Prevpac

DRUG DESCRIPTION

PREVPAC (lansoprazole, amoxicillin and clarithromycin) 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 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 Structural Formula Illustration

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. Components of the gelatin capsule include gelatin, titanium dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40 (inactive ingredients).

Amoxicillin Capsules, USP

Amoxicillin is a semisynthetic 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-aza-bicyclo[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. The yellow opaque capsules contain 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.

What are the possible side effects of amoxicillin, clarithromycin, and lansoprazole (Prevpac)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • signs of new infection, such as fever, chills, body aches, flu symptoms, mouth sores;
  • easy bruising or bleeding, unusual weakness;
  • agitation, confusion, unusual thoughts or behavior;
  • ...

Read All Potential Side Effects and See Pictures of Prevpac »

What are the precautions when taking lansoprazole, amoxicillin and clarithromycin (Prevpac)?

Before taking this product, tell your doctor or pharmacist if you are allergic to lansoprazole, amoxicillin, or clarithromycin; or to penicillins (such as ampicillin), cephalosporins (such as cephalexin), or macrolide antibiotics (such as erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, a certain type of muscle disease (myasthenia gravis), a certain type of viral infection (infectious mononucleosis).

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you...

Read All Potential Precautions of Prevpac »


Prevpac Consumer (continued)

SIDE EFFECTS: Diarrhea, headache, nausea, vomiting, and abnormal taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: muscle weakness, change in the amount of urine, dark urine, yellowing eyes/skin, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as agitation, confusion).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to lansoprazole, amoxicillin, or clarithromycin; or to penicillins (such as ampicillin), cephalosporins (such as cephalexin), or macrolide antibiotics (such as erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, a certain type of muscle disease (myasthenia gravis), a certain type of viral infection (infectious mononucleosis).

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw pain (especially with trouble breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.

Clarithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using this product, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this product safely.

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Amoxicillin passes into breast milk. It is unknown if lansoprazole or clarithromycin pass into breast milk. Consult your doctor before breast-feeding.


Prevpac Patient Information Including Side Effects

Brand Names: Prevpac

Generic Name: amoxicillin, clarithromycin, and lansoprazole (Pronunciation: a MOX i SIL in, kla RITH roe MYE sin, LAN soe PRA zole)

  • What is amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • What are the possible side effects of amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • What is the most important information I should know about amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • What should I discuss with my healthcare provider before taking amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • How should I take amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • What happens if I miss a dose (Prevpac)?
  • What happens if I overdose (Prevpac)?
  • What should I avoid while taking amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • What other drugs will affect amoxicillin, clarithromycin, and lansoprazole (Prevpac)?
  • Where can I get more information?

What is amoxicillin, clarithromycin, and lansoprazole (Prevpac)?

Amoxicillin is an antibiotic in the penicillin group of drugs. It fights bacteria in your body.

Clarithromycin is in a group of drugs called macrolide antibiotics. Clarithromycin fights bacteria in your body.

Lansoprazole decreases the amount of acid produced in the stomach.

The combination of amoxicillin, clarithromycin, and lansoprazole is used to prevent stomach ulcer caused by infection with Helicobacter pylori (H. pylori).

Amoxicillin, clarithromycin, and lansoprazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of amoxicillin, clarithromycin, and lansoprazole (Prevpac)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • signs of new infection, such as fever, chills, body aches, flu symptoms, mouth sores;
  • easy bruising or bleeding, unusual weakness;
  • agitation, confusion, unusual thoughts or behavior;
  • dizziness, fainting, fast or pounding heartbeat; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • unusual or unpleasant taste in your mouth;
  • headache;
  • nausea, vomiting, stomach pain;
  • constipation, dark colored stools;
  • dry mouth, increased thirst; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amoxicillin, clarithromycin, and lansoprazole (Prevpac)?

You should not take this medication if you are allergic to amoxicillin (Amoxil, Trimox, Dispermox), clarithromycin (Biaxin), lansoprazole (Prevacid), or to certain other antibiotics.

While you are taking amoxicillin, clarithromycin, and lansoprazole, do not take any of the following medications: cisapride (Propulsid), ergotamine (Ergomar, Cafergot, Ercaf, Migergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or pimozide (Orap).

Tell your doctor if you have kidney or liver disease, myasthenia gravis, or if you are allergic to any drugs (especially any antibiotics).

Amoxicillin can make birth control pills less effective, which may result in pregnancy. Before taking amoxicillin, clarithromycin, and lansoprazole, tell your doctor if you use birth control pills.

There are many other medicines that can interact with amoxicillin, clarithromycin, and lansoprazole. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Related Drug Centers
  • Prevpac


Related Drugs Index: