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Bismuth Subsalicylate, Metronidazole, and Tetracycline—For H. pylori (Systemic)
In the U.S.-
Bismuth subsalicylate ( BIS-muth sub-sa-LIS-a-late) , metronidazole ( me-troe-NI-da-zole) , and tetracycline ( tet-ra-SYE-kleen) are taken together with a histamine H 2 -receptor antagonist to treat ulcers related to infection with the H. pylori bacteria (germ).
This package contains a combination of three different medicines. The individual medicines contained in this package should not be used alone or for other purposes than to treat ulcers related to infection with H. pylori .
This combination of medicines is available only with your doctor's prescription, in the following dosage forms:
Before Using This Medicine
In deciding to use a medicine, the risks of taking this combination of medicines must be weighed against the good it will do. This is a decision you and your doctor will make. For this combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline), the following should be considered:
Allergies- Tell your doctor if you have ever had any unusual or allergic reaction to bismuth subsalicylate, aspirin or other salicylates, metronidazole, or tetracycline. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy- The use of this combination of medicines in pregnant women is not recommended. Tetracycline may have toxic effects on the fetus during the early stages of pregnancy. Also, use of tetracycline in the last half of pregnancy may cause the unborn infant's teeth to become permanently discolored.
Breast-feeding- Use of this combination of medicines is not recommended since metronidazole and tetracycline pass into breast milk and may cause serious unwanted effects in nursing babies.
Children- Infants and children up to 8 years of age should not take this combination of medicines unless directed by the child's doctor. Tetracycline may cause permanent discoloration of the teeth.
Children or teenagers who have or who are recovering from chickenpox or influenza should not use this combination of medicines unless directed by the child's doctor. If nausea or vomiting occurs after taking this combination of medicines, check with the child's doctor. Nausea or vomiting could be early signs of Reye's syndrome, a rare but serious illness.
Older adults- Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of this combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline) in the elderly with its use in other age groups.
Other medicines- Although certain medicines should not be used together at all, in other cases 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 combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline), it is especially important that your health care professional know if you are taking any of the following:
Other medical problems- The presence of other medical problems may affect the use of this combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline). Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine
This combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline) comes with instructions for the patient included in the package. Make sure you read and understand the instructions, or ask your health care professional if you need additional information or explanation. It is important that you understand and follow the instructions exactly.
Also, it is important that you complete the full course of therapy with this combination of medicines to help clear up the infection from H. pylori related to your ulcer.
Each day's therapy is packaged on a blister card that contains eight chewable tablets (each containing 262.4 milligrams [mg] of bismuth subsalicylate), four tablets (each containing 250 mg of metronidazole), and four capsules (each containing 500 mg of tetracycline).
If you miss a dose of this combination of medicines, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you miss more than four doses of this combination of medicines, check with your doctor.
To store this combination of medicines:
Precautions While Using This Medicine
Check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking bismuth subsalicylate in this combination of medicines may lead to overdose. If you have any questions about this, check with your health care professional.
Do not take milk, milk formulas, or other dairy products within 1 to 2 hours of the time you take tetracycline in this combination of medicines. Milk and other dairy products may keep tetracycline from working properly.
Do not take antacids or sodium bicarbonate within 1 to 2 hours of the time you take tetracycline in this combination of medicines. Also, do not take iron preparations (including vitamin preparations that contain iron) within 2 to 3 hours of the time you take tetracycline in this combination of medicines. To do so may keep tetracycline from working properly.
Drinking alcoholic beverages while taking metronidazole in this combination of medicines may cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also cause problems. These problems may last for at least a day after you stop taking metronidazole. Also, metronidazole may cause alcoholic beverages to taste different. Therefore, you should not drink alcoholic beverages or take other alcohol-containing preparations while you are taking metronidazole in this combination of medicines and for at least a day after stopping it .
The metronidazole in this combination of medicines may cause some people to become dizzy or lightheaded. Make sure you know how you react to this combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
Oral contraceptives (birth control pills) may not work properly if you take them while you are taking tetracycline in this combination of medicines. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking tetracycline in this combination of medicines. If you have any questions about this, check with your health care professional.
The tetracycline in this combination of medicines may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking the tetracycline in this combination of medicines:
Before having surgery (including dental surgery) with a general anesthetic, tell the medical doctor or dentist in charge that you are taking tetracycline in this combination of medicines.
Side Effects of This Medicine
Side Effects of This Medicine
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 as soon as possible if any of the following side effects occur:
Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:
In some patients, bismuth subsalicylate in this combination of medicines may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking bismuth subsalicylate.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Last updated: Tue, 06 Jan 2009 00:20:03 GMT