PRILOSEC - Dosage Omeprazole magnesium

PRILOSEC (omeprazole magnesium granule, delayed release) comes in different strengths and amounts, which is referred to as the dosing of PRILOSEC. The appearance of PRILOSEC can differ based on the dosing. Your doctor may change the dosage and prescription of PRILOSEC to get you the best results possible.

Dosage & Administration

recommended adult dosage regimen by indication

Table 1 shows the recommended dosage of PRILOSEC in adult patients by indication.

Table 1: Recommended Dosage Regimen of PRILOSEC in Adults by Indication
Indication	Dosage of PRILOSEC	Treatment Duration
Treatment of Active Duodenal Ulcer	20 mg once daily	4 weeks Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence	Triple Therapy PRILOSEC 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg Take all three drugs twice daily	10 days In patients with an ulcer present at the time of initiation of therapy, continue PRILOSEC 20 mg once daily for an additional 18 days for ulcer healing and symptom relief.
	Dual Therapy PRILOSEC 40 mg once daily Clarithromycin 500 mg three times daily	14 days In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief.
Active Benign Gastric Ulcer	40 mg once daily	4 to 8 weeks
Treatment of Symptomatic GERD	20 mg once daily	Up to 4 weeks
Treatment of EE due to Acid-Mediated GERD	20 mg once daily	4 to 8 weeks 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.
Maintenance of Healing of EE due to Acid-Mediated GERD	20 mg once daily Dosage reduction to 10 mg once daily is recommended for patients with hepatic impairment (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of healing of EE [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3, 12.5)].	Controlled studies do not extend beyond 12 months.
Pathological Hypersecretory Conditions	Starting dose is 60 mg once daily; adjust to patient needs Daily dosages of greater than 80 mg should be administered in divided doses. Dosages up to 120 mg three times daily have been administered.	As long as clinically indicated. Some patients with Zollinger-Ellison syndrome have been treated continuously for more than 5 years.

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
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 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.
		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

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.

Dosage Form & 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.

Overdosage

Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [see Adverse Reactions (6)]. Symptoms were transient, and no serious clinical outcome has been reported when PRILOSEC was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, 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.

Storage & Handling

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. They are supplied as follows:

NDC 0186-0606-31 unit of use bottles of 30

PRILOSEC delayed-release capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows:

NDC 0186-0742-31 unit of use bottles of 30

NDC 0186-0742-82 bottles of 1000

PRILOSEC delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:

NDC 0186-0743-31 unit of use bottles of 30

NDC 0186-0743-68 bottles of 100

PRILOSEC for delayed-release oral suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows:

NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets

NDC 0186-0610–01 unit dose packages of 30: 10 mg packets

Storage

Store PRILOSEC delayed-release capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

Store PRILOSEC for delayed-release oral suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature.]

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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