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

Logo ADCO-ACYCLOVIR TOPICAL CREAM

SCHEDULING STATUS:
S4        and
S2        when intended for topical application to lips

PROPRIETARY NAME
(and dosage form):

ADCO-ACYCLOVIR TOPICAL CREAM
Cream

COMPOSITION:
Each 1 g contains
aciclovir 0,05 g.
Preservative: Benzyl alcohol 0,75% m/m.

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:
S4
Aciclovir is effective in the treatment of viral infections due to herpes simplex type 1 and type 2 of the skin and genitalia in the initial and recurrent situation.
S2
Application to the lips in the early treatment of recurrent Herpes simplex virus infections.

CONTRA-INDICATIONS:
Aciclovir is contra-indicated in patients known to be allergic to aciclovir and propylene glycol.
Safety of ADCO-ACYCLOVIR TOPICAL CREAM in pregnancy and lactation has not been established.

WARNINGS:
Topical applications of aciclovir may sometimes produce burning or erythema.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children:
The topical cream may be applied five or six times daily every three or four hours for periods of five to ten days. Topical treatment of lesions caused by herpes simplex should be initiated as early as possible. It is particularly important to start treatment of recurrent episodes during the prodromal period or when the lesions first appear.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Aciclovir may sometimes cause transient burning or stinging. Erythema or mild drying and flaking of the skin have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Should aciclovir need to be removed, then haemodialysis would be effective. Further treatment is symptomatic and supportive.

IDENTIFICATION:
Smooth, white soft cream.

PRESENTATION:
Collapsible tubes of 2 g and 10 g.

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

REGISTRATION NUMBER:
28/20.2.8/0369

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext. 77
Private Bag X69

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8/10/97

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

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