Tigan (Page 2 of 2)

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 been reports of blood dyscrasias, blurring of vision, coma, convulsions, depression of mood, diarrhea, 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.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

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 the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m²). Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients with Renal Impairment

In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m²), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

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.

NOTE: The injectable form is intended for intramuscular administration only; it is not recommended for intravenous use.

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.

STORAGE

Store between 20° to 25°C (68° to 77°F).

(See USP Controlled Room Temperature.)

HOW SUPPLIED

Tigan® (trimethobenzamide hydrochloride) is available as follows:

NDC 42023-119-25 100 mg/mL in 2 mL Single Dose Vials, Pack of 25

Rx Only

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

R01/2022

OS118J-01-90-03

3000358H

PRINCIPAL DISPLAY PANEL — 200 mg/2 mL Carton

NDC 42023-119 -25

Tigan^®
(trimethobenzamide hydrochloride) Injection

200 mg/2 mL

(100 mg/mL)

For Intramuscular Use Only

2 mL Single Dose Vial

TIGAN trimethobenzamide hydrochloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-119 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CITRATE 0.5 mg in 1 mL CITRIC ACID MONOHYDRATE 0.2 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42023-119-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE 1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (42023-119-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017530 08/01/2008

Labeler — Par Pharmaceutical, Inc. (092733690)

Establishment
Name	Address	ID/FEI	Operations
Par Sterile Products LLC		808402890	analysis (42023-119), label (42023-119), manufacture (42023-119), pack (42023-119)

Revised: 03/2023 Par Pharmaceutical, Inc.