Omeprazole, clarithromycin, and amoxicillin (Oral)

Omeclamox®-Pak is a medicine made up of three parts: omeprazole, clarithromycin, and amoxicillin. It is used to treat people with an H. pylori infection and duodenal ulcers caused by H. pylori bacteria (germ).

Omeprazole is a proton pump inhibitor (PPI). It helps by reducing the amount of acid that the stomach makes. Clarithromycin and amoxicillin are both antibiotics. They work by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

You can get this medicine only with a prescription from your doctor.

It is important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working well and decide if you should keep using it. Blood, urine, and other lab tests may be needed to check for side effects. If your condition does not improve, or if it gets worse, talk to your doctor.

Do not use this medicine if you are also taking certain ergot medicines (for example, dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®) or pimozide (Orap®). Using these medicines together may increase the risk of 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 need 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 using this medicine.

Make sure your doctor knows if you are pregnant or planning to become pregnant. If you get pregnant while using this medicine, tell your doctor right away.

This medicine may cause diarrhea, which can sometimes be severe. It may happen 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 notice a change in how often you urinate or how much urine you produce, blood in your 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 signs of acute tubulointerstitial nephritis.

Cutaneous or systemic lupus erythematosus may develop or worsen in patients taking 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 sunlight.

Make sure any doctor or dentist treating 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of using the drug must be weighed against the good it will do. This is a decision you and your clinician will make. For this drug, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medicine or any other medications. Additionally inform 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. Nevertheless, elderly patients are more likely to have kidney issues, 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 chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medication while breastfeeding.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different medications 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 using 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 medication with any of the following medications is not recommended. Your clinician may decide not to treat you with this medication or change some of the other medications you take.

• Alfuzosin
• Alprazolam
• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• 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 medication with any of the following medications is normally not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how frequently you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Afatinib
• Ajmaline
• Alfentanil
• Amiodarone
• Amisulpride
• Amitriptyline
• Amlodipine
• Amobarbital
• Amphetamine
• Amprenavir
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Aprindine
• Aprobarbital
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Atazanavir
• Atezolizumab
• Atogepant
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Azithromycin
• Bedaquiline
• Belumosudil
• Belzutifan
• Benzhydrocodone
• Benzphetamine
• Berotralstat
• Betrixaban
• Bosutinib
• Bretylium
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Buserelin
• Butabarbital
• Butalbital
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Capecitabine
• Carbamazepine
• Cariprazine
• Cefuroxime Axetil
• Ceritinib
• Chloroquine
• Chlorpromazine
• Chlortetracycline
• Cholera Vaccine, Live
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clofazimine
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Conivaptan
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Dacomitinib
• Daridorexant
• Darunavir
• Dasabuvir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Delavirdine
• Demeclocycline
• Desipramine
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Diazepam
• Dienogest
• Digoxin
• Dihydrocodeine
• Diltiazem
• Disopyramide
• Docetaxel
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxycycline
• Droperidol
• Drospirenone
• Dutasteride
• Duvelisib
• Ebastine
• Edoxaban
• Efavirenz
• Elacestrant
• Elagolix
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamide
• Eravacycline
• Eribulin
• Erlotinib
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Estazolam
• Estradiol
• Eszopiclone
• Ethinyl Estradiol
• Ethynodiol
• Etrasimod
• Etravirine
• Everolimus
• Famotidine
• Fedratinib
• Felbamate
• Felodipine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluticasone
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Futibatinib
• Galantamine
• Gatifloxacin
• Gefitinib
• Gemifloxacin
• Gestodene
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Indinavir
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Isoflurane
• Isradipine
• Istradefylline
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Lapatinib
• Larotrectinib
• Ledipasvir
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Letrozole
• Leuprolide
• Levofloxacin
• Levoketoconazole
• Levomilnacipran
• Levonorgestrel
• Lisdexamfetamine
• Lofexidine
• Lopinavir
• Lorcainide
• Lorlatinib
• Losartan
• Lumacaftor
• Lumateperone
• Lumefantrine
• Lurbinectedin
• Lymecycline
• Macimorelin
• Macitentan
• Manidipine
• Mavacamten
• Meclocycline
• Mefloquine
• Meperidine
• Mephobarbital
• Mestranol
• Methacycline
• Methadone
• Methamphetamine
• Methohexital
• Methotrexate
• Methylphenidate
• Metronidazole
• Midazolam
• Midostaurin
• Mifepristone
• Minocycline
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mizolastine
• Mobocertinib
• Modafinil
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Mycophenolate Mofetil
• Nafarelin
• Nafcillin
• Nelfinavir
• Neratinib
• Netupitant
• Nicardipine
• Nifedipine
• Nilotinib
• Nirmatrelvir
• Nisoldipine
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Osilodrostat
• Osimertinib
• Ospemifene
• Oxaliplatin
• Oxcarbazepine
• Oxycodone
• Oxytetracycline
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perphenazine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pirmenol
• Pirtobrutinib
• Pitolisant
• Pixantrone
• Ponatinib
• Ponesimod
• Pralsetinib
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Reboxetine
• Regorafenib
• Relugolix
• Retapamulin
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rimegepant
• Riociguat
• Risperidone
• Ritonavir
• Rivaroxaban
• Roflumilast
• Rolitetracycline
• Romidepsin
• Ruxolitinib
• Salmeterol
• Saquinavir
• Sarecycline
• Secobarbital
• Secretin Human
• Selpercatinib
• Selumetinib
• Sertindole
• Sertraline
• Sevoflurane
• Sildenafil
• Simeprevir
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Sotorasib
• Sparsentan
• Spiramycin
• St John's Wort
• Sufentanil
• Sulfamethoxazole
• Sulfasalazine
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Talazoparib
• Tamoxifen
• Tamsulosin
• Tazemetostat
• Telaprevir
• Telavancin
• Telithromycin
• Temsirolimus
• Tenofovir Alafenamide
• Tetrabenazine
• Tetracycline
• Tezacaftor
• Thiopental
• Thiotepa
• Ticagrelor
• Tigecycline
• Tocilizumab
• Tolterodine
• Topotecan
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trimethoprim
• Trimipramine
• Triptorelin
• Upadacitinib
• Valbenazine
• Vamorolone
• Vandetanib
• Vardenafil
• Velpatasvir
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vinorelbine
• Vismodegib
• Vorapaxar
• Voriconazole
• Vorinostat
• Warfarin
• Zaleplon
• Zanubrutinib
• Zidovudine
• Zileuton
• Zolpidem
• Zuclopenthixol
• Zuranolone

Using this medication with any of the following drugs may cause an increased risk of certain side effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your clinician may change the dose or how frequently you use one or both of the drugs.

• Acenocoumarol
• Armodafinil
• Carbamazepine
• Cyanocobalamin
• Cyclosporine
• Delavirdine
• Diazepam
• Disulfiram
• Ginkgo Biloba
• Glipizide
• Glyburide
• Hexobarbital
• Indinavir
• Iron
• Khat
• Levothyroxine
• Linezolid
• Methylprednisolone
• Nevirapine
• Pravastatin
• Prednisone
• Probenecid
• Raltegravir
• Repaglinide
• Rifampin
• Tipranavir
• Triazolam

Interactions with Food/Tobacco/Alcohol

Certain medications 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 as well 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 medication 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 physician may change the dose or how frequently you use this medication, 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 drug. Make sure you inform your physician if you have any other medical issues, 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 issues (eg, arrhythmia, QT prolongation, torsades de pointes, ventricular arrhythmia) or
• Mononucleosis—Should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, you may need medical help.

Contact your doctor right away if you experience any of the following side effects:

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• cracks in the skin
• cough
• diarrhea
• difficulty 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or lessen some of these side effects. Speak with your health care professional if any of the following side effects persist, 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 happen in some patients. If you notice any other effects, consult 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.

In the U.S.

• Omeclamox-Pak

Available Dosage Forms:

• Capsule, Delayed Release
• Tablet
• Capsule

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.