Description:

Aciclovir Intravenous Infusion I.P. 500mg is a sterile lyophilized powder for reconstitution into an intravenous solution. It is a potent antiviral agent used to treat severe herpes simplex virus (HSV) infections (including herpes encephalitis, disseminated HSV, and neonatal HSV), varicella-zoster virus (VZV) infections (shingles, chickenpox in immunocompromised patients), and cytomegalovirus (CMV) infections in certain contexts. It works by inhibiting viral DNA polymerase, preventing viral replication.

Prescription:

Prescription-only (requires a doctor’s prescription in Ghana; administered only by healthcare professionals via IV infusion in hospitals/clinics; not for self-administration or OTC dispensing due to serious infections, renal toxicity risks, and need for monitoring).

Therapeutic Category:

Systemic Antiviral Agent (Nucleoside analogue antiviral for herpesvirus infections.

Active Ingredients/Composition:

• Active ingredient: Aciclovir sodium – equivalent to aciclovir 500 mg per vial (powder for reconstitution). Other ingredients: Sodium hydroxide (for pH adjustment during manufacture). The powder is white to off-white, sterile, and reconstituted with water for injection or compatible IV fluid to produce a clear solution.

Vitamins: None.

Minerals: None (trace sodium from sodium salt, but not therapeutic).

Variant:

• Aciclovir 500mg IV powder for infusion (standard 500mg vial). Related variants: Aciclovir 250mg vial (lower dose), oral aciclovir tablets/suspension, or topical aciclovir cream. The 500mg vial is the most common strength for IV use in adults.

Consume Type:

Injectable – Intravenous (IV) infusion (powder reconstituted and diluted; administered only by healthcare professionals; slow infusion to avoid renal toxicity).

Directions/Usage: Administered only in hospital/clinic under medical supervision.

• Adults: Typical dose 5–10 mg/kg IV every 8 hours (infused over 1 hour).
  • Herpes encephalitis: 10 mg/kg every 8 hours for 14–21 days.
  • Disseminated HSV or VZV in immunocompromised: 10 mg/kg every 8 hours for 7–10 days.
• Children: Weight-based (10–20 mg/kg every 8 hours).
• Renal impairment: Reduce dose/frequency (e.g., half dose if CrCl 10–50 mL/min).
• Reconstitution: Add 10 ml water for injection to 500mg vial; shake to dissolve.
• Dilution: Further dilute in compatible fluid (e.g., 0.9% NaCl or 5% dextrose) to ≤7 mg/ml; infuse over 1 hour.
• Hydration: Ensure adequate fluid intake to prevent crystalluria/renal toxicity.
• Duration: 5–21 days depending on infection and response.

Common Side Effects: Common:

• Phlebitis/inflammation at infusion site.
• Nausea, vomiting.
• Headache
• Rash
• Elevated liver enzymes. Rare/serious (seek immediate help): Renal impairment (crystalluria, acute kidney injury – ensure good hydration), neurotoxicity (confusion, hallucinations, seizures – especially in renal impairment), anaphylaxis, or severe skin reactions.

Package Type:

Glass vial of powder (500mg per vial; often in packs of 1 or 10 vials; labelled carton with reconstitution instructions and warnings).

Storage Advice: Store unopened vials at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Reconstituted solution: Use immediately or store refrigerated (2–8°C) for up to 12–24 hours (check label). Diluted infusion: Use within 4–8 hours at room temperature or 24 hours refrigerated.

Safety Advice:

• Administered only under medical supervision (risk of renal toxicity – monitor renal function, ensure adequate hydration, and slow infusion).
• Contraindicated in hypersensitivity to aciclovir/valaciclovir.
• Caution in renal impairment (dose adjustment required), dehydration, elderly, or concurrent nephrotoxic drugs (e.g., NSAIDs, aminoglycosides).
• Monitor renal function (creatinine, BUN) and urine output during treatment.
• If rash, fever, confusion, reduced urine output, or jaundice occurs, stop use and seek medical care.
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar aciclovir 500mg IV injections in Ghana include:

• Generic aciclovir 500mg IV powder (various importers).
• Zovirax IV (original GSK brand if stocked).
• Acyprove-500 Inj (John Lee brand, similar product). Alternatives: Valaciclovir oral (for milder cases), ganciclovir IV (for CMV), or foscarnet (for resistant HSV). Consult doctor/pharmacist in Accra (e.g., hospital pharmacy) for availability.

Manufacturer/Marketer:

John Lee Pharmaceuticals Pvt Ltd (India-based; primary manufacturer of Aciclovir Injection under brands like Acyprove-500 Inj). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported generic).

Country of Origin:

India (manufactured by John Lee Pharmaceuticals Pvt Ltd; imported to Ghana and available in local pharmacies/hospitals).