Novirax HC 5%+1%

INDICATIONS

This combination cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).

PHARMACOLOGY

Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against Herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) in cell culture and in vivo. The inhibitory activity of Acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV. 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 cell culture, Acyclovir Triphosphate stops replication of herpes viral DNA. This inhibition is accomplished in 3 ways:

Competitive inhibition of viral DNA polymerase
Incorporation into and termination of the growing viral DNA chain
Inactivation of the viral DNA polymerase

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is used topically for its anti-inflammatory effects which suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.

DOSAGE & ADMINISTRATION

The cream should be topically applied 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms.

SIDE EFFECTS

The following most common adverse reactions (<1%) were local skin reactions like drying or flaking of the skin; burning or tingling, erythema; pigmentation changes, application site reactions including signs and symptoms of inflammation.

PREGNANCY & LACTATION

Pregnancy Category B. There are no adequate and well-controlled studies of systemic Acyclovir in pregnant women. No studies have been performed in pregnant women. Systemic exposure of Acyclovir and Hydrocortisone following topical administration of this cream is minimal. It is not known whether topically applied Acyclovir or Hydrocortisone is excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.

PRECAUTIONS & WARNINGS

Acyclovir and Hydrocortisone should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should seek medical advice when a cold sore fails to heal within 2 weeks.

USE IN SPECIAL POPULATIONS

Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.

THERAPEUTIC CLASS

Hydrocortisone & Combined preparations

STORAGE CONDITIONS

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.