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 should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient.
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).
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
Chestnut Ridge, NY 10977
NDC 42023-119 -25
(trimethobenzamide hydrochloride) Injection
200 mg/2 mL
For Intramuscular Use Only
2 mL Single Dose Vial
| TIGAN |
trimethobenzamide hydrochloride injection
|Labeler — Par Pharmaceutical, Inc. (092733690)|
|Par Sterile Products LLC||808402890||analysis (42023-119), label (42023-119), manufacture (42023-119), pack (42023-119)|
Revised: 03/2023 Par Pharmaceutical, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.