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Pronunciation |
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(BIZ
muth sub sa LIS i late, me troe
NI da zole, & tet ra SYE kleen) |
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U.S. Brand
Names |
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Helidac™ |
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Generic
Available |
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No |
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Pharmacological Index |
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Antidiarrheal |
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Use |
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In combination with an H2-antagonist, used to treat and decrease
rate of recurrence of active duodenal ulcer associated with H. pylori
infection |
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Pregnancy Risk
Factor |
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D (tetracycline); B (metronidazole) |
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Contraindications |
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Pregnancy or lactation; children; significant renal/hepatic impairment;
hypersensitivity to salicylates, bismuth, metronidazole, tetracycline, or any
component |
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Warnings/Precautions |
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See individual monographs |
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Adverse
Reactions |
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See individual monographs
Central nervous system: Dizziness
Gastrointestinal: Nausea, diarrhea, abdominal pain, vomiting, anal
discomfort, anorexia
Neuromuscular & skeletal: Paresthesia |
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Overdosage/Toxicology |
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See individual monographs; the most concerning agent with this combination in
overdosage is bismuth subsalicylate due to the salicylate component
Note: Each 262.4 mg tablet of bismuth subsalicylate contains an equivalent
of 130 mg aspirin (150 mg/kg of aspirin is considered to be toxic; serious
life-threatening toxicity occurs with >300 mg/kg).
Treatment: Gastrointestinal decontamination (activated charcoal for immediate
release formulations (10 x dose of ASA in g), whole bowel irrigation for enteric
coated tablets or when serially increasing ASA plasma levels indicate the
presence of an intestinal bezoar), supportive and symptomatic treatment with
emphasis on correcting fluid, electrolyte, blood glucose, and acid-base
disturbances; elimination is enhanced with urinary alkalization (sodium
bicarbonate infusion with potassium), multiple-dose activated charcoal, and
hemodialysis. |
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Drug
Interactions |
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See individual monographs |
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Mechanism of
Action |
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Bismuth subsalicylate, metronidazole, and tetracycline individually have
demonstrated in vitro activity against most susceptible strains of
H. pylori isolated from patients with duodenal ulcers. Resistance to
metronidazole is increasing in the U.S.; an alternative regimen, not containing
metronidazole, if H. pylori is not eradicated follow
therapy. |
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Pharmacodynamics/Kinetics |
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No data on combination; see individual monographs |
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Usual Dosage |
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Adults: Chew 2 bismuth subsalicylate 262.4 mg tablets, swallow 1
metronidazole 250 mg tablet, and swallow 1 tetracycline 500 mg capsule plus an
H2-antagonist 4 times/day at meals and bedtime for 14 days; follow
with 8 oz of water |
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Monitoring
Parameters |
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See individual monographs |
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Mental Health: Effects
on Mental Status |
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Dizziness common; metronidazole has been reported to cause depression,
insomnia, confusion, panic, delusions, hallucinations, and exacerbation of
schizophrenia; tetracycline has been reported to produce memory disturbances as
well as mood stabilizing and antidepressant effects |
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Mental Health:
Effects on Psychiatric
Treatment |
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Metronidazole and tetracycline may increase serum lithium levels and produce
lithium toxicity; monitor serum lithium levels |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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Tetracyclines are not recommended for use during pregnancy since they can
cause enamel hypoplasia and permanent teeth discoloration; long-term use
associated with oral candidiasis |
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Patient
Information |
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Drink adequate amounts of fluid, particularly with the bedtime tetracycline
dose to reduce the risk of esophageal irritation and ulceration; if a dose is
missed, continue the normal regimen until the medication is gone; do not take
double doses; see your physician if more than 4 doses are missed or if ringing
in the ears occur; avoid alcoholic beverages during therapy and for at least 1
day afterward; avoid concurrent use of oral contraceptives (use an alternative
method) since tetracyclines may make birth control pills less effective; use
protective clothing and avoid prolonged exposure to the sun and ultraviolet
light; a temporary and harmless darkening of the tongue and a black stool may
occur. |
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Dosage Forms |
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Tablet:
Bismuth subsalicylate: Chewable: 262.4 mg
Metronidazole: 250 mg
Capsule: Tetracycline: 500 mg |
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