Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TRIHEXYPHENIDYL HYDROCHLORIDE (UNII: AO61G82577) (TRIHEXYPHENIDYL - UNII:6RC5V8B7PO)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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.
Trihexyphenidyl Hydrochloride Tablets, USP 2 mg are 10/32", scored, round, white, flat faced, tablets imprinted DAN DAN and 5335 supplied in NDC: 70518-1612-00 NDC: 70518-1612-01 NDC: 70518-1612-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Dispense in a tight container with child-resistant closure. Store at 20° to 25° (68° to 77°F) [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
TRIHEXYPHENIDYL HYDROCHLORIDE- TRIHEXYPHENIDYL HYDROCHLORIDE TABLET REMEDYREPACK INC. ---------- TRIHEXYPHENIDYL HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Trihexyphenidyl hydrochloride is a synthetic antispasmodic drug available in the following forms: Tablets, 2 mg and 5 mg. It is designated chemically 1-Piperidinepropanol,α-cyclohexyl-α-phenyl-, hydrochloride. The structural formula is represented below: C H NO•HCl M.W. 337.93 Trihexyphenidyl Hydrochloride Tablets USP 2 mg and 5 mg contain the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. CLINICAL PHARMACOLOGY Trihexyphenidyl HCl is the substituted piperidine salt, 3-(1-piperidyl)-1-phenylcyclohexyl-1-propanol hydrochloride, which 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 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. WARNINGS Patients to be treated with trihexyphenidyl HCl should have a gonioscope evaluation and close monitoring of intraocular pressures at regular periodic intervals. PRECAUTIONS Although trihexyphenidyl HCl is _not_ contraindicated for patients with cardiac, liver, or kidney disorders, or with hypertension, such patients should be maintained u Baca dokumen lengkap