DESCRIPTION
Each Tigan® 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.
For Tigan® 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.
INDICATIONS AND USAGE
Tigan® is
indicated for the
treatment of
postoperative nausea and
vomiting and for nausea
associated with
gastroenteritis.
CONTRAINDICTIONS
The
injectable form of Tigan®
is
contraindicated in pediatric patients and in
patients with known
hypersensitivity to
trimethobenzamide.
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: Trimethoben¬zamide hydrochloride
was studied in reproduction experiments in rats and rabbits and no
teratogenicity was sug¬gested. 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 receiv¬ing 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 ade¬quate 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
There have been reports of hypersensi¬tivity reactions and Parkinson-¬like
symptoms. There have been instances of hypotension reported following
par¬enteral 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
indicat¬ed in some cases.
Please see the full
prescribing information link above for additional information.
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