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Logo ADCO-ACYCLOVIR 200 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ADCO-ACYCLOVIR 200 mg
Tablets

COMPOSITION:
Each ADCO-ACYCLOVIR 200 mg Tablet contains 200 mg
aciclovir.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 Antiviral Agents

PHARMACOLOGICAL ACTION:
Aciclovir has antiviral activity that is essentially confined to the herpes viruses. It is particularly active in vitro against Herpes simplex type 1 and Herpes simplex type 2. Aciclovir inhibits viral replication by inhibiting DNA synthesis. This inhibition is due to intracellular conversion of aciclovir by viral thymidine kinase to the monophosphate with subsequent conversion to the diphosphate and the active triphosphate. This active form inhibits the herpes virus DNA polymerase enzyme as well as being incorporated into viral DNA.

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

CONTRA-INDICATIONS:
Aciclovir is contra-indicated in patients known to be hypersensitive to aciclovir and propylene glycol.
Safety in pregnancy and lactation has not been established. Aciclovir does pass into the breast milk.

DOSAGE AND DIRECTIONS FOR USE:
(A) Dosage in Adults:
  For treatment of initial and recurrent Herpes simplex infections of the skin and mucous membranes:
  200 mg Aciclovir should be taken five times per day at approximately four hourly intervals, omitting the night time dose. Treatment should continue for five days, but in 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 immuno- competent adults:
  A dose of 200 mg aciclovir 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 aciclovir taken twice daily at approximately twelve-hourly intervals. Dosage titration down to 200 mg oral aciclovir 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 aciclovir.
  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 Aciclovir 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 aciclovir should be taken daily for five days.
  For treatment of Varicella zoster and Herpes zoster infections in adults:
  A dose of 800 mg oral aciclovir should be taken five times daily at approximately four-hourly intervals, omitting the night-time dose. Treatment should continue for seven 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.
(B) Dosage in the Elderly:-
  In the elderly, total aciclovir body clearance declines, thus adequate hydration should be maintained. Special attention should be given to dosage reduction in elderly patients with impaired renal function.
(C) Dosage in Renal Impairment:-
  Dosage should be reduced in renal failure. The following is recommended:-

Normal Dose Regimen Creatinine Clearance
(ml/min/1,73 m²)
Adjusted Dosage Regimen
    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 dose after each dialysis.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
There have been reports of gastro-intestinal effects, including nausea, vomiting, diarrhoea and abdominal pains. Headache and skin rashes have been reported. Other events reported include transient rises in bilirubin and liver related enzymes, increases in blood urea and creatinine, small decreases in haematological indices, headaches, reversible neurological reactions and fatigue.
The reversible neurological reactions, notably dizziness, confusional states, hallucinations and somnolence have usually been reported in patients with renal impairment or other predisposing factors.
Interactions:-
Probenecid is reported to block the renal clearance of aciclovir.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-effects and Special Precautions. Ingestion of doses of aciclovir in excess of 5 g warrants close observation of the patient. Aciclovir is dialysable. Treatment is symptomatic and supportive.

IDENTIFICATION:
White hexagonal shaped tablets, scored on one side.

PRESENTATION:
Securitainer packs of 25 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
28/20.2.8/0552

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Private Bag X69
Bryanston
2021.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 September 1996

New addition to this site: April 2004
Source: Pharmaceutical Industry

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