"The US Food and Drug Administration (FDA) has approved Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF; 25 mg), the company announced.
DOSAGE AND ADMINISTRATION
Adults And Adolescents (13 Years and Older)
The recommended dose is 1250 mg (five 250 mg tablets or two 625 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. VIRACEPT should be taken with a meal. Patients unable to swallow the 250 or 625 mg tablets may dissolve the tablets in a small amount of water [see Method of Administration].
Pediatric Patients (2 to Less than 13 Years)
In children 2 years of age and older, the recommended oral dose of VIRACEPT Oral Powder or 250 mg tablets is 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily. All doses should be taken with a meal. Doses higher than the adult maximum dose of 2500 mg per day have not been studied in children.
For children unable to swallow tablets, VIRACEPT 250 mg tablet(s) may be dissolved in a small amount of water or, VIRACEPT Oral Powder may be administered [see Method of Administration].
The healthcare provider should assess appropriate formulation and dosage for each patient. Tables 1 and 2 provide dosing guidelines for VIRACEPT tablets and powder based on age and body weight.
Table 1: Dosing Table for Children 2 to less than 13
years of age (tablets)
|Body weight Kg||Twice daily (BID) 45 - 55 mg/kg ≥ 2 years||Three times daily (TID) 25 - 35 mg/kg ≥ 2 years|
|Number of tablets (250 mg)||Number of tablets (250 mg)|
|10 - 12||2||1|
|13 - 18||3||2|
|19 - 20||4||2|
|≥ 21||4 - 5*||3†|
|* For BID dosing, the maximum dose per day is 5 tablets BID
† For TID dosing, the maximum dose per day is 3 tablets TID
Table 2: Dosing Table for Children 2 to less than 13
years of age (powder)
|Body weight Kg||Twice daily (BID) 45 - 55 mg/kg||Three times daily (TID) 25 - 35 mg/kg|
|Scoops of powder (50 mg/1 g)||Teaspoons* of powder||Scoops of powder (50 mg/1 g)||Teaspoons* of powder|
|9.0 to < 10.5||10||2½||6||1½|
|10.5 to < 12||11||2 3/4||7||1 3/4|
|12 to < 14||13||3 1/4||8||2|
|14 to < 16||15||3%||9||2%|
|16 to < 18||Not recommended†||Not recommended†||10||2½|
|18 to < 23||Not recommended†||Not recommended†||12||3|
|≥ 23||Not recommended†||Not recommended†||15||3 3/4|
|* If a teaspoon is used to measure VIRACEPT oral powder,
1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level
† Use VIRACEPT 250 mg tablet
Method Of Administration
For Patients Unable to Swallow Viracept Tablets
- Place VIRACEPT tablet(s) in small amount of water.
- Once dissolved, mix the cloudy liquid well, and consume it immediately.
- The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed.
Viracept Oral Powder
- Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements
- Once mixed, the entire contents must be consumed in order to obtain the full dose.
- If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
- Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste.
- VIRACEPT Oral Powder should not be reconstituted with water in its original container.
VIRACEPT can be used in patients with mild hepatic impairment without any dose adjustment. VIRACEPT should not be used in patients with either moderate or severe hepatic impairment [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
VIRACEPT 250 mg Tablet: Light-blue, capsule-shaped tablets with a clear film coating engraved with “VIRACEPT” on one side and “250 mg” on the other.
VIRACEPT 625 mg Tablet: White oval tablet with a clear film coating engraved with “V” on one side and “625” on the other.
VIRACEPT Oral Powder: Off-white powder containing 50 mg (as nelfinavir-free base) in each level scoopful (1 gram).
Storage And Handling
VIRACEPT (nelfinavir mesylate) 250 mg: Light-blue, capsule-shaped tablets with a clear film coating engraved with “VIRACEPT” on one side and “250 mg” on the other.
Bottles of 300 (250 mg) tablets – NDC 63010-010-30
VIRACEPT (nelfinavir mesylate) 625 mg: White oval tablet with a clear film coating engraved with “V” on one side and “625” on the other.
Bottles of 120 (625 mg) tablets – NDC 63010-027-70
VIRACEPT (nelfinavir mesylate) Oral Powder is available as a 50 mg/g off-white powder containing 50 mg (as nelfinavir free base) in each level scoopful (1 gram).
Multiple use bottles of 144 grams of powder with scoop …….NDC 63010-011-90
VIRACEPT tablets and oral powder should be stored at 15° to 30°C (59° to 86°F).
Keep container tightly closed. Dispense in original container.
Distributed by: ViiV Healthcare Company, Research Triangle Park, NC 27709. Revised: March 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/27/2015
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