Adverse Reactions to Trimethobenzamide Hydrochloride
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.
Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.
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).
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).
CAPSULES, 300 mg
One 300 mg capsule t.i.d. or q.i.d.
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 10||NDC 21695-448-10|
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Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature]
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Mutual Pharmaceutical Company, Inc.
Philadelphia, PA 19124 USA
Rebel Distributors Corp.
Thousand Oaks, CA 91320
| TRIMETHOBENZAMIDE HYDROCHLORIDE |
|Labeler — Rebel Distributors Corp. (118802834)|
|Rebel Distributors Corp.||118802834||relabel, repack|
Revised: 12/2009 Rebel Distributors Corp.
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