Valgan 450

Valganciclovir HCl

Cytomegalovirus (CMV) retinitis in patients w/ AIDS. Prevention of CMV disease in kidney, heart & kidney-pancreas transplant patients at high risk eg, donor CMV seropositive/recipient CMV seronegative.

Adult Active CMV retinitis Induction: 900 mg bd for 21 days. Maintenance: Following induction, or in patients w/ inactive retinitis: 900 mg once daily. May repeat induction treatment if retinitis worsens. Prevention of CMV disease Kidney transplant-patient 900 mg once daily starting w/in 10 days post-transplantation & continuing until 100 days post-transplantation. May continue prophylaxis until 200 days post-transplantation. Heart, or kidney-pancreas transplant patient 900 mg once daily starting w/in 10 days post-transplantation & continuing 100 days post-transplantation. Patients w/ renal impairment: CrCl ≥60 mL/min Induction: 900 mg bd. Maintenance/prevention: 900 mg once daily, CrCl 40-59 mL/min Induction: 450 mg bd. Maintenance/prevention: 450 mg once daily, CrCl 25-39 mL/min Induction: 450 mg once daily. Maintenance/prevention: 450 mg every 2 days, CrCl 10-24 mL/min Induction: 450 mg every 2 days. Maintenance/prevention: 450 mg twice wkly.

Should be taken with food: Swallow whole, do not break/crush.

Hypersensitivity to valganciclovir or ganciclovir. Possible cross-hypersensitivity to aciclovir, valaciclovir & penciclovir. Lactation.

Not for liver transplant patients. Potential long-term carcinogenocity & reproductive toxicity. Not to be initiated if absolute neutrophil count <500 cells/microL or platelet count <25,000/microL, or Hb level <8 g/dL. Possible risk of developing leucopenia & neutropenia when extending prophylaxis beyond 100 days. Pre-existing haematological cytopenia or history of drug-related haematological cytopenia in patients receiving radiotherapy. Regularly monitor complete blood & platelet counts during therapy especially in patients in whom ganciclovir or other nucleoside analogues have previously resulted in leukopenia or in whom neutrophil count <1,000 cells/microL prior to treatment, & in neonates & infants. Careful adherence to dose recommendations when instituting therapy, switching from induction to maintenance therapy & in patients who may switch from oral ganciclovir to valganciclovir. Not to be used in patients on haemodialysis. Not for concomitant use w/ imipenem-cilastatin. Monitor for signs of added toxicity when used w/ didanosine, myelosuppressive drugs (eg, zidovudine), or substances affecting renal function. Lung & intestinal transplant patients. CMV retinitis diagnosis should be made by indirect ophthalmoscopy. Potential risk to foetus; potential teratogen & carcinogen. May cause temporary or permanent spermatogenesis inhibition in males. Women of reproductive potential should use effective contraception during & at least 30 days after treatment. Males are advised to practice barrier contraception during & for at least 90 days after treatment. May affect tasks requiring alertness eg, ability to drive & operate machinery. Increase haematological monitoring in patients w/ renal impairment. Hepatic impairment. Pregnancy. Not recommended in childn. Elderly <65 yr.

Candida infections including oral candidiasis, upper resp tract infection; neutropenia, anemia; decreased appetite; headache; cough, dyspnea; diarrhea, nausea, vomiting, abdominal pain; dermatitis; pyrexia, fatigue. Sepsis, flu, UTI, celullitis; thrombocytopenia, leukopenia, pancytopenia; hypersensitivity; decreased wt; depression, confusional state, anxiety; insomnia, peripheral neuropathy, dizziness, paraesthesia, hypoaesthesia, seizures, dysgeusia; visual impairment, retinal detachment, vitreous floaters, eye pain, conjunctivitis, macular edema; ear pain; hypotension; dyspepsia, flatulence, upper abdominal pain, constipation, mouth ulceration, dysphagia, abdominal distention, pancreatitis; abnormal hepatic function, increased blood alkaline phosphatase, AST & ALT; night sweats, pruritus, rash, alopecia; back pain, myalgia, arthalgia, muscle spasms; renal impairment, decreased renal CrCl, increased blood creatinine; pain, chills, malaise, asthenia.

Seizures in patients concomitantly taking imipenem-cilastatin. May have enhanced toxicity w/ drugs that are myelosuppressive or associated w/ renal impairment eg, nucleoside analogues (eg, zidovudine, didanosine, stavudine), immunosuppressants (eg, ciclosporin, tacrolimus, mycophenolate mofetil), antineoplastic agents (eg, doxorubicin, vinblastine, vincristine, hydroxyurea) & anti-infectives (eg, trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine). Potential neutropenia & anemia w/ zidovudine. Raised plasma conc of didanosine. Decreased renal clearance w/ probenecid. May enhance toxicity when co-administered w/, or given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations eg, dapsone, pentamidine, flucytosine, vincristine, vinblastine, adriamycin, amphotericin B, trimethoprim/sulpha combinations, nucleoside analogues, hydroxyurea & pegylated interferons/ribavirin (w/ or w/o boceprevir or telaprevir).

Antivirals

J05AB14 - valganciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.