Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride)

Trade Name : Trihexyphenidyl Hydrochloride

Pharmaceutical Associates, Inc.

SOLUTION

Strength 2 mg/5mL

TRIHEXYPHENIDYL HYDROCHLORIDE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) which is also known as Trihexyphenidyl Hydrochloride and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 2 mg/5mL per ml. Read more

Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

I06580218
Rx ONLY

Trihexyphenidyl Hydrochloride Oral Solution USP is a synthetic antispasmodic drug. It is designated chemically as u03b1-Cyclohexylu03b1-phenyl-1-piperidinepropanol hydrochloride and its structural formula is as follows:
Trihexyphenidyl hydrochloride occurs as a white or creamy-white, almost odorless, crystalline powder. It is very slightly soluble in ether and benzene, slightly soluble in water and soluble in methanol.
Each 5 mL (teaspoonful) for oral administration contains 2 mg trihexyphenidyl hydrochloride and alcohol 5% in a clear, colorless, lime-mint flavored preparation. In addition, it contains the following inactive ingredients: citric acid, flavoring, methylparaben, propylparaben, purified water, sodium chloride and sorbitol solution.

Trihexyphenidyl 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.

Trihexyphenidyl 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.

Trihexyphenidyl is contraindicated in patients with hypersensitivity to trihexyphenidyl or to any of the other ingredients. Trihexyphenidyl is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported.

Patients to be treated with trihexyphenidyl should have a gonioscope evaluation prior to initiation of therapy and close monitoring of intraocular pressures. The use of anticholinergic drugs may precipitate angle closure with an increase in intraocular pressure. If blurring of vision occurs during therapy, the possibility of narrow angle glaucoma should be considered. Blindness has been reported due to aggravation of narrow angle glaucoma. (See n n n and n n n ).n nn
Trihexyphenidyl should be administered with caution in hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, alcoholics, those who have central nervous system disease, or those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased so that the ability to maintain body heat equilibrium via perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred with the use of anticholinergics under the conditions described above.
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with dose reduction or discontinuation of trihexyphenidyl. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

No data

Minor side effects, such as dryness of the mouth, blurred 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 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 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, hallucinations, and paranoia, all of which may occur with any of the atropine-like drugs, have been reported rarely with trihexyphenidyl.
Potential side effects associated with the use of any atropine-like drugs, including trihexyphenidyl, include cognitive dysfunctions, including confusion and memory impairment; constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular pressure, choreiform movements, weakness, vomiting, and headache. Exacerbation of parkinsonism with abrupt treatment withdrawal has been reported. Neuroleptic malignant syndrome with abrupt treatment withdrawal has been reported (See n n n ).n nn
The occurrence of angle-closure glaucoma in patients receiving trihexyphenidyl has been reported (blindness has been reported in some cases). Paradoxical sinus bradycardia, dry skin, and cycloplegia have been reported.
In addition to adverse events seen in adults, the following adverse events have been reported in the literature in pediatric patients: hyperkinesia, psychosis, forgetfulness, weight loss, restlessness, chorea, and sleep alterations.

Although trihexyphenidyl is not classified as a controlled substance, the possibility of abuse should be borne in mind due to its stimulant and euphoriant properties.

The mean oral LDn n n of trihexyphenidyl has been reported to be 365 mg/kg (range, 325 to 410 mg/kg) in mice and 1660 mg/kg (1420 to 1940 mg/kg) in rats. At a dose of 40 mg/kg, dogs have exhibited emesis, restlessness followed by drowsiness, equilibrium disturbances, and mydriasis.n nn
In humans, doses up to 300 mg (5 mg/kg) have been ingested without fatalities or sequelae. However, rare cases of death associated with trihexyphenidyl overdosages taken in conjunction with other CNS-depressant agents have been reported or in patients with a compromised respiratory condition. Trihexyphenidyl blood concentrations associated with the fatalities ranged from 0.03 to 0.80 mg/l.

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether trihexyphenidyl 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 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.
Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.
Abrupt withdrawal of treatment may result in neuroleptic malignant syndrome (NMS) (See n n n ).n nn

Trihexyphenidyl Hydrochloride Oral Solution USP, a clear, colorless, lime-mint flavored preparation is supplied in the following oral dosage form:
NDC 0121-0658-16: 16 fl oz (473 mL) bottle
Dispense in a tight, light-resistant container with a child-resistant closure.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].

DO NOT FREEZE.
Manufactured By
Pharmaceuticaln n n Associates, Inc.n n n
R02/18

NDC 0121-0658-16
Trihexyphenidyl Hydrochloriden n n Oral Solution USPn nn
2 mg per 5 mL
This package is not for household dispensing.n n n EACH TEASPOONFUL (5 mL) CONTAINS:n n n Trihexyphenidyl HCl 2 mgn n n Alcohol 5%n nn
Preservatives:n n n Methylparaben 0.08%n n n Propylparaben 0.02%n n n pH Range: 2.0 - 3.0n nn
Usual Dosage: See Insert
Rx ONLY
16 fl oz (473 mL)
Pharmaceuticaln n n Associates, Inc.n n n Greenville, SC 29605n nn

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Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride)

Trade Name : Trihexyphenidyl Hydrochloride

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride)

Trade Name : Trihexyphenidyl Hydrochloride

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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