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

Logo ACITOP cream.

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form)

ACITOP cream.

COMPOSITION
Each gram of cream contains 50 mg of Acyclovir. (5.0% w/w Acyclovir)

Preservative: Chlorocresol 0.12% m/m.

PHARMACOLOGICAL CLASSIFICATION
A 20.2.8. Antiviral agent.

PHARMACOLOGICAL ACTION
Acyclovir is an acyclic guanine nucleoside analogue that lacks the 3'-hydroxyl on the side chain.
It is active against herpes simplex virus type 1 and 2.
Acyclovir is phosphorylated intracellularly by viral thymidine kinase to the active triphosphate that inhibits viral DNA synthesis and replication by inhibiting the viral DNA polymerase enzymes. The active triphosphate is also incorporated into the herpes virus DNA. Normal cellular processes are not affected.

INDICATIONS
ACITOP is indicated for the symptomatic treatment of herpes simplex infections of the lips. Both the initial and recurrent infections can be successfully treated.

CONTRA-INDICATIONS
Hypersensitivity to acyclovir, propylglycol and chlorocresol.

DOSAGE AND DIRECTIONS FOR USE
Adults and children:
Apply 5-6 times daily at four-hourly intervals.
Therapy should be initiated as soon as possible following the onset of signs and symptoms of herpes simplex infection. This is particularly important in the treatment of recurrent episodes.
Treatment should be continued for 5 days. If healing has not occurred, the treatment may be prolonged for up to 10 days.
Cover all lesions adequately.
Do not exceed the recommended dose.
Use a finger cot or a rubber glove to prevent auto inoculation.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Transient stinging, burning or erythema may occur.
Mild drying and flaking of the skin may occur with the application of ACITOP.
Avoid contact with the eyes.
Acyclovir is intended for cutaneous use only.
Safety in pregnancy has not been established.
Resistance has been reported with varicella zoster virus.
Not recommended for application to mucous membranes.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See ‘Side effects’and ‘Special precautions’.
Treatment is symptomatic and supportive if accidental ingestion has occurred. Acyclovir is dialysable.

IDENTIFICATION
A white to off- white smooth cream.

PRESENTATION
Packed in pure aluminium collapsible tubes, containing 2g, 5g or 10g of cream.

STORAGE INSTRUCTIONS
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
32/20.2.8/0719

NAME AND BUSINESS ADDRESS OF APPLICANT
Cipla Life Sciences (Pty) Ltd
Rosen Heights, Pasita Street, Rosen Park,
Bellville, 7530, R.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT.
June 2003.

8843 C

© CIPLA LIFE SCIENCES 2003

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2013/10/otc_acitop.pdf

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