Tigan Injection

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.

Tigan® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

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, convulsions, coma and extrapyramidal symptoms have
been reported with and without use of Tigan® (trimethobenzamide hydrochloride) or other antiemetic agents. In such disorders
caution should be exercised in administering Tigan®, particularly to patients who have recently received other CNS-acting agents
(phenothiazines, barbiturates, belladonna derivatives). Primary emphasis should be directed toward the restoration of body fluids and
electrolyte balance, the relief of fever and relief of the causative disease process. Overhydration should be avoided since it may result
in cerebral edema.
The antiemetic effects of Tigan® may render diagnosis more difficult in such conditions as appendicitis and obscure signs of toxicity
due to overdosage of other drugs.

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 some elderly patients. (See CLINICAL PHARMACOLOGY and DOSAGE AND
ADMINISTRATION).

Geriatric Use

Clinical studies of trimethobenzamide hydrochloride did not include sufficient numbers of patients aged 65 and over to determine
whether they respond differently from younger patients. Although there are studies reported in the literature that included elderly
patients greater than 65 years old with younger patients, it is not known if there are differences in efficacy or safety parameters for elderly and
non-elderly patients treated with trimethobenzamide. In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of
concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in
dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY and 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.

Store between 20° to 25°C (68° to 77°F).
(See USP Controlled Room Temperature.)

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 Companies, Inc.

Spring Valley, NY 10977

I02/15

3000358F

OS118J-01-90-01