DOSAGE AND ADMINISTRATION
Recommended Dose
EMTRIVA may be taken without regard to food.
Adult Patients (18 years of age and older)
- EMTRIVA capsules: one 200 mg capsule administered once daily orally.
- EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.
Pediatric Patients (0–3 months of age)
- EMTRIVA oral solution: 3 mg/kg administered once daily orally.
Pediatric Patients (3 months through 17 years)
- EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally.
- EMTRIVA capsules: for children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.
Dose Adjustment in Adult Patients with Renal Impairment
Significantly increased drug exposures were seen when EMTRIVA was administered to patients with renal impairment [See Clinical Pharmacology]. Therefore, the dosing interval or dose of EMTRIVA should be adjusted in patients with baseline creatinine clearance <50 mL/min using the following guidelines (see Table 1). The safety and effectiveness of these dose adjustment guidelines have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients.
Table 1 Dose Adjustment in Adult Patients with Renal Impairment | Creatinine Clearance (mL/min) |
|---|
| Formulation | ≥50 mL/min | 30–49 mL/min | 15–29 mL/min | <15 mL/min
or on hemodialysisHemodialysis Patients: If dosing on day of dialysis, give dose after dialysis |
|---|
Capsule
(200 mg) | 200 mg every
24 hours | 200 mg every
48 hours | 200 mg every
72 hours | 200 mg
every
96 hours |
Oral Solution
(10 mg/mL) | 240 mg every
24 hours
(24 mL) | 120 mg every
24 hours
(12 mL) | 80 mg every
24 hours
(8 mL) | 60 mg every
24 hours
(6 mL) |
Although there are insufficient data to recommend a specific dose adjustment of EMTRIVA in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval similar to adjustments for adults should be considered.
DOSAGE FORMS AND STRENGTHS
EMTRIVA is available as capsules and oral solution.
EMTRIVA capsules, containing 200 mg of emtricitabine, are size 1 hard gelatin capsules with a blue cap and white body, printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body.
EMTRIVA oral solution is a clear, orange to dark orange liquid containing 10 mg of emtricitabine per mL.
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