PEPTAZOL 30/MG EC CAP 28/CAP

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

GERD: 15-30mg once daily for 4-8 weeks; Erosive esophagitis: 30mg once daily for up to 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 10-14 days (in combination); Zollinger-Ellison syndrome: 60mg once daily, titrate as needed; NSAID-associated ulcer: 30mg once daily for 4-8 weeks

Initial Dose

30mg once daily before breakfast

Maintenance Dose

15-30mg once daily

Maximum Dose

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

Children's Dosage

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

How to Take

Swallow capsule whole before eating. Do not crush or chew. If swallowing is difficult, capsule may be opened and granules sprinkled on soft food (e.g., applesauce) or mixed in apple juice - swallow immediately without chewing

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): headache. Common (1-10%): diarrhea, nausea, abdominal pain, constipation, flatulence, dizziness, rash. Uncommon (<1%): hypomagnesemia (with prolonged use), acute interstitial nephritis, Stevens-Johnson syndrome, Clostridioides difficile-associated diarrhea, bone fractures

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 Clostridioides difficile-associated diarrhea. Acute interstitial nephritis reported. Use with caution in severe hepatic impairment. Concomitant use with clopidogrel may reduce antiplatelet effect

Age Restriction

Not approved under 1 year of age

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clopidogrel (reduced antiplatelet effect via CYP2C19 inhibition), methotrexate (increased methotrexate levels), atazanavir/nelfinavir (reduced absorption), rilpivirine (reduced efficacy), warfarin (increased INR), digoxin (increased digoxin levels), ketoconazole/itraconazole (reduced antifungal absorption), sucralfate (delayed lansoprazole absorption), tacrolimus (increased tacrolimus levels)

Food Interaction

Take 30-60 minutes before meals (on empty stomach) for optimal efficacy. Food reduces bioavailability if taken with or after meals

Special Populations

Breastfeeding

Caution

Children

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

Elderly

Standard adult dosing. Dose reduction not routinely required; however, use the lowest effective dose for the shortest duration necessary

Kidney Impairment

No adjustment needed

Liver Impairment

Mild-moderate impairment: no adjustment needed. Severe impairment (Child-Pugh C): reduce dose to maximum 15mg/day

Storage & Patient Advice

Missed Dose

Take as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular schedule. Do not double the dose

Overdose

Symptoms: nausea, vomiting, dizziness, abdominal pain, diarrhea, flushing, headache, tachycardia. No specific antidote. Treatment: supportive care, gastric lavage if indicated. Lansoprazole is not significantly removed by hemodialysis. Seek immediate medical attention

Patient Counseling

Take this capsule 30-60 minutes before your first meal of the day for best effect. 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 or in apple juice, but swallow immediately without chewing. Do not take antacids within 1 hour of this medication unless directed. Report any persistent diarrhea, muscle cramps, irregular heartbeat, or signs of kidney problems (decreased urination, swelling). If you are taking clopidogrel (blood thinner), inform your doctor as lansoprazole may reduce its effectiveness. Long-term use requires periodic monitoring of magnesium levels. Do not stop taking this medication without consulting your doctor if prescribed for ulcer healing or H. pylori eradication

Pharmacology

Half-Life

1-2 hours

Bioavailability

80-85% (enteric-coated formulation)

Metabolism

Hepatic via CYP2C19 (primary) and CYP3A4

Product Information

Available Dosage Forms

Enteric-coated capsule, orally disintegrating tablet, oral suspension

Composition per Dose

Each enteric-coated capsule: 30mg lansoprazole

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD, Ulcer

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