"Every year as many as 10 million U.S. children risk side effects from antibiotic prescriptions that are unlikely to help their upper respiratory conditions. Many of these infections are caused by viruses, which are not helped by antibiotics."...
Advise pregnant women that HELIDAC Therapy can cause fetal harm due to the tetracycline it contains. 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. (See WARNINGS)
Human Milk Feeding
Advise women to avoid feeding their infants with their milk during HELIDAC Therapy. Women should either discontinue feeding or pump and discard their milk during treatment and for 24 hours after the last dose. (See PRECAUTIONS)
Patients should be informed that HELIDAC Therapy may cause allergic reactions and should discontinue the drug at the first sign of urticaria, erythematous rash, flushing, and fever or other symptoms of an allergic reaction. (See CONTRAINDICATIONS)
Central Nervous System Effects
Metronidazole, tetracycline, and bismuth have all been associated with central nervous system effects, such as seizures, peripheral neuropathy, neurotoxicity and benign intracranial hypertension. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur. (See WARNINGS)
Avoid exposure to sun or sun lamps while taking HELIDAC Therapy. (See WARNINGS)
Patients should be advised to report to their doctor the use of any other medications while taking HELIDAC Therapy. The administration of any of the following drugs with HELIDAC Therapy may result in clinically significant adverse reactions or insufficient drug efficacies. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: DRUG INTERACTIONS)
- Alcoholic Beverages or Products Containing Propylene Glycol
- Oral Contraceptives
- Antacids, Multivitamins, or Dairy Products
- Antidiabetic agents
- Probenecid or Sulfinpyrazone
- Phenytoin, or Phenobarbital
Darkening of the Tongue and/or Stool
HELIDAC Therapy 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). (See PRECAUTIONS)
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.)
Administration with Fluids
Administration of adequate amounts of fluid, particularly with the bedtime dose of tetracycline hydrochloride, is recommended to reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS)
HELIDAC Therapy 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 HELIDAC Therapy is completed (See OVERDOSE and PRECAUTIONS: DRUG INTERACTIONS).
Patients should be counseled that antibacterial drugs, including HELIDAC Therapy, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When HELIDAC Therapy 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 HELIDAC Therapy or other antibacterial drugs in the future.
Last reviewed on RxList: 6/29/2012
This monograph has been modified to include the generic and brand name in many instances.
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