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Antifungals & Antivirals

Acyclovir STADA® 200 mg

 

Pack size:

Box of 5 blisters x 5 tablets.

 

Composition:

Each tablet contains acyclovir 200 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

Acyclovir is taken orally in:

  • Treatment of initial and recurrent Herpes simplex virus infection (type 1 and 2) in mucosa - skin (stomatitis, genital inflammation), in eye (keratitis).
  • Prophylaxis of HSV infection in mucosa - skin when recurrences occur at least 6 times a year, in eyes (recurrent keratitis occur after twice a year) or in eye surgery.
  • Varicella zoster virus Infection: 
    Herpes zoster, prophylaxis of complications in eye due to zoster in eye.
    Chickenpox in patients more than 2 years of age.
     

Treatment with acyclovir should be started as soon as possible when signs and symptoms of the disease occurs.

  • ​Treatment of primary Herpes simplex infections, including 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 in immunocompetent patients (at least 6 times a year): 800 mg daily in two to four divided doses. Therapy should be interrupted every 6 to 12 months for reassessment of the condition. 
    In infrequent recurrences of Herpes simplex (less than 6 times a year), episodic treatment of recurrences may be preferred; a dose of 200 mg five times daily for 5 days has been recommended, preferably begun during the prodromal period.
  • Prophylaxis of Herpes simplex in immunocompromised patients: 200 to 400 mg four times daily. 
  • HSV infection in eyes: 
    Treatment of keratitis: 400 mg x 5 times/day in 10 days.
    Prophylaxis of recurrence of keratitis (after 3 recurrences a year): 800 mg/day in 2 divided doses. Reassessment should be performed after 6 - 12 months of treatment.
    Eye surgery: 800 mg/day in 2 divided doses.
  • Herpes zoster:
    Adults and children > 2 years: 800 mg five times daily may be given for 5 to 10 days. 
  • Chickenpox: 
    Adults: 800 mg four or five times daily for 5 to 7 days. 
    Children > 2 years: 20 mg/kg, not more than 800 mg four times daily for 5 days.
    Children from 2 to 5 years: 400 mg four times daily.
    Children ≥ 6 years: 800 mg four times daily. 
  • Dose adjustment in patients with renal impairment:
    Doses and the number of times for taking acyclovir should depend on creatinine clearance.
    Hemodialysis: Add 1 dose immediately after hemodialysis. Oral doses for patients with renal impairment associated with HIV as follows: 


Or as prescribed by physicians. 
 

  • Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

     


Very rare:

  • Anaemia, leucopenia and thrombocytopenia.
  • Reversible neurological reactions including agitation, tremor, ataxia, dysarthria, psychotic symptoms, encephalopathy, drowsiness, confusional states, hallucinations, somnolence, convulsions, coma and malaise. These effects were usually reported in patients receiving high doses of acyclovir (usually given intravenously), with renal impairment, or with other predisposing factors. Acyclovir should be used with caution in patients with underlying neurological abnormalities.
  • Hepatitis and jaundice.
  • Acute renal failure, renal pain. Renal pain may be associated with renal failure.

Rare:

  • Anaphylaxis.
  • Dyspnoea.
  • Reversible rises in bilirubin and liver related enzymes.
  • Angioedema, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis.
  • Increases in blood urea and creatinine; renal impairment, usually during intravenous therapy, which is usually reversible and responds to hydration and/or dosage reduction but may progress to acute renal failure in patients with predisposing factors.

Common:

  • Dizziness and headache.
  • Nausea, vomiting, diarrhoea and abdominal pain.
  • Skin rashes, pruritus (including photosensitivity).
  • Fatigue, fever.

Uncommon:

  • Urticaria, accelerated diffuse hair loss. Accelerated diffuse hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to acyclovir therapy is uncertain.

     

  • 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 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.
  • The clinical status of the patient and the adverse event profile of acyclovir should be borne in mind when considering the patients' ability to drive or operate machinery. As acyclovir administration is occasionally associated with drowsiness and somnolence (usually in patients receiving high doses or with impaired renal function), patients should make sure that they are not affected before driving or using machinery. 
    There have been no studies to investigate the effect of acyclovir on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.

 

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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