PREVACID Delayed-release capsule / Delayed-release tablet Ref.[10609] Active ingredients: Lansoprazole

2.1 Recommended Adult Dosage by Indication

^* Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renallyimpaired patients.
^† Controlled studies did not extend beyond indicated duration.
^‡ For patients who do not heal with PREVACID or PREVACID SoluTab for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis, an additional eight week course of PREVACID or PREVACID SoluTab may be considered.
^§ Controlled studies did not extend beyond 12 months.
^¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with PREVACID for more than four years.

2.2 Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of Age

In clinical studies, PREVACID was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if PREVACID is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [see Use in Specific Populations (8.4)].

Pediatric Patients 12 to 17 Years of Age

2.3 Hepatic Impairment

The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in Specific Populations (8.6)].

2.4 Important Administration Information

• Take PREVACID or PREVACID SoluTab before meals.
• Do not crush or chew PREVACID capsule or PREVACID SoluTab.
• Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate [see Drug Interactions (7)].
• Antacids may be used concomitantly with PREVACID or PREVACID SoluTab.
• Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.

PREVACID capsules:

• Swallow whole; do not chew.
• For patients who have difficulty swallowing capsules, PREVACID capsules can be opened and administered orally or via a nasogastric tube in the soft foods or liquids specified below.
• Administration of PREVACID in foods or liquids other than those discussed below have not been studied clinically and therefore are not recommended.

Administration in Soft Foods (applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears):Administration in Liquids (apple juice, orange juice or tomato juice): Administration with Apple Juice Through a Nasogastric Tube (≥16 French)

1. Open capsule.
2. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
3. Swallow immediately.
4. Open capsule.
5. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces).
6. Mix briefly.
7. Swallow immediately.
8. To ensure complete delivery of the dose, rinse the glass with two or more volumes of juice and swallow the contents immediately.
9. Open capsule.
10. Sprinkle intact granules into 40 mL of apple juice.
11. Mix briefly.
12. Using a catheter tipped syringe, draw up the mixture.
13. Inject through the nasogastric tube into the stomach.
14. Flush with additional apple juice to clear the tube.

PREVACID SoluTab:

• Do not break or cut.
• Place the tablet on the tongue, allow it to disintegrate, with or without water, until the microgranules can be swallowed. Do not chew the microgranules.
• The tablet typically disintegrates in less than one minute.
• Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be administered with water via oral syringe or NG tube as follows:

Administration with Water in an Oral Syringe Administration with Water via a NG Tube (≥8 French)

1. Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
2. Shake gently to allow for a quick dispersal.
3. After the tablet has dispersed, administer the contents within 15 minutes of mixing into the mouth. Do not save the water and microgranule mixture for later use.
4. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.
5. Place a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or place a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water.
6. Shake gently to allow for a quick dispersal.
7. After the tablet has dispersed, shake the catheter-tip syringe gently in order to keep the microgranules from settling, and immediately inject the mixture through the NG tube into the stomach within 15 minutes of mixing. Do not save the water and microgranule mixture for later use.
8. Refill the catheter-tip syringe with approximately 5 mL of water, shake gently, and flush the tube.

Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of PREVACID with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.

In the event of over-exposure, 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 over-exposure.

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