HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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TIGAN®(trimethobenzamide HCl)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TIGAN® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Tigan is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage
The recommended adult dosage is 300 mg orally three or four times daily. Select the lowest effective daily...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Capsules: 300 mg trimethobenzamide hydrochloride; the capsule has an opaque purple cap marked "Tigan" and an opaque purple body marked "M079".
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Contraindications
4 CONTRAINDICATIONS
Tigan is contraindicated in patients with known hypersensitivity to trimethobenzamide [see Adverse Reactions (6)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Acute Dystonic Reactions and Other Extrapyramidal Symptoms (EPS)
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions from voluntary reports or clinical studies have been reported with trimethobenzamide. Because many of these reactions were reported voluntarily from a population of...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Alcohol
Alcohol may increase the CNS depressant effects of Tigan and may cause drowsiness [see 7.2 Other Drugs that...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
The limited available...
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Description
11 DESCRIPTION
Chemically, trimethobenzamide hydrochloride is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of trimethobenzamide as determined in animals is obscure, but may involve the chemoreceptor...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Tigan is available as a capsule for oral use with an opaque purple cap marked "Tigan" and an opaque purple body marked "M079". Each capsule contains 300 mg of trimethobenzamide...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Inform patients that Tigan can cause serious adverse reactions. Instruct patients to discontinue Tigan and contact a healthcare provider immediately if the following serious reactions occur...
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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at https://vaers.hhs.gov or call (800) 822-7967.