Tigan 100 mg/mL
trimethobenzamide hydrochloride · INJECTION · Par Health USA, LLC
Tigan is a injection containing trimethobenzamide hydrochloride at 100 mg/mL, taken intramuscular. Manufactured by Par Health USA, LLC.
Key Facts
- Brand Name
- Tigan
- Generic Name
- trimethobenzamide hydrochloride
- NDC Code (Product)
42023-119- Manufacturer
- Par Health USA, LLC
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- NDA017530
- Marketing Start
- 08/01/2008
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Indications Tigan ® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
Dosage & Administration
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/1.73m 2 ). 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/1.73m 2 ), 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…
Warnings
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 was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established. Usage with Alcohol: Concomitant use of alcohol with Tigan ® may result in an adverse drug interaction.
Contraindications
Contraindications The injectable form of Tigan ® is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.
Adverse Reactions
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 Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
Frequently Asked Questions
What is Tigan used for?
Tigan contains trimethobenzamide hydrochloride. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Tigan a controlled substance?
Tigan is not classified as a controlled substance by the DEA.
What is the generic name for Tigan?
The generic name for Tigan is trimethobenzamide hydrochloride. There are 4 other brand versions of trimethobenzamide hydrochloride.
What is the NDC code for Tigan 100 mg/mL?
The NDC (National Drug Code) for Tigan 100 mg/mL is 42023-119, listed by Par Health USA, LLC.