OMECLAMOX-PAK Dosage & Rx Info | Uses, Side Effects

Omeclamox-pak Generic Name & Formulations

Legal Class

General Description

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

Pharmacological Class

Proton pump inhibitor + antibiotics (macrolide + penicillin).

How Supplied

Daily administration card—1, 10

Manufacturer

Cumberland Pharmaceuticals, Inc.

Generic Availability

Mechanism of Action

Omeprazole, an antisecretory drug with the substituted benzimidazoles, suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose-dependent and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Omeprazole can also exhibit anti-bacterial activity depending on the culture conditions. Clarithromycin exerts its antibacterial activity by binding to the 50S ribosomal subunit of susceptible microorganisms resulting in inhibition of protein synthesis. Amoxicillin acts through the inhibition of biosynthesis of cell wall mucopeptide.

Omeclamox-pak Indications

Indications

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

Omeclamox-pak Dosage and Administration

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.

Omeclamox-pak Contraindications

Contraindications

Concomitant ergots, lurasidone, pimozide.

Omeclamox-pak Boxed Warnings

Not Applicable

Omeclamox-pak Warnings/Precautions

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. Embryo-fetal toxicity. Pregnancy, nursing mothers: not recommended.

Omeclamox-pak Pharmacokinetics

Distribution

Plasma protein bound: ~95% (omeprazole).

Metabolism

Hepatic.

Elimination

Renal. Half-life: 0.5–1 hour (omeprazole); 5–7 hours (clarithromycin); ~61.3 minutes (amoxicillin).

Omeclamox-pak Interactions

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, lurasidone. 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.

Omeclamox-pak Adverse Reactions

Adverse Reactions

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

Omeclamox-pak Clinical Trials

See Literature

Omeclamox-pak Note