Drugplain

Trihexyphenidyl Hydrochloride 2 mg/5mL

Trihexyphenidyl Hydrochloride · SYRUP · Akorn

1 Recall on Record
Plain English

Trihexyphenidyl Hydrochloride is a syrup containing trihexyphenidyl hydrochloride at 2 mg/5mL, taken oral. Manufactured by Akorn.

Key Facts

Brand Name
Trihexyphenidyl Hydrochloride
Generic Name
Trihexyphenidyl Hydrochloride
NDC Code (Product)
61748-054
Manufacturer
Akorn
Strength
2 mg/5mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
ANDA040251
Marketing Start
03/01/2001

Recall History

1 Recall on Record
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use70 reports
drug interaction59 reports
nausea52 reports
coma50 reports
ischaemic stroke42 reports
respiratory distress41 reports
respiratory failure37 reports
somnolence35 reports
fall34 reports
areflexia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & 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 may be administered the first day. The dose may then be increased by 2 mg increments at intervals of t

Warnings

WARNINGS 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 CONTRAINDICATIONS and ADVERSE REACTIONS ). 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. Neuroleptic Mal

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.

Drug 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 ).

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, di

Frequently Asked Questions

What is Trihexyphenidyl Hydrochloride used for?

Trihexyphenidyl Hydrochloride contains Trihexyphenidyl Hydrochloride. It is a syrup taken oral. Consult your doctor for specific uses.

Is Trihexyphenidyl Hydrochloride a controlled substance?

Trihexyphenidyl Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Trihexyphenidyl Hydrochloride?

The generic name for Trihexyphenidyl Hydrochloride is Trihexyphenidyl Hydrochloride. There are 4 other brand versions of Trihexyphenidyl Hydrochloride.

What is the NDC code for Trihexyphenidyl Hydrochloride 2 mg/5mL?

The NDC (National Drug Code) for Trihexyphenidyl Hydrochloride 2 mg/5mL is 61748-054, listed by Akorn.