WARNINGS AND PRECAUTIONS

• Efavirenz/emtricitabine/tenofovir should not be used in children.
• If this medication used during the first trimester of pregnancy harm to the baby may occur.
• People who have shown strong hypersensitivity to efavirenz, should not take efavirenz/emtricitabine and tenofovir.
• Breastfeeding is contraindicated while on this medication.
• Some mentioned drugs are contraindicated include: ergot derivative drugs, voriconazole, benzodiazepines midazolam and triazolam, calcium channel blocker bepridil, cisapride, pimozide and Hypericum perforatum.
• People with liver or kidney problems who are taking medications associated with liver toxicity should be monitored liver function and should receive one tablet by mouth once a day.
• Need to monitor the liver function test prior and also while on the treatment in patients who carried underlying hepatic disease, including hepatitis B or C coinfection, marked transaminase elevations.
• Discontinue efavirenz emtricitabine tenofovir disoproxil fumarate in circumstances of development of severe rash.
• Tenofovir disoproxil fumarate increases didanosine concentrations. So use with caution and patient should be monitored for evidence of didanosine toxicity (pancreatitis, neuropathy) when coadministered.
• Teevir is not recommended for patients with moderate or severe hepatic impairment.
• In adults and also in pediatric patients with efavirenz, cases of convulsions have been observed. Generally, this observation is with known medical history of seizures. Caution should be taken in such patients who are with a history of seizures.
• Patients who are receiving concomitant anticonvulsant medications primarily metabolized by the liver, such as phenytoin and phenobarbital, may require periodic monitoring of plasma levels.