NDC 61919-884 Trimethobenzamide

Trimethobenzamide

NDC Product Code 61919-884

NDC Code: 61919-884

Proprietary Name: Trimethobenzamide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Trimethobenzamide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PURPLE (C48327 - (LAVENDAR OPAQUE CAP AND LAVENDER OPAQUE BODY))
Shape: CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
NOVEL660;300MG
Score: 1

NDC Code Structure

  • 61919 - Direct_rx
    • 61919-884 - Trimethobenzamide

NDC 61919-884-30

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Product Information

Trimethobenzamide with NDC 61919-884 is a a human prescription drug product labeled by Direct_rx. The generic name of Trimethobenzamide is trimethobenzamide. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Direct_rx

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Trimethobenzamide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • GELATIN (UNII: 2G86QN327L)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SHELLAC (UNII: 46N107B71O)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLENE GLYCOL MONOETHYL ETHER (UNII: IDK7C2HS09)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Antiemetic - [EPC] (Established Pharmacologic Class)
  • Emesis Suppression - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Direct_rx
Labeler Code: 61919
FDA Application Number: ANDA076546 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-03-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Trimethobenzamide Product Label Images

Trimethobenzamide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Chemically, trimethobenzamide hydrochloride is N-[ρ -[2-(dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride. It has a molecular weight of 424.92 and the following structural formula:[b09aec67-figure-01]Each capsule for oral use contains trimethobenzamide hydrochloride equivalent to 300 mg.Inactive Ingredients: Lactose monohydrate, magnesium stearate and pregelatinized starch. The capsule shell contains the following ingredients: D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.White ink contains the following ingredients: 2-ethoxyethanol, industrial methylated spirit, lecithin, purified water, shellac glaze, simethicone emulsion and titanium dioxide.

Clinical Pharmacology

Mechanism of ActionThe mechanism of action of trimethobenzamide hydrochloride 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 hydrochloride, the emetic response to apomorphine is inhibited, while little or no protection is afforded against emesis induced by intragastric copper sulfate.PharmacokineticsThe pharmacokinetics of trimethobenzamide have been studied in healthy adult subjects. Following administration of 200 mg (100 mg/mL) trimethobenzamide I.M. injection, the time to reach maximum plasma concentration (Tmax) was about half an hour, about 15 minutes longer for trimethobenzamide 300 mg oral capsule than an I.M. injection. A single dose of trimethobenzamide 300 mg oral capsule provided a plasma concentration profile of trimethobenzamide similar to trimethobenzamide 200 mg I.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 – 50 % of a single dose in humans is excreted unchanged in the urine within 48 – 72 hours. The major pathway of trimethobenzamide metabolism is through oxidation resulting in the formation of trimethobenzamide N-oxide metabolite. The pharmacologic activity of this major metabolite has not been evaluated.Special PopulationsAgeThe 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).GenderSystemic exposure to trimethobenzamide was similar between men (N=40) and women (N=28).RacePharmacokinetics appeared to be similar for Caucasians (N=53) and African Americans (N=12).Renal ImpairmentThe 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 ADMNISTRATION).

Indications & Usage

Trimethobenzamide Hydrochloride Capsule, USP 300 mg is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Contraindications

Use of any dosage forms in patients with known hypersensitivity to trimethobenzamide is contraindicated.

Warnings

Caution should be exercised when administering trimethobenzamide hydrochloride capsules to children for the treatment of vomiting. Antiemetics are not recommended for treatment of uncomplicated vomiting in children and their use should be limited to prolonged vomiting of known etiology. There are two principal reasons for caution:1. The extrapyramidal symptoms which can occur secondary to trimethobenzamide hydrochloride capsules may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's syndrome or other encephalopathy.2. It has been suspected that drugs with hepatotoxic potential, such as trimethobenzamide hydrochloride capsules, may unfavorably alter the course of Reye's syndrome. Such drugs should therefore be avoided in children whose signs and symptoms (vomiting) could represent Reye's syndrome.Trimethobenzamide hydrochloride capsules 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 capsules may result in an adverse drug interaction.

Precautions

During the course of acute febrile illness, encephalitides, gastroenteritis, dehydration and electrolyte imbalance, especially in children and the elderly or debilitated, CNS reactions such as opisthotonos, convulsions, coma and extrapyramidal symptoms have been reported with and without use of trimethobenzamide hydrochloride capsules or other antiemetic agents. In such disorders caution should be exercised in administering trimethobenzamide hydrochloride capsules, particularly to patients who have recently received other CNS acting agents (phenothiazines, barbiturates, belladonna derivatives). Primary emphasis should be directed toward the restoration of body fluids and electrolyte balance, the relief of fever and relief of the causative disease process. Overhydration should be avoided since it may result in cerebral edema.The antiemetic effects of trimethobenzamide hydrochloride capsules may render diagnosis more difficult in such conditions as appendicitis and obscure signs of toxicity due to overdosage of other drugs.GeneralAdjustment of Dose in Renal FailureA substantial route of elimination of unchanged trimethobenzamide is via the kidney. Dosage adjustment should be considered in patients with reduced renal function including some elderly patients. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).Geriatric UseClinical studies of trimethobenzamide hydrochloride did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Although there are studies reported in the literature that included elderly patients >65 years old with younger patients, it is not known if there are differences in efficacy or safety parameters for elderly and non-elderly patients treated with trimethobenzamide. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINCAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

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.

Dosage & 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 PatientsDose 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 and Renal ImpairmentIn 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 PRECAUTIONS).Usual Adult Dosage: One 300 mg capsule 3 or 4 times daily.STORAGEStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

How Supplied

Trimethobenzamide Hydrochloride Capsules, USP 300 mg are filled gelatin capsules size 1 lavender opaque cap/lavender opaque body with a white imprint "Novel 660" on cap and "300 mg" on body.Available in bottles of 30'sBottles of 100 capsulesBottles of 500 capsules: Manufactured by:Novel Laboratories, Inc.Somerset, NJ 08873Distributed byLupin Pharmaceuticals, IncBaltimore, MD 21202PI6600000204Rev. 05/2016

* Please review the disclaimer below.

Previous Code
61919-883
Next Code
61919-885