Cymevene

Cymevene

ganciclovir

Manufacturer:

Cheplapharm

Distributor:

DKSH
Concise Prescribing Info
Contents
Ganciclovir
Indications/Uses
Cytomegalovirus (CMV) disease in immunocompromised individual. Prevention of CMV disease in patients w/ drug-induced immunosuppression following organ transplantation or cancer chemotherapy.
Dosage/Direction for Use
CMV disease Induction: 5 mg/kg IV infusion over 1 hr, every 12 hr for 14-21 days. Immunocompromised patients at risk of relapse Maintenance: 5 mg/kg IV infusion over 1 hr, once daily on 7 days wkly or 6 mg/kg once daily on 5 days per wk. Prevention of CMV disease Prophylaxis: 5 mg/kg IV infusion over 1 hr, once daily on 7 days/wk or 6 mg/kg once daily on 5 days/wk. Pre-emptive therapy: Induction treatment: 5 mg/kg IV infusion over 1 hr every 12 hr for 7-14 days. Maintenance treatment: 5 mg/kg IV infusion over 1 hr, once daily on 7 days wkly or 6 mg/kg once daily on 5 days wkly. Renal impairment CrCl ≥70 mL/min Induction dose: 5 mg/kg 12 hrly. Maintenance dose: 5 mg/kg/day, 50-69 mL/min Induction dose: 2.5 mg/kg 12 hrly. Maintenance dose: 2.5 mg/kg/day, 25-49 mL/min Induction dose: 2.5 mg/kg/day. Maintenance dose: 1.25 mg/kg/day, 10-24 mL/min Induction dose: 1.25 mg/kg/day. Maintenance dose: 0.625 mg/kg/day, <10 mL/min Induction dose: 1.25 mg/kg 3 times wkly after hemodialysis. Maintenance dose: 0.625 mg/kg 3 times wkly after hemodialysis.
Contraindications
Hypersensitivity to ganciclovir, valganciclovir.
Special Precautions
Known hypersensitivity to aciclovir or penciclovir. Advise patients to use contraceptive measures prior to treatment. May cause temporary or permanent inhibition of spermatogenesis in males. Preexisting hematological cytopenia or history of drug-related hematological cytopenia & in patients receiving radiotherapy. Do not initiate therapy if absolute neutrophil count is <500 cells/microliter or platelet count is <25,000 cells/microliter or the Hb is <8 g/dL. Severe leukopenia, neutropenia, anemia &/or thrombocytopenia. Concomitant use w/ imipenem-cilastatin, zidovudine, didanosine, drugs known to be myelosuppressive or associated w/ renal impairment. Monitor CBC & platelet counts during therapy particularly in renal impairment patients. Hepatic impairment. May impair ability to drive & operate machinery. Women of reproductive potential should use effective contraception during & for at least 30 days after treatment. Sexually active men are recommended to use condoms during & for at least 90 days after cessation of treatment. Pregnancy & lactation.
Adverse Reactions
Candida infections including oral candidiasis, upper resp tract infection; neutropenia, anemia; decreased appetite; headache; cough, dyspnoea; diarrhea, nausea, vomiting, abdominal pain; dermatitis; pyrexia, fatigue. Sepsis, influenza, UTI, cellulitis; thrombocytopenia, leucopenia, pancytopenia; hypersensitivity; decreased wt; depression, confusional state, anxiety; insomnia, peripheral neuropathy, dizziness, paresthesia, hypoaesthesia, convulsion, dysgeusia; retinal detachment, visual impairment, vitreous floaters, eye pain, conjunctivitis, macular edema; ear pain; hypotension; constipation, dyspepsia, flatulence, upper abdominal pain, mouth ulceration, dysphagia, abdominal distention, pancreatitis; increased blood alkaline phosphatase, abnormal hepatic function, increased aspartate aminotransferase & alanine aminotransferase; night sweats, pruritus, rash, alopecia; back pain, myalgia, arthralgia, muscle spasms; renal impairment, decreased renal CrCl, increased blood creatinine; inj site reaction, pain, chills, malaise, asthenia.
Drug Interactions
Convulsions may occur w/ imipenem-cilastatin. Toxicity may be enhanced w/ nucleoside analogues (eg, zidovudine, didanosine, stavudine), immunosuppressants (eg, ciclosporin, tacrolimus, mycophenolate mofetil), antineoplastic agents (eg, doxorubicin, vincristine, vinblastine, hydroxyurea) & anti-infectives (eg, trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine). Potential neutropenia & anemia may occur w/ zidovudine. Increase plasma conc of didanosine. Decreased renal clearance w/ probenecid.
MIMS Class
Antivirals
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 infusion 500 mg
Packing/Price
1's
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