pregnancy has not been established. Acyclovir should not be administered to pregnant women or nursing women as acyclovir passes into breast milk.

DOSAGE AND DIRECTIONS FOR USE:
DOSAGE IN ADULTS
For treatment of initial and recurrent Herpes simplex infections of the skin and mucous membranes:
200 mg acyclovir should be taken 5 times per day at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in a case of severe initial infection the treatment period may have to be extended.
In severely immunocompromised patients e.g. after marrow transplant or in patients with impaired absorption from the gut the dose can be doubled to 400 mg or, alternatively, intravenous dosing could be considered.
The first dose should be administered as early as possible after the start of an infection and for recurrent episodes this should preferably be during the prodromal period or when lesions first appear.
For suppression of recurrent genital Herpes simplex infections in immunocompetent adults:
A dose of 200 mg of acyclovir should be taken four times daily at approximately six-hourly intervals.
Many patients may be conveniently managed on a regimen of 400 mg of oral acyclovir taken twice daily at approximately twelve-hourly intervals. Dosage titration down to 200 mg oral acyclovir taken at approximately eight-hourly intervals, or even twice daily at approximately twelve-hourly intervals may prove effective. Some patients may experience break-through infections on total doses of 800 mg acyclovir.
Therapy should be interrupted periodically at intervals of six to twelve months, in order to observe possible changes in the natural history of the disease.
For prophylaxis of Herpes simplex infections in immunocompromised adults:
200 mg Acyclovir should be taken four times daily at approximately six hourly intervals. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg, or alternatively intravenous dosing could be considered. The duration of prophylactic administration is determined by the duration of the period at risk.
For treatment of Varicella zoster infections in adolescents (12 to 18 years):
A dose of 800 mg oral acyclovir should be taken four times daily for five days.
For treatment of Varicella zoster and Herpes zoster infections in adults:
A dose of 800 mg oral acyclovir should be taken five times daily at approximately four-hourly intervals, omitting the night-time dose. Treatment should continue for 7 days.
In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. Dosing should begin as early as possible after the start of an infection: treatment yields better results if initiated as soon as possible after rash onset.

DOSAGE IN THE ELDERLY:
In the elderly total acyclovir body clearance declines, thus adequate hydration should be maintained. Special attention should be given to dosage reduction in elderly patients with impaired renal function.

DOSAGE IN RENAL IMPAIRMENT:
Dosage should be reduced in renal failure. The following is recommended:

Normal dose regimen Creatinine Clearance         Adjusted Dosage Regimen
                        (mL/min/1,73 m²) Dose (mg) Dosing interval
200 mg every four hours for herpes simplex infections         0 - 10         200 every 12 hours,
800 mg every four hours for varicella zoster infections         >25         800 every 4 hours
5 times daily
          10 - 25         800 every 8 hours
          0 - 10         800 every 12 hours
Patients on haemodialysis should receive their usual appropriate daily dosage after each dialysis.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
There have been reports of skin rashes, headaches and gastro-intestinal effects such as nausea, vomiting and diarrhoea.
Patients with a suppressed immune response may be particularly prone to acyclovir-resistant mucocutaneous herpes simplex infections. Use with caution in patients with renal impairment.
The risk of renal impairment is increased by the concomitant use of nephrotoxic medicine.
Resistance has also been reported with varicella-zoster virus.
Probenecid blocks the renal clearance of acyclovir.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Round, blue, flat bevelled edged tablet, scored on one side.

PRESENTATION:
Securitainers of 25 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in airtight containers.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.2.8/0715

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION:
3 June 1994

        D714
        A&S PRINTERS

Updated on this site: April 2005
Source: Hospital Pharmacy

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005