Acyclovir
Visa No.: 400110330425
Product: Acyclovir STADA 200 mg tablet
API: Acyclovir
Product Category: Antiviral
Version approved leaflet: 359/QĐ-QLD_17/07/2025_125.2
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Visa No.: 400110308325
Product: Acyclovir STADA 400 mg tablet
API: Acyclovir
Product Category: Antiviral
Version approved leaflet: 299/QĐ-QLD_16/06/2025_125.1
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Visa No.: 400110308425
Product: Acyclovir STADA 800 mg tablet
API: Acyclovir
Product Category: Antiviral
Version approved leaflet: 299/QĐ-QLD_16/06/2025_125.1
INDICATIONS
Acyclovir STADA 200 mg tablets and Acyclovir STADA 400 mg tablets
Treatment of herpes simplex (HSV) of the skin and mucous membranes, including primary and recurrent genital herpes, excluding neonatal HSV infections and severe HSV infections in immunocompromised children.
Prevention of recurrent herpes simplex virus infections in patients with a normal immune response.
Prophylaxis of herpes simplex virus infections in immunocompromised patients.
Treatment of varicella (chickenpox) and herpes zoster (shingles).
Acyclovir STADA 800 mg tablet
Treatment of varicella (chickenpox) and herpes zoster (shingles), excluding neonatal HSV infections and severe HSV infections in immunocompromised children.
Acyclovir STADA 800 mg tablets are recommended for use in children aged over 6 years.
DOSAGE AND ADMINISTRATION
Dosage for Acyclovir STADA 200 mg tablet & Acyclovir STADA 400 mg tablet
Adult
Treatment of herpes simplex infections: 200 mg five times daily at approximately 4-hour intervals, omitting the night-time dose, for 5 days. Treatment may be extended in severe initial infections.
In patients with severely impaired immunity or impaired gastrointestinal absorption, the dose may be increased to 400 mg five times daily. Treatment should be initiated as early as possible.
For recurrent episodes, treatment should begin during the prodromal phase or at the first appearance of lesions
Suppression of recurrent herpes simplex infections (immunocompetent patients): 200 mg four times daily at approximately 6-hour intervals. Alternatively, 400 mg twice daily may be used.
Many patients may be adequately controlled with the more convenient regimen of 400 mg acyclovir twice daily at approximately 12-hour intervals.
Dose reduction to 200 mg acyclovir three times daily at approximately 8-hour intervals, or even 200 mg twice daily at approximately 12-hour intervals, has also been shown to be effective.
Some patients may experience breakthrough infections at a total daily dose of 800 mg acyclovir.
Regular interruption of suppressive therapy is recommended at intervals of six to twelve months in order to observe any possible changes in the natural history of the disease.
Prophylaxis of herpes simplex virus infection in immunocompromised patients: The recommended dose is 200 mg acyclovir four times daily at approximately 6-hour intervals.
In patients with severe immunodeficiency (such as following bone marrow transplantation) or in patients with impaired intestinal absorption, the dose may be doubled to 400 mg acyclovir, or intravenous administration may be considered.
The duration of prophylactic treatment should be determined by the period of risk.
Treatment of Chickenpox and herpes zoster infection: The recommended dose is 800 mg acyclovir five times daily at approximately 4-hour intervals, omitting the night-time dose. Treatment should be continued for 7 days.
In patients with severe immunodeficiency (such as following bone marrow transplantation) or in patients with impaired intestinal absorption, intravenous administration should be considered.
Treatment should be initiated as early as possible after onset of symptoms.
Treatment of herpes zoster is more effective when started as early as possible after rash onset.
Treatment of varicella in immunocompetent patients should be initiated within 24 hours after rash onset.
Pediatric Population
Treatment of Herpes Simplex Virus Infection and Prophylaxis in Immunocompromised Patients: Children aged 2 years and older should receive the adult dose.
Children under 2 years of age should receive half the adult dose.
For the treatment of neonatal herpes simplex virus infection, intravenous acyclovir is recommended
Treatment of varicella
Children aged 6 years and older: 800 mg acyclovir four times daily
Children aged 2–5 years: 400 mg acyclovir four times daily
Children under 2 years of age: 200 mg acyclovir four times daily
Treatment should be continued for 5 days.
Alternatively, dosing may be calculated more precisely as 20 mg/kg body weight, administered four times daily, with a maximum single dose of 800 mg.
There are no specific data regarding the suppression of recurrent herpes simplex infection or the treatment of herpes zoster in immunocompetent children.
Elderly Patients
Renal function should be considered in elderly patients, and the dose should be adjusted accordingly (see section Dosage in Renal Impairment below).
Adequate hydration should be maintained in elderly patients receiving high doses of acyclovir.
Renal Impairment:
Acyclovir should be used with caution in patients with renal impairment, and adequate hydration must be maintained.
For the management of herpes simplex virus infections in patients with impaired renal function, the recommended oral dose should not result in acyclovir accumulation exceeding plasma concentrations established as safe following intravenous administration.
In patients with severe renal impairment (creatinine clearance less than 10 mL/min), the dose should be adjusted to 200 mg acyclovir twice daily at approximately 12-hour intervals.
For the treatment of herpes zoster:
In patients with severe renal impairment (creatinine clearance less than 10 mL/min):
800 mg acyclovir twice daily at approximately 12-hour intervals
In patients with moderate renal impairment (creatinine clearance 10–25 mL/min): 800 mg acyclovir three times daily at approximately 8-hour intervals
Dosage of Acyclovir STADA 800 mg Tablets
Adults
Treatment of varicella and herpes zoster:
800 mg acyclovir five times daily at approximately 4-hour intervals, omitting the night-time dose. Treatment should be continued for 7 days.
In patients with severe immunodeficiency or impaired intestinal absorption, intravenous administration should be considered.
Treatment should be initiated as early as possible after symptom onset.: Treatment of herpes zoster is more effective when started early after rash onset. Treatment of varicella in immunocompetent patients should be initiated within 24 hours after rash onset.
Pediatric Population
Children aged 6 years and older: 800 mg acyclovir four times daily. Treatment should be continued for 5 days.
There are no specific data regarding the treatment of herpes zoster in immunocompetent children.
For the treatment of neonatal herpes virus infection, intravenous acyclovir is recommended.
Elderly Patients
Renal function should be considered in elderly patients, and the dose should be adjusted accordingly (see section Dosage in Renal Impairment below).
Hydration should be maintained in elderly patients receiving high doses of acyclovir.
Renal Impairment
Acyclovir should be used with caution in patients with renal impairment, and adequate hydration must be maintained.
For the treatment of herpes zoster, dose adjustment is recommended as follows:
In patients with severe renal impairment (creatinine clearance less than 10 mL/min):
800 mg acyclovir twice daily at approximately 12-hour intervals.
In patients with moderate renal impairment (creatinine clearance 10–25 mL/min):
800 mg acyclovir three times daily at approximately 8-hour intervals.
Method of Administration
For oral use. The tablets may be dispersed in a minimum of 50 mL of water or swallowed whole with a small amount of water. Ensure that patients receiving high-dose therapy maintain adequate fluid intake.
CONTRAINDICATIONS
Hypersensitivity to acyclovir or valaciclovir, or to any of the excipients of the medicinal product.
WARNINGS AND PRECAUTIONS
This medicinal product should be used under medical supervision. Read the instructions for use carefully before administration. If further information is required, consult a physician or pharmacist. Keep out of the reach of children..
