מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trihexyphenidyl hydrochloride
Genus Pharmaceuticals Holdings Ltd
N04AA01
Trihexyphenidyl hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090200; GTIN: 5030451001108
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trihexyphenidyl Tablets 2mg Artane Tablets 2mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Trihexyphenidyl 2mg contains 2mg trihexyphenidyl hydrochloride BP. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _Route of administration: _ _ _ Trihexyphenidyl Tablets are for oral administration. Each white scored tablet coded ‘GP 4434’ contains trihexyphenidyl hydrochloride 2mg. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Trihexyphenidyl is an antispasmodic drug which exerts a direct inhibitory effect on the parasympathetic nervous system. It also has a relaxing effect on smooth muscle. It is indicated in all forms of Parkinsonism (postencephalitic, arteriosclerotic and idiopathic). It is often useful as adjuvant therapy when treating these forms of Parkinsonism with levodopa. Trihexyphenidyl is effective in reducing the rigidity of muscle spasm, tremor and excessive salivation associated with Parkinsonism. Trihexyphenidyl is also indicated to control extrapyramidal disorders (eg akathisia manifested by extreme restlessness and dyskinesia characterised by spastic contractions and involuntary movements) due to central nervous system drugs such as reserpine and the phenothiazines. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Adults only: _Optimal dosage should always be determined empirically, usually by initiating therapy at a relatively low level and by subsequent graduated increments. The usual dosage for Parkinsonism is 6-10mg per day although some patients chiefly in the post-encephalitic group may require an average total dose of 12- 15mg daily. It should be given orally either three or four times a day at mealtimes. Normal dosage for drug-induced Parkinsonism is usually between 5mg and 15mg per day, although some cases have been controlled by 1mg daily. In all cases, trihexyphenidyl dosage should be increased or decreased only by small increments over a period of several days. In initial therapy the dose should be קרא את המסמך השלם