ACIPHEX SPRINKLE Delayed-release capsule Ref.[10531] Active ingredients: Rabeprazole

2.1 Dosage Regimen

ACIPHEX Sprinkle is recommended for up to 12 weeks in pediatric patients 1 to 11 years of age and is dosed by body weight:

• Less than 15 kg: 5 mg once daily with the option to increase to 10 mg once daily, if inadequate response.
• 15 kg or more: 10 mg once daily.

2.2 Administration Recommendations

• Take the dose 30 minutes before a meal.
• Do not swallow the capsule whole.
• Open a capsule and sprinkle entire contents on a small amount of soft food (e.g., applesauce, fruit or vegetable based baby food, or yogurt) or empty contents into a small amount of liquid (e.g., infant formula, apple juice, or pediatric electrolyte solution). Food or liquid should be at or below room temperature.
• Do not chew or crush the granules.
• Take the entire dose within 15 minutes of preparation.
• Do not store mixture for future use.
• Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take 2 doses at the same time.

Seven reports of accidental overdosage with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole once daily. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable.

In the event of overdosage, treatment should be symptomatic and supportive.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.