Combivir

Combivir

lamivudine + zidovudine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Lamivudine 150 mg, zidovudine 300 mg
Indications/Uses
Antiretroviral combination therapy for the treatment of HIV infection.
Dosage/Direction for Use
Adult & childn at least 30 kg 1 tab bd. Childn 21-30 kg ½ tab in the morning & 1 tab in the evening; 14-21 kg ½ tab bd.
Administration
May be taken with or without food: Swallow whole, do not crush. For patients w/ swallowing difficulties, tab may be crushed & added to small amount of semi-solid food or liqd then consume immediately.
Contraindications
Hypersensitivity. Abnormally low neutrophil counts (<0.75 x 109/L) or low Hb levels (<7.5 g/dL or 4.65 mmol/L).
Special Precautions
Opportunistic infections may continue to develop. Haematological adverse reactions eg, anaemia, neutropenia, leucopenia. Carefully monitor haematological parameters. Caution when administering in patient (particularly obese women) w/ hepatomegaly, hepatitis or other known risk factors for liver disease & hepatic steatosis. Mitochondrial dysfunction in HIV-negative infants exposed in utero &/or post-natally to nucleoside analogues. Risk of lipoatrophy; regularly assess for signs of lipoatrophy during therapy. Increase in wt & levels of blood lipids & glucose may occur. Increased risk of severe & potentially fatal hepatic adverse events in patients w/ chronic hepatitis B or C treated w/ combination antiretroviral therapy. Immediately stop treatment if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur. Immune reactivation syndrome. Osteonecrosis. Avoid concomitant use w/ stavudine. Not recommended w/ concomitant use of ribavirin or cladribine. Should not be taken w/ any other medicinal products containing lamivudine or medicinal products containing emtricitabine. Patients w/ renal & hepatic impairment. Pregnancy & lactation. Elderly.
Adverse Reactions
Headache; nausea, vomiting, abdominal pain or cramps, diarrhoea; malaise. Lamivudine: Insomnia; cough, nasal symptoms; rash, alopecia; arthralgia, muscle disorders; fatigue, fever. Zidovudine: Anaemia, neutropenia, leucopenia; dizziness; raised blood levels of liver enzymes & bilirubin; myalgia. Cases of lactic acidosis, associated w/ severe hepatomegaly & hepatic steatosis.
Drug Interactions
Lamivudine: Increased AUC w/ trimethoprim & sulfamethoxazole. Potential risk of cladribine loss of efficacy. Decreased AUC & Cmax w/ sorbitol soln (3.2 g, 10.2 g, 13.4 g). Zidovudine: Increased risk of anaemia w/ ribavirin. Decreased efficacy of both zidovudine & stavudine. Increased AUC w/ atovaquone, fluconazole, valproic acid, methadone, probenecid. Altered phenytoin conc. Decreased AUC w/ clarithromycin, rifampicin.
MIMS Class
Antivirals
ATC Classification
J05AR01 - zidovudine and lamivudine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Combivir film-coated tab
Packing/Price
60's
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