Cymevene

Cymevene

ganciclovir

Manufacturer:

Cheplapharm

Distributor:

DKSH
Concise Prescribing Info
Contents
Ganciclovir Na
Indications/Uses
Cytomegalovirus (CMV) retinitis in immunocompromised individuals including patients w/ AIDS. Prevention of CMV disease in transplant patients at risk for CMV disease. Prevention & treatment of life- or sight-threatening CMV disease in immunocompromised individuals.
Dosage/Direction for Use
CMV retinitis Induction (normal renal function): 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 for 7 days wkly or 6 mg/kg once daily for 5 days wkly. Prevention in transplant recipient Induction (normal renal function): 5 mg/kg IV infusion over 1 hr every 12 hr for 7-14 days. Maintenance: 5 mg/kg IV infusion over 1 hr once daily for 7 days wkly or 6 mg/kg once daily for 5 days wkly. Renal impairment CrCl ≥70 mL/min Induction: 5 mg/kg every 12 hr. Maintenance: 5 mg/kg daily, 50-69 mL/min Induction: 2.5 mg/kg every 12 hr. Maintenance: 2.5 mg/kg daily, 25-49 mL/min Induction: 2.5 mg/kg daily. Maintenance: 1.25 mg/kg daily, 10-24 mL/min Induction: 1.25 mg/kg daily. Maintenance: 0.625 mg/kg daily, <10 mL/min Induction: 1.25 mg/kg 3 times wkly after hemodialysis. Maintenance: 0.625 mg/kg 3 times wkly after hemodialysis.
Contraindications
Hypersensitivity to ganciclovir, valganciclovir. Lactation.
Special Precautions
Hypersensitivity w/ aciclovir, penciclovir, valaciclovir, famciclovir. Not to be administered by rapid or bolus IV inj. IM or SC inj may cause severe tissue irritation due to high pH. Not to be initiated in patients w/ ANC <500 cells/microlitre, or platelet count <25,000 cells/microlitre or Hb count <8 g/dL. May increase toxicity due to excessive plasma levels. Pre-existing hematological cytopenia or history of drug-related hematological cytopenia; severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow failure, aplastic anemia. Monitor CBC & platelet counts during therapy. Not to be used concomitantly w/ imipenem-cilastatin. Concomitant use w/ zidovudine, didanosine, drugs known to be myelosuppressive or associated w/ renal impairment; in patients receiving RT. May affect ability to drive & use machines. May cause temporary or permanent spermatogenesis inhibition in males. Women of childbearing potential should use effective contraception during & at least 30 days after treatment. Sexually active men should use effective contraception during & at least 90 days after treatment. Hepatic impairment. Avoid use during pregnancy & lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Candida infections, URTI; neutropenia, anemia; decreased appetite; headache; cough, dyspnoea; diarrhea, nausea, vomiting, abdominal pain; dermatitis; pyrexia, fatigue. Sepsis, flu, UTI, cellulitis; thrombocytopenia, leukopenia, pancytopenia; hypersensitivity; decreased wt; depression, confusional state, anxiety; nervous system & eye disorders; ear pain; hypotension; GI disorders; increased blood alkaline phosphatase, AST & ALT, abnormal hepatic function; 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 w/ imipenem-cilastatin. Enhanced toxicity w/ nucleoside analogues (eg, zidovudine, didanosine, stavudine), immunosuppressants (eg, ciclosporin, tacrolimus, mycophenolate mofetil), antineoplastics (eg, doxorubicin, vincristine, vinblastine, hydroxyurea), anti-infectives (eg, trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine). Neutropenia & anemia w/ zidovudine. Increased didanosine plasma conc. 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 conc 500 mg
Packing/Price
1's
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