Cymevene

Cymevene

ganciclovir

Manufacturer:

Cheplapharm

Distributor:

DKSH
Concise Prescribing Info
Contents
Ganciclovir
Indications/Uses
Prevention & treatment of life- or sight-threatening cytomegalovirus (CMV) disease in immunocompromised individuals.
Dosage/Direction for Use
CMV retinitis Induction: 5 mg/kg IV infusion over 1 hr every 12 hr for 14-21 days. Maintenance: 5 mg/kg IV infusion over 1 hr once daily, 7 days a wk or 6 mg/kg once daily on 5 days a wk. Patient w/ renal impairment CrCl ≥70 mL/min Induction: 5 mg/kg every 12 hr, maintenance: 5 mg/kg/day; 50-69 mL/min Induction: 2.5 mg/kg every 12 hr, maintenance: 2.5 mg/kg/day; 25-49 mL/min Induction: 2.5 mg/kg/day, maintenance: 1.25 mg/kg/day; 10-24 mL/min Induction: 1.25 mg/kg/day, maintenance: 0.625 mg/kg/day; <10 mL/min Induction: 1.25 mg/kg 3 times/wk after hemodialysis, maintenance: 0.625 mg/kg 3 times/wk after hemodialysis.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to ganciclovir or valganciclovir. Possible cross-hypersensitivity w/ aciclovir & valaciclovir.
Special Precautions
Do not administer by rapid or bolus IV inj. IM or SC inj may result in severe tissue irritation. Do not initiate therapy if absolute neutrophil count is <500 cells/microlitre or the platelet count is <25,000 cells/microlitre or the Hb is <8 g/dL. Monitor complete blood & platelet counts during therapy. Patients w/ severe leukopenia, neutropenia, anemia &/or thrombocytopenia; renal impairment. Convulsion, sedation, dizziness, ataxia, confusion &/or coma may occur & may affect ability to drive or operate machinery. Women of childbearing potential should use effective contraception during treatment. Male patients should practice barrier contraception during & for at least 90 days following treatment. Pregnancy & lactation. Childn (potential for long-term carcinogenicity & reproductive toxicity). Elderly.
Adverse Reactions
Leukopenia; sepsis, anorexia; diarrhea; increased blood creatinine. Anaphylaxis, decreased fertility in males. HIV-infected patients: Neutropenia, anemia, thrombocytopenia, lymphadenopathy; abdominal pain, dysphagia, esophageal candidiasis; pyrexia, candida, inj site infection or inflammation, secondary sepsis, Mycobacterium avium complex, pain, chest pain, +ve blood culture; hypoesthesia, anxiety; pruritus; cough, Pneumocystis carinii pneumonia, productive cough, sinus congestion; increased blood alkaline phosphatase; arthralgia. Transplant patients: Pancytopenia; headache, mucous membrane disorder, pyrexia, rigors, face edema; nausea, dyspepsia, abdominal distension; abnormal hepatic function, decreased blood Mg, hypocalcemia, hypokalemia; tremor, confusion; exfoliative dermatitis; rhinitis, dyspnea; tachycardia, hypotension; hematuria; eye hemorrhage; mylagia.
Drug Interactions
Increased AUC of didanosine & zidovudine. Risk of convulsions w/ imipenem-cilastin. Increased conc w/ mycophenolate mofetil. Decreased renal clearance w/ probenecid. May enhance toxicity w/ other drugs known to be myelosuppressive or associated w/ renal impairment (eg, dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, nucleoside analogues & hydroxyurea).
MIMS Class
ATC Classification
J05AB06 - ganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Cymevene powd for soln for inj 500 mg
Packing/Price
1's
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