Emtricitabine & Tenofovir Disoproxil Fumarate Tablets 200/300

Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )

• Testing: Prior to or when initiating emtricitabine test for hepatitis B virus infection
• Emtricitabine may be taken without regard to food
• Adult Patients (18 years of age and older) : Emtricitabine capsules: One 200 mg capsule administered once daily orally
• Pediatric Patients (3 months through 17 years of age) : Emtricitabine capsules: For children weighing more than 33 kg who can
• Swallow an intact capsule, one 200 mg capsule administered once daily orally
• Dose interval adjustment in adult patients with renal impairment : a
• Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis
• Formulation Creatinine Clearance (mL/min) ≥50 mL/min 30–49 mL/min 15–29 mL/min

Emtricitabine Capsules, containing 200 mg of emtricitabine, are size '1' capsules with sky blue cap imprinted with "EMT" in black and white body imprinted with "200" in black. Capsules: 200 mg ( 3 )

• The safety and efficacy of FTC in patients between 3 months and 21 years of age is supported by data from three open-label, nonrandomized clinical trials in which FTC was administered to 169 HIV-1 infected treatment-naive and experienced (defined as virologically suppressed on a 3TC containing regimen for which FTC was substituted for 3TC) subjects [see Clinical Studies ]
• The pharmacokinetics of FTC were studied in 20
• Neonates born to HIV-1 positive mothers [see Clinical Studies ] . …

Clinical trials of emtricitabine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV Inform patients that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and hepatitis B virus (HBV) who have discontinued emtricitabine
• Advise patients not to discontinue emtricitabine without first informing their healthcare provider. …

• Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products
• Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products

The potential for drug interactions with emtricitabine has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling [see Clinical Pharmacology ( 12.3 )].

Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.2 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.3 ) 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before or when initiating emtricitabine [see Dosage and Administration ( 2.1 )]. …

The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions ( 5.1 )] . Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.2 )] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions ( 5.3 )] . Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Skin hyperpigmentation was very common (≥10%) in pediatric patients. …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. …

If overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether FTC can be removed by peritoneal dialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.