BISMUTHSUBSALICYLATE (Oral)

Some commonly used brand names are:

In the U.S.?

• Bismatrol
• Bismatrol Extra Strength
• Extra Strength Kaopectate
• Kaopectate

Note:

Prior to 2003, Kaopectate contained attapulgite. It was reformulatedto contain bismuth subsalicylate as the active ingredient.

• Pepto-Bismol
• Pepto-Bismol Easy-to-Swallow Caplets
• Pepto-Bismol Maximum Strength

In Canada?

• Bismed
• Pepto-Bismol
• PMS-Bismuth Subsalicylate

Generic name product may be available in the U.S.

Category

• Antacid
• Antidiarrheal,antisecretory
• Antiulcer agent

Description

Bismuth subsalicylate (BIS-muth sub-sa-LIS-a-late) is used to treat diarrhea inadults and teenagers. It is also used to relieve the symptoms of an upsetstomach, such as heartburn, indigestion, and nausea in adults and teenagers.

This medicine is available without a prescription; however, your doctormay have special instructions on the proper use and dose for your medicalproblem. Bismuth subsalicylate is available in the following dosage forms:

Oral
• Oral suspension (U.S. and Canada)
• Tablets (U.S.)
• Chewable tablets (U.S. and Canada)

Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For bismuth subsalicylate, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to bismuth subsalicylate or to other salicylates, such asaspirin, including methyl salicylate (oil of wintergreen), or to any of thefollowing medicines:

• Carprofen (e.g., Rimadyl)
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen taken by mouth (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Naproxen (e.g., Naprosyn)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any othersubstances, such as certain foods, sulfites or other preservatives, or dyes.

Pregnancy?The occasional use of bismuth subsalicylate is notlikely to cause problems in the fetus or in the newborn baby. However, basedon what is known about the use of other salicylates, especially at high dosesand for long periods of time, the following information may also apply forbismuth subsalicylate.

Salicylates have not been shown to cause birth defects in humans. However,studies in animals have shown that salicylates may cause birth defects.

There is a chance that regular use of salicylates late in pregnancy maycause unwanted effects on the heart or blood flow in the fetus or in the newborninfant.

Use of salicylates during the last 2 weeks of pregnancy may cause bleedingproblems in the fetus before or during delivery or in the newborn infant.Also, too much use of salicylates during the last 3 months of pregnancy mayincrease the length of pregnancy, prolong labor, cause other problems duringdelivery, or cause severe bleeding in the mother before, during, or afterdelivery.

Breast-feeding?Salicylates pass into the breast milk. Althoughthey have not been shown to cause problems in nursing babies, it is possiblethat problems may occur if large amounts of salicylates are taken regularly.

Children?This medicine should not be used in children youngerthan 12 years of age. The fluid loss caused by diarrhea may result in a severecondition. In older children with diarrhea, medicine for diarrhea may be used,but it is also very important that a sufficient amount of liquids be givento replace the fluid lost by the body. If you have any questions about this,check with your health care professional.

Also, children are usually more sensitive to the effects of salicylates,especially if they have a fever or have lost large amounts of body fluid becauseof vomiting, diarrhea, or sweating.

The bismuth in this medicine may cause severe constipation in children.

In addition, do not use this medicine to treat nausea or vomiting in childrenor teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting is present, check with the child's doctor immediatelybecause this could be an early sign of Reye's syndrome.

Older adults?The fluid loss caused by diarrhea may result in asevere condition. For this reason, elderly persons with diarrhea should nottake this medicine without first checking with their doctor. It is also veryimportant that a sufficient amount of liquids be taken to replace the fluidlost by the body. If you have any questions about this, check with your healthcare professional.

Also, the elderly may be more sensitive to the effects of salicylates.This may increase the chance of side effects during treatment. In addition,the bismuth in this medicine may cause severe constipation in the elderly.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When taking bismuthsubsalicylate it is especially important that your health care professionalknow if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Heparin?The salicylate in this medicine may increase the chanceof bleeding

• Antidiabetics, oral (diabetes medicine you take by mouth)?Thismedicine may make the levels of sugar in the blood become too low

• Medicine for pain and/or inflammation (except narcotics)?Ifthese medicines contain salicylates, use of bismuth subsalicylate (which alsocontains salicylate) may lead to increased side effects and overdose

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)?Bismuth subsalicylate may makethese medicines less effective for treating gout

• Tetracyclines by mouth (medicine for infection)?The tabletform of bismuth subsalicylate should be taken at least 1 to 3 hours beforeor after tetracyclines; otherwise it may decrease the effectiveness of thetetracycline

Other medical problems?The presence of other medicalproblems may affect the use of bismuth subsalicylate. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Dysentery?This condition may get worse; a different kind oftreatment may be needed

• Gout?The salicylate in this medicine may worsen the gout andmake the medicines taken for gout less effective

• Hemophilia or other bleeding problems?The salicylate in thismedicine may increase the chance of bleeding

• Kidney disease?There is a greater chance of side effects becausethe body may be unable to get rid of the bismuth subsalicylate

• Stomach ulcer?Use of this medicine may make the ulcer worse

Proper Use of This Medicine

Make certainyour health care professional knows if you are on any special diet, such asa low-sodium or low-sugar diet.

For safe and effective use of this medicine:

• Follow your doctor's instructions if this medicine was prescribed.
• Follow the manufacturer's package directions if you are treatingyourself.

For patients using this medicine to treat diarrhea:

• It is very important that the fluid lost by thebody be replaced and that a proper diet be followed. For the first24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinatedcola, decaffeinated tea, broth, and gelatin. During the next 24 hours youmay eat bland foods, such as cooked cereals, bread, crackers, and applesauce.Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholicbeverages may make the diarrhea worse.
• If too much fluid has been lost by the body due to the diarrhea aserious condition may develop. Check with your doctor as soon as possibleif any of the following signs of too much fluid loss occur:
  • Decreased urination
  • Dizziness and lightheadedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

If you are taking the oral suspension: Use the dose cup that is includedto measure out the right amount of medicine. If you are unsure, contact yourdoctor or pharmacist.

If you are taking the oral tablets: Swallow the tablet whole with a glassof water. Do not crush or chew the tablet.

If you are taking the chewable tablets: Chew up the tablet or allow itto completely disintegrate in your mouth before swallowing it.

Dosing?The dose of bismuth subsalicylate will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of bismuth subsalicylate. If your doseis different, do not change it unless your doctor tells you to do so.

The number of tablets or tablespoonfuls or teaspoonfuls of suspension thatyou take depends on the strength of the medicine.

• For oral dosage form (suspension):
  • For diarrhea or upset stomach:
    • Adults and teenagers?The usual dose is 2 tablespoonfuls everyhalf-hour to one hour if needed. You should not take more than 16 tablespoonfulsof the regular-strength suspension or 8 tablespoonfuls of the concentratein twenty-four hours.
    • Children?Should not be used in children younger than 12 yearsof age.
• For oral dosage forms (tablets or chewabletablets):
  • For diarrhea or upset stomach:
    • Adults and teenagers?The usual dose is 2 tablets every half-hourto one hour. You should not take more than 16 tablets in twenty-four hours.
    • Children?Should not be used in children younger than 12 yearsof age.

Missed dose?If your doctor has ordered you to take this medicineaccording to a regular schedule and you miss a dose, take it as soon as youremember. However, if it is almost time for your next dose, skip the misseddose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose is very dangerous inyoung children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
• Keep the liquid form of this medicine from freezing.
• 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 this medicine may lead to overdose. If you have anyquestions about this, check with your health care professional.

For diabetic patients:

• False urine sugar test results may occur if you are regularly takinglarge amounts of bismuth subsalicylate or other salicylates.
• Smaller doses or occasional use of bismuth subsalicylate usuallywill not affect urine sugar tests. However, check with your health care professional(especially if your diabetes is not well-controlled) if:
  • you are not sure how much salicylate you are taking every day.
  • you notice any change in your urine sugar test results.
  • you have any other questions about this possible problem.

If you think that you or anyone else may have takenan overdose, get emergency help at once. Taking an overdose of thismedicine may cause unconsciousness or death. Signs of overdose include convulsions(seizures), hearing loss, confusion, ringing or buzzing in the ears, severedrowsiness or tiredness, severe excitement or nervousness, and fast or deepbreathing.

If you are taking this medicine for diarrhea, check with your doctor:

• if your symptoms do not improve within 2 days or if they become worse.
• if you also have a high fever.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.

When this medicine is usedoccasionally or for short periods of time at low doses, side effects usuallyare rare. However, check with your doctor immediately if any of thefollowing side effects occur, since they may indicate that too much medicineis being taken:

Anxiety; any loss of hearing; confusion; constipation (severe); diarrhea (severe or continuing); difficultyin speaking or slurred speech; dizziness or lightheadedness; drowsiness (severe); fast or deep breathing; headache (severe or continuing); increased sweating; increasedthirst; mental depression; muscle spasms (especially of face, neck, and back); muscle weakness; nausea or vomiting (severe or continuing); ringing or buzzing in ears (continuing); stomach pain (severe or continuing); trembling; uncontrollable flapping movements of thehands (especially in elderly patients) or other uncontrolled body movements; vision problems

In some patientsbismuth subsalicylate may cause dark tongue and/or grayish black stools. Thisis only temporary and will go away when you stop taking this medicine.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.