Description
Indications of Novirax 5
Acyclovir cream is a nucleoside analog DNA polymerase inhibitor for herpes simplex virus (HSV) that is used to treat recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents aged 12 and up.
Pharmacology
Acyclovir is an antiviral medication used to treat the herpes simplex virus. HSV types 1 (HSV-1) and 2 (HSV-2) are inhibited by acyclovir, a synthetic purine nucleoside analogue with cell culture and in vivo inhibitory action (HSV-2). Acyclovir’s inhibitory effect is very specific due to its affinity for the HSV-encoded enzyme thymidine kinase (TK). Acyclovir is converted to acyclovir monophosphate, a nucleotide analogue, by this viral enzyme. Cellular guanylate kinase converts the monophosphate to diphosphate, which is then transformed to triphosphate by a number of cellular enzymes. Acyclovir triphosphate inhibits the replication of herpes virus DNA in cell culture.
Dosage & Administration of Novirax 5
Acyclovir cream should be applied five times per day for four days. 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. For adolescents 12 years of age and older, the dosage is the same as in adults.
Interaction of Novirax 5
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.
Contraindications
Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.
Side Effects of Novirax 5
Dry lips, desquamation, dryness of skin, cracked lips, scorching skin, pruritus, flakiness of skin, and stinging on skin were the most prevalent adverse events at the site of topical application; each adverse reaction happened in fewer than 1% of patients receiving Acyclovir cream and placebo. Due to an adverse event, three patients on Acyclovir cream and one patient on placebo stopped treatment.
Pregnancy & Lactation
Pregnancy Classification B. Acyclovir cream has not been studied in pregnant women in a sufficient and well-controlled manner. Only if the possible benefit outweighs the risk to the fetus should acyclovir cream be used during pregnancy. It’s unclear whether acyclovir used topically is excreted in breast milk. Following topical treatment, systemic exposure is negligible.
Precautions & Warnings
In individuals with herpes labialis, acyclovir cream should only be given to the affected exterior portions of the lips and face. Application to human mucous membranes is not recommended due to a lack of data. Acyclovir cream should only be applied to the skin and should not be used in the eyes, mouth, or nose. Irritation and contact are possible with cream. In immunocompromised patients, the effect of Acyclovir cream has not been demonstrated.
Therapeutic Class
Topical Antiviral preparations
Storage Conditions
Store Acyclovir cream at room temperature between 20°C to 25°C.
Pharmaceutical Name of Novirax 5
Ibn Sina Pharmaceuticals Ltd.
Acyclovir applies to
- Treatment of viral infections caused by herpes simplex virus (types I and II) and varicella-zoster virus (herpes zoster and chickenpox).
- Treatment of herpes simplex virus infections of the skin and mucous membranes, including early and recurrent genital herpes and herpes labialis.
- Prevention of herpes simplex infection in immunodeficiency patients
Pharmacology
Aciclovir is a synthetic purine derivative. Aciclovir exerts antiviral activity against Herpes simplex virus (HSV) and Varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. In cells infected with the herpes virus, the antiviral activity of aciclovir appears to depend mainly on the intracellular conversion of the drug to aciclovir triphosphate. Aciclovir is converted to aciclovir monophosphate primarily via the virus-encoded thymidine kinase; monophosphate is phosphorylated to diphosphate via cellular guanylate kinase, then via another cellular enzyme to triphosphate, which is the pharmacologically active form of the drug. 1530% of an oral dose of the drug is absorbed via the G1 route. Peak plasma concentrations usually occur within 1.52 hours after oral administration. It is widely distributed in body tissues and fluids, including the brain, saliva, lung, liver, muscle, spleen, uterus, mucosal and vaginal fluids, CSF, and vesicular fluid. Aciclovir is excreted by the kidneys by glomerular filtration and tubular secretion
Dosage & Administration of Novirax 5
Treatment of initial herpes simplex: 200 mg 5 times daily usually for 5 days.
For immunocompromised patients:
- Adult: 400 mg 5 times daily for 5 days (longer if new lesions appear during treatment or if healing is incomplete; increase dose to 800 mg 5 times daily for genital herpes in immunocompromised) or as directed by the registered physician.
- Children under 2 years: Half of the adult dose.
- Children over 2 years: Adult dose.
Prevention of recurrence of herpes simplex:
- Adult: 200 mg 4 times daily or 400 mg twice daily possibly reduced to 200 mg 2 or 3 times daily and interrupted every 6-12 months.
- Children under 2 years: Half of the adult dose.
- Children over 2 years: Adult dose.
Prophylactic treatment of herpes simplex in immunocompromised patients:
- Adult: 200 to 400 mg 4 times daily.
- Children under 2 years: Half of the adult dose.
- Children over 2 years: Adult dose.
Treatment of vericella (chicken pox):
- Adult and children over 40 kg: 800 mg 4 times daily for 5 days.
- Children below 40 kg: 20 mg/kg (maximum 800 mg) per dose orally 4 times daily (80 mg/kg/day) for 5 days.
- Children 1 month-2 years: 200 mg 4 times daily for 5 days.
- Children 2-5 years:400 mg 4 times daily for 5 days.
- Children 6-12 years:800 mg 4 times daily for 5 days.
Treatment of herpes zoster (Shingles): 800 mg 5 times daily for 7 days.
Treatment of initial rectal (Proctitis) herpes infections: An oral Aciclovir dosage of 400 mg 5 times daily for 10 days or until clinical resolution occurs has been recommended.
Renal Impairment: For patients with severe renal impairment, a reduction of the doses is recommended.
Interactions
Probenecid reduces Aciclovir excretion and so increases plasma concentration and risk of toxicity.
Contraindications
Aciclovir is contraindicated in patients known to be hypersensitive to Aciclovir.
Side-Effects of Novirax 5
Rash, digestive disorders, increased bilirubin and liver enzymes, increased blood urea and creatinine, decreased hematological indicators, headache, neurological reactions, fatigue.
Pregnancy
Pregnancy category B. Acyclovir should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Caution should be taken when administering to breastfeeding mothers.
Precautions
This drug should be given with caution in patients with renal impairment and should be dose-adjusted according to creatinine clearance. For newborns, monitor the number of neutrophils at least twice a week.
Therapeutic Class
Herpes simplex & Varicella-zoster virus infections
Storage Conditions
Should be stored below 25°C. It should be protected from light and moisture. Keep out of the reach of children.
Pharmaceutical Name
Drug International Ltd
