Medically reviewed by Drugs.com. Last updated on Jan 25, 2021.
Generic name: LAMIVUDINE 300mg, TENOFOVIR DISOPROXIL FUMARATE 300mg
Dosage form: tablet, film coated
2.1 Testing Prior to Initiation and During Treatment with TEMIXYS
Prior to initiation treatment with TEMIXYS, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].
Prior to initiation and during use of TEMIXYS, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.2)].
Recommended Dose for Adult and Pediatric Patients Weighing at Least 35 kg
TEMIXYS is a two-drug fixed-dose combination product containing 300 mg of lamivudine (3TC) and 300 mg of tenofovir disoproxil fumarate (TDF). The recommended dosage of TEMIXYS in HIV-1 infected adult and pediatric patients weighing at least 35 kg is one tablet taken orally once daily with or without food.
Not Recommended in Renal Impairment
Because TEMIXYS is a fixed-dose combination formulation and cannot be dose adjusted, it is not recommended for patients with impaired renal function (creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis [see Use in Specific Population (8.6)].
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