Recommended Dosage in Adult Patients

The recommended oral dosage of INTELENCE for adult patients is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The type of food does not affect the exposure to INTELENCE [see Clinical Pharmacology (12.3)] .

Recommended Dosage During Pregnancy

The recommended oral dosage of INTELENCE for pregnant individuals is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal [see Use in Specific Populations (8.1)] .

Recommended Dosage in Pediatric Patients (2 Years to Less Than 18 Years of Age)

The recommended dosage of INTELENCE for pediatric patients 2 years to less than 18 years of age and weighing at least 10 kg is based on body weight (see Table 1) not exceeding the recommended adult dosage. INTELENCE should be taken orally, following a meal. The type of food does not affect the exposure to INTELENCE [see Clinical Pharmacology (12.3)] .

Method of Administration

Instruct patients to swallow the INTELENCE tablet(s) whole with liquid such as water. Patients who are unable to swallow the INTELENCE tablet(s) whole may disperse the tablet(s) in water. Instruct the patient to do the following:

• place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication,
• stir well until the water looks milky,
• add approximately 15 mL (1 tablespoon) of liquid. Water may be used but other liquids, such as orange juice or milk, may improve taste. Patients should not place the tablets in orange juice or milk without first adding water. The use of warm (temperature greater than 104°F [greater than 40°C]) or carbonated beverages should be avoided.
• drink the mixture immediately,
• rinse the glass several times with orange juice, milk or water and completely swallow the rinse each time to make sure the patient takes the entire dose.