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2.1 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 Dosage and Administration (2.3)].
2.2 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 Dosage and Administration (2.3)].
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 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) Kg * For BID dosing, the maximum dose per day is 5 tablets BID † For TID dosing, the maximum dose per day is 3 tablets TID 10 – 12 2 1 13 – 18 3 2 19 – 20 4 2 ≥21 4 – 5* 3† Table 2: Dosing Table for Children 2 to less than 13 years of age (powder) Body weight Twice daily (BID)45 – 55 mg/kg Three times daily (TID)25 – 35 mg/kg * If a teaspoon is used to measure VIRACEPT oral powder, 1 level teaspoon contains 200 mg of VIRACEPT (4 level scoops equals 1 level teaspoon) † Use VIRACEPT 250 mg tablet 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 2¾ 7 1¾ 12 to <14 13 3¼ 8 2 14 to <16 15 3¾ 9 2¼ 16 to <18 Not recommended† Not recommended† 10 2½ 18 to <23 Not recommended† Not recommended† 12 3 ≥23 Not recommended† Not recommended† 15 3¾
2.3 Method of Administration
For Patients Unable to Swallow Viracept TabletsPlace 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 PowderMix 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.
2.4 Hepatic Impairment
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 (5.2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100 mg or two 200 mg tablets) three times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.
The 100 mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100 mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200 mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200 mg tablets are approximately one-third smaller in size than the 100 mg tablets.
RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics-Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.
Patients taking both RESCRIPTOR and antacids should be advised to take them at least one hour apart.
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