Omeclamox-Pak therapy pack

Generic Name: omeprazole/clarithromycin/amoxicillin (oh-MEP-ra-zole/kla-RITH-roe-MYE-sin/a-MOX-i-SIL-in)
Brand Name: Omeclamox-Pak

Omeclamox-Pak therapy pack is used for:

Treating certain patients who have Helicobacter pylori infection and duodenal ulcer.

Omeclamox-Pak therapy pack is a proton pump inhibitor (PPI), penicillin antibiotic, and macrolide antibiotic combination. It works by killing H. pylori bacteria and reducing stomach acid. This helps to heal the ulcer and prevent it from coming back.

Do NOT use Omeclamox-Pak therapy pack if:

  • you are allergic to any ingredient in Omeclamox-Pak therapy pack, to any penicillin antibiotic (eg, ampicillin), or to any macrolide antibiotic (eg, erythromycin)
  • you have infectious mononucleosis (mono)
  • you have had liver problems or yellowing of the skin or eyes caused by previous use of clarithromycin
  • you have a very slow heartbeat or certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome, ventricular arrhythmias)
  • you have low blood potassium or magnesium levels
  • you are taking alfuzosin, certain antiarrhythmics (eg, amiodarone, dofetilide, dronedarone, procainamide, propafenone, quinidine, sotalol), asenapine, atazanavir, avanafil, bosutinib, cabazitaxel, cisapride, citalopram, clopidogrel, conivaptan, crizotinib, dasatinib, diltiazem, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), everolimus, ivabradine, lovastatin, lurasidone, nelfinavir, nilotinib, pimozide, quinupristin/dalfopristin, ranolazine, regorafenib, rifampin, rilpivirine, salmeterol, sildenafil, silodosin, simvastatin, St. John's wort, tadalafil, tamsulosin, tetrabenazine, tetracycline antibiotics (eg, doxycycline), ticagrelor, tolvaptan, vardenafil, or vincristine
  • you have kidney or liver problems and you are also taking colchicine

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Omeclamox-Pak therapy pack:

Some medical conditions may interact with Omeclamox-Pak therapy pack. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a cephalosporin antibiotic (eg, cephalexin) or other beta-lactam antibiotic (eg, imipenem)
  • if you have liver or kidney problems, the blood disorder porphyria, myasthenia gravis, gonorrhea, or stomach or bowel cancer
  • if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)
  • if you have a history of heart problems (eg, fast, slow, or irregular heartbeat) or low blood potassium or magnesium levels
  • if you are taking any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Omeclamox-Pak therapy pack. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for abortion, alcoholism, allergies, anxiety, arthritis, asthma or other lung or breathing problems, blood thinning, blood vessel problems, cancer, Cushing syndrome, cystic fibrosis, decreased blood clot formation, depression or other mental or mood problems, diabetes, enlarged prostate, erectile dysfunction, gout, hepatitis C infection, high blood pressure, high cholesterol, high prolactin levels, HIV, Huntington chorea, immune system suppression, infections, inflammation, iron replacement, irregular heartbeat or other heart problems, migraines, myelofibrosis, narcotic addiction, nausea and vomiting, pain, parathyroid problems, pulmonary arterial hypertension [PAH], overactive bladder, seizures, sleep, stomach or bowel problems, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with Omeclamox-Pak therapy pack. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Omeclamox-Pak therapy pack

This may not be a complete list of all interactions that may occur. Ask your health care provider if Omeclamox-Pak therapy pack may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Omeclamox-Pak therapy pack:

Use Omeclamox-Pak therapy pack as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Omeclamox-Pak therapy pack by mouth before a meal in the morning and in the evening unless your doctor tells you otherwise.
  • Swallow Omeclamox-Pak therapy pack whole. Do not break, crush, or chew before swallowing.
  • If you are also taking zidovudine, do not take it within 2 hours before or after you take clarithromycin.
  • To clear up your infection completely, take Omeclamox-Pak therapy pack for the full course of treatment. Keep taking it even if you feel better in a few days.
  • Continue to take Omeclamox-Pak therapy pack even if you feel well. Do not miss any doses.
  • If you miss a dose of Omeclamox-Pak therapy pack, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of Omeclamox-Pak therapy pack.

Important safety information:

  • Omeclamox-Pak therapy pack may cause drowsiness or dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Omeclamox-Pak therapy pack with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Omeclamox-Pak therapy pack only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Do NOT change your dose, stop taking Omeclamox-Pak therapy pack, or take Omeclamox-Pak therapy pack for longer than prescribed without checking with your doctor.
  • Omeprazole, an ingredient in Omeclamox-Pak therapy pack, may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Omeclamox-Pak therapy pack in high doses, for long periods of time, or if you are older than 50 years old. Contact your doctor if you have any questions about this information.
  • Omeclamox-Pak therapy pack contains a PPI. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Omeclamox-Pak therapy pack for a long time or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).
  • Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Omeclamox-Pak therapy pack.
  • Be sure to use Omeclamox-Pak therapy pack for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Long-term or repeated use of Omeclamox-Pak therapy pack may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
  • Severe and sometimes fatal liver problems have been reported with clarithromycin. This has usually been reversible when the medicine is stopped. Discuss any questions or concerns with your doctor. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • Tell your doctor or dentist that you take Omeclamox-Pak therapy pack before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Omeclamox-Pak therapy pack may rarely affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • There have been reports of tooth discoloration with the use of clarithromycin. This has usually been reversible with a dental cleaning.
  • There have been reports of hearing loss with use of clarithromycin, usually in elderly women. This has usually been reversible. Discuss any questions or concerns with your doctor.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Omeclamox-Pak therapy pack. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Do not receive a live vaccine (eg, oral typhoid vaccine) while you are taking Omeclamox-Pak therapy pack. Talk with your doctor before you receive any vaccine.
  • Omeclamox-Pak therapy pack may interfere with certain lab tests, including certain urine glucose tests. Be sure your doctor and lab personnel know you are taking Omeclamox-Pak therapy pack.
  • Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Omeclamox-Pak therapy pack. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Omeclamox-Pak therapy pack should be used with caution in Asian patients; the risk of side effects may be increased in these patients.
  • Use Omeclamox-Pak therapy pack with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval); liver problems; kidney problems; and hip, wrist, and spine fractures.
  • Omeclamox-Pak therapy pack should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Clarithromycin has been shown to cause harm to the fetus. It is not recommended for use during pregnancy except when no other antibiotics can be used. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Omeclamox-Pak therapy pack while you are pregnant. Omeclamox-Pak therapy pack is found in breast milk. Do not breast-feed while taking Omeclamox-Pak therapy pack.

Possible side effects of Omeclamox-Pak therapy pack:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in taste; dry mouth; headache; indigestion; mild diarrhea or stomach pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody or watery stools; bone pain; chest pain; confusion; decreased urination; dizziness; fast, slow, or irregular heartbeat; hallucinations; loss of taste or sense of smell; mental or mood changes (eg, depression); muscle pain or weakness; nightmares; pain, swelling, sores, or white patches in the mouth; purple spots on the skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea, nausea, or vomiting; severe or persistent stomach pain (with or without nausea or vomiting); stomach cramps; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent nausea or loss of appetite); tremor; trouble sleeping; unexplained weight loss; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; diarrhea; dry mouth; fast heartbeat; flushing; increased sweating; severe headache, drowsiness, or nausea; stomach pain; vomiting.

Proper storage of Omeclamox-Pak therapy pack:

Store Omeclamox-Pak therapy pack at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Omeclamox-Pak therapy pack out of the reach of children and away from pets.

General information:

  • If you have any questions about Omeclamox-Pak therapy pack, please talk with your doctor, pharmacist, or other health care provider.
  • Omeclamox-Pak therapy pack is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Omeclamox-Pak therapy pack or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Omeclamox-Pak therapy pack. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Omeclamox-Pak therapy pack. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Omeclamox-Pak therapy pack.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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