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BISMUTH SUBSALICYLATE/METRONIDAZOLE/TETRACYCLINE HYDROCHLORIDE- bismuth subsalicylate chewable tablets/metronidazole tablets/tetracycline hydrochloride capsules kit


Patient Information

Pregnant Women

Advise pregnant women that Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules can cause fetal harm. Tetracycline use during the second and third trimesters of pregnancy can cause permanent discoloration of the teeth (yellow-gray brown) and may inhibit bone development and metronidazole has been shown in one study to increase the risk of cleft lip with or without cleft palate (seeWARNINGS).

Human Milk Feeding

Advise women to avoid feeding their infants with their milk during Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules therapy. Women should either discontinue feeding or pump and discard their milk during treatment and for 24 hours after the last dose (seePRECAUTIONS, Nursing Mothers).

Hypersensitivity

Inform patients that Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules may cause allergic reactions and to discontinue Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules at the first sign of urticaria, erythematous rash, flushing, and fever or other symptoms of an allergic reaction (seeCONTRAINDICATIONS).

Central Nervous System Effects

Inform patients of the risk of central and peripheral nervous system effects with Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and to discontinue Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and report immediately to their health-care provider if any neurologic symptoms occur (seeWARNINGS).

Photosensivity

Avoid exposure to sun or sun lamps while taking Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules (seePRECAUTIONS).

Photosensivity

Patients should be advised to report to their doctor the use of any other medications while taking Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules. The administration of any of the following drugs with Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules may result in clinically significant adverse reactions or insufficient drug efficacies (seeCONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS).

Methoxyflurane
Disulfiram
Alcoholic Beverages, or Products Containing Propylene Glycol
Oral Contraceptives
Anticoagulants
Lithium
Antacids, Multivitamins, or Dairy Products
Antidiabetic agents
Aspirin
Probenecid or Sulfinpyrazone
Cimetidine
Phenytoinor Phenobarbital

Darkening of the Tongue and/or Stool

Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules may cause temporary and harmless darkening of the tongue and/or black stool and is generally reversible within several days after treatment is stopped. Stool darkening should not be confused with melena (blood in the stool) (seePRECAUTIONS).

Dosing and Administration Information

Each dose includes 4 pills: 2 pink round chewable tablets (bismuth subsalicylate), 1 white round tablet (metronidazole), and 1 black and yellow capsule (tetracycline hydrochloride). Each dose (all 4 pills) should be taken 4 times a day, at mealtimes and bedtime. Patients should be instructed to chew and swallow the pink round tablets (bismuth subsalicylate tablets) and to swallow the white round tablet (metronidazole tablet) and the black and yellow capsule (tetracycline hydrochloride capsule) whole with a full glass of water (8 ounces). Concomitantly prescribed H2 antagonist therapy should be taken as directed.

Missed doses can be made up by continuing the normal dosing schedule until the medication is gone. Patients should not take double doses. (If more than 4 doses are missed, the prescriber should be contacted (seeDOSAGE AND ADMINISTRATION).

Salicylate Toxicity

Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules contains salicylates. If taken with aspirin and ringing in the ears occurs, the prescriber should be consulted concerning discontinuation of the aspirin therapy until the Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules therapy is completed (seeOVERDOSAGE, WARNINGS, and DRUG INTERACTIONS).

Antibacterial Resistance

Patients should be counseled that antibacterial drugs, including Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and
(2) increase the likelihood that bacteria will develop resistance and will not be treatable by Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules or other antibacterial drugs in the future.



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