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OMECLAMOX-PAK
Hyperacidity, GERD, and ulcers
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Drug Name:

OMECLAMOX-PAK Rx

Generic Name and Formulations:
Omeprazole 20mg (2 del-rel caps containing enteric-coated granules), clarithromycin 500mg (2 tabs), amoxicillin 500mg (4 caps); per daily administration card.

Company:
Pernix Therapeutics

Therapeutic Use:

Indications for OMECLAMOX-PAK:

Treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori.

Adult:

Swallow whole. Take on an empty stomach. Omeprazole 20mg + clarithromycin 500mg + amoxicillin 1g, all twice daily (AM + PM) for 10 days.

Children:

Not established.

Contraindications:

Concomitant ergots, pimozide.

Warnings/Precautions:

Symptomatic response does not preclude gastric malignancy. Discontinue if acute interstitial nephritis, cutaneous/systemic lupus erythematosus occurs. Hepatic impairment, Asian patients: avoid. Myasthenia gravis (monitor). Mononucleosis. Renal impairment. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. Clarithromycin: cardiac arrhythmias possible with concomitant pimozide. Vasospasm and ischemia with ergots. Colchicine toxicity (esp. in elderly). Torsades de pointes with quinidine, disopyramide. Potentiates digoxin, theophylline, carbamazepine, sildenafil, statins (lovastatin, simvastatin). Monitor QT prolongation with concomitant antiarrhythmics. May potentiate oral anticoagulants. CNS effects with triazolobenziodidiazepines (eg, triazolam, alprazolam) and benzodiazepines (eg, midazolam). Omeprazole: Increased INR and PT with concomitant warfarin. Antagonizes atazanavir, nelfinavir: not recommended. Consider dose reduction of concomitant saquinavir, cilostazol. Potentiates tacrolimus; monitor. May interfere with absorption of drugs for which gastric pH is important (eg, ketoconazole, atazanavir, erlotinib, mycophenolate mofetil, ampicillin esters, iron salts). Amoxicillin: Potentiated by probenecid. May interfere with testing for glucose in urine using Clinitest, Benedict's or Fehling's Solution.

Pharmacological Class:

Proton pump inhibitor + antibiotics (macrolide + penicillin).

Adverse Reactions:

Diarrhea, taste perversion, headache; superinfection (discontinue if occurs), C. difficile-associated diarrhea.

Generic Availability:

NO

How Supplied:

Daily administration card—1, 10

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