EPIVIR Solution (Oral)
Lamivudine
10mg/ml
GLAXOSMITHKLINE INC.
| Pack size | 240ml Bottle |
|---|---|
| Dispensing mode | POM |
| Source | CANADA |
| Agent | AL BAKER TRADING EST. |
| Retail Price | 220.50 AED |
Indications
EPIVIR Solution (Oral) is used for:
HIV infection, Chronic hepatitis B
Adult Dose
Oral
HIV infection
Adult: 150 mg bid or 300 mg once daily, in combination with other antiretrovirals.
Chronic hepatitis B
Adult: 100 mg once daily. For patients with concomitant HIV infection: 300 mg once daily or in 2 divided doses.
Child Dose
Oral
HIV infection
Child: 3 mth-12 yr: 4 mg/kg bid. Max: 300 mg/day.
Chronic hepatitis B
Child: >2 yr: 3 mg/kg once daily. Max: 100 mg/day.
Renal Dose
Oral
HIV infection
Renal impairment: Dialysis patients: Not recommended.
CrCl (ml/min)
30-49 1st dose 150 mg, then 150 mg once daily.
15-29 1st dose 150 mg, then 100 mg once daily.
5-14 1st dose 150 mg, then 50 mg once daily.
<5 1st dose 50 mg, then 25 mg once daily.
Chronic hepatitis B
Renal impairment: Haemodialysis patients: Dose adjustment in accordance with CrCl. Peritoneal dialysis patients: Not recommended.
CrCl (ml/min)
30-49 1st dose 100 mg, then 50 mg once daily.
15-29 1st dose 100 mg, then 25 mg once daily.
5-14 1st dose 35 mg, then 15 mg once daily.
<5 1st dose 35 mg, then 10 mg once daily.
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Lactation.
Precautions
Discontinue use if there is rapid increase in aminotransferase levels, progressive hepatomegaly, or metabolic or lactic acidosis of unknown origin. Discontinue use if clinical signs, symptoms or lab abnormalities suggestive of pancreatitis develop. Hepatomegaly or other risk factors for hepatic impairment. Monitor hepatic function in chronic hepatitis B patients. Exclude HIV infection prior to hepatitis B therapy. Renal impairment. Pregnancy.
Pregnancy-Lactation
Pregnancy
Available data from the APR show no difference in the overall risk of birth defects for lamivudine or zidovudine compared with background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population; APR uses the MACDP as the U.S. reference population for birth defects in the general population; MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks gestation; rate of miscarriage is not reported in the APR
Lactation
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection; lamivudine is present in human milk; there is no information on effects of lamivudine or zidovudine on breastfed infant or effects of drugs on milk production; because of potential for (1) HIV-1 transmission (in HIV-negative infants), (2)developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving therapy
Interactions
Renal excretion may be inhibited by high doses of trimethoprim (co-trimoxazole). May antagonise the antiviral action of zalcitabine.
Adverse Effects
Side effects of Lamivudine :
>10%
Cough, Diarrhea, Fatigue & malaise, Fever (peds), Headache, Musculoskeletal pain, Nausea, Nervous system neuropathy, Pancreatitis, Peripheral neuropathy, Nasal S/S, Vomiting
1-10%
Abdominal cramps, abdominal pain, Anorexia &/or decr appetite, Arthralgia, Chills, Depression, Dizziness, Dyspepsia, Insomnia, Myalgia, Rash, Thrombocytopenia, Creatine phosphokinase increased
Frequency Not Defined
Body fat redistribution, Elevated amylase, Neutropenia, Hepatitis B exacerbation
Potentially Fatal: Lactic acidosis associated with severe hepatomegaly and hepatic steatosis.
Mechanism of Action
Lamivudine, a nucleoside analogue, is phosphorylated in the body to the active triphosphate form. In the active form, it inhibits hepatitis B virus polymerase and HIV reverse transcriptase enzymes.
Note
EPIVIR 10mg/ml Solution (Oral) manufactured by GLAXOSMITHKLINE INC.. Its generic name is Lamivudine. EPIVIR is availble in United Arab Emirates.
Farmaco UAE drug index information on EPIVIR Solution (Oral) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.