Tigan
Trimethobenzamide Hydrochloride
General Injectables & Vaccines, Inc
Human Prescription Drug
NDC 52584-119Tigan also known as Trimethobenzamide Hydrochloride is a human prescription drug labeled by 'General Injectables & Vaccines, Inc'. National Drug Code (NDC) number for Tigan is 52584-119. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Tigan drug includes Trimethobenzamide Hydrochloride - 100 mg/mL . The currest status of Tigan drug is Active.
Drug Information:
| Drug NDC: | 52584-119 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Tigan |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Trimethobenzamide Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | General Injectables & Vaccines, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TRIMETHOBENZAMIDE HYDROCHLORIDE - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAMUSCULAR
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Aug, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 30 Sep, 2024 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA017530 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 28 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | General Injectables & Vaccines, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1726680
1726682
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | WDQ5P1SX7Q
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Antiemetic [EPC]
Emesis Suppression [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52584-119-25 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-119-25) / 2 mL in 1 VIAL, SINGLE-DOSE | 01 Aug, 2010 | 30 Sep, 2024 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Tigan trimethobenzamide hydrochloride trimethobenzamide hydrochloride trimethobenzamide sodium citrate citric acid monohydrate
Indications and 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.
Dosage and 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/1.73m2). 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/1.73m2), 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
Read more...: 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.
Contraindications:
Contraindications the injectable form of tigan® is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.
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 jhp at 1-866-923-2547 or medwatch at 1-800-fda-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.
Description:
Description chemically, trimethobenzamide hcl is n-[p-[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. it has a molecular weight of 424.93 and the following structural formula: single-dose vials : each 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. 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. formula1.jpg
Clinical Pharmacology:
Clinical pharmacology mechanism of action the mechanism of action of tigan® as determined in animals is obscure, but may involve the chemoreceptor trigger zone (ctz), an area in the medulla oblongata through which emetic impulses are conveyed to the vomiting center; direct impulses to the vomiting center apparently are not similarly inhibited. in dogs pretreated with trimethobenzamide hcl, the emetic response to apomorphine is inhibited, while little or no protection is afforded against emesis induced by intragastric copper sulfate. pharmacokinetics the pharmacokinetics of trimethobenzamide have been studied in healthy adult subjects. following administration of 200 mg (100 mg/ml) tigan i.m. injection, the time to reach maximum plasma concentration (tmax) was about half an hour, about 15 minutes longer for tigan 300 mg oral capsule than an i.m. injection. a single dose of tigan 300 mg oral capsule provided a plasma concentration profile of trimethobenzamide similar to tigan 200 mg i
Read more....m. the relative bioavailability of the capsule formulation compared to the solution is 100%. the mean elimination half-life of trimethobenzamide is 7 to 9 hours. between 30 â 50% of a single dose in humans is excreted unchanged in the urine within 48 â 72 hours. the metabolic disposition of trimethobenzamide in humans is not known. specifically, it is not known if active metabolites are generated in humans. special populations age the clearance of trimethobenzamide is not known in patients with renal impairment. however, it may be advisable to consider reduction in the dosing of trimethobenzamide in elderly patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney and that elderly patients may have various degrees of renal impairment. (see precautions: general and dosage and administration ). gender systemic exposure to trimethobenzamide was similar between men (n=40) and women (n=28). race pharmacokinetics appeared to be similar for caucasians (n=53) and african americans (n=12). renal impairment the clearance of trimethobenzamide is not known in patients with renal impairment. however, it may be advisable to consider reduction in the dosing of trimethobenzamide in patients with renal impairment considering that a substantial amount of excretion and elimination of trimethobenzamide occurs via the kidney. (see precautions: general and dosage and administration ).
How Supplied:
How supplied tigan® (trimethobenzamide hydrochloride) is available as follows: ndc 42023-119-25 100 mg/ml in 2 ml single-dose vials, pack of 25 ndc 42023-118-01 100 mg/ml in 20 ml multi-dose vials, pack of 1 rx only manufacturered by: par pharmaceutical chestnut ridge, ny r04/16 3000358f os118j-01-90-01
Package Label Principal Display Panel:
Sample package label label1.jpg