drug-information.ru

|Helidac

BISMUTH SUBSALICYLATE, METRONIDAZOLE, AND TETRACYCLINE—FOR H. PYLORI (Systemic)

Some commonly used brand names are:

In the U.S.—

• Helidac

Category

• Antiulcer agents

Description

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:

• Oral
• Blister card containing chewable tablets, tablets, and capsules (U.S.)

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:

• Alcohol—Consuming alcohol during treatment or for at least 1 day after treatment with metronidazole in this combination of medicines may cause stomach pain, nausea, vomiting, headaches, and flushing or redness of the face

• Antacids or
• Iron-containing medicine or
• Sodium bicarbonate or
• Zinc—Use of these medicines with tetracycline in this combination of medicines may decrease the effect of tetracycline

• Anticoagulants (blood thinners)—This combination of medicines may change the bleeding times in patients taking anticoagulants

• Antidiabetic medicines (diabetes medicine you take by mouth) or
• Insulin—The bismuth subsalicylate in this combination of medicines may make the levels of sugar in the blood become too low

• Aspirin or
• Other salicylates—The bismuth subsalicylate in this combination of medicines may add to the effects of aspirin or other salicylates, increasing the risk of toxicity

• Barbiturates, especially phenobarbital or
• Carbamazepine (e.g., Tegretol) or
• Glutethimide (e.g., Doriglute) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin) or
• Primidone (e.g., Mysoline) or
• Rifampin (e.g., Rifadin)—Taking any of these medicines with metronidazole in this combination of medicines may decrease the effects of metronidazole

• Disulfiram (e.g., Antabuse)—Patients taking disulfiram with metronidazole in this combination of medicines may have an increased risk of side effects

• Oral contraceptives (birth control pills)—Use of birth control pills with tetracycline in this combination of medicines may decrease the effect of the birth control pills and increase the chance of unwanted pregnancy

• Penicillin—Use of penicillin with tetracycline in this combination of medicines may decrease the effects of penicillin

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:

• Kidney disease or
• Liver disease—Higher blood levels of metronidazole and tetracycline in this combination of medicines may occur, resulting in an increased risk of side effects

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.

Dosing—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).

• For oral dosage forms (blister card containing chewable tablets, tablets, and capsules):
  • For the treatment of ulcers related to infection with H. pylori :
    • Adults—For each dose of this combination of medicines:
      • Chew and swallow two tablets of bismuth subsalicylate (525 mg)
      • Swallow one tablet of metronidazole (250 mg)
      • Swallow one capsule of tetracycline (500 mg)
      
      Be sure to swallow the tablet of metronidazole and the capsule of tetracycline with a full glass (eight ounces) of water. This will help prevent irritation of the esophagus (tube between the throat and stomach) or stomach.
      Each dose of this combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline) is taken four times a day, with meals and at bedtime, for fourteen days. Your doctor will also prescribe for you another medicine, a histamine H ₂ -receptor antagonist, which will come with its own directions and must be taken along with this combination of medicines
    • Children—Use and dose must be determined by your doctor.

Missed dose—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.

Storage—To store this combination of medicines:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause these medicines to break down.
• Keep these medicines from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

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

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.

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.

Revised: 07/28/1998

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.