Emtriva 200mg Information
Emtriva 200mg (Emtricitabine) Indications And Usage
EMTRIVA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Additional important information regarding the use of EMTRIVA for the treatment of HIV-1 Infection:
Emtriva 200mg (Emtricitabine) Dosage And Administration
Significantly increased drug exposures were seen when EMTRIVA was administered to patients with renal impairment . Therefore, the dosing interval or dose of EMTRIVA should be adjusted in patients with baseline creatinine clearance
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.
Emtriva 200mg (Emtricitabine) 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.
Emtriva 200mg (Emtricitabine) Contraindications
EMTRIVA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products.
Emtriva 200mg (Emtricitabine) Adverse Reactions
The following adverse reactions are discussed in other sections of the labeling:
Emtriva 200mg (Emtricitabine) Drug Interactions
The potential for drug interactions with EMTRIVA has been studied in combination with zidovudine, indinavir, stavudine, famciclovir, and tenofovir disoproxil fumarate. There were no clinically significant drug interactions for any of these drugs Drug interactions studies are described elsewhere in the labeling
Emtriva 200mg (Emtricitabine) Use In Specific Populations
Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1.
mothers should be instructed not to breast-feed if they are receiving EMTRIVA
The safety and efficacy of emtricitabine in patients between 3 months and 21 years of age is supported by data from three open-label, non-randomized clinical studies in which emtricitabine was administered to 169 HIV-1 infected treatment-naive and experienced (defined as virologically suppressed on a lamivudine containing regimen for which emtricitabine was substituted for lamivudine) subjects .
The pharmacokinetics of emtricitabine were studied in 20 neonates born to HIV-1-positive mothers . All neonates were HIV-1 negative at the end of the study; the efficacy of emtricitabine in preventing or treating HIV-1 could not be determined.
Emtriva 200mg (Emtricitabine) Overdosage
There is no known antidote for EMTRIVA. Limited clinical experience is available at doses higher than the therapeutic dose of EMTRIVA. In one clinical pharmacology study single doses of emtricitabine 1200 mg were administered to 11 patients. No severe adverse reactions were reported.
The effects of higher doses are not known. If overdose occurs the patient should be monitored for signs of toxicity, and standard supportive treatment applied as necessary.
Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.
Emtriva 200mg (Emtricitabine) Description
EMTRIVA is the brand name of emtricitabine, a synthetic nucleoside analog with activity against human immunodeficiency virus type 1 (HIV-1) reverse transcriptase.
The chemical name of emtricitabine is 5-fluoro-1-(2,5)-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position.
It has a molecular formula of CHFNOS and a molecular weight of 247.24. It has the following structural formula:
Emtricitabine is a white to off-white powder with a solubility of approximately 112 mg/mL in water at 25 °C. The log P for emtricitabine is -0.43 and the pKa is 2.65.
EMTRIVA is available as capsules or as an oral solution.
EMTRIVA capsules are for oral administration. Each capsule contains 200 mg of emtricitabine and the inactive ingredients, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone.
EMTRIVA oral solution is for oral administration. One milliliter (1 mL) of EMTRIVA oral solution contains 10 mg of emtricitabine in an aqueous solution with the following inactive ingredients: cotton candy flavor, FD&C yellow No. 6, edetate disodium, methylparaben, and propylparaben (added as preservatives), sodium phosphate (monobasic), propylene glycol, water, and xylitol (added as a sweetener). Sodium hydroxide and hydrochloric acid may be used to adjust pH.
Emtriva 200mg (Emtricitabine) Clinical Studies
In three open-label, non-randomized clinical studies, emtricitabine was administered to 169 HIV-1 infected treatment-naive and experienced (defined as virologically suppressed on a lamivudine containing regimen for which emtricitabine was substituted for lamivudine) patients between 3 months and 21 years of age. Patients received once-daily EMTRIVA oral solution (6 mg/kg to a maximum of 240 mg/day) or EMTRIVA capsules (a single 200 mg capsule once daily) in combination with at least two other antiretroviral agents.
Patients had a mean age of 7.9 years (range 0.3–21), 49% were male, 15% Caucasian, 61% Black and 24% Hispanic. Patients had a median baseline HIV-1 RNA of 4.6 log copies/mL (range 1.7–6.4) and a mean baseline CD4 cell count of 745 cells/mm (range 2–2650). Through 48 weeks of therapy, the overall proportion of patients who achieved and sustained an HIV-1 RNA
The pharmacokinetics of emtricitabine were studied in 20 neonates born to HIV-1-positive mothers. Each mother received prenatal and intrapartum combination antiretroviral therapy. Neonates received up to 6 weeks of zidovudine prophylactically after birth. The neonates were administered two short courses of emtricitabine oral solution (each 3 mg/kg once daily × 4 days) during the first 3 months of life. Emtricitabine exposures in neonates were similar to the exposures achieved in patients >3 months to 17 years During the two short dosing periods on emtricitabine there were no safety issues identified in the treated neonates. All neonates were HIV-1 negative at the end of the study; the efficacy of emtricitabine in preventing or treating HIV-1 could not be determined.
Emtriva 200mg (Emtricitabine) How Supplied/storage And Handling
Capsules
The size 1 hard gelatin capsules with a blue cap and white body contain 200 mg of emtricitabine, are printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body, and are available in unit of use bottles (closed with induction sealed child-resistant closures) of:
Oral Solution
The oral solution is a clear, orange to dark orange liquid, contains 10 mg/mL of emtricitabine, and is available in unit of use plastic, amber bottles ( closed with child resistant closures and packaged with a marked dosing cup) of:
Emtriva 200mg (Emtricitabine) Patient Counseling Information
Emtriva 200mg (Emtricitabine)
Emtriva 200mg (Emtricitabine)
