PEPTAZOL 15/MG CAP 14/CAP

Indications

Approved Uses

Gastroesophageal reflux disease (GERD), duodenal ulcer, gastric ulcer, Helicobacter pylori eradication (in combination therapy), NSAID-associated gastric ulcer, Zollinger-Ellison syndrome, erosive esophagitis

Dosage & Administration

Dosing by Condition

GERD (mild/heartburn): 15mg once daily for up to 8 weeks. Erosive esophagitis: 30mg once daily for 4-8 weeks. Duodenal ulcer: 15mg once daily for 4 weeks. Gastric ulcer: 30mg once daily for 4-8 weeks. H. pylori eradication: 30mg twice daily for 7-14 days (with antibiotics). Zollinger-Ellison syndrome: 60mg once daily, titrate as needed. NSAID-associated ulcer prevention: 15mg once daily

Initial Dose

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

Maintenance Dose

15mg once daily

Maximum Dose

120mg/day (in Zollinger-Ellison syndrome); 30mg/day for standard indications

Children's Dosage

Children 1-11 years (≤30kg): 15mg once daily; (>30kg): 30mg once daily. Children 12-17 years: 15mg once daily (GERD) or 30mg once daily (erosive esophagitis). Not recommended under 1 year of age

Dose Adjustment Notes

Severe hepatic impairment: reduce dose to maximum 15mg/day. No renal dose adjustment required. Titrate Zollinger-Ellison syndrome dosing based on gastric acid output

How to Take

Swallow capsule whole before eating (30-60 minutes before a meal). Do not crush or chew the capsule. If swallowing is difficult, capsule may be opened and granules sprinkled on soft food (e.g., applesauce) or mixed in apple juice - do not chew granules

Safety & Warnings

Contraindications

Hypersensitivity to lansoprazole or any benzimidazole PPI, concurrent use with rilpivirine-containing products

Warnings & Precautions

Long-term use (>1 year) associated with hypomagnesemia, vitamin B12 deficiency, and increased fracture risk. May mask symptoms of gastric malignancy - exclude malignancy before initiating therapy. Risk of Clostridium difficile infection with prolonged use. Avoid concomitant use with rilpivirine. Use with caution in severe hepatic impairment. Subacute cutaneous lupus erythematosus reported; discontinue if rash occurs. Acute interstitial nephritis may occur at any point during therapy

Age Restriction

Not recommended under 1 year of age

Drug Interactions

Interaction Severity

MAJOR: Rilpivirine (significantly reduced antiplatelet/antiviral efficacy - contraindicated), Clopidogrel (reduced antiplatelet effect via CYP2C19 inhibition - avoid combination). MODERATE: Methotrexate (increased methotrexate toxicity), Warfarin (increased INR and bleeding risk), Tacrolimus (increased tacrolimus plasma levels), Atazanavir/Nelfinavir (reduced antiviral absorption). MINOR: Ketoconazole/Itraconazole (reduced antifungal absorption), Digoxin (modest increase in digoxin levels), Sucralfate (delayed lansoprazole absorption - administer lansoprazole 30 minutes before sucralfate)

Special Populations

Pregnancy

Not assigned (Risk Summary: Limited data; potential risks to fetus)

Breastfeeding

Caution

Children

Children 1-11 years (≤30kg): 15mg once daily; (>30kg): 30mg once daily. Children 12-17 years: 15mg once daily (GERD) or 30mg once daily (erosive esophagitis). Not recommended under 1 year of age

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime for short-term use; however, rebound acid hypersecretion may occur after abrupt discontinuation following long-term use - consider gradual tapering after prolonged therapy

Patient Counseling

Take this capsule 30-60 minutes before your first meal of the day for best results. Swallow the capsule whole - do not crush or chew. If you have difficulty swallowing, you may open the capsule and sprinkle the granules on soft food, but do not chew the granules. Do not take for longer than recommended without medical advice. Long-term use can lower magnesium levels - report muscle cramps, irregular heartbeat, or tremors. Report any persistent diarrhea, as it may indicate a serious bowel infection. Inform your doctor if you develop a rash, as this medication can rarely cause skin reactions. This medication may mask symptoms of stomach cancer - consult your doctor if symptoms persist or worsen.

Monitoring Requirements

Magnesium levels with prolonged use (>1 year); vitamin B12 levels with long-term use; renal function if acute interstitial nephritis is suspected

Pharmacology

Mechanism of Action

Irreversibly inhibits the H+/K+-ATPase enzyme (proton pump) in gastric parietal cells, blocking the final step of acid secretion and reducing gastric acid production

Onset of Action

1-2 hours for initial acid suppression; maximum effect within 2-4 days of regular dosing

Duration of Effect

Over 24 hours

Excretion

Biliary/fecal (primary route); renal (~33%)

Protein Binding

97%

Product Information

Available Dosage Forms

Capsule (delayed-release), orally disintegrating tablet

Composition per Dose

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

Gi Condition

Acid Reflux/GERD, Ulcer

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