OMEPRAZOLE/CLARITHROMYCIN/AMOXICILLIN - ORAL

OMEPRAZOLE/CLARITHROMYCIN/AMOXICILLIN - ORAL

PHONETIC PRONUNCIATION: (oh-MEP-ra-zole/kla-RITH-roe-MYE-sin/a-MOX-i-sil-in)

COMMON BRAND NAME(S): Omeclamox-Pak

GENERIC NAME(S): omeprazole/clarithromycin/amoxicillin trihydrate

Uses

USES: This product is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning. Treating ulcers reduces the risk of serious damage to the lining of the stomach/intestines (such as bleeding, tearing, blockage). Omeprazole is known as a proton pump inhibitor (PPI). It works by blocking acid production in the stomach. Decreasing excess stomach acid can help ulcers heal. Amoxicillin and clarithromycin are antibiotics used to treat a wide variety of bacterial infections (including H. pylori). Treating the infection helps reduce the risk of ulcers returning. Amoxicillin is a penicillin-type antibiotic and clarithromycin is a macrolide-type antibiotic. They work by stopping the growth of bacteria. The antibiotics in this product treat only bacterial infections. Antibiotics do not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.


How to use OMEPRAZOLE/CLARITHROMYCIN/AMOXICILLIN - ORAL

HOW TO USE: Each packet contains both the morning and evening doses of this medication (a 1-day supply). Consult your doctor or pharmacist for instructions on the proper use of this product. Take this medication by mouth as directed by your doctor, usually 1 dose (4 pills) before a meal, twice daily. Swallow the omeprazole capsules whole. Do not crush or chew. If you have trouble swallowing the omeprazole capsule, you may open the capsule if it is not sealed and carefully sprinkle its contents on a spoonful of soft, cool applesauce. Swallow all of the mixture right away without chewing it. Then drink a glass of cool water to make sure you have swallowed all of the dose. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug. For the best effect, take this product at evenly spaced times. To help you remember, take this product at the same times every day. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. The dosage and length of treatment are based on your medical condition and response to treatment. Tell your doctor if your condition persists or worsens.

Side Effects

SIDE EFFECTS: Diarrhea, headache, nausea, vomiting, and abnormal taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: muscle weakness, dark urine, yellowing eyes/skin, easy bruising/bleeding, mental/mood changes (such as agitation, confusion), signs of lupus (such as rash on nose and cheeks, new or worsening joint pain). Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat. This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea or opioid medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool. Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine). Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to omeprazole, amoxicillin, or clarithromycin; or to penicillins (such as ampicillin), cephalosporins (such as cephalexin), or macrolide antibiotics (such as erythromycin); or to esomeprazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including liver problems with past clarithromycin use), kidney disease, heart disease (coronary artery disease, heart attack), a certain type of muscle disease (myasthenia gravis), a certain type of viral infection (infectious mononucleosis), lupus. Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss. Clarithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using this product, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to. Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor. Amoxicillin, clarithromycin, and omeprazole pass into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: clindamycin, clopidogrel, digoxin, ergot alkaloids (such as dihydroergotamine, ergotamine), methotrexate (especially high-dose treatment), rifamycins (such as rifabutin, rifampin), saquinavir, St John's wort. Many drugs besides clarithromycin may affect the heart rhythm (QT prolongation), including amiodarone, cisapride, disopyramide, dofetilide, dronedarone, ibutilide, pimozide, procainamide, propafenone, quinidine, sotalol, among others. Some products need stomach acid so that the body can absorb them properly. Omeprazole decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, erlotinib, nelfinavir, pazopanib, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others. Clarithromycin can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alfuzosin, colchicine, eletriptan, eplerenone, lurasidone, ranolazine, silodosin, tamsulosin, certain statins (such as atorvastatin, lovastatin, simvastatin), ticagrelor, among others. Although most antibiotics are unlikely to affect hormonal birth control such as pills, patch, or ring, a few antibiotics (such as rifampin, rifabutin) can decrease their effectiveness. This could result in pregnancy. If you use hormonal birth control, ask your doctor or pharmacist for more details. Omeprazole is very similar to esomeprazole. Do not use any medications containing esomeprazole while using omeprazole. This medication may interfere with certain laboratory tests (including urine glucose test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: change in the amount of urine.

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R 158 or 54 312 or GG849, OMEPRAZOLE 20 mg

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Faq for OMEPRAZOLE/CLARITHROMYCIN/AMOXICILLIN - ORAL

- This medication is a combination of three drugs (omeprazole, clarithromycin, and amoxicillin) and it is used to treat stomach ulcers caused by Helicobacter pylori (H. pylori) infection.

- Omeprazole reduces the amount of acid produced by the stomach, clarithromycin is an antibiotic that fights bacteria, and amoxicillin works by stopping the growth of bacteria. Together, these drugs help eliminate the H. pylori infection and heal the stomach ulcers.

- The common side effects may include diarrhea, nausea, vomiting, stomach pain, headache, and changes in taste or metallic taste in the mouth. It is important to consult your doctor if any of these side effects persist or worsen.

- This medication is usually taken twice daily, with or without food. It is important to follow the prescribed dosing instructions provided by your doctor and complete the full course of treatment, even if you start feeling better.

- Yes, there are a few precautions and warnings. Inform your doctor or pharmacist about any allergies you may have, as this medication may contain inactive ingredients that can cause allergic reactions or other problems. It is also important to disclose your medical history, especially if you have liver disease, kidney disease, or a history of any stomach problems. Certain medications, such as blood thinners or antifungal drugs, may interact with this medication, so it is important to inform your doctor about all the medications you are currently taking.

- The duration of treatment varies depending on the condition being treated and the individual patient. It is important to complete the full course of treatment as prescribed by your doctor, even if symptoms improve before the treatment is finished.

- If you miss a dose, take it as soon as you remember. However, if it is close to the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

- It is generally recommended to avoid consuming alcohol while taking this medication. Alcohol can irritate the stomach and may interfere with the effectiveness of the antibiotics.

- It is important to discuss the potential risks and benefits of this medication with your doctor if you are pregnant or breastfeeding. Omeprazole is generally considered safe during pregnancy, while clarithromycin and amoxicillin may have some risks. Your doctor will weigh the potential benefits against the possible risks before prescribing this medication.

The duration of treatment varies based on the severity of the infection and individual response. Typically, symptoms start to improve within a few days of starting the medication.

Yes, it can interact with certain medications, including blood thinners, anti-seizure drugs, and other antibiotics. Inform your healthcare provider about all the medications you are taking to avoid any potential interactions.

It is important to discuss the potential risks and benefits with your healthcare provider before using this medication during pregnancy. They will assess the situation and determine if the benefits outweigh the potential risks.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.