Tigan
Generic: TRIMETHOBENZAMIDE HYDROCHLORIDE
Basic Information
Manufacturer
Par Health USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
7da90678-b229-4ad6-9193-2b8a3e9ba695
Indications & Usage
INDICATIONS Tigan ® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
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.
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.
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 Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
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 Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.