TRIMETHOBENZAMIDE HYDROCHLORIDE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

TRIMETHOBENZAMIDE HYDROCHLORIDE (UNII: WDQ5P1SX7Q) (TRIMETHOBENZAMIDE - UNII:W2X096QY97)

Предлага се от:

Lupin Pharmaceuticals,Inc.

INN (Международно Name):

TRIMETHOBENZAMIDE HYDROCHLORIDE

Композиция:

TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Limitation of Use: Trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects, and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment. Trimethobenzamide hydrochloride capsules are contraindicated in patients with known hypersensitivity to trimethobenzamide [see Adverse Reactions (6)] . Risk Summary The limited available data with trimethobenzamide in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.  No adverse developmental effect was observed in animal reproduction studies with administration of trimethobenzamide hydrochloride during organogenesis in pregnant rats at doses 0.16 and 0.8 times the recommended human dose (RHD) and in pregnant rabbits at doses 1.6 times the RHD [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproduction studies with trimethobenzamide hydrochloride were conducted in rats and rabbits following administration of trimethobenzamide hydrochloride during organogenesis and no adverse developmental effect was observed in either species. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg/kg and 100 mg/kg (0.16 and 0.8 times the RHD of 1200 mg/day, based on body surface area) and increased resorptions in rabbits receiving 100 mg/kg (1.6 times the RHD of 1200 mg/day, based on body surface area). In each study, these adverse effects were attributed to one or two dams. Risk Summary There is no information on the presence of trimethobenzamide in human milk, the effects of trimethobenzamide hydrochloride capsules on the breastfed infant or the effects of trimethobenzamide hydrochloride capsules on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of trimethobenzamide hydrochloride capsules to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trimethobenzamide hydrochloride capsules and any potential adverse effects on the breastfed infant from trimethobenzamide hydrochloride capsules or from the underlying maternal condition. The safety and effectiveness of trimethobenzamide hydrochloride capsules in pediatric patients has not been established. Trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of EPS and other serious CNS effects, and the risk of exacerbation of underlying disease in pediatric patients with Reye's Syndrome, or other hepatic impairment [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)]. Clinical studies of trimethobenzamide did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Although there are studies reported in the literature that included geriatric patients 65 years and older with younger patients, it is not known if there are differences in efficacy or safety parameters for geriatric and non-geriatric patients treated with trimethobenzamide hydrochloride capsules. Trimethobenzamide is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because geriatric patients are more likely to have decreased renal function, reduce the daily dosage of trimethobenzamide hydrochloride capsules by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability. Monitor renal function [see Dosage and Administration (2.2), Use in Specific Populations (8.6)] . Trimethobenzamide is eliminated by renal excretion [see Clinical Pharmacology (12.3)] . In patients with renal impairment (creatinine clearance 70 mL/min/1.73m2 or less), reduce the daily dosage by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability. Monitor renal function [see Dosage and Administration (2.2)]. Avoid trimethobenzamide hydrochloride capsules in patients whose signs and symptoms suggest the presence of hepatic impairment due to the risk of hepatotoxicity [see Warnings and Precautions (5.4)]. Discontinue trimethobenzamide hydrochloride capsules in patients who develop impaired liver function while taking trimethobenzamide hydrochloride capsules.

Каталог на резюме:

Trimethobenzamide hydrochloride capsules, USP are available as filled gelatin capsules size 1 lavender opaque cap/lavender opaque body with a white imprint "Novel 660" on cap and "300 mg" on body. Each capsule contains 300 mg of trimethobenzamide hydrochloride. Store at 20°C to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

TRIMETHOBENZAMIDE HYDROCHLORIDE - TRIMETHOBENZAMIDE
HYDROCHLORIDE CAPSULE
LUPIN PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRIMETHOBENZAMIDE
HYDROCHLODIRE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TRIMETHOBENZAMIDE HYDROCHLODIRE CAPSULES
INITIAL U.S. APPROVAL:1974
INDICATIONS AND USAGE
Trimethobenzamide hydrochloride capsules are an antiemetic indicated
in adults for the treatment of
postoperative nausea and vomiting and for nausea associated with
gastroenteritis. (1)
Limitation of Use:
• Trimethobenzamide hydrochloride capsules are not recommended for
use in pediatric patients due to
the risk of extrapyramidal signs and symptoms and other serious
central nervous system (CNS) effects
and the risk of exacerbation of the underlying disease in pediatric
patients with Reye's syndrome or other
hepatic impairment. (1, 8.4)
DOSAGE AND ADMINISTRATION • The recommended adult dosage is 300 mg orally three or four times
daily. (2.1)
• Geriatric patients and/or patients with renal impairment
(creatinine clearance 70 mL/min/1.73m2 or
less): Reduce the daily dosage by increasing the dosing interval;
monitor renal function. (2.2, 8.5, 8.6)
• Select the lowest effective daily dosage and adjust as needed
based upon therapeutic response and
tolerability. (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Capsule: 300 mg of trimethobenzamide hydrochloride (3)
CONTRAINDICATIONS
Known hypersensitivity to trimethobenzamide (4)
WARNINGS AND PRECAUTIONS
Acute Dystonic Reactions and Other Extrapyramidal Symptoms (EPS) :
Depending on the severity of
symptoms, reduce the dosage or discontinue the drug. Treat acute
dystonic reactions with
anticholinergics. Avoid trimethobenzamide hydrochloride capsules in
patients receiving other drugs that
are likely to cause EPS. (5.1, 7.2)
Masking of Other Serious Disorders : EPS and other CNS symptoms in
patients treated with
trimethobenzamide hydrochloride capsules may be confused with CN