RISEK 20/MG 14/CAP

Indications

Approved Uses

GERD (including erosive esophagitis), peptic ulcer disease (duodenal and gastric ulcer), Helicobacter pylori eradication as part of combination therapy, Zollinger-Ellison syndrome/other pathological hypersecretory conditions, and treatment/prevention of NSAID-associated gastric/duodenal ulcers (where included in local labeling).

Dosage & Administration

Dosing by Condition

GERD (symptomatic): 20 mg once daily for 4 weeks; may extend to 8 weeks if needed. Erosive esophagitis: 20 mg once daily for 4-8 weeks (some patients may require 40 mg daily per severity/label). Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20 mg once daily for 4-8 weeks (40 mg daily may be used in some labels/severe or refractory cases). H. pylori eradication: 20 mg twice daily with appropriate antibiotics for 10-14 days (regimen-dependent). Zollinger-Ellison: start 60 mg once daily and titrate; doses >80 mg/day in divided doses; usual max about 120 mg/day. NSAID-associated ulcer treatment: 20 mg once daily for 4-8 weeks; prevention while continuing NSAID: 20 mg once daily.

Initial Dose

20mg once daily.

Maintenance Dose

10-20mg once daily for GERD.

Maximum Dose

120mg per day (Zollinger-Ellison syndrome); 40mg per day for standard indications

Children's Dosage

Children 1-2 years (≥10kg): 10mg once daily; Children 2-16 years (10-20kg): 10mg once daily; Children 2-16 years (>20kg): 20mg once daily; for GERD and erosive esophagitis

Dose Adjustment Notes

Renal impairment: no dose adjustment required. Hepatic impairment: consider dose reduction in severe hepatic impairment; in practice many references recommend not exceeding 20 mg/day for maintenance/GERD-type indications in severe liver disease, while higher doses for hypersecretory states may still be used with caution and monitoring. For Zollinger-Ellison, doses >80 mg/day should be divided.

How to Take

Take orally 30-60 minutes before a meal (preferably before breakfast). Swallow the hard capsule whole with water; do not crush or chew. If unable to swallow, the capsule may be opened and the enteric-coated granules/pellets sprinkled on a small amount of applesauce (or mixed with a slightly acidic liquid such as apple juice) and swallowed immediately without chewing; do not store the mixture.

Side Effects

Common Side Effects

Headache, nausea, diarrhea, abdominal pain, flatulence, constipation, vomiting, dizziness

Safety & Warnings

Warnings & Precautions

Precautions: may mask gastric malignancy (evaluate alarm features), risk of C. difficile diarrhea, acute interstitial nephritis, hypomagnesemia (monitor if prolonged use/with diuretics/digoxin), osteoporosis-related fractures with long-term/high-dose use, vitamin B12 deficiency with long-term use, lupus (SCLE/SLE), and caution in severe hepatic impairment/poor CYP2C19 metabolizers.

Age Restriction

Pediatric use: generally approved/used for children ≥1 year for specific indications (e.g., GERD/erosive esophagitis); not recommended for <1 year unless specialist-directed.

Drug Interactions

Drug Interactions

Key interactions: clopidogrel (reduced activation/antiplatelet effect via CYP2C19 inhibition), high-dose methotrexate (delayed clearance/toxicity), warfarin (↑INR/bleeding risk-monitor), phenytoin and diazepam (↑levels via CYP2C19 inhibition), digoxin (↑exposure esp. with hypomagnesemia), drugs needing acidic pH (e.g., ketoconazole/itraconazole-↓absorption), and contraindicated/avoid with rilpivirine and with nelfinavir/atazanavir (↓antiviral exposure).

Food Interaction

Take on an empty stomach 30-60 minutes before a meal; food can delay absorption and reduce/slow onset, so pre-meal dosing optimizes efficacy.

Special Populations

Pregnancy

Not assigned (FDA)

Breastfeeding

Caution

Children

Children 1-2 years (≥10kg): 10mg once daily; Children 2-16 years (10-20kg): 10mg once daily; Children 2-16 years (>20kg): 20mg once daily; for GERD and erosive esophagitis

Elderly

Standard adult dosing; no routine dose adjustment required, but use the lowest effective dose for the shortest duration necessary

Kidney Impairment

No adjustment needed.

Liver Impairment

Severe hepatic impairment: consider dose reduction; typical maximum 20 mg/day. Mild-moderate impairment: usually no adjustment.

Storage & Patient Advice

Stopping the Medicine

Can be stopped if clinically appropriate; after long-term therapy, consider tapering (or step-down to H2 blocker/PRN) to reduce rebound acid hypersecretion.

Patient Counseling

Take 30-60 minutes before a meal (preferably breakfast). Swallow capsule whole; do not crush/chew; if needed, open and swallow pellets with applesauce/acidic liquid without chewing. Use for the prescribed duration; seek care for persistent/severe diarrhea, rash, or signs of allergy; report symptoms suggestive of low magnesium (muscle cramps, palpitations, seizures) with long-term use. Tell your clinician about clopidogrel, warfarin, antiretrovirals (e.g., rilpivirine/nelfinavir/atazanavir), methotrexate, tacrolimus, phenytoin/diazepam, and digoxin. Long-term use may be associated with low magnesium, B12 deficiency, and fracture risk in susceptible patients.

Monitoring Requirements

Long-term therapy: consider monitoring magnesium (especially if also on diuretics or digoxin) and assess for vitamin B12 deficiency with prolonged use (e.g., >2-3 years) or symptoms; monitor INR if on warfarin; monitor for clinical signs of C. difficile-associated diarrhea and for renal adverse effects (e.g., interstitial nephritis) if symptomatic.

Pharmacology

Mechanism of Action

Irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump), blocking the final step of acid secretion and reducing basal and stimulated gastric acid output.

Onset of Action

Initial acid suppression begins within about 1 hour after a dose, but maximal/steady effect typically requires 3-4 days of once-daily dosing (not within 2 hours).

Duration of Effect

Approximately 24 hours of acid suppression per dose, with antisecretory effect persisting beyond plasma half-life due to irreversible proton pump inhibition; full steady-state effect requires several days.

Half-Life

0.5-1 hour.

Metabolism

Extensively metabolized in the liver, primarily via CYP2C19 (major) and CYP3A4, to inactive metabolites.

Product Information

Available Dosage Forms

Capsule, hard (delayed-release)

Composition per Dose

Each capsule: 20mg omeprazole (as enteric-coated granules)

Generic Availability

Yes

OTC Alternatives

OTC options for mild/intermittent symptoms include antacids (e.g., calcium carbonate; aluminum/magnesium hydroxide) and H2-receptor antagonists (e.g., famotidine).

Gi Condition

Acid Reflux/GERD, Ulcer

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