📋 Indications & Clinical Dosage
*Prevention of cytomegalo virus disease during immuno-suppressive therapy following organ transplantation:*
BY IV INF: Adult: 5 mg/kg every 12 hours for 7-14 days.
*Treatment of life-threatening or sight-threatening cytomegalo virus infections in immune-compromised patients only:*
BY IV INF: Adult: Initially 5 mg/kg every 12 hours for 14-21 days, followed by maintenance 6 mg/kg daily on 5 days of the week, alternatively 5 mg/kg daily until adequate recovery of immunity, maintenance only for patients at risk of relapse of retinitis, if retinitis progresses initial induction treatment may be repeated.
ORAL: Adult: 1000mg 3 times daily or 500 mg 6 times daily.
💊 Mode of Administration
Administered by IV infusion. After reconstitution the required dose may be diluted in 50-250 ml (usually 100 ml) of compatible infusion solution and given over 1 hour, greater than 10 mg/ml concentration are not recommended. Reconstitute powder with unpreserved sterile water, dilute in 250-1000 ml D5W or NS to a concentration of10 mg/ml for infusion.
⛔ Contraindications
Hypersensitivity to ganciclovir or acyclovir, abnormally low haemoglobin, neutrophil, or platelet counts.
⚠️ Precautions & Warnings
Ensure effective contraception during treatment and barrier contraception for men during and for at least 90 days after treatment. Ensure close monitoring of full blood count, history of cytopenia, low platelet count, potential carcinogen and teratogen, renal impairment, radiotherapy, ensure adequate hydration during intravenous administration, vesicant-infuse into vein with adequate flow preferably using plastic cannula, children (possible risk of long-term carcinogenic or reproductive toxicity-not for neonatal or congenital cytomegalovirus disease).
🔄 Drug Interactions
Myelosuppresants, zidovudine, didanosine, imipenem, probenecid.
⚠️ Adverse Reactions / Side Effects
: Diarrhoea, nausea, vomiting, dyspepsia, abdominal pain, constipation, flatulence, dySphagia, hepatic dysfunction; dyspnoea, chest pain, cough; headache, insomnia, convulsions, dizziness, neuropathy, depression, anxiety, confusion, abnormal thinking, fatigue, weight loss, anorexia; infection, fever, night sweats; anaemia, leucopenia, thrombocytopenia, pancytopenia, renal impairment; myalgia, arthralgia; macular oedema, retinal detachment, vitreous floaters, eye pain; ear pain, taste disturbance; dermatitis, pruritus; injection-site reactions; less commonly mouth ulcers, pancreatitis, arrhythmias, hypotension, anaphylactic reactions, psychosis, tremor, male infertility, hae-maturia, disturbances in hearing and vision, and alopecia.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Avoid, use only when no safer alternative exists for a serious problem.
Lactation / Breastfeeding:
Contraindicated
🧪 Compatibility & Storage Stability
Compatibility: Stable in 135W, LR, NS, incompatible with bacteriostatic WFI
Stability & Storage: Stability at room temperature (25C) and at refrigeration temperature (4C) is 5 days. Intact vial should be stored at room temperature and protected from temperatures >40C. Reconstituted solution is stable for 12 hours at room temperature.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.