See Supplemental Patient Information
- Metronidazole has been shown to be carcinogenic in mice and rats; avoid unnecessary use and reserve for approved conditions [US Black Box Warning]
- Do not administer bismuth subsalicylate to treat nausea or vomiting in children and teenagers who have or who are recovering from chicken pox or flu. Advise patients to consult their physician if nausea or vomiting is present as this could be an early sign of Reye's syndrome, a rare but serious illness
- Excessive doses of bismuth subsalicylate may cause neurotoxicity; effects have been reversible with discontinuation of therapy
- Metronidazole may cause convulsive seizures and peripheral neuropathy during therapy. Promptly discontinue therapy on appearance of abnormal neurologic signs
- Metronidazole should be administered with caution to patients with central nervous system diseases
- Tetracycline may cause permanent discoloration of the teeth during long-term use or following repeated short-term courses when used during last half of pregnancy, infancy or childhood up to the age of 8 years. Do not use during pregnancy
- Tetracycline may cause photosensitivity manifested by an exaggerated sunburn reaction. Discontinue tetracycline at the first evidence of skin erythema
- Tetracycline may cause an increase in blood urea nitrogen (BUN). When administered in patients with significantly impaired renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis
- Prescribing therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
- Bismuth subsalicylate may cause a temporary and harmless darkening of the tongue and/or black stool. Do not confuse stool darkening with melena
- Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. Use with caution in patients with evidence of, or history of, blood dyscrasia. Metronidazole may cause mild leukopenia
- Known or previously unrecognized candidiasis may present more prominent symptoms during metronidazole use and requires treatment with an antifungal agent
- Tetracycline use may result in overgrowth of nonsusceptible organisms, including fungi. Discontinue therapy if superinfection occurs and institute appropriate therapy
- Tetracycline may cause pseudotumor cerebri in adults, manifested by headache and blurred vision. Although this condition usually resolves soon after therapy discontinuation, the possibility for permanent sequelae exists
Cautions: Use cautiously in
- Anticoagulant use
- SLE
- Geriatric patients
Supplemental Patient Information
- Advise patients to use a different or additional form of contraception as concurrent use of tetracyclines may render oral contraceptives less effective
- Caution patients receiving therapy to avoid exposure to sun or sun lamps
- Instruct patients to avoid alcoholic beverages during therapy and for at least one day after completion of all doses
Pregnancy Category:D
Breastfeeding: Because of the possibility of absorption of salicylate from the breastmilk by the infant, alternatives are preferred. Metronidazole is excreted in breastmilk. With maternal intravenous and oral therapy, breastfed infants receive metronidazole in doses that are less than those used to treat infections in infants. Candidal infections and diarrhea have been reported in breastfed infants. Oral and rectal colonization with Candida might be more common in infants exposed to metronidazole. Most sources consider that tetracyclines are contraindicated during breastfeeding due to possible staining of infants' dental enamel or bone deposition of tetracyclines. However, short-term use of tetracyclines would not adversely affect the breastfed infant. Avoid prolonged or repeated courses of therapy during nursing. Monitor the infant for adverse events such as rash, diarrhea or candidiasis. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 29 June 2011). Due to the potential for serious adverse reactions in nursing infants from tetracyclines, manufacturer recommends discontinuation of nursing or discontinuation of the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Helidac (bismuth subsalicylate/metronidazole/tetracycline)
- KIT: 262.4 mg (8 chewable tabs)/250 mg (4 tabs)/500 mg (4 caps)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Helidac MISC [Box] (PROMETHEUS)
56 = $727.45
112 = $1440.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Helidac Therapy Pack
Ingredient(s): Bismuth subsalicylate mixture with Metronidazole and Tetracycline
Imprint: barr;010
Color(s): Black, Yellow
Shape: Capsule
Size (mm): 22.00
Score: 1
Inactive Ingredient(s): lactose / magnesium stearate / sodium lauryl sulfate / d&c yellow no. 10 / fd&c blue no. 1 / fd&c red no. 40 / gelatin / titanium dioxide / benzyl alcohol / butylparaben / edetate calcium disodium / fd&c yellow no. 6 / methylparaben / propylparaben / silicon dioxide / sodium propionate
Drug Label Author:
Prometheus Laboratories Inc.
DEA Schedule:
Non-Scheduled
