Acivirax 400 mg 30 tabs

Acivirax Acyclovir 400 mg 30 Tablets

Composition:

Each tablet contains 400mg Acyclovir

Indications:

1)Treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding severe HSV infections in immunocompromised children).

2) Suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.

3) Prophylaxis of herpes simplex infections in immunocompromised patients.

4) Treatment of varicella (chickenpox) infection.

Dosage and method of administration:

Adults: Treatment of herpes simplex infections: 200mg acyclovir should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for five days, but in severe initial infections this may have to be extended.

Dosage titration down to 200mg acyclovir taken three times daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective.

Dosage in the pediatric population: 

Treatment of herpes simplex infections, and prophylaxis of herpes simplex infections in the immunocompromised: children aged two years and over should be given the adult doses and children below the age of two years should be given half the adult dose. 

Treatment of varicella infection: 

children under 2 years should be given 200mg four times daily. Children aged 2-5 years should be given 400mg four times daily. Children aged 6 years and over should be given

800mg four times daily. Treatment should continue for 5 days. Dosing may be more accurately calculated as 20mg/kg body weight (not to exceed 800mg four times daily). 

Dosage in the elderly: 

The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly.

However, for patients with severe renal impairment (creatinine clearance less than 10ml/minute) an adjustment of dosage to 200mg acyclovir twice daily at approximately twelve-hourly intervals is recommended.

In the treatment of herpes zoster infections it is recommended to adjust the dosage to 800 mg acyclovir twice daily at approximately twelve - hourly intervals for patients with severe renal impairment and to 800 mg acyclovir three times daily at intervals of approximately eight hours for patients with moderate renal impairment.

Method of administration

Patients who experience difficulty in swallowing the tablets may disperse them in a minimum of 50ml water which should be stirred before drinking.

Contraindications:

Hypersensitivity to the active substance, valacyclovir or to any of the excipients

Precautions for use:

-Use in patients with renal impairment and in elderly patients:

The risk of renal impairment is increased by use with other nephrotoxic drugs.

Acyclovir is eliminated by renal clearance, therefore the dose must be reduced in patients with renal impairment. 

-Elderly patients are likely to have reduced renal function and therefore the need for dose reduction must be considered in this group of patients. 

-Prolonged or repeated courses of acyclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued acyclovir treatment.

-Acivirax 400 mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pregnancy:

Experience in humans is limited so the use of acyclovir should be considered only when the potential benefits outweigh the possibility of unknown risks.

Breast-feeding

Following oral administration of 200mg acyclovir five times a day, acyclovir has been detected in breast milk at concentrations ranging from 0.6-4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to acyclovir doses of up to 0.3mg/kg/day. Caution is therefore advised if acyclovir is to be administered to a nursing mother.

Side Effects:

-Blood and the lymphatic system disorders: Very rare: Anaemia, leucopenia and thrombocytopenia.

Immune system disorders: Rare: Anaphylaxis.

-Nervous system disorders: Common: Dizziness and headache. Very rare: Reversible neurological reactions including agitation, tremor, ataxia, dysarthria, psychotic symptoms, encephalopathy, drowsiness, confusional states, hallucinations, somnolence, convulsions, coma and malaise. 

-Respiratory, thoracic and mediastinal disorders: Rare: Dyspnoea

-Gastrointestinal disorders: Common: Nausea, vomiting, diarrhea and abdominal pain.

-Hepato-biliary disorders: Rare: Reversible rises in bilirubin and liver related enzymes. Very rare: Hepatitis and jaundice.

-Skin and subcutaneous tissue disorders: Common: Skin rashes, pruritus (including photosensitivity). Uncommon: Urticaria, accelerated diffuse hair loss.

-Renal and urinary disorders: Rare: Increases in blood urea and creatinine.

-General disorders: Common: Fatigue, fever.

Storage Method:

Store at a temperature not exceeding 30 C.

Package:

A carton box contains 3 blisters with 10 tablets in each and an insert leaflet.