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PREVPAC (lansoprazole/ amoxicillin/clarithromycin): Treatment to Eliminate Helicobacter Pylori

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PREVPAC is a convenient daily dose pack that contains a multiple-drug treatment to eliminate H. pylori (Helicobacter pylori, pronounced HELI-co-back-ter pie-LORRIE) and to reduce the risk of duodenal ulcer recurrence. Each PREVPAC contains daily administration cards for a 10- or 14-day treatment regimen. Each card contains three different prescription drugs for one day of treatment. It includes an acid-reducing drug called Prevacid and two antibiotics called amoxicillin capsules, USP and BIAXIN® Filmtab® (clarithromycin tablets, USP).

What is PREVPAC used for?
How do I use PREVPAC?
How long will I need to take PREVPAC?
What are the possible side effects with PREVPAC?
Can I take PREVPAC if I am pregnant or nursing?
Who should not take PREVPAC?
Can I take PREVPAC with other medications?
When should I call my doctor?
Where can I get more information about PREVPAC?


What is PREVPAC used for?
Bacteria called H. pylori are a major cause of duodenal ulcers, located in the first part of the small intestine just below the stomach. Eliminating H. pylori greatly reduces the chances that a duodenal ulcer will return. The triple-drug treatment in PREVPAC is used to eliminate H. pylori to reduce the risk of duodenal ulcers from coming back.

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How do I use PREVPAC?
In the morning, take one capsule of PREVACID 30 mg, 2 capsules of amoxicillin 500 mg, and 1 tablet of BIAXIN Filmtab 500 mg. In the evening, repeat this by taking one capsule of PREVACID 30 mg, 2 capsules of amoxicillin 500 mg, and 1 tablet of BIAXIN Filmtab 500 mg. Continue taking this twice-daily treatment for 10 or 14 days, as prescribed by your doctor. It can help you remember if you make PREVPAC a part of your daily routine. Your doctor's instructions should be printed on your prescription label.

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How long will I need to take PREVPAC?
The triple-drug treatment with PREVPAC usually takes up to two weeks to get rid of H. pylori. Your results may vary. Even if you feel better quickly, you should take all of your medication as directed. If you stop taking your medication early, you may not completely eliminate the H. pylori.

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What are the possible side effects with PREVPAC?
Like all medicines, the triple-drug treatment in PREVPAC may cause some side effects. In studies, the most common side effects reported with PREVPAC were diarrhea, headache, and taste perversion. Other side effects have been reported with PREVPAC, but less often.

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Can I take PREVPAC if I am pregnant or nursing?
Since the triple-drug treatment in PREVPAC contains clarithromycin, it should not be taken if you are pregnant unless special circumstances exist such that no alternative treatment is appropriate. Only your doctor can determine if this is the right treatment for you.

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Who should not take PREVPAC?
Besides those who are pregnant or nursing, you should not take PREVPAC if you are allergic to any ingredient in Prevacid, penicillin or any macrolide antibiotic. You should also not take PREVPAC if you are taking cisapride, pimozide, astemizole or terfenadine or if you have certain kidney problems.

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Can I take PREVPAC with other medications?
Make sure your doctor is aware of all the medicines and supplements you are taking. If you are taking digoxin, sucralfate, carbamazepine, phenytoin, warfarin, or theophylline, your doctor may perform additional blood tests or adjust the dose or timing of your medication. PREVPAC may theoretically interfere with drugs that need stomach acid to work, drugs like ketoconazole, ampicillin esters, iron salts, and digoxin.

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When should I call my doctor?
Call your doctor right away if your duodenal ulcer symptoms get worse while you are taking the triple-therapy PREVPAC or if they do not go away by the end of your treatment. If you have any signs of an allergic reaction, such as hives or trouble breathing, you should seek immediate medical attention. You should also call your doctor if you are concerned about any side effects or if you have any questions about your treatment.

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Where can I get more information about PREVPAC?
Ask your doctor for more information about H. pylori or PREVPAC and see the complete prescribing information for PREVPAC.

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Important Safety Information for Prevacid

If you suffer from persistent heartburn two or more days a week, despite treatment and diet changes, it could be acid reflux disease. Prescription Prevacid Capsules and Prevacid SoluTabTM (lansoprazole) Orally Disintegrating Tablets are used for the treatment of acid reflux disease including erosive esophagitis and for maintenance of healed erosive esophagitis. Your results may vary. Most erosions heal in 4–8 weeks. Prevacid may not be right for everyone and has a low occurrence of side effects such as diarrhea, abdominal pain and nausea. Symptom relief does not rule out other serious stomach conditions. Talk to your doctor or healthcare professional to see if Prevacid is right for you. Prevacid products should not be crushed or chewed.

Please see the complete Prescribing Information for more information and talk to your doctor.

Important Safety Information for Prevacid NapraPACTM(lansoprazole delayed-release capsules and naproxen tablets kit)

NSAIDs may increase the chance of a heart attack or stroke that can lead to death. Prevacid NapraPAC should not be used right before or after certain heart surgeries.

With any NSAID use, stomach or intestinal problems can occur without warning and can lead to death.

With Prescription Prevacid NapraPAC, people with a history of gastric ulcer can continue treatment for osteoarthritis and rheumatoid arthritis, and reduce the risk of stomach ulcer coming back. Your results may vary. Controlled studies lasted up to 12 weeks.

You should not take Naprosyn if you've had aspirin-sensitive asthma or allergic reactions to aspirin or other arthritis medicines. In rare cases, continued use of arthritis medicines may lead to serious stomach problems, such as bleeding, without warning signs. You should not take Naprosyn if you are taking other medications containing naproxen, such as Aleve® (naproxen sodium) or Anaprox® (naproxen sodium).

Tell your doctor if you have liver, kidney or fluid retention problems. Naprosyn should not be taken in late pregnancy. If you experience drowsiness or dizziness while taking Naprosyn, you should exercise caution when performing activities that require alertness.

The most frequently reported side effects of Naprosyn, with incidence between three and nine percent were constipation, heartburn, abdominal pain, nausea, headache, dizziness, drowsiness, itching, skin eruptions, ecchymosis (bruising), tinnitus (ringing in the ear), edema (excess fluid in tissues), and dyspnea (shortness of breath).

Prevacid has a low occurrence of side effects such as diarrhea, abdominal pain and nausea. Other serious stomach conditions may still exist.

Prevacid NapraPAC should only be used exactly as prescribed.

Please see the complete Prescribing Information and Medication Guide for Prevacid NapraPAC for more information and talk to your doctor.

Naprosyn and NapraPAC are trademarks of Syntex Pharmaceuticals International Ltd. Aleve and Anaprox are not trademarks of TAP Pharmaceutical Products Inc.

Important Safety Information for PREVPAC® (lansoprazole /amoxicillin /clarithromycin)

PREVPAC is indicated for the treatment of patients with H. pylori (Helicobacter pylori) infection and duodenal ulcer disease to eradicate H. pylori. Your results may vary.

The most frequently reported adverse events with PREVPAC were diarrhea (7%), headache (6%) and taste perversion (5%).

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Eradication of H. pylori reduces the risk of duodenal ulcer recurrence. In patients who fail this therapy, susceptibility testing should be done if possible. If clarithromycin resistance is demonstrated, a non-clarithromycin-containing regimen is recommended.

PREVPAC is not recommended for patients with creatinine clearance less than 30 mL/min. PREVPAC is contraindicated in patients taking cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine.

Colchicine toxicity has been reported with concomitant use of clarithromycin and colchicine, especially in geriatric patients; some has occurred in patients with renal insufficiency. Patients should be monitored for clinical symptoms of colchicine toxicity. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate. Amoxicillin is contraindicated in patients who are allergic to penicillin.

For further warnings, precautions or adverse reactions for amoxicillin and clarithromycin, please see the complete prescribing information for amoxicillin and for BIAXIN® Filmtab® (clarithromycin tablets, USP).

Please see the complete Prescribing Information for Prevacid PREVPAC for more information and talk to your doctor.

BIAXIN Filmtab is not a trademark of TAP Pharmaceutical Products Inc.



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