Miracid

Miracid

omeprazole

Manufacturer:

Berlin Pharm

Distributor:

Berlin Pharm
Concise Prescribing Info
Contents
Omeprazole
Indications/Uses
Duodenal & gastric ulcer; GERD; pathologic GI hypersecretory conditions eg, Zollinger-Ellison syndrome. In combination w/ clarithromycin or amoxicillin & clarithromycin for duodenal ulcer associated w/ H. pylori.
Dosage/Direction for Use
Duodenal ulcer Short-term treatment: 20 mg once daily w/in 2-4 wk, continued up to additional 4 wk for some patients. May be increased to 40 mg in patients w/ poor response. Duodenal ulcer associated w/ H. pylori In combination w/ clarithromycin: 40 mg omeprazole once daily in morning for 14 days. Additional 20 mg omeprazole once daily for 14 days in patients w/ active ulcer during initiation of anti-H. pylori therapy. In combination w/ clarithromycin & amoxicillin: 20 mg omeprazole bid in morning & evening for 10 days. Additional 20 mg omeprazole once daily for 18 days in patients w/ active ulcer during initiation of anti-H. pylori therapy. Active benign gastric ulcer Short-term treatment: 40 mg once daily for 4-8 wk. Symptomatic GERD w/o erosive esophageal lesions Short term treatment: 40 mg once daily for 4 wk. Erosive esophagitis 20 mg once daily for 4-8 wk, up to 40 mg. Continued up to 12 wk. Pathological GI hypersecretory syndrome Individualized dosage. Initially 60 mg once daily.
Administration
Should be taken on an empty stomach: Best taken 30 min before meals. Cap must be swallowed intact, do not open/chew/crush.
Contraindications
Hypersensitivity to omeprazole, esomeprazole or other substituted benzimidazoles eg, lansoprazole, pantoprazole, rabeprazole. Concomitant use w/ rilpivirine.
Special Precautions
Discontinue if heartburn persists or worsens after 14 days of therapy or treatment is needed more frequently than every 4 mth. Patients w/ heartburn for >3 mth or in conjunction w/ lightheadedness, sweating or dizziness; chest or shoulder pain w/ lightheadedness, shortness of breath, sweating or pain spreading to arm, neck or shoulders; frequent chest pain, unexplained wt loss, nausea & vomiting, stomach pain or frequent wheezing (especially w/ heartburn) prior to treatment. Not to be used in patients w/ difficulty or pain w/ swallowing; vomiting w/ blood; bloody blackened stools. Asian patient. Concomitant use w/ warfarin, antifungal (eg, ketoconazole), diazepam or digoxin. Hepatic impairment. Pregnancy & lactation. Elderly.
Adverse Reactions
Diarrhea, nausea, constipation, abdominal pain, vomiting, flatulence; headache, dizziness; back pain; URTI, cough. TEN, SJS.
Drug Interactions
Increased digoxin absorption. Decreased ketoconazole & itraconazole absorption. Altered metabolism of drugs w/ narrow therapeutic window eg, diazepam, phenytoin, warfarin. Inhibited omeprazole-omeprazole sulfone transformation w/ ketoconazole. Inhibited metabolism/transport effects w/ moderate CYP2C19, 2C9 & weak CYP1A2, 2D6 substrates. Induced metabolism/transport effects w/ weak/moderate CYP1A2 substrates. Concomitant use w/ clopidogrel, dasatinib, delavirdine, erlotinib, nelfinavir, pimozide, ponatinib, posaconazole, rifampin, rilpivirine, risedronate, St. John's wort. Increased levels/effects of amphetamines, aripiprazole, benzodiazepines, carvedilol, cilostazol, citalopram, clozapine, systemic cyclosporine, CYP2C19 & CYP2C9 substrates, dexmethylphenidate, escitalopram, fosphenytoin, lomitapide, MTX, methylphenidate, phenytoin, pimozine, raltegravir, risedronate, saquinavir, systemic tacrolimus, vit K antagonists, voriconazole, alprazolam, carbamazepine, clobazam, clorazepate, diazepam, digoxin, disulfiram, fluvastatin, midazolam, triazolam, armodafinil. Increased levels/effects by fluconazole, systemic ketoconazole, voriconazole. Decreased levels/effects of atazanavir, ampicillin, bisphosphonate derivatives, bosutinib, cefditoren, clopidogrel, clozapine, dabigatran etexilate, dasatinib, delavirdine, erlotinib, gefitinib, indinavir, Fe salts, itraconazole, systemic ketoconazole, mesalamine, multivit/minerals (w/ A, D, E, K, folate, Fe), mycophenolate, nelfinavir, nilotinib, ponatinib, posaconazole, rilpivirine, risedronate, vismodegib, bendamustine. Decreased levels/effects by strong CYP2C19 inducers, peg-interferon α-2b, rifampin, St. John's wort, tipranavir. Gastric mucosal irritation w/ ethanol. Delayed absorption w/ food. Decreased efficacy w/ cranberry.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Miracid cap 20 mg
Packing/Price
1 × 14's;10 × 10's;35 × 10's
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