Novirax 5% Cream 5gm

Uses of Acyclovir

• Genital Herpes
• Herpes labialis

How does Acyclovir work?

Acyclovir works by inhibiting the multiplication of the virus and thereby reducing the severity of the infection.

Side Effects of Acyclovir

Common adverse reactions at the application site include dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging. These occurred in less than 1% of patients. Discontinuation due to adverse events occurred in three patients on Novirax cream and one patient on placebo.

Quick Suggestions:

• Acyclovir helps in the treatment of herpes, chickenpox, and shingles.
• Do not skip any doses and finish the full course of treatment even if you feel better.
• Drink plenty of water while on treatment with this medicine. This helps to prevent dehydration and kidney damage.
• If you have genital herpes, use barrier methods (condoms) for contraception and avoid sexual contact while the sores are present.
• Inform your doctor if you are pregnant or planning to conceive or breastfeeding.

Indication of Acyclovir

Novirax cream is a topical antiviral medication designed to treat recurrent herpes labialis. With a well-established pharmacological profile, it provides targeted relief by inhibiting viral DNA replication. Suitable for use in both adults and adolescents over 12 years of age, it should be applied five times daily for optimal results. The product is safe with minimal side effects and no significant drug interactions.

Pharmacology

Acyclovir, the active ingredient in Novirax cream, is an antiviral drug effective against herpes simplex virus (HSV). It is a synthetic purine nucleoside analog with inhibitory activity against HSV types 1 (HSV-1) and 2 (HSV-2). Acyclovir's action is highly selective due to its affinity for the HSV-encoded enzyme thymidine kinase (TK), which converts acyclovir into acyclovir monophosphate, then to diphosphate by cellular guanylate kinase, and finally to triphosphate by various cellular enzymes. Acyclovir triphosphate inhibits herpes viral DNA replication through:

1. Competitive inhibition of viral DNA polymerase.
2. Incorporation into and termination of the growing viral DNA chain.
3. Inactivation of the viral DNA polymerase.

Dosage & Administration of Acyclovir

• Adults and Adolescents (12 years and older): Apply acyclovir cream five times daily for four days.
• Initiation of Therapy: Begin as early as possible following the onset of herpes labialis signs or symptoms (during the prodrome or when lesions appear).
• Pediatric Use: Safety and effectiveness in patients under 12 years have not been established. In patients aged 12-17, the safety profile was similar to adults.
• Geriatric Use: Insufficient data to determine differences in response compared to younger subjects. Minimal systemic absorption suggests no significant differences.

Drug Interactions for Acyclovir

1. Drug-Drug Interaction:

• Probenecid: Used to treat gout, can increase blood levels of  Acyclovir.
• Cimetidine: Used to treat stomach ulcers, may increase  Acyclovir blood levels.
• Mycophenolate Mofetil: Used to prevent organ rejection, can affect  Acyclovir blood levels.
• Aminophylline and Theophylline: Used to treat asthma, may interact with  Acyclovir and affect its effectiveness or increase side effects.

2. Drug-Food Interaction:

• Non-Prescription Medications, Vitamins, Nutritional Supplements, and Herbal Products:  Acyclovir may interact with various over-the-counter medications, vitamins, supplements, and herbal products you are taking or plan to take, potentially affecting its effectiveness or increasing side effects. Always consult with your doctor before combining  Acyclovir with other substances.

3. Drug-Disease Interaction:

• Renal Dysfunction or Disease:  Acyclovir can affect kidney function, so inform your doctor if you have any kidney-related issues.
• Hemodialysis: Patients undergoing hemodialysis may require dose adjustments as the procedure can alter  Acyclovir levels.
• Organ Transplant: Inform your doctor if you have had an organ transplant as it may affect  Acyclovir use and dosage.
• Immunodeficiency: Individuals with weakened immune systems need to be cautious as  Acyclovir may have specific considerations in such conditions.
• Bone Marrow Transplantation: This condition may affect  Acyclovir's use and effectiveness.
• Neutropenia: Lower-than-normal levels of neutrophils can influence the use of  Acyclovir and require careful monitoring and possible dose adjustments.

Contraindications

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

Pregnancy & Lactation

• Pregnancy: Category B. Use only if the potential benefit justifies the potential risk to the fetus.
• Lactation: It is unknown if topically applied acyclovir is excreted in breast milk. Systemic exposure from topical administration is minimal.

Precautions & Warnings

• Apply only to the affected external aspects of the lips and face.
• Avoid application to human mucous membranes.
• For cutaneous use only; avoid use in the eye or inside the mouth or nose.
• Potential for irritation and contact sensitivity.
• Effectiveness in immunocompromised patients has not been established.

Storage Conditions:

Store Novirax cream at room temperature between 20°C to 25°C.