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Bismuth subsalicylate, Metronidazole, Tetracycline hydrochloride
Bismuth subsalicylate, Metronidazole, Tetracycline hydrochloride (Helidac)
Bismuth subsalicylate, Metronidazole, Tetracycline
(
BIS-muth, meh-troh-
NYE-dah-zohl, teh-trah-
SYE-kleen)
Pregnancy Category: B (Metronidazole), D (Tetracycline)
Helidac
(Rx)
Classification:
Agent to treat
Helicobacter pylori infections
See Also:
See also
Metronidazole
[ and
Tetracycline hydrochloride
][.
]
Action/Kinetics:
The information to follow was derived from each drug being given alone and not in the combination in this product. Bismuth subsalicylate is hydrolyzed in the GI tract to bismuth and salicylic acid. Less than 1% of bismuth from PO doses of bismuth subsalicylate is absorbed into the general circulation. However, more than 80% of salicylic acid is absorbed. Metronidazole is well absorbed from the GI tract.
Peak plasma levels, metronidazole: 1-2 hr;
t
1/2, elimination: 8 hr. Metronidazole is metabolized by the liver and is excreted through both the urine (60% to 80%) and the feces (6% to 15%). Tetracyclines are readily absorbed from the GI tract. The relative contributions of systemic versus local antimicrobial activity against
H. pylori for agents used in eradication therapy have not been determined.
Uses:
In combination with an H
2 antagonist to treat active duodenal ulcer associated with
H. pylori infection.
Contraindications:
Use during pregnancy or lactation, in children, or in renal or hepatic impairment. Hypersensitivity to bismuth subsalicylate, metronidazole or other imidazole derivatives, and any tetracycline. Use in those allergic to aspirin or salicylates. Children and teenagers who have or who are recovering from chicken pox or the flu should not take bismuth subsalicylate due to the possibility of Reye's syndrome. Tetracyclines should not be used during tooth development in children (i.e., last half of pregnancy, infancy, and childhood to 8 years of age) due to the possibility of permanent tooth discoloration.
Special Concerns:
Use with caution in elderly clients and in clients with evidence or history of blood dyscrasias. Safety and efficacy have not been determined in children.
Side Effects:
See also
Metronidazole
[ and
Tetracyclines
][ for specific side effects for these drugs.
The following side effects were noted when the three drugs were given concomitantly.
GI: N&V;, diarrhea, abdominal pain, melena, anal discomfort, anorexia, constipation.
CNS: Dizziness, paresthesia, insomnia.
Miscellaneous: Asthenia, pain, upper respiratory infection.
Excessive doses of bismuth subsalicylate may cause neurotoxicity, which is reversible if therapy is terminated. Large doses of metronidazole have been associated with seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity). Metronidazole may exacerbate candidiasis. Tetracycline use may cause superinfection, benign intracranial hypertension (pseudotumor cerebri), and photosensitivity.]
Drug Interactions:
See also
Metronidazole,
[and
Tetracyclines
][. There may be a decrease in absorption of tetracycline due to the presence of bismuth or calcium carbonate (an excipient in bismuth subsalicylate tablets).
]
How Supplied:
Patient Pak. Capsule: Tetracycline hydrochloride, 500 mg;
Tablets: Bismuth subsalicylate, 262.4 mg; Metronidzole, 250 mg.
Dosage
?Tablets (Bismuth Subsalicylate, Metronidazole) and Capsules (Tetracycline Hydrochloride)
Treatment of H. pylori
.
Each dose includes two pink, round chewable tablets (525 mg bismuth subsalicylate), one white tablet (250 mg metronidazole), and one pale orange and white capsule (500 mg tetracycline hydrochloride). Each dose is taken q.i.d. with meals and at bedtime for 14 days.
NOTE: Concomitant therapy with an H
2 antagonist is also required. |
