Triple Therapy (Oral)

Prevpac® is a product that contains three components: lansoprazole, amoxicillin, and clarithromycin. This medicine is used to treat patients with H. pylori infection and duodenal ulcers caused by H. pylori bacteria.

Lansoprazole is a proton pump inhibitor (PPI). It works by reducing the amount of acid made by the stomach. Amoxicillin and clarithromycin 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.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking 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 with your doctor.

Do not use this medicine if you are also taking astemizole (Hismanal®), atazanavir (Reyataz®), cisapride (Propulsid®), lovastatin (Mevacor®), pimozide (Orap®), simvastatin (Zocor®), terfenadine (Seldane®), certain ergot medicines (like dihydroergotamine, ergotamine, D.H.E. 45®, Ergomar®, Ergostat®, or Migranal®), or medicines that contain rilpivirine. If you have kidney or liver disease, do not take this medicine with colchicine (Colcrys®). Using these medicines together may increase the risk of serious side effects.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and needs immediate medical attention. Call your doctor right away if you have a rash, itching, fever or chills, hoarseness, sores or ulcers on the skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be signs of a serious liver problem.

Contact your doctor right away if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem like QT prolongation.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling in your body, feet, or ankles, or unusual weight gain after receiving this medicine. These could be signs of a serious kidney problem called acute interstitial nephritis.

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, talk with your doctor.

Cutaneous or systemic lupus erythematosus may occur 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 in 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.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (such as St. John's wort) or vitamin supplements.

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

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this drug or any other medications. Also 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 Prevpac® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of Prevpac® in the elderly. However, elderly patients are more likely to have kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving this medication.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential risks prior to using this drug while breastfeeding.

Interactions with 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 physician 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 medications 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 medications is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines 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 medicine with any of the following medicines is normally not recommended, 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
• 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
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Dacomitinib
• Daridorexant
• Darunavir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Delavirdine
• Demeclocycline
• Desipramine
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• 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
• 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
• Ondansetron
• Osilodrostat
• Osimertinib
• Ospemifene
• Oxaliplatin
• Oxcarbazepine
• Oxycodone
• Oxytetracycline
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• 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
• 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 medicines may cause an increased chance 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 frequently you use one or both of the medications.

• Acenocoumarol
• Cyclosporine
• Delavirdine
• Diazepam
• Dicumarol
• Glipizide
• Glyburide
• Hexobarbital
• Indinavir
• Khat
• Levothyroxine
• Linezolid
• Methylprednisolone
• Nevirapine
• Phenprocoumon
• Pravastatin
• Prednisone
• Probenecid
• Repaglinide
• Rifampin
• Tacrolimus
• Tipranavir
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 drug 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 frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Allergy to amoxicillin or penicillins or cephalosporins, history of or
• Allergy to clarithromycin, erythromycin, or macrolide antibiotics or
• Allergy to lansoprazole—Should not be used in patients with these conditions.

• Cholestatic jaundice, history of or
• Heart rhythm issues (eg, QT prolongation, torsades de pointes, ventricular arrhythmia), history of or
• Liver disease, history of—Should not be used in patients with a history of these conditions caused by clarithromycin.

• 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.

• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected—Should be corrected first prior to using this medicine.

• Kidney disease, severe—Use is not advised in patients with this condition.

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
• clay colored stools
• dark urine
• diarrhea
• difficulty with swallowing
• dizziness or fainting
• fast, slow, or irregular heartbeat
• fever
• headache
• hives, itching, or skin rash
• joint or muscle pain
• loss of appetite
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain or tenderness
• swelling of the body, feet, and ankles
• tightness in the chest
• unusual tiredness or weakness
• unusual weight gain
• vomiting
• watery and severe diarrhea, which may also be bloody
• yellow eyes or skin

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

Less common

• Confusion
• discoloration of the tongue
• itching of the vagina or genital area
• pain during sexual intercourse
• redness, swelling, or soreness of the tongue
• sore mouth or tongue
• thick, white vaginal discharge with no odor or with a mild odor
• white patches in the mouth, tongue, or throat

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.

In the U.S.

• Prevpac
• Triple Therapy

Available Dosage Forms:

• Tablet
• Capsule
• Capsule, Delayed Release

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.

Prevpac® comes with an individual daily administration card that contains: 2 pink and black capsules of lansoprazole, 4 opaque, yellow capsules of amoxicillin, and 2 yellow tablets of clarithromycin.

Swallow the capsules and tablet whole. Do not crush, break, chew, or open any of them. Take each dose on an empty stomach, before a meal.

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—30 milligrams (mg) or 1 capsule of lansoprazole, 1000 mg or 2 capsules of amoxicillin, and 500 mg or 1 tablet of clarithromycin taken together two times per day (morning and evening) for 10 or 14 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.