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The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV"...
(darunavir) Tablets and Oral Suspension
PREZISTA (darunavir), in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)hexahydrofuro[2,3-b]furan-3-yl ester monoethanolate. Its molecular formula is C27H37N3O7S• C2H5OH and its molecular weight is 593.73. Darunavir ethanolate has the following structural formula:
Darunavir ethanolate is a white to off-white powder with a solubility of approximately 0.15 mg/mL in water at 20°C.
PREZISTA 100 mg/mL oral suspension is available as a white to off-white opaque suspension for oral administration.
PREZISTA 75 mg tablets are available as white, caplet-shaped, film-coated tablets for oral administration.
PREZISTA 150 mg tablets are available as white, oval-shaped, film-coated tablets for oral administration.
PREZISTA 600 mg tablets are available as orange, oval-shaped, film-coated tablets for oral administration.
PREZISTA 800 mg tablets are available as dark red, oval-shaped, film-coated tablets for oral administration.
Each mL of the oral suspension contains darunavir ethanolate equivalent to 100 mg darunavir. In addition, each mL contains the inactive ingredients hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment) and purified water.
Each 75 mg tablet contains darunavir ethanolate equivalent to 75 mg of darunavir. Each 150 mg tablet contains darunavir ethanolate equivalent to 150 mg of darunavir. Each 600 mg tablet contains darunavir ethanolate equivalent to 600 mg of darunavir. Each 800 mg tablet contains darunavir ethanolate equivalent to 800 mg of darunavir. During storage, partial conversion from ethanolate to hydrate may occur; however, this does not affect product quality or performance. Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. The 800 mg tablet also contains hypromellose. The 75 and 150 mg tablet film coating, OPADRY® White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 600 mg tablet film coating, OPADRY® Orange, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film coating, OPADRY® Dark Red, contains iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.
All dosages for PREZISTA are expressed in terms of the free form of darunavir.
What are the possible side effects of darunavir (Prezista)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using darunavir and call your doctor at once if you have:
- the first sign of any skin rash, no matter how mild;
- signs of a new infection, such as fever or chills, cough, flu symptoms, easy bruising or bleeding;
- increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
- diarrhea, unexplained weight loss, menstrual changes, impotence, loss of...
What are the precautions when taking darunavir (Prezista)?
Before taking darunavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Since darunavir must be taken with ritonavir, tell your doctor if you are allergic to ritonavir. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C), diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,...
Last reviewed on RxList: 4/18/2014
This monograph has been modified to include the generic and brand name in many instances.
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