Linked Life Data

Trimethobenzamide Hydrochloride (Capsule)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1364

Statements in which the resource exists as a subject.
PredicateObject
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Trimethobenzamide Hydrochloride (Capsule)
dailymed-instance:dosage
Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.<br/>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/1.73m). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. .<br/>Patients with Renal Impairment: In subjects with renal impairment (creatinine clearance���70 mL/min/1.73m), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. . CAPSULES, 300 mg Usual Adult Dosage One 300 mg capsule t.i.d. or q.i.d.
dailymed-instance:descripti...
Chemically, trimethobenzamide HCl is N-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural formula: Each capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg. Inactive Ingredients: Gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, FDA/E172 Red Iron Oxide, titanium dioxide. The imprinting ink contains FD&C Blue #2, FD&C Red #40, FD&C Blue #1 and D&C Yellow #10 Lake.
dailymed-instance:clinicalP...
Mechanism of Action: The mechanism of action of trimethobenzamide hydrochloride capsules as determined in animals is obscure, but may involve the chemoreceptor trigger zone (CTZ), an area in the medulla oblongata through which emetic impulses are conveyed to the vomiting center; direct impulses to the vomiting center apparently are not similarly inhibited. In dogs pretreated with trimethobenzamide HCl, the emetic response to apomorphine is inhibited, while little or no protection is afforded against emesis induced by intragastric copper sulfate.<br/>Pharmacokinetics: The pharmacokinetics of trimethobenzamide have been studied in healthy adult subjects. Following administration of 200 mg (100 mg/mL) trimethobenzamide hydrochloride I.M. injection, the time to reach maximum plasma concentration (T) was about half an hour, about 15 minutes longer for trimethobenzamide hydrochloride 300 mg oral capsule than an I.M. injection. A single dose of trimethobenzamide 300 mg oral capsule provided a plasma concentration profile of trimethobenzamide similar to trimethobenzamide hydrochloride 200 mg I.M. The relative bioavailability of the capsule formulation compared to the solution is 100%. The mean elimination half-life of trimethobenzamide is 7 to 9 hours. Between 30���50% of a single dose in humans is excreted unchanged in the urine within 48���72 hours. The metabolic disposition of trimethobenzamide in humans is not known. Specifically, it is not known if active metabolites are generated in humans.<br/>Special Populations:<br/>Age: The clearance of trimethobenzamide is not known in patients with renal impairment. However, it may be advisable to consider reduction in the dosing of trimethobenzamide in elderly patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney and that elderly patients may have various degrees of renal impairment. .<br/>Gender: Systemic exposure to trimethobenzamide was similar between men (N=40) and women (N=28).<br/>Race: Pharmacokinetics appeared to be similar for Caucasians (N=53) and African Americans (N=12).<br/>Renal Impairment: The clearance of trimethobenzamide is not known in patients with renal impairment. However, it may be advisable to consider reduction in the dosing of trimethobenzamide in patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney. .
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Use of any dosage form in patients with known hypersensitivity to trimethobenzamide is contraindicated.
dailymed-instance:supply
Trimethobenzamide hydrochloride capsules are supplied as follows: Trimethobenzamide hydrochloride capsules 300 mg, swedish orange opaque, imprinted MUTUAL over 401 on both the body and cap. Bottles of 30 NDC 53489-376-07 Bottles of 60 NDC 53489-376-06 Bottles of 100 NDC 53489-376-01 Bottles of 250 NDC 53489-376-03 Bottles of 500 NDC 53489-376-05 Bottles of 1000 NDC 53489-376-10 Store at 20��to 25��C (68��to 77��F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
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dailymed-instance:genericMe...
Trimethobenzamide Hydrochloride
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Trimethobenzamide Hydrochloride (Capsule)
dailymed-instance:adverseRe...
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.
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dailymed-instance:name
Trimethobenzamide Hydrochloride