Prevpac

What is Prevpac used for?

Prevpac is a prescription medicine that is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.

Description

PREVPAC consists of a daily administration card containing two PREVACID 30 mg capsules, four amoxicillin 500-mg capsules, USP, and two clarithromycin 500 mg tablets, USP, for oral administration.

 

PREVACID® (lansoprazole) Delayed-Release Capsules

The active ingredient in PREVACID delayed release capsules is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. PREVACID has the following structure:

Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.

Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.

 

Amoxicillin Capsules, USP

Amoxicillin is a semi synthetic antibiotic, an analogue of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2S, 5R, 6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate. Its empirical formula is C16H19N3O5S • 3H2O with a molecular weight of 419.45. Amoxicillin has the following structure:

Amoxicillin capsules are intended for oral administration. Each yellow opaque capsule contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin.

Inactive ingredients: Capsule shells – yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide; Capsule contents – cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2.

 

BIAXIN® Filmtab® (clarithromycin tablets, USP)

Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically, it is 6-0-methylerythromycin. The molecular formula is C38H69NO13, and the molecular weight is 747.96. Clarithromycin has the following structure:

Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each yellow oval film-coated immediate-release tablet contains 500 mg of clarithromycin and the following inactive ingredients: hypromellose, hydroxypropyl cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sorbic acid, sorbitan monooleate, titanium dioxide, and vanillin.

Before taking Prevpac, tell your doctor:

• If you are allergic to Prevpac; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If Prevpac caused liver problems before.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you have any of these health problems: Low magnesium levels, low potassium levels, or slow heartbeat.
• If you have kidney or liver disease and are taking colchicine.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Prevpac, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with Prevpac.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prevpac with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Prevpac?

• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Call your doctor if you have throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
• Avoid drinking alcohol while taking Prevpac.
• This medicine may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take Prevpac in high doses or for longer than a year, or if you are older than 50 years old.
• Rarely, low magnesium levels have happened in people taking drugs like this one for at least 3 months. Most of the time, this happened after 1 year of treatment. You will need to have blood work if you take Prevpac for a long time or with certain other drugs.
• Very bad and sometimes deadly liver problems have happened with Prevpac. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad and sometimes deadly type of heartbeat that is not normal (long QT on ECG) has happened with Prevpac. Some other drugs taken along with Prevpac may add to this effect. Get medical help right away if your heartbeat does not feel normal.
• Lupus has happened with Prevpac, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• If you have heart disease, talk with your doctor. In one study, people with heart disease who took clarithromycin had a higher chance of death a year or more later than those who did not take clarithromycin. The cause of this was not known. Other studies have shown different results.
• If you are 65 or older, use Prevpac with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Prevpac.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Prevpac, call your doctor right away.

How is Prevpac best taken?

Use Prevpac as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep using Prevpac as you have been told by your doctor or other health care provider, even if you feel well.
• Take Prevpac before meals.
• If you also take sucralfate, take Prevpac at least 30 minutes before taking sucralfate.
• Tell all of your health care providers that you take Prevpac. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes) and test your urine glucose, talk with your doctor to find out which tests are best to use.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Prevpac.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Prevpac that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Dizziness or passing out.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Bone pain.
• Fever or chills.
• Sore throat.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Tooth staining.
• Redness or white patches in mouth or throat.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Prevpac?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Bad taste in your mouth.
• Diarrhea.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Prevpac?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – CARTON

• triple therapy
  PREVPAC®
  LANSOPRAZOLE
  AMOXICILLIN
  CLARITHROMYCIN
• 14 DAILY PATIENT CARDS
• EACH DAILY PATIENT
  CARD CONTAINS:
  2 PREVACID® (lansoprazole) 30-mg capsules;
  4 AMOXICILLIN CAPSULES, USP, 500 mg; and
  2 BIAXIN® Filmtab® (clarithromycin tablets, USP) 500 mg
• Rx only

SRC: NLM .