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Antifungals & Antivirals

Acyclovir STADA® 400 mg

 

Pack size:

Box of 7 blisters x 5 tablets.

 

Composition:

Each tablet contains acyclovir 400 mg.

 

Shelf-life:

48 months from the date of manufacturing.

Store in a well-closed container, in a dry place. 

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Orally taken in:

  • Treatment for Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital Herpes.
    200 mg five times daily (usually every 4 hours while awake) for 5 to 10 days. Severely immunocompromised patients or those with impaired absorption: 400 mg five times daily for 5 days.
  • Suppression of recurrent Herpes simplex infections in immunocompetent patients.
    800 mg daily in two to four divided doses; dosage reduction to 400 - 600 mg daily can be tried. Higher doses of 1 gram daily have also been used. Therapy should be interrupted every 6 to 12 months for reassessment of the condition.
  • Prophylaxis of Herpes simplex infections in immunocompromised patients.
     200 to 400 mg four times daily.
    Chronic suppressive treatment: is not suitable for mild or infrequent recurrences of Herpes simplex. In such cases episodic treatment of recurrences may be more beneficial; a dose of 200 mg five times daily for 5 days has been recommended, preferably initiated during the prodromal period.
  • Treatment of Varicella (chickenpox) and Herpes zoster (shingles) infections.
    Chickenpox: 800 mg four or five times daily for 5 to 7 days.
    Herpes zoster: 800 mg five times daily may be given for 7 to 10 days.
  • Children's doses: 
    Treatment of Herpes simplex infections and prophylaxis of Herpes simplex infections in the Immunocompromised: 
    - Children aged 2 years and over: As for adults.
    - Children aged under 2 years: Half the adult dose. 
    Treatment of chickenpox: Treatment should continue for five days.
    - Children aged 6 years and over: 800 mg four times daily.
    - Children aged 2 to 5 years: 400 mg four times daily.
    - Children aged under 2 years: 200 mg four times daily.
  • Patient with renal impairment:
    Doses of acyclovir should be reduced in renal impairment according to creatinine clearance (CC). 
    CC less than 10 ml/minute: 
    Herpes simplex infections: 200 mg every 12 hours.
    Varicella-zoster infections: 800 mg every 12 hours. 
    CC between 10 and 25 ml/minute: 
    - Varicella-zoster infections: 800 mg three times daily every 8 hours.

​Or as prescribed by physicians.

 

  • Patients who develop hypersensitivity to acyclovir or valacyclovir.

 

  • Renal impairment may be associated with systemic use of acyclovir in some patients; it is usually reversible and is reported to respond to hydration and/or dosage reduction or withdrawal, but may progress to acute renal failure.
  • Occasional adverse effects after systemic administration include increased serum bilirubin and liver enzymes, haematological changes, skin rashes (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), fever, headache, dizziness and gastrointestinal effects such as nausea, vomiting and diarrhoea. Anaphylaxis has been reported. Hepatitis and jaundice have been reported rarely.

     

  • Acyclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment. Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. These reactions were generally reversible on discontinuation of treatment.
  • There have been no studies to investigate the effect of acyclovir on driving performance or the ability to operate machinery.
  • There are no adequate and well-controlled studies in pregnant women. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Acyclovir should be administered to a nursing mother with caution and only when indicated.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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