Omeprazole-Amoxicillin-Clarithromycin

Omeprazole-Amoxicillin-Clarithromycin is a combination medication used for the treatment of duodenal ulcers.

• Omeprazole-Amoxicillin-Clarithromycin is available under the following different brand names: Omeclamox-Pak

Common side effects of Omeprazole-Amoxicillin-Clarithromycin include:

• diarrhea,
• headache, and
• unusual or unpleasant taste in the mouth

Serious side effects of Omeprazole-Amoxicillin-Clarithromycin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• severe stomach pain,
• watery or bloody diarrhea,
• fast or pounding heartbeats,
• fluttering in the chest,
• shortness of breath,
• sudden dizziness,
• upper stomach pain,
• itching,
• loss of appetite,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• urinating more or less than usual,
• blood in the urine,
• swelling,
• rapid weight gain,
• joint pain, and
• skin rash on the cheeks or arms that worsens in sunlight

Rare side effects of Omeprazole-Amoxicillin-Clarithromycin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule/capsule/tablet prepack

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

Duodenal Ulcer

Adult dosage

• Omeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg coadministered orally twice daily (morning and evening) for 10 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Omeprazole-Amoxicillin-Clarithromycin has severe interactions with the following drugs:
  • erlotinib
  • mavacamten
  • nelfinavir
  • rilpivirine
• Omeprazole-Amoxicillin-Clarithromycin has serious interactions with at least 43 other drugs.
• Omeprazole-Amoxicillin-Clarithromycin has moderate interactions with at least 99 other drugs.
• Omeprazole-Amoxicillin-Clarithromycin has minor interactions with at least 55 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Coadministration with pimozide, ergotamine or dihydroergotamine
• Omeprazole
  • Hypersensitivity to omeprazole, benzimidazoles 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 less than 25 mL/min); history of acute porphyria

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Omeprazole-Amoxicillin-Clarithromycin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Omeprazole-Amoxicillin-Clarithromycin?”

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 (above 1 yr), high-dose therapy
  • Hypomagnesemia may occur with prolonged use (i.e., more than 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
  • Symptomatic response does not preclude concomitant underlying malignancy
  • Acute tubulointerstitial nephritis (TIN) is reported in patients taking PPIs; TIN may occur at any point during PPI therapy; patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions, to non-specific symptoms of decreased renal function (eg, malaise, nausea, anorexia); in reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (eg, fever, rash or arthralgia); discontinue the drug and evaluate patients with suspected acute TIN
• Cutaneous and systemic lupus
  • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; these events have occurred as both new onset and exacerbation of existing autoimmune disease; majority of PPI-induced lupus erythematosus cases were CLE; the most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly; generally, histological findings were observed without organ involvement
  • Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs; PPI-associated SLE is usually milder than non-drug induced SLE; onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly; the majority of patients presented with rash; however, arthralgia and cytopenia were also reported
  • Avoid administration of PPIs for longer than medically indicated; if signs or symptoms consistent with CLE or SLE are noted in patients receiving therapy, discontinue the drug and refer the patient to an appropriate specialist for evaluation
  • Most patients improve with discontinuation of PPI alone in 4 to 12 weeks; serological testing (eg, ANA) may be positive, and elevated serological test results may take longer to resolve than the clinical manifestation
• Amoxicillin
  • Allergy to cephalosporins, carbapenems
  • Endocarditis prophylaxis: use only for high-risk patients, per recent AHA Guidelines
  • High doses may cause false urine glucose tests by some methods
• Clarithromycin
  • Severe renal impairment
  • Do not refrigerate the 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
  • Colchicine toxicity, some fatal, reported with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency; monitor patients for clinical symptoms of colchicine toxicity
  • Bacterial resistance and superinfection
  • The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy due to clarithromycin and amoxicillin components; if superinfections occur, discontinue therapy and institute appropriate therapy
  • Prescribing clarithromycin or amoxicillin component in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria
• Clostridioides difficile-associated diarrhea (CDAD)
• CDAD reported with the use of clarithromycin and amoxicillin; may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile
• C. difficile produces toxins A and B which contribute to the development of CDAD; hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy
• CDAD must be considered in all patients who present with diarrhea following antibiotic use; careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents; if CDAD is suspected or confirmed, ongoing antibiotic use is not directed against C. difficile may need to be discontinued
• Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
• Use caution in renal/hepatic impairment, diabetes

Pregnancy and Lactation

• Based on findings in animal studies for omeprazole and clarithromycin during pregnancy may cause fetal harm; therapy is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate; Ii therapy is administered during pregnancy, or if pregnancy occurs while receiving therapy, the patient should be apprised of the potential hazard to the fetus; there are no adequate and well-controlled studies of omeprazole, clarithromycin, or amoxicillin (used separately or together) in pregnant women
• Lactation
  • Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of maternal weight-adjusted dose; in a separate observational study, reported adverse effects on breastfed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin
  • No data are available to assess the effects of clarithromycin or 14-OH clarithromycin on milk production
  • Limited data from a single case report suggest omeprazole may be present in human milk; there are no clinical data on the effects of omeprazole on the breastfed infant or milk production
  • Data from a published clinical lactation study indicate that amoxicillin is present in human milk; published adverse effects with amoxicillin exposure in a breastfed infant include diarrhea; there are no data on the effects of amoxicillin on milk production
  • Development and health benefits of breastfeeding should be considered along with the mother’s clinical need for omeprazole or clarithromycin or amoxicillin and any potential adverse effects on the breastfed child from clarithromycin or underlying maternal condition.