TRIHEXYPHENIDYL HYDROCHLORIDE- trihexyphenidyl hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trihexyphenidyl HCl 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 HCl is contraindicated in patients with hypersensitivity to trihexyphenidyl HCl or to any of the tablet ingredients. Trihexyphenidyl HCl is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported. Although trihexyphenidyl HCl 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 Tablets, USP 2 mg are white colored, round debossed with N, T on either side of the score line and '2' on the other side.   Trihexyphenidyl Hydrochloride Tablets, USP 2 mg are available in Bottle of 100 tablets (NDC 16571-160-10) Bottle of 1000 tablets (NDC 16571-160-11) Trihexyphenidyl Hydrochloride Tablets, USP 5 mg are white colored, round debossed with N, T on either side of the score line and '5' on other side.  Trihexyphenidyl Hydrochloride Tablets, USP 5 mg are available in Bottle of 100 tablets (NDC 16571-161-10) Bottle of 1000 tablets (NDC 16571-161-11) Dispense in a tight container with child-resistant closure. Store at 20°-25°C (68°- 77°F). [See USP controlled room temperature.] Manufactured by: NATCO PHARMA LIMITED Kothur-509 228, India. Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Rev.: 02-Jun/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIHEXYPHENIDYL HYDROCHLORIDE- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS
TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP
R ONLY
DESCRIPTION
Trihexyphenidyl HCl is a synthetic antispasmodic drug. It is
designated chemically as α-Cyclohexylα-
phenyl-1-piperidinepropanol hydrochloride and its structural formula
is as follows:
Trihexyphenidyl HCl 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.
Trihexyphenidyl Hydrochloride Tablets USP 2 mg and 5 mg contain the
following inactive
ingredients: magnesium stearate, microcrystalline cellulose and sodium
starch glycolate.
CLINICAL PHARMACOLOGY
Trihexyphenidyl HCl 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 HCl is indicated as an adjunct in the treatment of all
forms of parkinsonism
X
(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 HCl is contraindicated in patients with
hypersensitivity to trihexyphenidyl HCl or to
any of the tablet ingredients. Trihexyphenidyl HCl is also
contraindicated in patients with narrow angle
glaucoma. Blindness after long-term use due to narrow angle glaucoma
has been reported.
WARNINGS
Patients to be treated with trihexyphenidyl HCl s