Omeprazole, clarithromycin, and amoxicillin (Oral route)

Pronunciation:

oh-MEP-ra-zole, kla-rith-roe-MYE-sin, a-mox-i-SIL-in

Brand Names:

Omeclamox-Pak

Dosage Forms:

Capsule, Delayed Release
Tablet
Capsule

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
Eliglustat
Eplerenone
Ergotamine
Finerenone
Flibanserin
Fluconazole
Gepirone
Isavuconazonium Sulfate
Ivabradine
Ketoconazole
Levoketoconazole
Lomitapide
Lovastatin
Lurasidone
Maraviroc
Mavacamten
Mesoridazine
Naloxegol
Nelfinavir
Nimodipine
Pacritinib
Pimozide
Piperaquine
Posaconazole
Ranolazine
Rilpivirine
Saquinavir
Silodosin
Simvastatin
Sparfloxacin
Terfenadine
Thioridazine
Tolvaptan
Ubrogepant
Venetoclax
Voclosporin
Ziprasidone

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
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
Avacopan
Avanafil
Avapritinib
Avatrombopag
Axitinib
Azithromycin
Bedaquiline
Belumosudil
Belzutifan
Benzhydrocodone
Benzphetamine
Betrixaban
Bictegravir
Boceprevir
Bosentan
Bosutinib
Bretylium
Brexpiprazole
Brigatinib
Bromocriptine
Budesonide
Buprenorphine
Buserelin
Buspirone
Cabazitaxel
Cabozantinib
Calcifediol
Cannabidiol
Capecitabine
Capivasertib
Capmatinib
Carbamazepine
Cariprazine
Cefuroxime Axetil
Cenobamate
Ceritinib
Chloroquine
Chlorpromazine
Chlortetracycline
Cholera Vaccine, Live
Cilostazol
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clindamycin
Clofazimine
Clomipramine
Clopidogrel
Clorazepate
Clothiapine
Clozapine
Cobicistat
Cobimetinib
Codeine
Conivaptan
Copanlisib
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabigatran Etexilate
Dabrafenib
Daclatasvir
Dacomitinib
Daridorexant
Darifenacin
Darolutamide
Darunavir
Dasabuvir
Dasatinib
Deflazacort
Degarelix
Delamanid
Delavirdine
Demeclocycline
Desipramine
Deslorelin
Desogestrel
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Diazepam
Dienogest
Digoxin
Dihydrocodeine
Diltiazem
Dipyrone
Disopyramide
Docetaxel
Dofetilide
Dolasetron
Dolutegravir
Donepezil
Doravirine
Doxepin
Doxorubicin
Doxorubicin Hydrochloride Liposome
Doxycycline
Droperidol
Drospirenone
Duvelisib
Ebastine
Edoxaban
Efavirenz
Elacestrant
Elagolix
Elbasvir
Elexacaftor
Encorafenib
Entrectinib
Enzalutamide
Eravacycline
Erdafitinib
Eribulin
Erlotinib
Erythromycin
Escitalopram
Eslicarbazepine Acetate
Estradiol
Eszopiclone
Ethinyl Estradiol
Ethynodiol
Etrasimod
Etravirine
Everolimus
Famotidine
Fedratinib
Felbamate
Felodipine
Fentanyl
Fesoterodine
Fexinidazole
Fingolimod
Flecainide
Fluconazole
Fluoxetine
Fluticasone
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fostamatinib
Fostemsavir
Futibatinib
Galantamine
Ganaxolone
Gatifloxacin
Gefitinib
Gemifloxacin
Gestodene
Gilteritinib
Glasdegib
Gonadorelin
Goserelin
Granisetron
Grazoprevir
Halofantrine
Haloperidol
Halothane
Histrelin
Hydrocodone
Hydrocortisone
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibrexafungerp
Ibrutinib
Ibutilide
Idelalisib
Ifosfamide
Iloperidone
Imatinib
Imipramine
Indinavir
Infigratinib
Inotuzumab Ozogamicin
Irinotecan
Irinotecan Liposome
Isoflurane
Istradefylline
Itraconazole
Ivacaftor
Ivosidenib
Ixabepilone
Ixazomib
Ketoconazole
Lapatinib
Larotrectinib
Ledipasvir
Lefamulin
Lemborexant
Lenacapavir
Leniolisib
Lenvatinib
Lercanidipine
Lesinurad
Leuprolide
Levamlodipine
Levofloxacin
Levoketoconazole
Levomethadyl
Levomilnacipran
Levonorgestrel
Linagliptin
Lisdexamfetamine
Lofexidine
Loperamide
Lopinavir
Loratadine
Lorlatinib
Lumacaftor
Lumateperone
Lumefantrine
Lurbinectedin
Lymecycline
Macimorelin
Macitentan
Manidipine
Mavacamten
Meclocycline
Mefloquine
Meperidine
Mestranol
Methacycline
Methadone
Methamphetamine
Methotrexate
Methotrimeprazine
Methylphenidate
Methylprednisolone
Metronidazole
Midazolam
Midostaurin
Mifepristone
Minocycline
Mirtazapine
Mirvetuximab Soravtansine-gynx
Mitapivat
Mitotane
Mizolastine
Mobocertinib
Modafinil
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Mycophenolate Mofetil
Nafarelin
Nafcillin
Naldemedine
Nelfinavir
Neratinib
Netupitant
Nifedipine
Nilotinib
Nintedanib
Nirmatrelvir
Nirogacestat
Nisoldipine
Nivolumab
Nomegestrol
Norethindrone
Norfloxacin
Norgestimate
Norgestrel
Octreotide
Ofloxacin
Olanzapine
Olaparib
Oliceridine
Omaveloxolone
Ombitasvir
Omeprazole
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxycodone
Oxytetracycline
Ozanimod
Palbociclib
Paliperidone
Palovarotene
Panobinostat
Papaverine
Paritaprevir
Paroxetine
Pasireotide
Pazopanib
Pemigatinib
Pentamidine
Pentazocine
Perphenazine
Pexidartinib
Phenobarbital
Phenytoin
Pimavanserin
Pipamperone
Pirtobrutinib
Pitolisant
Pixantrone
Ponatinib
Ponesimod
Prajmaline
Pralsetinib
Pravastatin
Praziquantel
Primidone
Probenecid
Probucol
Procainamide
Prochlorperazine
Progesterone
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Quizartinib
Reboxetine
Regorafenib
Relugolix
Repotrectinib
Retapamulin
Ribociclib
Rifabutin
Rifampin
Rifapentine
Rilpivirine
Rimegepant
Riociguat
Risperidone
Ritonavir
Rivaroxaban
Roflumilast
Rolapitant
Rolitetracycline
Romidepsin
Ruxolitinib
Salmeterol
Samidorphan
Saquinavir
Sarecycline
Secretin Human
Selpercatinib
Selumetinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Sildenafil
Simeprevir
Siponimod
Sirolimus
Sirolimus Protein-Bound
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sonidegib
Sorafenib
Sotalol
Sotorasib
Sparsentan
Sparteine
Spiramycin
St John's Wort
Sufentanil
Sulfamethoxazole
Sulfasalazine
Sulpiride
Sultopride
Sunitinib
Suvorexant
Tacrolimus
Tadalafil
Talazoparib
Tamoxifen
Tamsulosin
Tazemetostat
Tedisamil
Telaprevir
Telavancin
Telithromycin
Telotristat Ethyl
Temsirolimus
Tenofovir Alafenamide
Tepotinib
Tetrabenazine
Tetracycline
Tezacaftor
Theophylline
Thiotepa
Ticagrelor
Tigecycline
Tivozanib
Tolterodine
Topotecan
Toremifene
Trabectedin
Tramadol
Trazodone
Tretinoin
Triazolam
Triclabendazole
Trimethoprim
Trimipramine
Triptorelin
Tucatinib
Ulipristal
Upadacitinib
Valbenazine
Valproic Acid
Vamorolone
Vandetanib
Vardenafil
Velpatasvir
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinblastine
Vincristine
Vincristine Sulfate Liposome
Vinflunine
Vinorelbine
Vismodegib
Vorapaxar
Voriconazole
Vorinostat
Voxelotor
Voxilaprevir
Warfarin
Zanubrutinib
Zidovudine
Zolpidem
Zotepine
Zuclopenthixol
Zuranolone

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
Armodafinil
Cyanocobalamin
Delavirdine
Disulfiram
Ginkgo Biloba
Glipizide
Glyburide
Iron
Khat
Levothyroxine
Linezolid
Nevirapine
Prednisone
Raltegravir
Repaglinide
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 of This Medicine:

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.

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 While Using This Medicine:

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 of This Medicine:

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.

Last Updated: 4/24/2024

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