Virustat 200 mg/5 ml oral suspension 120 ml

Virustat 200 mg/5 ml oral suspension 120 ml 

Composition:
Each 5 ml contains:
Acyclovir 200 mg.
Excipients:
Microcrystalline cellulose, Carboxymethyl cellulose sodium (CMC-Na 11.2–18.6%), Liquid sorbitol 70% non-crystalline, Methyl paraben, Propyl paraben, Propylene glycol, Vanilla flavor, Sodium citrate dihydrate, Citric acid anhydrous, Purified water.
Description:
VIRUSTAT is an antiviral product containing acyclovir.
It inhibits replication of Herpesviridae by blocking viral DNA polymerase.
It is intended for the treatment of acute and recurrent herpesvirus infections including herpes zoster, genital herpes, and chickenpox.
Maximum effectiveness is achieved when therapy begins as early as possible.
Indications for Use:
- Acute treatment of herpes zoster
- Treatment of initial and recurrent episodes of genital herpes
- Treatment of chickenpox (varicella).
Dosage and Method of Administration:
Adults:
Herpes simplex (treatment):
- 200 mg 5 times daily every 4 hours, omitting nighttime dose.
- Duration: 5 days; longer for severe initial infections.
- Severe immunocompromised or poor absorption: 400 mg.
- Start as early as possible.
Herpes simplex (suppression):
- 200 mg 4 times daily (6 h intervals).
- Alternative regimens: 400 mg twice daily; or 200 mg 3 times daily; or 200 mg twice daily.
- Interrupt therapy every 6-12 months.
Herpes simplex prophylaxis (immunocompromised):
- 200 mg 4 times daily.
- Severe immunosuppression or impaired absorption: 400 mg.
- Duration depends on risk period.
Varicella and Herpes zoster:
- 800 mg 5 times daily every -4 hours, omitting nighttime dose.
- Duration: 7 days.
- Start as soon as possible after rash onset.
Children ≥ 2 years:
Herpes simplex (treatment/prophylaxis):
- Adult dose.
Varicella:
- 6 years: 800 mg 4 times daily
- 2-6 years: 400 mg 4 times daily
- Weight-based: 20 mg/kg 4 times daily (max 800 mg)
- Duration: 5 days.
Elderly:
- Total clearance decreases with renal function; hydration required.
- Dose reduction in renal impairment.
Renal impairment:
Severe impairment (creatinine clearance < 10 ml/min):
200 mg twice daily (Herpes simplex).
Contraindications:
- Hypersensitivity to acyclovir or valacyclovir
- Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Children under 2 years.
Precautions:
- Dose adjustment in renal impairment
- Caution with nephrotoxic drugs: risk of renal dysfunction and reversible CNS symptoms
- Maintain adequate hydration
- Probenecid and cimetidine increase acyclovir AUC
- TTP/HUS reported in immunocompromised patients
- Neurological reactions possible, especially in elderly or renal impairment.
Side Effects:
General: anaphylaxis, angioedema, fever, pain, peripheral edema
Nervous system: agitation, ataxia, coma, confusion, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizures, somnolence, tremors
Gastrointestinal: diarrhea, GI distress, nausea
Hematologic: anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia
Hepatic: increased liver enzymes, hepatitis, hyperbilirubinemia, jaundice
Musculoskeletal: myalgia
Skin: alopecia, erythema multiforme, photosensitivity rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Special senses: visual abnormalities
Renal: renal failure, renal pain, increased BUN and creatinine, hematuria.
Pregnancy and Breastfeeding:
Pregnancy:
Registry data show no increased risk of birth defects.
Use with caution after evaluating benefit/risk.
Lactation:
Acyclovir appears in milk at 0.6-4.1 × plasma levels.
Infant exposure may reach 0.3 mg/kg/day.
Use with caution in nursing women.
Storage Conditions:
Keep at a temperature not exceeding 30°C.
Keep out of reach of children.
Packaging:
Carton box containing a 120 ml bottle with leaflet.