home > drugs a-z list > helidac (bismuth subsalicylate) drug center > helidac (bismuth subsalicylate) drug - medication guide and patient information

• Scientists have discovered that most ulcers are caused by an infection from a specific germ called H. pylori.
• The medicines in this therapy have been demonstrated to treat the infection in the majority of cases when taken correctly. Treating the infection is important to reduce the risk of the ulcer coming back.
• Each pill of every dose is important. Studies have shown that taking all this medicine is very important to eradicate all the ulcer-causing germs. If doses are skipped or treatment is stopped early, some of these germs may not be eradicated and another ulcer can develop.

Dosing and Administration

IT MAY BE USEFUL TO OPEN THE THERAPY AND EXPLAIN DOSING WHILE SHOWING THE PATIENT ONE OF THE DOSING BLISTER CARDS.

• 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).
• Take 1 dose (all 4 pills) 4 times a day - at mealtimes and bedtime.
• Chew and swallow the 2 pink tablets.

Then swallow the white tablet and black and yellow capsule whole with a full glass of water (8 ounces).

Remember: Chew-Chew-Swallow-Swallow = 1 dose.

• All 4 daily doses are contained on an individual blister card.
• This therapy contains 14 blister cards, one card for each day of the 14-day treatment plan.
• If you miss a dose, do not take a double dose. Instead, make up any missed doses by continuing your normal dosing schedule until the medication is gone. (Please contact prescriber if more than 4 doses are missed.)
• Each dose should be taken with a full glass of water (8 ounces), especially the bedtime dose.*
• Concomitantly prescribed H₂ antagonist therapy should be taken as directed.

*To reduce risk of esophageal imitation and ulceration due to tetracycline

OTHER IMPORTANT INFORMATION TO GUIDE YOUR DISCUSSION WITH THE PATIENT

Contraindications

HELIDAC (bismuth subsalicylate) Therapy is contraindicated in the following patient populations:

• Pregnant or nursing women
• Pediatric patients
• Patients with renal or hepatic impairment
• Patients with known hypersensitivity to bismuth subsalicylate, metronidazole or other nitroimidazole derivatives, or any of the tetracyclines; this product does not contain aspirin, but should not be administered to those patients who have a known allergy to aspirin or salicylates.

WARNINGS and PRECAUTIONS (also see Contraindications): The following is a partial list. Please refer to the Package Insert for more complete information.

• Patients should avoid:
  - Alcohol during therapy and at least 1 day after completion of all doses due to potential metronidazole effects
  - Sun lamps or sun because of possible photosensitivity secondary to tetracycline
  - Other medications without first consulting with your pharmacist or prescriber (See Drug Interactions)
• Administer with caution in patients with central nervous system diseases.
• Administer with caution in elderly patients who may suffer from asymptomatic renal and hepatic dysfunction.
• Bismuth subsalicylate may cause a temporary and harmless darkening of the tongue and/or black stool. This should not be confused with melena (blood in the stool).

Adverse Reactions

Adverse reactions associated with the individual components of HELIDAC (bismuth subsalicylate) Therapy have been well described and are included in the Package Insert. The most common adverse reactions ≥ 1.5%) reported in clinical trials where all three components were given concomitantly are as follows: nausea (12.0%), diarrhea (6.8%), abdominal pain (6.8%), melena (3.0%), upper respiratory infection (2.3%), constipation (1.9%), anorexia (1.5%), asthenia (1.5%), vomiting (1.5%), discolored tongue (1.5%), headache (1.5%), dyspepsia (1.5%), and dizziness (1.5%). The majority of the events were related to the gastrointestinal tract, were reversible, and usually did not lead to discontinuation of therapy.

Some other possible adverse reactions include:

Temporary and harmless darkening of the tongue and/or black stool

• Metallic taste in the mouth
• Temporary darkening of the urine (rare)
• Sore mouth
• Yeast infections in women

As with most medications, rare but serious side effects have been reported with the use of the components contained in HELIDAC (bismuth subsalicylate) Therapy. (See Package Insert.) Patients should be instructed to report any unusual symptoms to their pharmacist or prescriber.

Drug Interactions: See Package Insert for more complete information.

Alcohol: There is a potential for a disulfiram-like interaction with metronidazole. Patients should be warned not to drink alcoholic beverages or alcohol-containing products during therapy and for at least 1 day after the therapy is completed.

Antacids containing aluminum, calcium, or magnesium, and preparations containing iron, zinc, or sodium bicarbonate; or milk or dairy products: Absorption of tetracycline may be impaired when co-administered.

Anticoagulants: Individual components of HELIDAC (bismuth subsalicylate) Therapy have the potential to interact with anticoagulants. Monitoring anticoagulant therapy with appropriate adjustment of the anticoagulant dosage may be warranted if concurrent therapy is instituted. (See Package Insert.)

Antidiabetics: There is a possible enhanced hypoglycemic effect when given with salicylates.

Cimetidine: The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole.

Oral Contraceptives: As with many antibacterial preparations, concomitant use of HELIDAC (bismuth subsalicylate) Therapy may reduce the effectiveness of estrogen-containing oral contraceptives; breakthrough bleeding may occur. Patients should be advised to use an additional or different form of contraception. Women who become pregnant while taking HELIDAC (bismuth subsalicylate) therapy should be advised to notify their prescriber immediately.

See the Package Insert regarding the following possible, suspected, or confirmed interactions: aspirin, probenecid, sulfinpyrazone, methoxyflurane, penicillin, disulfiram (within 2 weeks), lithium, and microsomal liver enzyme inducers, such as phenytoin or phenobarbital.

In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium toxicity.

Although there is an anticipated reduction in tetracycline systemic absorption due to an interaction with bismuth and/or bismuth subsalicylate tablet excipients (calcium carbonate), the relative contribution of systemic versus local antimicrobial activity against H. pylori for these agents has not been established.

Last reviewed on RxList: 12/7/2009
This monograph has been modified to include the generic and brand name in many instances.