BSP Pharma


Concise Prescribing Info
Ganciclovir Na
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.
Hypersensitivity to ganciclovir, valganciclovir. Lactation.
Special Precautions
Not to be administered by rapid or bolus IV inj. May increase toxicity due to excessive plasma levels. IM or SC may cause severe tissue irritation due to high pH. Hypersensitivity w/ aciclovir, penciclovir, valaciclovir, famciclovir. Not to be initiated in patients w/ absolute neutrophil count <500 cells/microlitre, or platelet count <25,000 cells/microlitre or Hb count <8 g/dL. Pre-existing hematological cytopenia or history of drug-related hematological cytopenia. Severe leukopenia, neutropenia, anemia, thrombocytopenia. Monitor complete blood & 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 radiotherapy. May affect ability to drive & use machines. 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, upper resp tract infection; neutropenia, anemia; decreased appetite; headache; cough, dyspnoea; diarrhoea, 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 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
ATC Classification
J05AB06 - ganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Cymevene infusion conc 500 mg
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