Nelfinavirdosage

See full prescribing information for administration instructions

Adults and adolescents 13 years and older (tablets): 1250 mg twice daily or 750 mg three times daily with a meal

Children 2 to less than 13 years (oral powder or 250 mg tablets): 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily with a meal. Refer to Tables 1 and 2 of the full prescribing information for specific dosing guidelines based on age and body weight

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.

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. 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 10 – 12 2 1 13 – 18 3 2 19 – 20 4 2 ≥21 4 – 5 For BID dosing, the maximum dose per day is 5 tablets BID 3 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 Twice daily (BID) 45 – 55 mg/kg Three times daily (TID) 25 – 35 mg/kg Kg Scoops of powder (50 mg/1 g) Teaspoons 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) 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 Use VIRACEPT 250 mg tablet 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 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.

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.