Trimethobenzamide Hydrochloride (Page 2 of 2)

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 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 with 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).

CAPSULES, 300 mg

Usual Adult Dosage

One 300 mg capsule t.i.d. or q.i.d.

HOW SUPPLIED

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










Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by:
Mutual Pharmaceutical Company, Inc.
Philadelphia, PA 19124 USA


Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320

Package Label
(click image for full-size original)

TRIMETHOBENZAMIDE HYDROCHLORIDE
trimethobenzamide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-448(NDC:53489-376)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trimethobenzamide Hydrochloride (Trimethobenzamide) Trimethobenzamide 300 mg
Inactive Ingredients
Ingredient Name Strength
gelatin
magnesium stearate
cellulose, microcrystalline
sodium starch glycolate type A potato
titanium dioxide
FD&C Blue No. 2
D&C Red No. 40
D&C Blue No. 1
D&C Yellow No. 10
ferrosoferric oxide
Shellac
propylene glycol
Product Characteristics
Color orange (Swedish Orange Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Mutual;401
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-448-10 10 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076570 08/28/2003
Labeler — Rebel Distributors Corp. (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp. 118802834 relabel, repack

Revised: 12/2009 Rebel Distributors Corp.

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