Emtriva 10 mg/mL

EMTRICITABINE · SOLUTION · Gilead Sciences, Inc.

1 Recall on Record

Plain English

Emtriva is a solution containing emtricitabine at 10 mg/mL, taken oral. Manufactured by Gilead Sciences, Inc..

Key Facts

Brand Name: Emtriva
Generic Name: EMTRICITABINE
NDC Code (Product): 61958-0602
Manufacturer: Gilead Sciences, Inc.
Strength: 10 mg/mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: NDA021896
Drug Class: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
Marketing Start: 09/28/2005

Recall History

1 Recall on Record

Class II10/01/2014

Gilead Sciences, Inc.

Defective Container; leaking around the cap

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug interaction656 reports

foetal exposure during pregnancy621 reports

anxiety432 reports

drug resistance431 reports

virologic failure404 reports

drug ineffective321 reports

immune reconstitution inflammatory syndrome299 reports

off label use265 reports

pain264 reports

emotional distress239 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Testing: Prior to or when initiating EMTRIVA test for hepatitis B virus infection. ( 2.1 ) EMTRIVA may be taken without regard to food. ( 2.2 ) Adult Patients (18 years of age and older) ( 2.3 ): 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) ( 2.4 ): EMTRIVA oral solution: 3 mg/kg administered once daily orally. Pediatric Patients (3 months through 17 years of age) ( 2.5 ): EMTRIVA capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally. EMTRIVA oral solution: 6 mg/kg up to a maximum of 240 mg (24 mL) administered once daily orally. Dose interval adjustment in adult patients with renal impairment ( 2.6 ): Creatinine Clearance (mL/min) Formulation ≥50 mL/min 30–49 mL/min 15–29 mL/min <15 mL/min or on hemodialysis Hemodialysis 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) 12…

Contraindications

4 CONTRAINDICATIONS EMTRIVA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. EMTRIVA is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS The potential for drug interactions with EMTRIVA 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) ].

Adverse Reactions

6 ADVERSE REACTIONS 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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials Experience in Adults More than 2,000 adult subjects with HIV-1 infecti…

Frequently Asked Questions

What is Emtriva used for?

Emtriva contains EMTRICITABINE. It is a solution taken oral. Consult your doctor for specific uses.

Is Emtriva a controlled substance?

Emtriva is not classified as a controlled substance by the DEA.

What is the generic name for Emtriva?

The generic name for Emtriva is EMTRICITABINE. There are 11 other brand versions of EMTRICITABINE.

What is the NDC code for Emtriva 10 mg/mL?

The NDC (National Drug Code) for Emtriva 10 mg/mL is 61958-0602, listed by Gilead Sciences, Inc..

Product NDC

61958-0602

Package NDC

61958-0602-1

Other Emtricitabine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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