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K-Cab

K-Cab

Manufacturer:

HK inno.

Distributor:

Pacific Healthcare

Marketer:

Pacific Healthcare
Concise Prescribing Info
Contents
Tegoprazan
Indications/Uses
Erosive & non-erosive GERD; gastric ulcer. H. pylori eradication concurrently given w/ appropriate antibiotic therapy in patients w/ peptic ulcer &/or chronic atrophic gastritis.
Dosage/Direction for Use
Adult Erosive & non-erosive GERD 50 mg once daily for 4 wk. Patient who does not heal or has persistent symptoms after 4 wk May consider additional 4-wk treatment. Gastric ulcer 50 mg once daily for 8 wk. H. pylori eradication in patients w/ peptic ulcer &/or chronic atrophic gastritis Tegoprazan 50 mg, clarithromycin 500 mg & amoxicillin 1 g bid for 7 days.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to tegoprazan or substituted benzimidazoles. Concomitant use w/ atazanavir, nelfinavir or rilpivirine-containing products. Pregnancy & lactation.
Special Precautions
May alleviate symptoms & delay diagnosis; exclude malignancy in the presence of any alarming symptoms (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melena) & when gastric ulcer is suspected or present. Cyanocobalamin deficiency due to long-term therapy. Increased risk for osteoporosis-related fractures of hip, wrist, or spine in patients who received high-dose & long-term therapy; GI infections (eg, Salmonella, Campylobacter, Clostridium difficile) & Clostridium difficile-associated diarrhea especially in hospitalized patients. Tetany, arrhythmias & seizures. Monitor Mg levels prior to treatment initiation & periodically in patients expected to be on prolonged treatment or in concomitant use w/ digoxin or drugs that may cause hypomagnesemia eg, diuretics. Hepatic & renal impairment. Discontinue nursing during therapy. Elderly. Ped & adolescent patients.
Adverse Reactions
Nausea, diarrhea, dyspepsia, upper abdominal pain, abdominal pain & distention; nasopharyngitis, viral URTI, cystitis; chest discomfort, asthenia; increased creatine phosphokinase; headache, dizziness, dysgeusia; urticaria, pruritus, erythema.
Drug Interactions
Decreased absorption of drugs where gastric pH is important determinant of their bioavailability; ketoconazole, itraconazole, ampicillin ester, atazanavir, Fe salts, erlotinib, gefitinib & mycophenolate mofetil. Increased absorption of digoxin. Decreased plasma conc of atazanavir, nelfinavir or rilpivirine. Increased AUCT w/ & of clarithromycin.
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).
Presentation/Packing
Form
K-Cab FC tab 50 mg
Packing/Price
30's
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