Tenof EM

Tenof EM

tenofovir + emtricitabine

Manufacturer:

Camber

Distributor:

Camber
Concise Prescribing Info
Contents
Emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg
Indications/Uses
HIV-1 infection in adults in combination w/ other antiretroviral agents (eg, NNRTIs or PIs).
Dosage/Direction for Use
1 tab once daily. Patients w/ CrCl ≥50 mL/min 1 tab every 24 hr, 30-49 mL/min 1 tab every 48 hr.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue in case of lactic acidosis & severe hepatomegaly w/ steatosis. Patients w/ known risk factors for liver disease. Perform test for presence of chronic HBV prior to treatment. Closely monitor hepatic function in patients who have discontinued treatment & are co-infected w/ HIV & HBV for several mth. Initiate anti-hepatitis B therapy, if needed. Avoid concomitant use w/ nephrotoxic agents. Decrease bone mineral density. May cause fat redistribution including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral/facial wasting, breast enlargement & "Cushingoid appearance". Immune reconstitution syndrome. Renal impairment. Pregnancy & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Abnormal dreams, depression, dizziness, fatigue, headache, insomnia, somnolence; rash; diarrhea, nausea, vomiting; nasopharyngitis, sinusitis, upper resp tract.
Drug Interactions
Increased tenofovir AUC & Cmax w/ atazanavir. Increased tenofovir Cmax w/ indinavir. Increased tenofovir AUC w/ lopinavir/ritonavir. Increase Cmax of abacavir. Serum conc may be increased w/ drugs that reduce renal function (eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir). May increase Cmax & AUC of didanosine. Decrease Cmax of lamivudine. Increase Cmax & AUC of zidovudine.
MIMS Class
Antivirals
ATC Classification
J05AR03 - tenofovir disoproxil and emtricitabine ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Tenof EM FC tab 200 mg/300 mg
Packing/Price
30's;60's
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