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COMPLERA Access
Overview
What is COMPLERA Access?
COMPLERA is a fixed-dose combination tablet containing emtricitabine, rilpivirine hydrochloride, and tenofovir DF. EMTRIVA is the brand name for emtricitabine, a synthetic nucleoside analog of cytidine. Edurant is the brand name for rilpivirine, a non-nucleoside reverse transcriptase inhibitor. VIREAD is the brand name for tenofovir DF, which is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. VIREAD and EMTRIVA are the components of TRUVADA.
COMPLERA tablets are for oral administration. Each tablet contains 200 mg of emtricitabine, 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of rilpivirine), and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablets are film coated with a coating material containing hypromellose, lactose monohydrate, triacetin and titanium dioxide.
What does COMPLERA Access look like?
What are the available doses of COMPLERA Access?
Tablets: 200 mg of emtricitabine, 25 mg of rilpivirine, and 300 mg of tenofovir disoproxil fumarate. ()
What should I talk to my health care provider before I take COMPLERA Access?
How should I use COMPLERA Access?
COMPLERA™, a combination of two nucleoside analog HIV-1 reverse transcriptase inhibitors (NRTIs) (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (NNRTI) (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).
Additional monitoring of HIV-1 RNA and regimen tolerability is recommended after replacing therapy to assess for potential virologic failure or rebound.
The recommended dose of COMPLERA in patients 12 years of age and older and weighing at least 35 kg is one tablet taken orally once daily with food
What interacts with COMPLERA Access?
Sorry No Records found
What are the warnings of COMPLERA Access?
Sorry No Records found
What are the precautions of COMPLERA Access?
Sorry No Records found
What are the side effects of COMPLERA Access?
Sorry No records found
What should I look out for while using COMPLERA Access?
COMPLERA should not be coadministered with the following drugs, as significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to COMPLERA or to the class of NNRTIs :
COMPLERA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of COMPLERA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA or VIREAD, which are components of COMPLERA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue COMPLERA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
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What might happen if I take too much COMPLERA Access?
If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with COMPLERA consists of general supportive measures, including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
How should I store and handle COMPLERA Access?
Topiramate Tablets USP should be stored in tightly-closed containers at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.COMPLERA tablets are white, capsule shaped, film coated and debossed with "GSI" on both sides. Each bottle contains 30 tablets, a silica gel desiccant, and a polyester fiber coil, and is closed with a child-resistant closure.
