Trihexyphenidyl Hydrochloride


Actavis Pharma, Inc.
Human Prescription Drug
NDC 0591-5337
Trihexyphenidyl Hydrochloride is a drug for further processing labeled by 'Actavis Pharma, Inc.'. National Drug Code (NDC) number for Trihexyphenidyl Hydrochloride is 0591-5337. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Trihexyphenidyl Hydrochloride drug includes Trihexyphenidyl Hydrochloride - 5 mg/1 . The currest status of Trihexyphenidyl Hydrochloride drug is Active.

Drug Information:

Drug NDC: 0591-5337
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: Trihexyphenidyl Hydrochloride
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: Trihexyphenidyl Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Actavis Pharma, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
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:TRIHEXYPHENIDYL HYDROCHLORIDE - 5 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: ANDA
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 Nov, 1987
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 26 Dec, 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: ANDA084364
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: 31 Dec, 2023
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:Actavis Pharma, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:905269
905283
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.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:AO61G82577
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.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0591-5337-01100 TABLET in 1 BOTTLE, PLASTIC (0591-5337-01)01 Nov, 1987N/ANo
0591-5337-101000 TABLET in 1 BOTTLE, PLASTIC (0591-5337-10)01 Nov, 1987N/ANo
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:

Trihexyphenidyl hydrochloride trihexyphenidyl hydrochloride trihexyphenidyl hydrochloride trihexyphenidyl silicon dioxide anhydrous dibasic calcium phosphate lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato dan;dan;5335 flat faced trihexyphenidyl hydrochloride trihexyphenidyl hydrochloride trihexyphenidyl hydrochloride trihexyphenidyl silicon dioxide anhydrous dibasic calcium phosphate lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato dan;dan;5337

Indications and Usage:

Indications this drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). it is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

Warnings:

Warnings patients to be treated with trihexyphenidyl hcl should have a gonioscope evaluation and close monitoring of intraocular pressures at regular periodic intervals.

Dosage and Administration:

Dosage and administration dosage should be individualized. the initial dose should be low and then increased gradually, especially in patients over 60 years of age. whether trihexyphenidyl hcl may best be given before or after meals should be determined by the way the patient reacts. postencephalitic patients, who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances, is sometimes an effective adjuvant. if trihexyphenidyl hcl tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. if taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water. trihexyphenidyl hcl in idiopathic parkinsonism as initial therapy for parkinsonism, 1 mg may be administered the first day. the dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given
daily. the total daily dose will depend upon what is found to be the optimal level. many patients derive maximum benefit from this daily total of 6 to 10 mg, but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg. trihexyphenidyl hcl in drug-induced parkinsonism the size and frequency of dose of trihexyphenidyl hcl needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. the total daily dosage usually ranges between 5 and 15 mg, although, in some cases, these reactions have been satisfactorily controlled on as little as 1 mg daily. it may be advisable to commence therapy with a single 1 mg dose. if the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer on instituting trihexyphenidyl hcl therapy and then adjusting dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions. it is sometimes possible to maintain the patient on a reduced trihexyphenidyl hcl dosage after the reactions have remained under control for several days. instances have been reported in which these reactions have remained in remission for long periods after trihexyphenidyl hcl therapy was discontinued. concomitant use of trihexyphenidyl hcl with levodopa when trihexyphenidyl hcl is used concomitantly with levodopa, the usual dose of each may need to be reduced. careful adjustment is necessary, depending on side effects and degree of symptom control. trihexyphenidyl hcl dosage of 3 to 6 mg daily, in divided doses, is usually adequate. concomitant use of trihexyphenidyl hcl with other parasympathetic inhibitors trihexyphenidyl hcl may be substituted, in whole or in part, for other parasympathetic inhibitors. the usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of trihexyphenidyl hcl is increased. trihexyphenidyl hydrochloride tablets - the total daily intake of trihexyphenidyl hcl tablets is tolerated best if divided into 3 doses and taken at mealtimes. high doses (> 10 mg daily) may be divided into 4 parts, with 3 doses administered at meal times and the fourth at bedtime.

Adverse Reactions:

Adverse reactions minor side effects, such as dryness of the mouth, blurring of vision, dizziness, mild nausea, or nervousness, will be experienced by 30 to 50 percent of all patients. these sensations, however, are much less troublesome with trihexyphenidyl hcl than with belladonna alkaloids and are usually less disturbing than unalleviated parkinsonism. such reactions tend to become less pronounced, and even to disappear, as treatment continues. even before these reactions have remitted spontaneously, they may often be controlled by careful adjustment of the dosage form, amount of drug, or interval between doses. isolated instances of suppurative parotitis secondary to excessive dryness of the mouth, skin rashes, dilatation of the colon, paralytic ileus, and certain psychiatric manifestations such as delusions and hallucinations, plus one doubtful case of paranoia all of which may occur with any of the atropine-like drugs, have been rarely reported with trihexyphenidyl hydrochloride.
patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. such patients should be allowed to develop a tolerance through the initial administration of a small dose and gradual increase in dose until an effective level is reached. if a severe reaction should occur, administration of the drug should be discontinued for a few days and then resumed at a lower dosage. psychiatric disturbances can result from indiscriminate use (leading to overdosage) to sustain continued euphoria. potential side effects associated with the use of any atropine-like drugs include constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular tension, weakness, vomiting, and headache. the occurrence of angle-closure glaucoma due to long-term treatment with trihexyphenidyl hydrochloride has been reported. to report suspected adverse events, contact actavis at 1-800-272-5525 or fda at 1-800-fda-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Description:

Description trihexyphenidyl hydrochloride is a synthetic antispasmodic drug available in the following forms: tablets, 2 mg and 5 mg. it is designated chemically 1-piperidinepropanol,?-cyclohexyl-?-phenyl-, hydrochloride. the structural formula is represented below: c 20 h 31 no•hcl m.w. 337.93 trihexyphenidyl hydrochloride tablets usp 2 mg and 5 mg contain the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. 7066154a-figure-01

Clinical Pharmacology:

Clinical pharmacology trihexyphenidyl hcl is the substituted piperidine salt, 3-(1-piperidyl)-1-phenylcyclohexyl-1-propanol hydrochloride, which exerts a direct inhibitory effect upon the parasympathetic nervous system. it also has a relaxing effect on smooth musculature; exerted both directly upon the muscle tissue itself and indirectly through an inhibitory effect upon the parasympathetic nervous system. its therapeutic properties are similar to those of atropine, although undesirable side effects are ordinarily less frequent and severe than with the latter.

How Supplied:

How supplied trihexyphenidyl hydrochloride tablets, usp 2 mg are 10/32", scored, round, white, flat faced, tablets imprinted dan dan and 5335 supplied in bottles of 100 and 1000. trihexyphenidyl hydrochloride tablets, usp 5 mg are 12/32", scored, round, white, tablets imprinted dan dan and 5337 supplied in bottles of 100 and 1000. dispense in a tight container with child-resistant closure. store at 20° to 25° (68° to 77°f) [see usp controlled room temperature]. manufactured by: watson pharma private limited verna, salcette goa 403 722 india distributed by: actavis pharma, inc. parsippany, nj 07054 usa revised: june 2015 190805-1

Package Label Principal Display Panel:

Principal display panel ndc 0591- 5335 -01 trihexyphenidyl hydrochloride tablets, usp 2 mg 100 tablets rx only trihexyphenidyl hcl tablets

Principal display panel ndc 0591- 5337 -01 trihexyphenidyl hydrochloride tablets, usp 5 mg 100 tablets rx only trihexyphenidyl hydrochloride tablets


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