Omeprazole

Adult uses include active duodenal ulcer, H. pylori eradication with specified antibiotics to reduce duodenal-ulcer recurrence, benign gastric ulcer, symptomatic GERD, erosive esophagitis (EE), maintenance of healed EE, and pathological hypersecretory conditions such as Zollinger–Ellison syndrome. Pediatric indications and ages depend on the product; see the pediatric dosing card.

For adults aged 18 or older with heartburn on at least 2 days per week. It is not immediate relief: full effect can take 1–4 days.

The Rx label contains clarithromycin-based regimens. ACG 2024 recommends 14-day optimized bismuth quadruple therapy when susceptibility is unknown and advises against empiric PPI–clarithromycin triple therapy without proven clarithromycin susceptibility. A clinician must select the full regimen, address allergies and interactions, and confirm eradication.

Label triple regimen: omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily for 10 days. Label dual regimen: omeprazole 40 mg daily plus clarithromycin 500 mg three times daily for 14 days. These labeled regimens do not establish preferred empiric therapy today. With an ulcer present, the label specifies continued omeprazole 20 mg daily for 18 days after triple therapy or 14 days after dual therapy. Review current susceptibility-based guidance and each antibiotic’s full label.

Prilosec suspension is not established below 1 month, or for symptomatic GERD/maintenance below 1 year. The selected capsule label specifies GERD, EE, and EE maintenance from age 2; do not extend the suspension age approval to that capsule. A pharmacist must supply a suitable strength and exact preparation.

One tablet every morning before eating, with water, daily for 14 days; maximum one daily. Swallow whole without chewing, crushing, or sucking. Repeat no more often than every 4 months unless a doctor directs otherwise. Under age 18: ask a doctor.

Take Rx therapy before meals. Swallow capsules whole; the selected capsule may be opened onto one tablespoon of nonhot soft applesauce, swallowed immediately with cool water. Do not chew/crush pellets or store the mixture.

Prilosec packets: mix 2.5 mg with 5 mL water or 10 mg with 15 mL water; stir, wait 2–3 minutes, stir again, and drink within 30 minutes. Rinse remaining medicine with water and drink. NG/gastric delivery requires size ≥6 and a catheter-tip syringe; follow the linked instructions, including a same-volume water flush. Multiple packets require pharmacist directions.

For maintenance of healed EE, reduce to 10 mg once daily in Child–Pugh A, B, or C hepatic impairment and in Asian patients as specified by these labels. This is not a blanket dose for every indication. Renal impairment does not produce a clinically meaningful change in parent-drug disposition in the cited PK studies; individualize therapy and distinguish baseline impairment from suspected drug-induced nephritis.

Hypersensitivity to the formulation or substituted benzimidazoles; concurrent rilpivirine-containing products. When antibiotics are prescribed for H. pylori, their contraindications also apply.

The selected omeprazole prescription and OTC labels have no boxed warning. Their contraindications, warnings, and product-specific limits still apply.

Commonly reported adult trial effects include headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. Serious labeled reactions include nephritis, anaphylaxis, severe skin reactions, and electrolyte disturbances. Trial frequencies do not establish an OTC user’s individual risk.

Antibiotics, cyclosporine, disulfiram, ritonavir-containing medicines, and other regimens also require reconciliation; the linked interaction tables provide product-specific actions.

Available epidemiologic data have not demonstrated increased major congenital-malformation risk with first-trimester exposure; adequately controlled pregnancy studies are lacking. Discuss clinical need with the treating clinician. OTC labeling asks pregnant users to consult a health professional before use.

Limited data suggest milk transfer. The Rx label notes insufficient clinical data on infant effects or milk production; weigh maternal treatment need alongside breastfeeding benefits. OTC users should ask a health professional before use.

Use the exact pediatric product and indication limits in the dosing card. Pediatric ulcer eradication, gastric/duodenal ulcers, and hypersecretory conditions are not established uses in these labels. Older age alone requires no dose adjustment in the Rx labels, but alarm symptoms, interacting medicines, and long-term treatment risks warrant review.

Hepatic impairment and CYP2C19 metabolic variation can increase exposure. The labeled 10 mg maintenance-EE adjustment for hepatic impairment and Asian patients is indication-specific. Renal PK findings do not rule out acute drug-associated kidney injury.

Omeprazole inhibits parietal-cell H⁺/K⁺-ATPase, suppressing basal and stimulated gastric acid secretion. The effect accumulates with daily dosing and reaches a plateau after about 4 days; it is not an immediate antacid.

Absorption

Delayed-release granules protect acid-labile drug until they leave the stomach; formulation-specific exposure differs.

Metabolism

Extensive hepatic CYP2C19 metabolism, with CYP3A4 contribution; inhibits CYP2C19.

Half-life

Approximately 0.5–1 hour in healthy subjects; prolonged with hepatic disease.

Elimination

Predominantly urinary metabolites, with remaining metabolites in feces; little unchanged drug in urine.

• Assess symptom response and alarm features. OTC symptoms that continue/worsen, or need for >14 days or more frequent courses, require a doctor.
• Consider baseline and periodic magnesium with prolonged treatment, digoxin, or diuretics; monitor calcium when a preexisting hypocalcemia risk exists. Assess B12 deficiency when clinically suggested.
• Evaluate kidney symptoms, persistent diarrhea, rash/joint pain, and osteoporosis risk. Monitor interacting-drug levels or INR as indicated.
• H. pylori: confirm eradication with fecal antigen, urea breath test, or biopsy-based testing ≥4 weeks after antibiotics; stop PPI/PCAB ≥2 weeks before testing under the clinician’s plan.

• Keep the exact product directions; OTC and prescription durations differ. Tell the clinician about all medicines and supplements before starting.
• Take before food as directed; do not chew delayed-release pellets or tablets. Prepare the suspension exactly and discard a mixture not used within 30 minutes.
• For a missed Rx dose, take when remembered unless the next dose is due; do not double.
• Seek care for reduced urine, bloody urine, persistent watery stools, or severe skin symptoms. Seek urgent assessment for bleeding or chest pain with sweating/breathlessness.

Do not identify a medicine by color alone. Confirm the package with a pharmacist.

Dosage form / strength

Delayed-release granules for oral suspension · 2.5 or 10 mg per packet

Appearance

Fine yellow powder with white–brownish active granules and pale yellow inactive granules

Example package NDC

70515-610-01 · 30 single-dose 10 mg packets

Prilosec Rx suspension

2.5 and 10 mg single-dose packets.

Selected Rx capsule

10 mg delayed release; other manufacturers/strengths require their labels.

Selected Prilosec OTC

20 mg delayed-release tablet.

Other products

Capsule strengths and omeprazole/sodium-bicarbonate combinations have separate labels; combination products are outside this reference.

Prilosec packets: 25°C, excursions 15–30°C. Selected capsules: 20–25°C in a tight container protected from light/moisture. Selected OTC tablets: 20–25°C, protected from moisture; retain carton and do not use an opened/torn blister. Keep out of children’s reach.