(and dosage form):
Each tablet contains 50 mg orphenadrine hydrochloride
A 5.4.1 Anti-Parkinsonism preparations.
PHARMACOLOGICAL ACTION :
Orphenadrine hydrochloride is a centrally acting anticholinergic agent of benefit in Parkinsonism. It favourably influences akinesia, rigidity and tremor as well as secondary symptoms such as depressed mood, sialorrhea and hyperhidrosis.
Prostatic enlargement, paralytic ileus, pyloric stenosis, closed-angle glaucoma and patients with a narrow angle between the iris and the cornea. Should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure, and in cardiac surgery.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE AND DIRECTIONS FOR USE:
One tablet twice a day to two tablets four times a day.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dryness of the mouth with difficulty in swallowing, thirst, dilatation of the pupils with loss of accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of the skin, bradycardia followed by tachycardia, with palpitations and arrhythmias, a desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastro-intestinal tract leading to constipation.
Occasionally vomiting, giddiness and staggering may occur. Retrosternal pain may occur due to increased gastric reflux. In the treatment of Parkinsonism, increases in dosage, and transfer to other forms of treatment should be gradual and anticholinergic agents should not be withdrawn abruptly. If higher doses provoke severe mental disturbances the drug should be discontinued, but minor reactions may be controlled by reducing the dosage until tolerance has developed. The effects of anticholinergic agents may be enhanced by the concomitant administration of other drugs with anticholinergic properties, such as amantadine, some antihistaminics, butyrophenones and phenothiazines, and tricyclic anti-depressants.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium. Depression of the central nervous system, with hypertension or circulatory failure and respiratory depression.
Treatment of acute poisoning is to empty the stomach. A saline purgative should be given to promote peristalsis. Excitement may be controlled by small doses of a short-acting barbiturate. Supportive therapy may require oxygen and assisted respiration, ice-bags or alcohol sponges for hyperpyrexia, especially in children, bladder catheterisation, and the administration of fluids.
Yellow sugar-coated tablets.
Containers of 100 tablets
Store below 25°C. Protect from moisture.
KEEP OUT OF REACH OF CHILDREN
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Updated on this site: November 2005
Source: Hospital Pharmacy
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2005