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TRIMETHOBENZAMIDE HYDROCHLORIDE capsule
[REMEDYREPACK INC. ]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

DESCRIPTION

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:
MM1


Each capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg.
Inactive Ingredients: FDA/E172 Red Iron Oxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and titanium dioxide. The imprinting ink contains D&C Yellow #10 Lake, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, Iron Oxide Black, propylene glycol and shellac glaze.

CLINICAL PHARMACOLOGY

Mechanism of Action
The mechanism of action of trimethobenzamide hydrochloride capsules, USP as determined in animals is obscure, but may involve the chemoreceptor trigger zone (CTZ), an area in the medulla oblongata through which emetic impluses are conveyed to the vomiting center; direct impulses to the vomiting center are not similarily inhibited. In dogs pretreated with trimethobenzamide HCl, the emetic response to apomorphine is inhibited, while little or not protection is afforded against emesis induced by intragastric copper sulfate.

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 (Tmax) 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 hydrochloride 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 3050% of a single dose in humans is excreted unchanged in the urine within 4872 hours. The major pathway of trimethobenzamide metabolism is through oxidation resulting in the formation of trimethobenzamide N-oxide metabolite. The pharmacologic activity of this major metabolite has not been evaluated.

USE IN SPECIFIC POPULATIONS

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. (SeePRECAUTIONS: GeneralandDOSAGE AND ADMINISTRATION).

Gender
Systemic exposure to trimethobenzamide was similar between men (N=40) and women (N=28).

Race
Pharmacokinetics appeared to be similar for Caucasians (N=53) and African Americans (N=12).

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. (SeePRECAUTIONS: GeneralandDOSAGE AND ADMINISTRATION).

INDICATIONS & USAGE

Trimethobenzamide hydrochloride capsules, USP are indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

CONTRAINDICATIONS

Use of any dosage form in patients with known hypersensitivity to trimethobenzamide is contraindicated.

WARNINGS

Caution should be exercised when administering trimethobenzamide hydrochloride capsules, USP to children for the treatment of vomiting. Antiemetics are not recommended for treatment of uncomplicated vomiting in children and their use should be limited to prolonged vomiting of known etiology. There are two principal reasons for caution:
     1. The extrapyramidal symptoms which can occur secondary to trimethobenzamide hydrochloride capsules, USP may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy.
     2. It has been suspected that drugs with hepatotoxic potential, such as trimethobenzamide hydrochloride capsules, USP, may unfavorably alter the course of Reye's syndrome. Such drugs should therefore be avoided in children whose signs and symptoms (vomiting) could represent Reye's syndrome.
Trimethobenzamide hydrochloride capsules, USP may produce drowsiness. Patients should not operate motor vehicles or other dangerous machinery until their individual responses have been determined.

Usage in Pregnancy: Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established.


Usage with Alcohol: Concomitant use of alcohol with trimethobenzamide hydrochloride capsules, USP may result in an adverse drug interaction.

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, USP or other antiemetic agents. In such disorders caution should be exercised in administering trimethobenzamide hydrochloride capsules, USP, 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, USP 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. (SeeCLINICAL PHARMACOLOGYandDOSAGE 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. (SeeCLINICAL PHARMACOLOGYandDOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

There have been reports of hypersensitivity reactions and Parkinson-like symptoms. There have been instances of hypotension reported following parental 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; therfore, the drug should be discontinued at the first sign onf sensitization. While these symptoms will usually disappear spontaneously, symptomatic treatment may be indicated in some cases.

DOSAGE & ADMINISTRATION

(SeeWARNINGSandPRECAUTIONS.)
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 clearancemL/min/1.73m2). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (SeeCLINICAL PHARMACOLOGYandPRECAUTIONS).

Patients with Renal Impairment
In subjects with renal impairment (creatinine clearancemL/min/1.73m2), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (SeeCLINICAL PHARMACOLOGYandPRECAUTIONS).
CAPSULES, 300 mg
Usual Adult Dosage
One 300 mg capsule t.i.d. or q.i.d.

HOW SUPPLIED

Trimethobenzamide hydrochloride capsules, USP are supplied as follows:
Trimethobenzamide hydrochloride capsules, USP 300 mg, swedish orange opaque, imprinted MUTUAL over 401 on both the body and cap.
Bottles of 30NDC 53489-376-07Bottles of 60NDC 53489-376-06Bottles of 100NDC 53489-376-01Bottles of 250NDC 53489-376-03Bottles of 500NDC 53489-376-05Bottles of 1000NDC 53489-376-10

STORAGE AND HANDLING

Store at 20to 25(68to 77
[See USP Controlled Room Temperature]
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Trimethobenzamide Hydrochloride
GENERIC: Trimethobenzamide Hydrochloride
DOSAGE: CAPSULE
ADMINSTRATION: ORAL
NDC: 49349-496-02
STRENGTH:300 mg
COLOR: brown
SHAPE: CAPSULE
SCORE: No score
SIZE: 18 mm
IMPRINT: 30
QTY: 30

MM2


MM3


TRIMETHOBENZAMIDE HYDROCHLORIDE 
trimethobenzamide hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:49349-496(NDC:53489-376)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient NameStrength
ferric oxide red 
gelatin 
magnesium stearate 
cellulose, microcrystalline 
titanium dioxide 
D&C yellow no. 10 
Aluminum oxide 
FD&C blue no. 1 
FD&C blue no. 2 
FD&C red no. 40 
ferrosoferric oxide 
propylene glycol  
shellac 
Sodium Starch Glycolate Type A Potato 
Product Characteristics
ColorbrownScoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code MUTUAL;401
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-496-0230 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07657008/18/2011
Labeler - REMEDYREPACK INC. (829572556)

Revised: 8/2011
 
REMEDYREPACK INC.

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