TRIHEXYPHENIDYL HYDROCHLORIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIHEXYPHENIDYL HYDROCHLORIDE (UNII: AO61G82577) (TRIHEXYPHENIDYL - UNII:6RC5V8B7PO)

Available from:

Akorn

INN (International Name):

TRIHEXYPHENIDYL HYDROCHLORIDE

Composition:

TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Trihexyphenidyl Hydrochloride Oral Solution, containing trihexyphenidyl hydrochloride 2 mg per 5 mL, is a clear, colorless lime-peppermint flavored liquid supplied in 473 mL (16 fl. oz) bottles, NDC 61748-054-16. Dispense in a tight, light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DO NOT FREEZE. Rx Only Manufactured by: MIKART, INC. Atlanta, GA 30318 Marketed by: VersaPharm, Inc. – An Akorn Company Lake Forest, IL 60045 Code 734A00                         Rev 03/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIHEXYPHENIDYL HYDROCHLORIDE- TRIHEXYPHENIDYL HYDROCHLORIDE SYRUP
AKORN
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TRIHEXYPHENIDYL HYDROCHLORIDE ORAL SOLUTION, USP 2 MG PER 5 ML
RX ONLY
DESCRIPTION
Trihexyphenidyl Hydrochloride Oral Solution USP is a synthetic
antispasmodic drug. It is
designated chemically as α-Cyclohexyl-α-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 and sorbitol solution.
CLINICAL PHARMACOLOGY
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.
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.
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 af