TIGAN Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

61570-079

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1. Indications and Usage

Tigan is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Limitation of Use: Tigan is not recommended for use in pediatric ...

2. Dosage and Administration

2.1 Recommended Adult Dosage The recommended adult dosage is 300 mg orally three or four times daily. Select the lowest effective daily dosage and adjust as needed based upon therapeutic response and tolerability. ...

3. Dosage Forms and Strengths

Capsules: 300 mg trimethobenzamide hydrochloride; the capsule has an opaque purple cap marked Tigan and an opaque purple body marked M079.

4. Contraindications

Tigan is contraindicated in patients with known hypersensitivity to trimethobenzamide [see Adverse Reactions (6)].

5. Warnings and Precautions

5.1 Acute Dystonic Reactions and Other Extrapyramidal Symptoms (EPS) Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, may occur with Tigan. Dystonic reactions may include ...

6. Adverse Reactions

The following adverse reactions from voluntary reports or clinical studies have been reported with trimethobenzamide. Because many of these reactions were reported voluntarily from a population of uncertain ...

7. Drug Interactions

7.1 Alcohol Alcohol may increase the CNS depressant effects of Tigan and may cause drowsiness [see Warnings and Precautions (5.3, 5.5)]. Avoid concomitant use of Tigan with alcohol. 7.2 Other ...

8.1. Pregnancy

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 ...

8.2. Lactation

Risk Summary There is no information on the presence of trimethobenzamide in human milk, the effects of Tigan on the breastfed infant or the effects of Tigan on milk production. The lack of clinical data ...

8.4. Pediatric Use

The safety and effectiveness of Tigan in pediatric patients has not been established. Tigan is not recommended for use in pediatric patients due to the risk of EPS and other serious CNS effects, and the ...

8.5. Geriatric Use

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 ...

8.6. Renal Impairment

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 ...

8.7. Hepatic Impairment

Avoid Tigan 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 Tigan in patients ...

11. Description

Chemically, trimethobenzamide hydrochloride is N-[p[2(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.93 and the following structural ...

12.1. Mechanism of Action

The mechanism of action of trimethobenzamide 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 ...

12.3. Pharmacokinetics

Absorption The pharmacokinetics of trimethobenzamide in healthy adult subjects were compared when Tigan was administered as a 300 mg oral capsule or a 200 mg (100 mg/mL) intramuscular injection. The time ...

16.1. How Supplied

Tigan is available as a capsule for oral use with an opaque purple cap marked Tigan and an opaque purple body marked M079. Each capsule contains 300 mg of trimethobenzamide hydrochloride. NDC Number ...

16.2. Storage and Handling

Store at 25°C (77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]

17. Patient Counseling Information

Inform patients that Tigan can cause serious adverse reactions. Instruct patients to discontinue Tigan and contact a healthcare provider immediately if the following serious reactions occur: Acute Dystonic ...