TIGAN- trimethobenzamide hydrochloride injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Trimethobenzamide Hydrochloride (UNII: WDQ5P1SX7Q) (Trimethobenzamide - UNII:W2X096QY97)

Boleh didapati daripada:

Henry Schein, Inc

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Tigan ® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. The injectable form of Tigan® is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide. The injectable form of Tigan® is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.

Ringkasan produk:

Tigan® (trimethobenzamide hydrochloride) is available as follows: NDC 42023-119-25 100 mg/mL in 2 mL Single-Dose Vials, Pack of 25 NDC 42023-118-01 100 mg/mL in 20 mL Multi-Dose Vials, Pack of 1 Rx Only Manufacturered by: Par Pharmaceutical Chestnut Ridge, NY R04/16 3000358F OS118J-01-90-01

Status kebenaran:

New Drug Application

Ciri produk

TIGAN- TRIMETHOBENZAMIDE HYDROCHLORIDE INJECTION
HENRY SCHEIN, INC
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TIGAN 100 MG/ML INJECTION 2 ML SINGLE DOSE VIAL
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:
SINGLE-DOSE VIALS: Each 2-mL single-dose vial contains 200 mg
trimethobenzamide
hydrochloride compounded with 1 mg sodium
citrate and 0.4 mg citric acid as buffers and pH adjusted to
approximately 5.0 with
sodium hydroxide.
MULTI-DOSE VIALS: Each mL contains 100 mg trimethobenzamide
hydrochloride
compounded with 0.45% phenol as preservative, 0.5
mg sodium citrate and 0.2 mg citric acid as buffers and pH adjusted to
approximately
5.0 with sodium hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism of action of Tigan® 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.
PHARMACOKINETICS
The pharmacokinetics of trimethobenzamide have been studied in healthy
adult subjects.
Following administration of 200 mg
(100 mg/mL) Tigan I.M. injection, the time to reach maximum plasma
concentration
(Tmax) was about half an hour, about 15
minutes longer for Tigan 300 mg oral capsule than an I.M. injection. A
single dose of
Tigan 300 mg oral capsule provided a plasma
concentration profile of trimethobenzamide similar to Tigan 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 –