Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

INDICATIONS AND USAGE 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.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Hereditary ATTR amyloidosis

Hereditary ATTR amyloidosis

Explore the pathophysiology, epidemiology and multi-system symptoms associated with hereditary ATTR amyloidosis, as well as how to achieve an early and accurate diagnosis.

EPNS 2019 Congress Highlights

EPNS 2019 Congress Highlights

The epgonline.org team is creating daily reports from the 13th European Paediatric Neurology Society (EPNS) Congress, held in Athens, Greece from 17th to 21st September 2019, to bring you coverage of cutting-edge science and advances in clinical care across all fields of paediatric neurology. 

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS 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.
Special warnings and precautions
PRECAUTIONS General Patients with cardiac, liver, or kidney disorders, or with hypertension, should be closely monitored. Since trihexyphenidyl has atropine-like properties, patients on long-term treatment should be carefully monitored for untoward reactions. Since trihexyphenidyl has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Incipient glaucoma may be precipitated by parasympatholytic drugs such as trihexyphenidyl. Tardive dyskinesia may appear in some patients on long-term therapy with antipsychotic drugs or may occur after therapy with these drugs has been discontinued. Antiparkinsonism agents do not alleviate the symptoms of tardive dyskinesia, and in some instances may aggravate them. However, parkinsonism and tardive dyskinesia often coexist in patients receiving chronic neuroleptic treatment, and anticholinergic therapy with trihexyphenidyl may relieve some of these parkinsonism symptoms. Trihexyphenidyl is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson's disease. 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. (See DRUG ABUSE AND DEPENDENCE ). Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided (See DOSAGE AND ADMINISTRATION ). Information for Patients Trihexyphenidyl may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that trihexyphenidyl therapy does not adversely affect their ability to engage in such activities. Because of increased sedative effects, patients should be cautioned to avoid the use of alcohol or other CNS depressants while taking trihexyphenidyl. Since this medication may increase the susceptibility to heat stroke (gastrointestinal (GI) problems, fever, heat intolerance), use with caution during hot weather. (See WARNINGS ). Patients should be advised to report the occurrence of GI problems, fever, or heat intolerance promptly since paralytic ileus, hyperthermia, or heat stroke may occur. If GI upset occurs, trihexyphenidyl may be taken with food. Patients should have close monitoring of intraocular pressure. (See WARNINGS ). Drug Interactions Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with trihexyphenidyl, and thus, an abuse potential exists. Concurrent use of alcohol or other CNS depressants with trihexyphenidyl may cause increased sedative effects. Monoamine oxidase inhibitors and tricyclic antidepressants possessing significant anticholinergic activity may intensify the anticholinergic effects of antidyskinetic agents because of the secondary anticholinergic activities of these medications. Prophylactic administration of anticholinergic agents, such as trihexyphenidyl, as a prevention of drug-induced parkinsonism during neuroleptic therapy is not recommended. There may be an increased risk for the development of tardive dyskinesia during concomitant administration of anticholinergics and neuroleptics (See PRECAUTIONS, General ). The usual dose of either trihexyphenidyl or levodopa may need to be reduced during concomitant therapy, since concomitant administration may increase drug-induced involuntary movements (See DOSAGE AND ADMINISTRATION ). Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity studies or adequate genotoxicity or fertility studies have been conducted for trihexyphenidyl. Pregnancy TERATOGENIC EFFECTS PREGNANCY CATEGORY C Animal reproduction studies to evaluate teratogenic and embryotoxic potential have not been conducted with trihexyphenidyl. It is also not known whether trihexyphenidyl can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Trihexyphenidyl should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trihexyphenidyl is administered to a nursing woman. As with other anticholinergics, trihexyphenidyl may cause suppression of lactation. Therefore, trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant. Pediatric Use Safety and effectiveness in pediatric patients have not been established. (See also ADVERSE REACTIONS ). Geriatric Use Sensitivity to the actions of parasympatholytic drugs may increase with age, particularly over the age of 60; therefore, elderly patients generally should be started on low doses of trihexyphenidyl and observed closely. Trihexyphenidyl has been shown to cause some cognitive dysfunctions in the elderly, including confusion and memory impairment. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ).
Adverse reactions
ADVERSE REACTIONS 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 WARNINGS, Neuroleptic Malignant Syndrome ). 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.

Usage information

Dosing 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 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 WARNINGS ). Idiopathic Parkinsonism As initial therapy for parkinsonism, 1 mg of trihexyphenidyl hydrochloride oral solution USP 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. Drug-Induced Parkinsonism The size and frequency of the trihexyphenidyl dose 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 with 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 when instituting trihexyphenidyl therapy and then adjusting the 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 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 therapy was discontinued. Concomitant Use with Levodopa When trihexyphenidyl 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. A trihexyphenidyl dosage of 3 to 6 mg daily, in divided doses, is usually adequate. Concomitant Use with Other Parasympathetic Inhibitors Trihexyphenidyl 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 is increased. The total daily intake of trihexyphenidyl hydrochloride oral solution USP 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 mealtimes and the fourth at bedtime.
Pregnancy and lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trihexyphenidyl is administered to a nursing woman. As with other anticholinergics, trihexyphenidyl may cause suppression of lactation. Therefore, trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant.

Interactions

Drug Interactions Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with trihexyphenidyl, and thus, an abuse potential exists. Concurrent use of alcohol or other CNS depressants with trihexyphenidyl may cause increased sedative effects. Monoamine oxidase inhibitors and tricyclic antidepressants possessing significant anticholinergic activity may intensify the anticholinergic effects of antidyskinetic agents because of the secondary anticholinergic activities of these medications. Prophylactic administration of anticholinergic agents, such as trihexyphenidyl, as a prevention of drug-induced parkinsonism during neuroleptic therapy is not recommended. There may be an increased risk for the development of tardive dyskinesia during concomitant administration of anticholinergics and neuroleptics (See PRECAUTIONS, General ). The usual dose of either trihexyphenidyl or levodopa may need to be reduced during concomitant therapy, since concomitant administration may increase drug-induced involuntary movements (See DOSAGE AND ADMINISTRATION ).

More information

Category Value
Authorisation number ANDA040177
Agency product number AO61G82577
Orphan designation No
Product NDC 0121-0658
Date Last Revised 11-06-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 905273
Storage and handling STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Marketing authorisation holder Pharmaceutical Associates, Inc.