BISMUTHSUBSALICYLATE, 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 infectionwith the H. pylori bacteria (germ).

This package contains a combination of three different medicines. The individualmedicines contained in this package should not be used alone or for otherpurposes 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 againstthe good it will do. This is a decision you and your doctor will make. Forthis combination of medicines (bismuth subsalicylate, metronidazole, and tetracycline),the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to bismuth subsalicylate, aspirin or other salicylates,metronidazole, or tetracycline. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?The use of this combination of medicines in pregnantwomen is not recommended. Tetracycline may have toxic effects on the fetusduring the early stages of pregnancy. Also, use of tetracycline in the lasthalf of pregnancy may cause the unborn infant's teeth to become permanentlydiscolored.

Breast-feeding?Use of this combination of medicines is not recommendedsince metronidazole and tetracycline pass into breast milk and may cause seriousunwanted effects in nursing babies.

Children?Infants and children up to 8 years of age shouldnot 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 orinfluenza should not use this combination of medicines unless directed bythe child's doctor. If nausea or vomiting occurs after taking this combinationof medicines, check with the child's doctor. Nausea or vomiting could be earlysigns of Reye's syndrome, a rare but serious illness.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing theuse 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 usedtogether at all, in other cases different medicines may be used together evenif an interaction might occur. In these cases, your doctor may want to changethe dose, or other precautions may be necessary. When you are taking thiscombination of medicines (bismuth subsalicylate, metronidazole, and tetracycline),it is especially important that your health care professional know if youare taking any of the following:

• Alcohol?Consuming alcohol during treatment or for at least1 day after treatment with metronidazole in this combination of medicinesmay cause stomach pain, nausea, vomiting, headaches, and flushing or rednessof the face

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

• Anticoagulants (blood thinners)?This combination of medicinesmay 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 medicinesmay make the levels of sugar in the blood become too low

• Aspirin or
• Other salicylates?The bismuth subsalicylate in this combinationof medicines may add to the effects of aspirin or other salicylates, increasingthe 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 withmetronidazole in this combination of medicines may decrease the effects ofmetronidazole

• Disulfiram (e.g., Antabuse)?Patients taking disulfiram withmetronidazole in this combination of medicines may have an increased riskof side effects

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

• Penicillin?Use of penicillin with tetracycline in this combinationof medicines may decrease the effects of penicillin

Other medical problems?The presence of other medicalproblems may affect the use of this combination of medicines (bismuth subsalicylate,metronidazole, and tetracycline). Make sure you tell your doctor if you haveany other medical problems, especially:

• Kidney disease or
• Liver disease?Higher blood levels of metronidazole and tetracyclinein this combination of medicines may occur, resulting in an increased riskof side effects

Proper Use of This Medicine

This combinationof medicines (bismuth subsalicylate, metronidazole, and tetracycline) comeswith instructions for the patient included in the package. Make sure you readand understand the instructions, or ask your health care professional if youneed additional information or explanation. It is important that you understandand follow the instructions exactly.

Also, it is important that you complete the full course of therapy withthis 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 blistercard 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 containingchewable 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 tetracyclinewith a full glass (eight ounces) of water. This will help prevent irritationof 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, forfourteen days. Your doctor will also prescribe for you another medicine, ahistamine H ₂-receptor antagonist, which willcome with its own directions and must be taken along with this combinationof 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 doubledoses. 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 otherdamp 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 surethat 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 orother salicylates, be especially careful. Using other salicylate-containingproducts while taking bismuth subsalicylate in this combination of medicinesmay lead to overdose. If you have any questions about this, check with yourhealth 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 combinationof medicines. Milk and other dairy products may keep tetracycline from workingproperly.

Do not take antacids or sodium bicarbonate within1 to 2 hours of the time you take tetracycline in this combination of medicines.Also, do not take iron preparations (includingvitamin preparations that contain iron) within 2 to 3 hours of the time youtake tetracycline in this combination of medicines. To do so may keep tetracyclinefrom working properly.

Drinking alcoholic beverages while taking metronidazole in this combinationof medicines may cause stomach pain, nausea, vomiting, headache, or flushingor redness of the face. Other alcohol-containing preparations (for example,elixirs, cough syrups, tonics) may also cause problems. These problems maylast for at least a day after you stop taking metronidazole. Also, metronidazolemay cause alcoholic beverages to taste different. Therefore, you should not drink alcoholic beverages or take other alcohol-containingpreparations while you are taking metronidazole in this combination of medicinesand for at least a day after stopping it.

The metronidazole in this combination of medicines may cause some peopleto become dizzy or lightheaded. Make sure you know howyou 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 workproperly if you take them while you are taking tetracycline in this combinationof medicines. Unplanned pregnancies may occur. You should use a differentor additional means of birth control while you are taking tetracyclinein this combination of medicines. If you have any questions about this, checkwith your health care professional.

The tetracycline in this combination of medicines may cause your skin tobe more sensitive to sunlight than it is normally. Exposure to sunlight, evenfor brief periods of time, may cause a skin rash, itching, redness or otherdiscoloration of the skin, or a severe sunburn. When you begin taking thetetracycline in this combination of medicines:

• Stay out of direct sunlight, especially between the hours of 10:00a.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 aboutthis, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour 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 tetracyclinein this combination of medicines.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 possibleif any of the following side effects occur:

More common

Abdominal pain; bloody or black, tarrystools; diarrhea; nausea

Less common

Burning, prickling, or tingling sensations; dizziness; vomiting

Rare

Bloody vomit; convulsions (seizures); fainting; heart attack; high blood pressure; irritation of the mouth; irritation of the tongue; joint pain and swelling; pain; sensitivity of skin to sunlight; skin rash; trouble in swallowing

Symptoms of overdose

Clumsiness or unsteadiness; confusion; continuing ringing or buzzing in ears; convulsions; diarrhea; fast heartbeat; fast or deep breathing; fever; nausea; pain, numbness, or tingling in arms, legs, hands, or feet; unusual tiredness; vomiting

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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

Less common or rare

Burning or itching around anus; constipation; general feeling of discomfort or illness; loss of appetite; nervousness; trouble in sleeping; unusual tirednessor weakness

In some patients,bismuth subsalicylate in this combination of medicines may cause dark tongueand/or grayish black stools. This is only temporary and will go away whenyou stop taking bismuth subsalicylate.

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.