Ganciclovir


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Cytomegaloviral retinitis 1 g tid as maintenance dose. Alternatively, 500 mg 6 times daily (approx 3 hourly during waking hour). Prophylaxis of cytomegaloviral infections in immunocompromised patients 1 g tid. IV Cytomegaloviral infections Initial: 5 mg/kg 12 hrly for 14-21 days, then 5 mg/kg once daily for 7 days/wk or 6 mg/kg once daily for 5 days/wk. Prophylaxis of cytomegaloviral infections in immunocompromised patients Initial: 5 mg/kg 12 hrly for 7-14 days, then 5 mg/kg once daily for 7 days/wk or 6 mg/kg once daily for 5 days/wk. Ophth Herpes simplex keratitis As 0.15% gel: Apply 1 drop in the inferior conjunctival sac of the affected eye 5 times/day.
Dosage Details
Intravenous
Cytomegaloviral infections
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.
Adverse Reactions
Haematologic effects (e.g. neutropenia, thrombocytopenia, anaemia, eosinophilia); headache, seizure, coma, confusion, thought disorders, dysphoria, agitation, hallucinations, abnormal dreams/nightmares, nervousness/anxiety, delirium, dizziness, dysaesthesia, asthenia, intention tremor, abnormal reflexes, ataxia, paraesthesia, psychosis, somnolence, obtundation; elevated serum aminotransferase and alkaline phosphatase levels; nausea, vomiting, diarrhoea, anorexia, GI haemorrhage, abdominal pain; increased serum creatinine and BUN levels, haematuria; inflammation, phlebitis and/or pain at inj site; burning or brief tingling sensations, superficial punctate keratitis, visual disturbance (ophth); fever, rash, oedema, myalgia, chills, malaise, cardiac arrhythmia, MI, cardiac arrest, HTN, hypotension, hypoglycaemia, dyspnoea, alopecia, urticaria, pruritus, hyponatraemia, deafness, syndrome of inappropriate secretion of antidiuretic hormone (SIADH).
IV/Ophth/Parenteral: C
Patient Counseling Information
This drug may cause convulsion, sedation, ataxia and/or confusion, if affected, do not drive or operate machinery.
MonitoringParameters
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

Chemical Structure Image
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)

Storage
Store between 20-25°C.
MIMS Class
References
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.

Disclaimer: This information is independently developed by MIMS based on Ganciclovir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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