Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/281
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Trimethobenzamide Hydrochloride (Injection, Solution)
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| dailymed-instance:dosage |
(See WARNINGS and PRECAUTIONS.) Dosage should be adjusted according to the indication
for therapy, severity of symptoms, and the response of the patient. Injectable���100 mg/mL (Not for use in pediatric patients.) Usual Adult Dosage. 2 mL (200
mg) t.i.d. or q.i.d. intramuscularly. Intramuscular
administration may cause pain, stinging, burning, redness, and swelling
at the site of injection. Such effects may be minimized by deep injection
into the upper outer quadrant of the gluteal region, and by avoiding
the escape of solution along the route. Note: The injectable form is intended for
intramuscular administration only; it is not recommended for intravenous
use. Parenteral drug
products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
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| dailymed-instance:descripti... |
Trimethobenzamide hydrochloride is a sterile solution
for intramuscular injection. Each 1 mL contains 100 mg trimethobenzamide
hydrochloride compounded with 0.45% phenol as preservative, 0.5 mg
sodium citrate anhydrous and 0.2 mg citric acid anhydrous as buffers,
and 0.1 mg edetate disodium as stabilizer in Water for Injection.
pH is adjusted with sodium hydroxide or hydrochloric acid. Trimethobenzamide hydrochloride is an antiemetic agent
which is known chemically as N-[p-[2-(Dimethylamino)ethoxy] benzyl]-3,4,5,-trimethoxybenzamide monohydrochloride.
It has a molecular weight of 424.92, and has the following structural
formula:
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| dailymed-instance:clinicalP... |
Mechanism of Action The mechanism of action of trimethobenzamide
hydrochloride 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 hydrochloride,
the emetic response to apomorphine is inhibited, while little or no
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 I.M. injection, the time to
reach maximum plasma concentration (T) was about half
an hour, about 15 minutes longer for trimethobenzamide 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 200 mg I.M. The relative bioavailability
of the capsule formulation compared tothe solution is 100%. The mean
elimination half-life of trimethobenzamide is 7 to 9 hours. Special Populations 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).
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The injectable form of trimethobenzamide hydrochloride
is contraindicated in pediatric patients, and in patients with known
hypersensitivity to trimethobenzamide.
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To prevent needle-stick
injuries, needles should not be recapped, purposely bent or broken
by hand. Store at 20 to 25��C
(68 to 77��F) [See USP Controlled Room Temperature.] Revised: January, 2008
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| dailymed-instance:precautio... |
During the course of acute febrile illness, encephalitides,
gastroenteritis, dehydration and electrolyte imbalance, especially
in pediatrics 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 or
other antiemetic agents. In such disorders caution should be exercised
in administering trimethobenzamide, particularly to patients who have
recently received other CNS-acting agents (phenothiazines, barbiturates,
belladonna derivatives). Primary emphasis shouldbe 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 may render
diagnosis more difficult in such conditions as appendicitis and obscure
signs of toxicity due to overdosage of other drugs.
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| dailymed-instance:genericMe... |
Trimethobenzamide Hydrochloride
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| dailymed-instance:fullName |
Trimethobenzamide Hydrochloride (Injection, Solution)
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| 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, 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:warning |
Caution should be exercised when administering trimethobenzamide
hydrochloride to pediatric patients for the treatment of vomiting.
Antiemetics are not recommended for treatment of uncomplicated vomiting
in pediatric patients and their use should be limited to prolonged
vomiting of known etiology. There are two principal reasons for caution: Trimethobenzamide hydrochloride 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 may result in an adverse drug
interaction.
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For the treatment of postoperative nausea and vomiting
and nausea associated with gastroenteritis.
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| dailymed-instance:name |
Trimethobenzamide Hydrochloride
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