Trimethobenzamide Hydrochloride

Trimethobenzamide Hydrochloride is an FDA-registered drug product whose active ingredient is TRIMETHOBENZAMIDE HYDROCHLORIDE. It is labelled by BPI Labs, LLC taken by intramuscular and marketed as a human prescription drug product. Identifiers on file: NDC 54288-158, application ANDA219606, label effective 20260807. It is one of 2 FDA drug label records sharing the active ingredient TRIMETHOBENZAMIDE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TRIMETHOBENZAMIDE HYDROCHLORIDE are most often described in connection with: usage trimethobenzamide, hydrochloride injection, treatment postoperative, nausea associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Trimethobenzamide Hydrochloride Injection is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

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 PRECAUTIONS ). 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. Discard unused portion.

CONTRAINDICATIONS Trimethobenzamide Hydrochloride Injection is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.

WARNINGS Trimethobenzamide Hydrochloride Injection 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 Trimethobenzamide Hydrochloride Injection may result in an adverse drug interaction.

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 BPI Labs, LLC at (727) 471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 2 drug label records with TRIMETHOBENZAMIDE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Trimethobenzamide Hydrochloride used for?
INDICATIONS AND USAGE Trimethobenzamide Hydrochloride Injection is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Who makes Trimethobenzamide Hydrochloride?
BPI Labs, LLC is the labeler of record for Trimethobenzamide Hydrochloride. 2 FDA label records share the active ingredient TRIMETHOBENZAMIDE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Trimethobenzamide Hydrochloride come in?
administered by intramuscular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Trimethobenzamide Hydrochloride prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TRIMETHOBENZAMIDE HYDROCHLORIDE?
Yes. 2 FDA drug label records list TRIMETHOBENZAMIDE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Trimethobenzamide Hydrochloride been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.