Ganciclovir
Antiviral, Systemic · DNA polymerase inhibitor
Indications
Life-threatening or sight-threatening cytomegalovirus infections in immunocompromised patients only; prevention of cytomegalovirus disease during immunosuppressive therapy following organ transplantation; local treatment of CMV retinitis.
Dosage
INJECTION: Adults & Children: Above 3 mth age: By IV infusion, initially (induction) 5 mg/ kg every 12 hr for 14-21 days for treatment or for 7-14 days for prevention; maintenance (for patients at risk of relapse of retinitis) 6 mg/kg daily on 5 days per wk or 5 mg/kg daily until adequate recovery of immunity; if retinitis progresses initial induction treatment may be repeated. ORAL: Adults: CMV disease: 1000 mg 3 times daily or 500 mg 6 times daily.
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. Concentration greater than 10 mg/mL are not recommended. Reconstitution: Reconstitute powder with unpreserved sterile water, dilute in 250-1000 mL D5W or NS to a concentration =10 mg/mL for infusion. Compatibility: Stable in D5W, LR, NS. Incompatible with bacteriostatic WFI. Stability: Intact vial should be stored at room temperature and protected from temperatures >40°C. Reconstituted solution is stable for 12 hours at room temperature. Stability at room temperature (25°C) and at refrigeration temperature (4°C) is 5 days.
Adverse 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, haematuria, disturbances in hearing and vision and alopecia.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated or not recommended. Contraindications: Ensure effective contraception during treatment and barrier contraception for men during and for at least 90 days after treatment. Hypersensitivity to ganciclovir or acyclovir, abnormally low haemoglobin, neutrophil, or platelet counts. Precautions: 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).
Interactions
Myelosuppresants, zidovudine, didanosine, imipenem, probenecid.
Advice to Patient
Take oral form with meals. Contact prescriber if there is fever, chills, rash, unusual bruising or bleeding, white plaques in mouth, unhealed sores, infection, stomach pain, weakness, tingling/pain in extremities, change in vision, swelling/redness/pain at injection site. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Frequent blood tests and regular eye examinations are required to monitor condition. Avoid highly crowded place to prevent infection. Do not get vaccinated without consulting prescriber. Avoid direct sunlight, wear sunscreen, proper eyewear and protective clothing to prevent photosensitivity.
Pharmacokinetics
Half-life elimination: Neonates 2-49 days of age: 2.4 hrs. Children 9 mths-12 yrs: 2.4 ± 0.7 hrs. Adults: Mean: IV: 3.5 ± 0.9 hrs. Oral: 4.8 ± 0.9 hrs; CrCl <25 mL/min: 10.7 ± 5.7 hrs. Excretion: Urine (80%-99%).
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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