Emtricitabine and Tenofovir Alafenamide Tablets (Descovy) is an innovative fixed-dose combination antiretroviral preparation, composed of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF).
What Kind of Medication is Emtricitabine and Tenofovir Alafenamide Tablets (Descovy)?
Drug Category and Composition
Emtricitabine and Tenofovir Alafenamide Tablets is a fixed-dose combination product containing two HIV nucleoside reverse transcriptase inhibitors (NRTIs): Emtricitabine (FTC) and Tenofovir Alafenamide (TAF).
Among them, Emtricitabine is a synthetic cytosine nucleoside analog, while Tenofovir Alafenamide is a phosphonoamidate prodrug of Tenofovir.
Main Application Areas
Emtricitabine and Tenofovir Alafenamide Tablets are mainly used in two areas: treatment of HIV-1 infection and HIV-1 pre-exposure prophylaxis (PrEP).
When used for the treatment of HIV-1 infection, it must be administered in combination with other antiretroviral drugs.
Specifications and Properties of Emtricitabine and Tenofovir Alafenamide Tablets (Descovy)
200 mg/25 mg Tablets
Each tablet contains 200 mg of Emtricitabine and 25 mg of Tenofovir Alafenamide, which is equivalent to 28 mg of Tenofovir Alafenamide Fumarate.
The tablets are blue, rectangular film-coated tablets, engraved with "GSI" on one side and "225" on the other side.
120 mg/15 mg Tablets
Each tablet contains 120 mg of Emtricitabine and 15 mg of Tenofovir Alafenamide, which is equivalent to 16.8 mg of Tenofovir Alafenamide Fumarate.
The tablets are white, round film-coated tablets, engraved with "GSI" on one side and "15" on the other side.
Active Ingredients
Emtricitabine (FTC): Its chemical name is 4-amino-5-fluoro-1-[(2R-hydroxymethyl-1,3-oxathiolan-5S-yl)]-(1H)-pyrimidin-2-one. The molecular formula is C₈H₁₀FN₃O₃S, and the molecular weight is 247.24.
It appears as a white to off-white powder, with a solubility of approximately 112 mg/mL in water.
Excipients Composition: The tablet core contains croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
Film-Coating Materials
The 200 mg/25 mg tablets use coating materials containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
The 120 mg/15 mg tablets adopt a coating system containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.
Storage Methods for Emtricitabine and Tenofovir Alafenamide Tablets (Descovy)
Standard Storage Conditions
Emtricitabine and Tenofovir Alafenamide Tablets must be stored at 25°C (77°F), with a permitted short-term fluctuation range of 15°C to 30°C (59°F to 86°F).
Packaging Characteristics
The medication is packaged in child-resistant designs, available in two forms: bottle packaging and blister packaging, each containing 30 tablets.
Bottle Packaging Features: Includes a silica gel desiccant, a polyester coil, and a child-resistant cap. The bottle must be kept tightly closed to ensure the stability of the medication.
Blister Packaging Features: Sealed with child-safe laminated foil lidding material. Each blister cavity contains a cut-to-size desiccant film, which is heat-staked to the foil lidding material.
Special Precautions
Emtricitabine and Tenofovir Alafenamide Tablets must be stored in their original container; transfer to other containers is prohibited.
The medication should be placed out of the reach of children to prevent accidental ingestion.
Only the original container should be used when dispensing the medication.
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