If you are about to start Prevpac, speak with your doctor about what you need to know. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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.
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 problems 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 medicine.
Information about this lansoprazole-amoxicillin-and-clarithromycin-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 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 taking 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 medicine with any of the following medicines is not recommended.
Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases.
If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines 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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 problems (eg, QT prolongation, torsades de pointes, ventricular arrhythmia), history of or Liver disease:
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):
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 before using this medicine.
Kidney disease, severe:
Use is not recommended in patients with this condition.
3 Proper Usage
Proper usage of Prevpac requires strict adherence to your doctor’s orders. 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.
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 as a single dose two times per day before meals.
Children: Use and dose must be determined by your doctor.
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.
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.
4 Precautions to Take
Before using Prevpac, there are some precautions you must take. It is important that your doctor checks your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor.
These could be symptoms of a serious liver problem. Contact your doctor right away if you have any changes to 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 such as QT prolongation.
These could be symptoms of 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, check with your doctor.
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 they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
Bad, unusual or unpleasant (after) taste change in taste
Less common or rare:
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.
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