TAKEPRON 15/MG HARD CAP 14/CAP

Indications

Approved Uses

Treatment of duodenal and gastric ulcers, Treatment of reflux esophagitis, Prophylaxis of reflux esophagitis, Eradication of Helicobacter pylori in combination with antibiotics, Treatment and prophylaxis of NSAID-associated benign gastric and duodenal ulcers, Symptomatic gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome.

Dosage & Administration

Dosing by Condition

Symptomatic GERD/heartburn: 15 mg once daily for up to 8 weeks (some patients may require 30 mg once daily).
Erosive esophagitis (healing): 30 mg once daily for 4-8 weeks.
Maintenance of healed erosive esophagitis: 15 mg once daily.
Duodenal ulcer: 15 mg once daily for 2-4 weeks (some regimens use 30 mg daily depending on severity/local labeling).
Gastric ulcer: 30 mg once daily for 4-8 weeks.
H. pylori eradication (with antibiotics): 30 mg twice daily for 10-14 days (7-14 days depending on regimen/guideline).
NSAID-associated ulcer prophylaxis: 15 mg once daily (typically during NSAID therapy).
Zollinger-Ellison syndrome: Initial 60 mg once daily; titrate to response; divide doses if >30 mg/day and/or if needed for symptom control.

Initial Dose

15mg once daily (for mild GERD/heartburn) or 30mg once daily (for erosive esophagitis or ulcers)

Maintenance Dose

15mg once daily.

Maximum Dose

120 mg/day (e.g., Zollinger-Ellison syndrome; typical max for standard indications is 30 mg/day)

Children's Dosage

Approved for children 1 year and older for GERD and erosive esophagitis. For children 1-11 years: ≤30 kg: 15mg once daily; >30 kg: 30mg once daily. For children 12-17 years: 15mg once daily for non-erosive GERD, 30mg once daily for erosive esophagitis.

How to Take

Oral: take once daily on an empty stomach, ideally 30-60 minutes before a meal (often 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 sprinkled on a small amount of soft food (e.g., applesauce) or mixed with juice and swallowed immediately-do not chew the granules.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1%): headache, diarrhea, abdominal pain, nausea, constipation (± flatulence). Uncommon (<1%): rash/pruritus/urticaria, dizziness, elevated liver enzymes. Rare (<0.1%): severe cutaneous adverse reactions (SJS/TEN), acute interstitial nephritis, pancreatitis, and subacute cutaneous lupus erythematosus; C. difficile-associated diarrhea is an important serious risk (frequency not reliably quantified in trials).

Safety & Warnings

Contraindications

Hypersensitivity to lansoprazole/other substituted benzimidazoles (PPIs); concomitant use with rilpivirine-containing products

Warnings & Precautions

May mask gastric malignancy (evaluate alarm features/consider malignancy if indicated); increased risk of C. difficile-associated diarrhea; long-term/high-dose use: fracture risk, hypomagnesemia (monitor in prolonged therapy or with digoxin/diuretics), possible vitamin B12 deficiency; acute tubulointerstitial nephritis; cutaneous/systemic lupus erythematosus; may cause false-negative chromogranin A testing; fundic gland polyps with long-term use

Drug Interactions

Food Interaction

Food decreases/delays absorption and can reduce effect; take on an empty stomach 30-60 minutes before meals for best efficacy.

Special Populations

Children

Approved for children 1 year and older for GERD and erosive esophagitis. For children 1-11 years: ≤30 kg: 15mg once daily; >30 kg: 30mg once daily. For children 12-17 years: 15mg once daily for non-erosive GERD, 30mg once daily for erosive esophagitis.

Storage & Patient Advice

Patient Counseling

Take on an empty stomach 30-60 minutes before a meal (often breakfast). Swallow the capsule whole; do not crush/chew; if needed, open and swallow granules with soft food/juice without chewing. Use for the shortest duration needed; seek medical advice if symptoms persist/return. Report severe/persistent diarrhea, rash with joint pain, or symptoms of low magnesium (muscle cramps/spasms, palpitations). If taking sucralfate, take lansoprazole at least 30 minutes before it; tell your clinician about warfarin, tacrolimus, clopidogrel, methotrexate, and HIV medicines (rilpivirine/atazanavir/nelfinavir should be avoided).

Monitoring Requirements

Long-term therapy: consider serum magnesium (especially >1 year and/or with diuretics or digoxin); consider vitamin B12 with prolonged use/risk factors; monitor for renal injury if symptoms suggest acute interstitial nephritis; consider bone health/fracture risk in high-risk patients.

Pharmacology

Mechanism of Action

Proton pump inhibitor: irreversibly inhibits the gastric parietal cell H+/K+-ATPase (proton pump), suppressing the final step of gastric acid secretion (basal and stimulated).

Onset of Action

Initial acid suppression begins within ~1-3 hours after a dose; maximal effect typically requires 3-4 days of daily dosing.

Duration of Effect

Approximately 24 hours of acid suppression after a dose (supporting once-daily dosing), though the pharmacodynamic effect can persist beyond the plasma half-life.

Half-Life

1-2 hours.

Bioavailability

Oral bioavailability is generally >80% after repeated dosing (approximately 80-90%).

Product Information

Available Dosage Forms

For this SFDA-registered product: hard capsule for oral use (15 mg). (Other lansoprazole products may exist as orally disintegrating tablets, but that is not a dosage form for TAKEPRON 15 mg hard capsules.)

Composition per Dose

Each hard capsule: 15mg lansoprazole (as enteric-coated granules)

Gi Condition

Acid Reflux/GERD, Ulcer

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