rd gelatin, colored pink and black with "TAP" and "PREVACID 30" imprinted on the capsules. They are available as follows:
PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg, are white to yellowish white uncoated tablets with orange to dark brown speckles, with "15" debossed on one side of the tablet. The 30 mg are white to yellowish white uncoated tablets with orange to dark brown speckles, with "30" debossed on one side of the tablet. The tablets are available as follows:
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
[See FDA-Approved Patient Labeling]
Patient should be informed of the following:
Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.3)].
Information for Patients
PREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below [see Dosage and Administration (2.3)].
PREVACID should be taken before eating.
PREVACID products SHOULD NOT BE CRUSHED OR CHEWED.
Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.
Administration Options
1. PREVACID Delayed-Release Capsules – Oral Administration
PREVACID Delayed-Release Capsules should be swallowed whole.
Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows:
Open capsule.
Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
Swallow immediately.
PREVACID Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
Open capsule.
Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
Mix briefly.
Swallow immediately.
To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
PREVACID Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, PREVACID Delayed-Release Capsules can be administered as follows:
Open capsule.
Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
Inject through the nasogastric tube into the stomach.
Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
2. PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets
PREVACID SoluTab should not be broken or cut.
PREVACID SoluTab should not be chewed.
Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
The tablet typically disintegrates in less than 1 minute.
Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be del
