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omeprazole/amoxicillin/clarithromycin (Rx)Brand and Other Names:Omeclamox-Pak

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

omeprazole/amoxicillin/clarithromycin

capsule/capsule/tablet prepack

  • 20mg/500mg/500mg
  • Amoxicillin dose consists of two 500mg capsules (ie, 1000mg/dose)
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Duodenal Ulcer

Indicated for eradication of H pylori to reduce risk of duodenal ulcer recurrence

Omeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg coadministered PO BID (morning and evening) for 10 days

Renal & Hepatic Impairment

Renal impairment: No dose adjustment necessary

Hepatic impairment: Avoid use

Other Information

Combination therapy (omeprazole, amoxicillin, clarithromycin) indicated for the treatment of patients with H pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H pylori

To reduce development of drug-resistant bacteria and maintain efficacy of antibacterial drugs, use only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria

Safety and efficacy not established

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Interactions

Interaction Checker

omeprazole/amoxicillin/clarithromycin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Clarithromycin

            • GI effects, general (13%)

            1-10%

            Clarithromycin

            • Headache (2%)
            • Abdominal pain (2%)
            • Abnormal taste (3-7%)
            • Diarrhea (3-6%)
            • Dyspepsia (2%)
            • Heartburn (2%)
            • Nausea (3-6%)
            • Increased BUN (4%)
            • Increased PT (1%)
            • Vomiting (1%)
            • GI intolerance
            • Decrease WBC Rash

            Omeprazole

            • Acid regurgitation (1.9%)
            • Upper respiratory infection (1.9%)
            • Constipation (1.5%)
            • Dizziness (1.5%)
            • Rash (1.5%)
            • Asthenia (1.3%)
            • Back pain (1.1%)
            • Cough (1.1%)

            <1%

            Clarithromycin

            • QT prolongation
            • Neurology/Psychiatric: Anxiety, dizziness, hallucinations, manic behavior, neuromuscular blockade, psychosis, seizures
            • Gastrointestinal: Anorexia, glossitis, pancreatitis, jaundice, hepatitis/hepatic dysfunction, C difficile colitis
            • Laboratory: Bilirubin increased, elevated AST, LFTs, alkaline phosphate, serum creatinine; hypoglycemia, leukopenia, neutropenia, thrombocytopenia
            • Anaphylaxis, dyspnea, Stevens-Johnson syndrome

            Frequency Not Defined

            Omeprazole

            • Fracture of bone, osteoporosis-related
            • Hepatotoxicity (rare)
            • Hip fracture
            • Interstitial nephritis (rare)
            • Pancreatitis (rare)
            • Rhabdomyolysis
            • Toxic epidermal necrolysis (rare)

            Amoxicillin

            • Headache
            • Rash
            • Diarrhea, nausea, vomiting
            • Anemia
            • AST/ALT elevation
            • Anaphylaxis
            • Candidiasis (mucocutaneous), pseudomembranous colitis, serum sickness

            Clarithromycin

            • Torsade de pointes (rare)
            • Allergic reactions: urticaria & skin eruptions, leukocytoclastic vasculitis, toxic epidermal necrolysis, pruritus, rash
            • Transient CNS effects: psychosis, anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, nightmares, tinnitus, tremor, and vertigo
            • Hepatic failure
            • Stomatitis
            • Acute renal failure
            • Reversible hearing loss (hypoacusis)

            Postmarketing Reports

            See individual drug monographs for more information

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            Warnings

            Contraindications

            Coadministration with pimozide, ergotamine or dihydroergotamine

            Omeprazole

            • • Hypersensitivity to omeprazole or other proton pump inhibitors

            Amoxicillin

            • Allergy to penicillins, cephalosporins, imipenem
            • Infectious mononucleosis (relative)
            • Concomitant live bacterial vaccines

            Clarithromycin

            • Clarithromycin/ranitidine bicitrate contraindicated in: severe renal impairment (CrCl<25 mL/min); history of acute porphyria

            Cautions

            Omeprazole

            • Liver disease may require dosage reduction
            • Published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy
            • Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, or seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
            • PPIs possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs with diarrhea that does not improve
            • Symptomatic response does not preclude concomitant underlying malignancy
            • Acute interstitial nephritis reported in patients taking PPIs
            • Concomitant use with colchicine has resulted in deaths, especially in elderly with renal insufficiency; monitor patients for clinical symptoms of colchicine toxicity

            Amoxicillin

            • Allergy to cephalosporins, carbapenems
            • Endocarditis prophylaxis: use only for high risk patients, per recent AHA Guidelines
            • High doses may cause false urine glucose test by some methods

            Clarithromycin

            • Severe renal impairment
            • Do not refrigerate oral solution
            • Endocarditis prophylaxis: use only for high risk patients, per recent AHA Guidelines
            • Exacerbation of symptoms of myasthenia gravis and new onset of symptoms reported with clarithromycin; monitor patients for symptoms
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            Pregnancy & Lactation

            Pregnancy category: C

            Based on the pregnancy category for omeprazole and clarithromycin

            No adequate and well-controlled studies in pregnant women; do not use clarithromycin or omeprazole in pregnant women except in circumstances in which no alternative therapy is appropriate

            Lactation: Not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Omeprazole

            • Proton pump inhibitor; binds to H+/K+-exchange ATPase (proton pump) in gastric parietal cells resulting in blocking acid secretion

            Amoxicillin

            • Ampicillin derivative; elicits antibacterial effect by inhibiting biosynthesis of cell wall mucopeptide

            Clarithromycin

            • Semisynthetic macrolide antibiotic that reversibly binds to P site of 50S ribosomal subunit of susceptible organisms and may inhibit RNA-dependent protein synthesis by stimulating dissociation of peptidyl t-RNA from ribosomes, causing bacterial growth inhibition

            Pharmacokinetics

            Omeprazole

            • Half-Life: 0.5-1 hr; increases to 3 hr with hepatic impairment
            • Bioavailability: 30-40%
            • Peak Plasma Time: 0.5-3.5 hr
            • Protein Bound: 95-96%
            • Total Body Clearance: 500-600 mL/min
            • Metabolism: hepatic
            • Excretion: 77% urine; 16-19% feces (mainly in bile)

            Amoxicillin

            • Half-Life: 1.5 hr
            • Absorption: 74-92%
            • Distribution: most body fluids and bone, CSF<1%
            • Peak Plasma Time: 1-2 hr
            • Protein Bound: 17-20%
            • Metabolism: hepatic
            • Excretion: urine

            Clarithromycin

            • Half-Life: 3-7 hr
            • Peak Plasma Time: 2-4 hr
            • Absorption: highly stable in presence of gastric acid (unlike erythromycin); food delays but does not affect extent of absorption
            • Distribution: widely into most body tissues except CNS Metabolism: partially hepatic (P450 enzyme CYP3A4); converted to 14-OH clarithromycin (active metabolite)
            • Renal Clearance: approximates normal GFR
            • Excretion: primarily urine
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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