Description
Omeclamox®-Pak is a product containing three components: omeprazole, clarithromycin, and amoxicillin. This medicine is used to treat patients with H. pylori infection and duodenal ulcers caused by H. pylori bacteria (germ).
Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach. Clarithromycin and amoxicillin both belong to the class of medicines known as antibiotics. They work by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Delayed Release
- Tablet
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Omeclamox®-Pak in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Omeclamox®-Pak in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfuzosin
- Alprazolam
- Astemizole
- Bepridil
- Cisapride
- Colchicine
- Conivaptan
- Dihydroergotamine
- Domperidone
- Dronedarone
- Eletriptan
- Eplerenone
- Ergotamine
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Ketoconazole
- Levoketoconazole
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mesoridazine
- Naloxegol
- Nimodipine
- Pacritinib
- Pimozide
- Piperaquine
- Posaconazole
- Ranolazine
- Rilpivirine
- Saquinavir
- Silodosin
- Simvastatin
- Sparfloxacin
- Suzetrigine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Acecainide
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afatinib
- Ajmaline
- Alfentanil
- Amiodarone
- Amisulpride
- Amitriptyline
- Amlodipine
- Amphetamine
- Amprenavir
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Asenapine
- Atazanavir
- Atezolizumab
- Atogepant
- Atorvastatin
- Atrasentan
- Avacopan
- Avanafil
- Avapritinib
- Avatrombopag
- Axitinib
- Azathioprine
- Azithromycin
- Bedaquiline
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acenocoumarol
- Apalutamide
- Apixaban
- Armodafinil
- Cyanocobalamin
- Delavirdine
- Disulfiram
- Ginkgo Biloba
- Glipizide
- Glyburide
- Iron
- Khat
- Levothyroxine
- Linezolid
- Prednisone
- Raltegravir
- Repaglinide
- Rivaroxaban
- Tipranavir
- Triazolam
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Cranberry
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diarrhea or
- Kidney disease or
- Liver disease or
- Myasthenia gravis (severe muscle weakness) or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- Heart rhythm problems (eg, arrhythmia, QT prolongation, torsades de pointes, ventricular arrhythmia) or
- Mononucleosis—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Omeclamox®-Pak comes with an individual daily administration card that contains: 2 opaque, lavender and gray capsules of omeprazole, 4 opaque, peach and orange capsules of amoxicillin, and 2 white tablets of clarithromycin.
Swallow the capsules and tablets whole. Do not crush, break, chew, or open any of them. Take each dose on an empty stomach, before the morning and evening meals.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (kit):
- For treatment of duodenal ulcers and H. pylori infections:
- Adults—20 milligrams (mg) or 1 capsule of omeprazole, 1000 mg or 2 capsules of amoxicillin, and 500 mg or 1 tablet of clarithromycin taken as a single dose 2 times per day for 10 days.
- Children—Use and dose must be determined by your doctor.
- For treatment of duodenal ulcers and H. pylori infections:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor.
Do not use this medicine if you are also using certain ergot medicines (eg, dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®) or pimozide (Orap®). Using these medicines together may increase risk for more serious side effects.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cracks in the skin, cough, diarrhea, joint or muscle pain, loss of heat from the body, red irritated eyes, red or swollen skin, red skin lesions, often with a purple center, scaly skin, sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat, or unusual tiredness or weakness while you are using this medicine.
Make sure your doctor knows if you are pregnant or planning to become pregnant. If you become pregnant while using this medicine, tell your doctor right away.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.
Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of acute tubulointerstitial nephritis.
Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese before using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Blistering, peeling, or loosening of the skin
- chills
- cracks in the skin
- cough
- diarrhea
- difficulty with swallowing
- dizziness
- fast heartbeat
- fever or chills
- hives or welts, itching, or skin rash
- increased sensitivity of the skin to sunlight
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of heat from the body
- muscle pain or weakness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, swollen skin
- red irritated eyes
- red skin lesions, often with a purple center
- redness of the skin
- redness or discoloration of the skin
- scaly skin
- severe sunburn
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach tenderness, cramps, or pain
- swelling of the body, feet, and ankles
- tightness in the chest
- unusual tiredness or weakness
- unusual weight gain
- watery and severe diarrhea, which may also be bloody
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bad, unusual, or unpleasant (after) taste
- change in taste
- headache
Incidence not known
- Hair loss, thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20137701
