Data from FDA - Curated by EPG Health - Last updated 15 June 2018

Indication(s)

INDICATIONS AND USAGE Trimethobenzamide Hydrochloride Capsule, USP 300 mg is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

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Advisory information

contraindications
CONTRAINDICATIONS Use of any dosage forms in patients with known hypersensitivity to trimethobenzamide is contraindicated.
Special warnings and precautions
PRECAUTIONS During the course of acute febrile illness, encephalitides, gastroenteritis, dehydration and electrolyte imbalance, especially in children and the elderly or debilitated, CNS reactions such as opisthotonos, convulsions, coma and extrapyramidal symptoms have been reported with and without use of trimethobenzamide hydrochloride capsules or other antiemetic agents. In such disorders caution should be exercised in administering trimethobenzamide hydrochloride capsules, particularly to patients who have recently received other CNS acting agents (phenothiazines, barbiturates, belladonna derivatives). Primary emphasis should be directed toward the restoration of body fluids and electrolyte balance, the relief of fever and relief of the causative disease process. Overhydration should be avoided since it may result in cerebral edema. The antiemetic effects of trimethobenzamide hydrochloride capsules may render diagnosis more difficult in such conditions as appendicitis and obscure signs of toxicity due to overdosage of other drugs. General Adjustment of Dose in Renal Failure A substantial route of elimination of unchanged trimethobenzamide is via the kidney. Dosage adjustment should be considered in patients with reduced renal function including some elderly patients. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Geriatric Use Clinical studies of trimethobenzamide hydrochloride did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Although there are studies reported in the literature that included elderly patients >65 years old with younger patients, it is not known if there are differences in efficacy or safety parameters for elderly and non-elderly patients treated with trimethobenzamide. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINCAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Adverse reactions
ADVERSE REACTIONS There have been reports of hypersensitivity reactions and Parkinson-like symptoms. There have been instances of hypotension reported following parenteral administration to surgical patients. There have been reports of blood dyscrasias, blurring of vision, coma, convulsions, depression of mood, diarrhea, disorientation, dizziness, drowsiness, headache, jaundice, muscle cramps and opisthotonos. If these occur, the administration of the drug should be discontinued. Allergic-type skin reactions have been observed; therefore, the drug should be discontinued at the first sign of sensitization. While these symptoms will usually disappear spontaneously, symptomatic treatment may be indicated in some cases.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION (See WARNINGS and PRECAUTIONS.) Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient. Geriatric Patients Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS). Patients and Renal Impairment In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and PRECAUTIONS). Usual Adult Dosage: One 300 mg capsule 3 or 4 times daily. STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

More information

Category Value
Authorisation number ANDA076546
Agency product number WDQ5P1SX7Q
Orphan designation No
Product NDC 71335-0800
Date Last Revised 26-05-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 860771
Marketing authorisation holder Bryant Ranch Prepack