PRILOSEC (Page 2 of 13)

2.2 Recommended Pediatric Dosage Regimen by Indication

Table 2 shows the recommended dosage of PRILOSEC in pediatric patients by indication.

Table 2: Recommended Dosage Regimen of PRILOSEC in Pediatric Patients by Indication
*
The efficacy of PRILOSEC used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of PRILOSEC may be considered.

Indication

PRILOSEC Dosage Regimen and Duration

Patient Age

Weight-Based Dose (mg)

Regimen and Duration

Treatment of Symptomatic GERD

1 to 16 years

5 to less than 10 kg: 5 mg

Once daily for up to 4 weeks

10 to less than 20 kg: 10 mg

20 kg and greater: 20 mg

Treatment of EE due to Acid-Mediated GERD

1 to 16 years

5 to less than 10 kg: 5 mg

Once daily for 4 to 8 weeks *

10 to less than 20 kg: 10 mg

20 kg and greater: 20 mg

1 month to less than 1 year

3 to less than 5 kg: 2.5 mg

Once daily up to 6 weeks

5 to less than 10 kg: 5 mg

10 kg and greater: 10 mg

Maintenance of Healing of EE due to Acid-Mediated GERD

1 to 16 years

5 to less than 10 kg: 5 mg

Once daily. Controlled studies do not extend beyond 12 months

10 to less than 20 kg: 10 mg

20 kg and greater: 20 mg

2.3 Administration Instructions

Take PRILOSEC before meals.
Antacids may be used concomitantly with PRILOSEC.
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.

PRILOSEC Delayed-Release Capsules

Swallow PRILOSEC delayed-release capsules whole; do not chew.
For patients unable to swallow an intact capsule, PRILOSEC delayed-release capsules can be opened and administered as follows:
1.
Place one tablespoon of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2.
Open the capsule.
3.
Carefully empty all of the pellets inside the capsule on the applesauce.
4.
Mix the pellets with the applesauce.
5.
Swallow applesauce and pellets immediately with a glass of cool water to ensure complete swallowing of the pellets. Do not chew or crush the pellets. Do not save the applesauce and pellets for future use.

PRILOSEC For Delayed-Release Oral Suspension

PRILOSEC for delayed-release oral suspension is intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube.

Oral Administration in Water

1.
Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
2.
Empty the contents of a 10 mg packet into a container containing 15 mL of water.
3.
Stir
4.
Leave 2 to 3 minutes to thicken.
5.
Stir and drink within 30 minutes.
6.
If any material remains after drinking, add more water, stir and drink immediately.

Administration with Water via a NG or Gastric Tube (Size 6 or Larger)

1.
Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering through a nasogastric tube or gastric tube.
2.
Immediately shake the syringe and leave 2 to 3 minutes to thicken.
3.
Shake the syringe and inject through the nasogastric or gastric tube into the stomach within 30 minutes.
4.
Refill the syringe with an equal amount of water.
5.
Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.

3 DOSAGE FORMS AND STRENGTHS

PRILOSEC Delayed-Release Capsules

10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body.
20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on the body.
40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body.

PRILOSEC For Delayed-Release Oral Suspension

2.5 mg and 10 mg unit dose packets containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules.

4 CONTRAINDICATIONS

PRILOSEC is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [see Warnings and Precautions (5.2),Adverse Reactions (6)].
Proton pump inhibitors (PPIs), including PRILOSEC, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PRILOSEC, refer to the CONTRAINDICATIONS section of their package inserts.

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with PRILOSEC does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

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