Klozivex

Acyclovir (Klozivex) 50 mg/g Cream is a white to off-white colored homogenous cream.
Each gram contains: Acyclovir USP 50 mg.

Antiviral.
Pharmacology: Pharmacodynamics: Mechanism of Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: competitive inhibition of viral DNA polymerase; incorporation into and termination of the growing viral DNA chain; and inactivation of the viral DNA polymerase.
The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK.

Indicated for the treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.

Acyclovir (Klozivex) 50 mg/g (5% w/w) Cream should be applied five (5) times daily approximately four (4) hourly intervals omitting the night time application. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis, i.e. during the prodrome or when lesions appear. The treatment should be continued for at least 4 days for herpes labialis and 5 days for genital herpes. If healing has not occurred treatment may be continued for up to 10 days.

Overdosage by topical application of acyclovir cream is unlikely because of minimal systemic exposure.

Acyclovir Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.

Acyclovir (Klozivex) is not recommended for application to mucous membranes, such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye.
In severely immune-compromised patients (eg. AIDS patients or bone marrow transplant recipients) oral acyclovir dosing should be considered. Such patients should encouraged to consult a physician concerning the treatment of any infection.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Pregnancy: Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the acyclovir cream. Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies with systemic exposure of acyclovir have been conducted. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
Lactation: Acyclovir is minimally absorbed systemically following topical route of administration, and breastfeeding is not expected to result in exposure of the child to acyclovir cream. There are no data on the effects of acyclovir cream on the breastfed infant or on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for acyclovir cream and any potential adverse effects on the breastfed child from acyclovir cream or from the underlying maternal condition.

The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving acyclovir cream and placebo. Immediate hypersensitivity reactions including angioedema is identified as very rare adverse reaction.

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir cream. Due to minimal systemic absorption of acyclovir cream, systemic drug interactions are unlikely.

Store at temperatures not exceeding 30°C.

Topical Antivirals

D06BB03 - aciclovir ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.

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