TIGAN Solution for injection (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
HF Acquisition Co LLC, DBA HealthFirst
Λέξεις κλειδιά
51662-1430
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1. Description
Chemically, trimethobenzamide hydrochloride (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 ...
2. 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 ...
3. Indications and Usage
Tigan is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
4. Contraindications
The injectable form of Tigan is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.
5. Warnings
Tigan 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 ...
6. 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, ...
6.1. 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 ...
7. Adverse Reactions
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 ...
10. 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 ...
11. How Supplied
TIGAN==== (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION is supplied in the following dosage forms. NDC 51662-1430-1 TIGAN==== (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION 200mg/2mL (100mg/mL) 2mL VIAL HF ...
12. Storage and handling
Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature)