TRIHEXYPHENIDYL HYDROCHLORIDE
Generic: TRIHEXYPHENIDYL HYDROCHLORIDE
Basic Information
Manufacturer
Novitium Pharma LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
83608c13-509d-448b-8559-5f5e8a9a0d75
Indications & Usage
INDICATIONS & USAGE 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.
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 hydrochloride should have a gonioscope evaluation and close monitoring of intraocular pressures at regular periodic intervals.
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 hydrochloride 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 REACTIONS, contact Novitium Pharma LLC at 1-516-305-1658 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
These sensations, however, are much less troublesome with trihexyphenidyl hydrochloride 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 REACTIONS, contact Novitium Pharma LLC at 1-516-305-1658 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .