Adult: Induction: 5 mg/kg 12 hrly for 14-21 days. Maintenance: 5 mg/kg once daily for 7 days per wk or 6 mg/kg once daily for 5 days per wk. Doses to be given by IV infusion over 1 hr.
Intravenous Prophylaxis of cytomegaloviral infections in immunocompromised patients
Adult: Induction: 5 mg/kg 12 hrly for 7-14 days. Maintenance: 5 mg/kg once daily for 7 days per wk or 6 mg/kg once daily for 5 days per wk. Doses to be given by IV infusion over 1 hr.
Ophthalmic Herpes simplex keratitis
Adult: As 0.15% gel: Apply 1 drop in the inferior conjunctival sac of the affected eye 5 times daily (approx 3 hrly while awake) until corneal healing occurs, then 1 drop tid for 7 days after healing.
Oral CMV (cytomegalovirus) retinitis
Adult: As maintenance dose following an IV induction dose: 1 g tid. Alternatively, 500 mg 6 times daily (approx 3 hourly during waking hours).
Oral Prophylaxis of cytomegaloviral infections in immunocompromised patients
Adult: 1 g tid.
Renal Impairment
Oral:
CrCl (mL/min)
Dosage
<10
500 mg 3 times wkly, after haemodialysis.
10-24
500 mg once daily.
25-49
1 g once daily or 500 mg bid.
50-69
1.5 g once daily or 500 mg tid.
Intravenous:
Dialysis patients: 1.25 mg/kg for induction or 0.625 mg/kg for maintenance, to be given post-dialysis on days when dialysis is performed.
CrCl (mL/min)
Dosage
10-24
1.25 mg/kg/day for induction, then 0.625 mg/kg/day for maintenance.
25-49
2.5 mg/kg/day for induction, then 1.25 mg/kg/day for maintenance.
50-69
2.5 mg/kg 12 hrly for induction, then 2.5 mg/kg/day for maintenance.
Administration
Should be taken with food.
Reconstitution
Add 10 mL of sterile water for inj to the vial labelled as containing 500 mg to provide a soln containing 50 mg/mL. Withdraw the appropriate dose of reconstituted soln from the vial and further dilute in 50-250 (usually 100) mL of a compatible IV infusion soln.
Incompatibility
Paraben preserved bacteriostatic water for inj, amifostine, amsacrine, aztreonam, cefepime, cytarabine, doxorubicin, fludarabine, foscarnet, gemcitabine, ondansetron, piperacillin/tazobactam, vinorelbine.
Contraindications
Hypersensitivity to ganciclovir or valganciclovir and other antivirals (e.g. aciclovir, valaciclovir).
Special Precautions
Patient w/ pre-existing cytopenias or a history of cytopenic reactions to other drugs, chemicals or radiation therapy. Renal impairment. Pregnancy and lactation.
This drug may cause convulsion, sedation, ataxia and/or confusion, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor haematological function (CBC w/ differential and platelet count), serum creatinine.
Overdosage
Symptoms: Haematological toxicity (e.g. pancytopenia, bone marrow depression, medullary aplasia, leucopenia, neutropenia, granulocytopenia); hepatotoxicity (e.g. hepatitis, liver function disorder); renal toxicity (e.g. worsening of haematuria in patient w/ renal impairment, acute renal failure, elevated creatinine); GI toxicity (e.g. abdominal pain, diarrhoea, vomiting); neurotoxicity (e.g. generalised tremor, convulsion). Management: Symptomatic and supportive treatment. Haemodialysis and hydration may be useful in enhancing elimination of drug. For neutropenia, treatment w/ haematopoietic growth factors may be considered.
Drug Interactions
Increased risk of haematologic toxicity w/ zidovudine. May increase serum levels of didanosine. Increased serum concentration w/ probenecid and other drugs that inhibit renal tubular secretion and resorption. Use of IV ganciclovir w/ oral mycophenolate mofetil may result in increased plasma concentrations of both drugs due to competition for renal tubular secretion. Concomitant use w/ immunosuppressive agents (e.g. azathioprine, ciclosporin, corticosteroids) may result in excessive suppression of bone marrow or the immune system. Generalised seizure may occur when taken w/ imipenem and cilastatin. Concurrent use w/ drugs that inhibit replication of rapidly dividing cells (e.g. dapsone, pentamidine, pyrimethamine, flucytosine, cytotoxic antineoplastic agents, amphotericin B, co-trimoxazole, other nucleoside analogues) may result in additive toxicity.
Food Interaction
Food increases bioavailability of ganciclovir.
Action
Description: Ganciclovir is an acyclic nucleoside analogue of 2’-deoxyguanosine that has antiviral effect against human cytomegalovirus and other human herpes viruses. It is phosphorylated to a substrate which competitively inhibits the binding of deoxyguanosine triphosphate to DNA polymerase resulting in inhibition of viral DNA synthesis. Pharmacokinetics: Absorption: Poorly absorbed from the GI tract. Bioavailability is increased w/ food intake. Bioavailability: Approx 5% (oral). Distribution: Widely distributed into body tissues and fluids including intra-ocular fluid and CSF (IV). Plasma protein binding: 1-2%. Excretion: Via urine, mainly by glomerular filtration and also active tubular secretion as unchanged drug. Half-life: Approx 2.5-4.5 hr (IV); approx 4-5.7 hr (oral).
Chemical Structure
Ganciclovir Source: National Center for Biotechnology Information. PubChem Database. Ganciclovir, CID=135398740, https://pubchem.ncbi.nlm.nih.gov/compound/Ganciclovir (accessed on Jan. 22, 2020)
Anon. Ganciclovir (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 28/10/2014.Anon. Ganciclovir (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 28/10/2014.Buckingham R (ed). Ganciclovir. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 28/10/2014.Ganciclovir Capsule (Ranbaxy Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 28/10/2014.Ganciclovir Sodium Injection, Powder, Lyophilized, for Solution (Fresenius Kabi USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 28/10/2014.McEvoy GK, Snow EK, Miller J et al (eds). Ganciclovir Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 28/10/2014.Zirgan Gel (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 28/10/2014.
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