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Omeprazole Dosage

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Usual Adult Dose for Duodenal Ulcer

20 mg orally once a day before a meal. Most patients heal within 4 to 8 weeks.

Usual Adult Dose for Helicobacter pylori Infection

Dual therapy: omeprazole 40 mg orally once a day in the morning plus clarithromycin 500 mg orally 3 times a day on days 1 to 14. Beginning on day 15, omeprazole 20 mg orally once a day in the morning on days 15 to 28.

Triple therapy: omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg all given orally twice a day for 10 days. If an ulcer is present at the initiation of therapy, continue omeprazole 20 mg orally once a day for an additional 18 days.

Study (n=294) - Canadian Adult Dyspepsia Empiric Treatment-Helicobacter pylori positive (CADET-Hp): omeprazole 20 mg, metronidazole 500 mg, and clarithromycin 500 mg, twice daily for 7 days.

Usual Adult Dose for Gastric Ulcer

40 mg orally once a day before a meal for 4 to 8 weeks.

Usual Adult Dose for Erosive Esophagitis

20 mg orally once a day before a meal. This dosage may be increased to 40 mg per day based on desired clinical response and patient tolerance. Studies have been completed up to 12 months for maintenance therapy of erosive esophagitis.

Usual Adult Dose for Zollinger-Ellison Syndrome

Initial: 60 mg orally once a day. Dosage should be individualized to patient's needs.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.

Usual Adult Dose for Gastroesophageal Reflux Disease

Initial: 20 mg orally once a day before a meal for 4 to 8 weeks. This dosage may be increased to 40 mg per day if needed.

Maintenance: long-term treatment with doses of 10 to 20 mg per day may be required for maintenance therapy of refractory disease and appears to be safe.

Usual Adult Dose for Multiple Endocrine Adenomas

Initial: 60 mg orally once a day before a meal. This dosage may be titrated based on desired clinical response and patient tolerance.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.

Usual Adult Dose for Systemic Mastocytosis

Initial: 60 mg orally once a day before a meal. This dosage may be titrated based on desired clinical response and patient tolerance.

Maintenance: doses up to 120 mg 3 times a day have been administered. Daily doses greater than 80 mg should be divided.

Usual Adult Dose for Dyspepsia

Prevention of frequent heartburn: 20 mg orally once daily, before a meal, for 14 days.

Usual Pediatric Dose for Erosive Esophagitis

Oral:
Infants:
GERD: 0.7 mg/kg/dose once daily reduced the percentage of time gastric and esophageal pH less than 4, as well as the number of reflux episodes in 10 neonates [mean PMA: 36.1 weeks, (34 to 40 weeks)] in a trial. Higher doses of 1 to 1.5 mg/kg/day have been reported

Children and Adolescents 1 to 16 years:
GERD, ulcers, esophagitis:
Manufacturer recommendations:
5 kg to less than 10 kg: 5 mg once daily
10 kg to less than or equal to 20 kg: 10 mg once daily
Greater than 20 kg: 20 mg once daily

Alternate dosing:
Children 1 to 16 years:
1 mg/kg/dose once or twice daily

Adjunctive therapy of duodenal ulcers associated with Helicobacter pylori (in combination with antibiotic therapy either clarithromycin or clarithromycin and amoxicillin) in children:
15 to 30 kg: 10 mg twice daily
Greater than 30 kg: 20 mg twice daily

Comment: The safety and efficacy of omeprazole use in patients less than 1 year of age and for pediatric uses other than the treatment of GERD and maintenance of healing of erosive esophagitis has not been established.

Usual Pediatric Dose for Gastroesophageal Reflux Disease

Oral:
Infants:
GERD: 0.7 mg/kg/dose once daily reduced the percentage of time gastric and esophageal pH less than 4, as well as the number of reflux episodes in 10 neonates [mean PMA: 36.1 weeks, (34 to 40 weeks)] in a trial. Higher doses of 1 to 1.5 mg/kg/day have been reported

Children and Adolescents 1 to 16 years:
GERD, ulcers, esophagitis:
Manufacturer recommendations:
5 kg to less than 10 kg: 5 mg once daily
10 kg to less than or equal to 20 kg: 10 mg once daily
Greater than 20 kg: 20 mg once daily

Alternate dosing:
Children 1 to 16 years:
1 mg/kg/dose once or twice daily

Adjunctive therapy of duodenal ulcers associated with Helicobacter pylori (in combination with antibiotic therapy either clarithromycin or clarithromycin and amoxicillin) in children:
15 to 30 kg: 10 mg twice daily
Greater than 30 kg: 20 mg twice daily

Comment: The safety and efficacy of omeprazole use in patients less than 1 year of age and for pediatric uses other than the treatment of GERD and maintenance of healing of erosive esophagitis has not been established.

Renal Dose Adjustments

No adjustments recommended

Liver Dose Adjustments

The manufacturer recommends dose adjustments in patients with hepatic impairment, specially where maintenance of healing of erosive esophagitis is needed.

Dose Adjustments

The manufacturer recommends dose adjustments in Asian patients, especially where maintenance of healing of erosive esophagitis is needed.

For the over-the-counter product, the manufacturer advises not to use drug for more than 14 days in a row. And, a 14-day course can be repeated only every 4 months.

Precautions

Symptomatic relief does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients on long therapy with omeprazole.

Proton pump inhibitors should be used with caution in patients who have hypocalcemia or hypoparathyroidism.

Calcium absorption is decreased in patients with achlorhydria.

Proton pump inhibitors could contribute to the development of vitamin B12 deficiency with prolonged use.

Proton pump inhibitors may interfere with the detection of H pylori by the urea breath test. Therefore, testing for H pylori with the urea breath test is not recommended in patients who have received proton pump inhibitors in the preceding two weeks.

Proton pump inhibitors should be used with caution in patients who have hypocalcemia or hypoparathyroidism.

Calcium absorption is decreased in patients with achlorhydria.

Proton pump inhibitors could contribute to the development of vitamin B12 deficiency with prolonged use.

Omeprazole powder for oral suspension contains 20 mEq of sodium bicarbonate per dose (460 mg Sodium). Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. Sodium bicarbonate should be used with caution in patients with Bartter's syndrome, respiratory alkalosis, and hypokalemia. Milk-alkali syndrome may occur on long-term administration of bicarbonate with calcium or milk.

Dialysis

Not readily dialyzable

Other Comments

Some patients with Zollinger-Ellison syndrome have been treated continuously for greater than 5 years.

The omeprazole powder for oral suspension should be taken 1 hour before a meal (on an empty stomach).

The omeprazole delayed release capsules should be taken 30 minutes before food or meals. Swallow the capsule whole; do not open, crush, or chew.

Several methods of administration have been used in patients unable to swallow the capsule: Sprinkle content of capsule (granules) onto 1 teaspoon of applesauce or yogurt, or add to fruit juice (apple, grape, grapefruit, cranberry, orange, pineapple, tomato, or V-8 juice) and give orally. Do not chew granules.

For patients fed through a nasogastric tube: open capsule and flush 6 to 10 granules with water (10 to 20 mL) at a time, until all gone (total water volume 120 to 140 mL); or place granules in 30 mL water and give through nasogastric tube, using a 30 mL syringe. Flush nasogastric tube with 15 mL water afterwards.

Omeprazole delayed-release 20 mg tablet is available over-the-counter for the treatment of frequent heartburn.

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