K-Cab Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tegoprazan

Indications/Uses

Erosive/non-erosive GERD, gastric ulcer. H. pylori eradication w/ appropriate antibiotic therapy in patients w/ peptic ulcer &/or chronic atrophic gastritis.

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Dosage/Direction for Use

Adult Erosive GERD 50 mg once daily for 4 wk, additional 4-wk may be considered in patient who do not heal or have persistent symptoms after 4 wk. Non-erosive GERD 50 mg once daily for 4 wk. Gastric ulcer 50 mg once daily for 8 wk. H. pylori eradication Tegoprazan 50 mg, clarithromycin 500 mg & amoxicillin 1 g bd for 7 days.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity to tegoprazan or substituted benzimidazoles. Concomitant use w/ atazanavir, nelfinavir or rilpivirin-containing products. Pregnancy & lactation.

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Special Precautions

Exclude gastric malignancy prior to treatment. Increased risk for osteoporosis-related hip, wrist or spine fractures; GI infections eg, Salmonella, Campylobacter, Clostridium difficile. Vit B₁₂ deficiency. Periodic monitoring of Mg levels prior to initiation. High-dose & long-term use. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Nausea, diarrhea, dyspepsia; nasopharyngitis, viral URTI; chest discomfort.

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Drug Interactions

Decreased absorption of ketoconazole, itraconazole, ampicillin ester, atazanavir, Fe salts, erlotinib, gefitinib, mycophenolate mofetil. Increased absorption of digoxin. Decreased plasma conc of nelfinavir, rilpivirin. Increased AUC_T of clarithromycin. Increased exposure w/ CYP3A4 & P-gp inhibitors. Decreased AUC_0-12 & C_ss,max w/ metronidazole, tetracycline, bismuth.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Antacids, Antireflux Agents & Antiulcerants

ATC Classification

A02BC09 - tegoprazan ; Belongs to the class of potassium-competitive acid blocker. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Regulatory Classification

Presentation/Packing

Form

K-Cab FC tab 50 mg

Packing/Price

30's

K-Cab

Manufacturer:

Pharmaniaga Marketing

Distributor:

Pharmaniaga Logistics