(and dosage form):
Each 1 g of the cream contains:
|| 50 mg |
|As preservatives:|| |
|| 0,15% m/m|
|| 0,08 % m/m|
A.20.2.8 Antiviral agents
Aciclovir is an antiviral agent with activity in-vitro against Herpes simplex virus types 1 and 2, (HSV-1 and HSV-2). Aciclovir is phosphorylated after entry into herpes infected cells to the active compound aciclovir triphosphate. The first step in this process is dependent on the presence of the HSV coded thymidine kinase. Thymidine kinase converts aciclovir into aciclovir monophosphate. The monophosphate is further converted to diphosphate by cellular guanylate kinase and to triphosphate which is the active form of the medicine. Aciclovir triphosphate interferes with HSV DNA polymerase and inhibits viral DNA replication.
The absorption of aciclovir cream through the intact skin is minimal; aciclovir is not detected in blood or urine.
Lovire Cream is indicated for the treatment of Herpes simplex virus infections of the lips in initial and recurrent situations.
Aciclovir is contra-indicated in patients known to be hypersensitive to aciclovir or to the ingredients of Lovire Cream.
DOSAGE AND DIRECTIONS FOR USE:
Lovire Cream should be applied five times daily at approximately four hourly intervals. It is important that the therapy be initiated as early as possible following the onset of infection. Ideally it should begin during the prodromal period or when lesions first appear. A sufficient quantity of cream should be used to cover all lesions adequately. The patients should be advised to wash their hands before and after applying the cream, and avoid unnecessary rubbing of the lesions or touching them with a towel. Alternatively, a finger cot or rubber glove should be used to prevent aggravating or transferring the infection. Lovire Cream should not be used for treatment of ocular herpes infections.
Treatment should be continued for 5-10 days.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Transient burning or stinging, mild drying or flaking of the skin may follow application of aciclovir cream in some patients. Erythema and itching have been seen to occur in a small number of patients.
Less frequently, cases of contact dermatitis have been reported.
The use of aciclovir cream should be limited to skin lesions. It is not recommended for application to mucous membranes such as in the mouth, eye or vagina as it may be irritant.
Severely immunocompromised patients (e.g.. AIDS patients) should be considered for oral aciclovir dosing.
It is important that such patients consult a physician concerning the treatment of any infection.
Safety in pregnancy and lactation has not been established.
Although probenecid increases the mean half-life and area under the plasma concentration curve of systemically administered aciclovir, this is unlikely to be relevant following the topical application of aciclovir.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage by topical application of Aciclovir Cream is unlikely because of limited transcutaneous absorption. In the event of accidental ingestion, treatment should be symptomatic and supportive.
White to off-white, opaque, smooth cream having a characteristic odour without any grittiness packed in 2 g/10 g lacquered aluminium collapsible tubes with membrane and polypropylene cap with spike.
2 g and 10 g printed white aluminium collapsible tubes fitted with a white poly propylene screw cap with a spike.
Store below 25°C. Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
RANBAXY (SA) (PTY) LTD
1006 Lenchen Avenue North
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New to this site: March 2003
Source: Pharmaceutical Industry
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