INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BENZHEXOL TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

BENZHEXOL TABLETS

COMPOSITION:
Each tablet contains 2 mg
Benzhexol Hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 5.4.1 Anti-Parkinsonism preparations.

PHARMACOLOGICAL ACTION:
Benzhexol hydrochloride resembles atropine in its peripheral actions on autonomic effector cells, having an inhibitory effect on the parasympathetic nervous system. It is one half as active as atropine on smooth muscle and one third as active as a mydriatic. It possesses about one tenth the potency of atropine on salivary glands and cardiac-vagal mechanisms. On the C.N.S., the actions of benzhexol likewise resembles those of atropine. In animals, it abolishes tremor induced by nicotine and tremorine as does atropine. Benzhexol does not selectively depress polysynaptic pathways. Present evidence suggests that benzhexol acts by blocking acetylcholine at certain cerebral synaptic sites.

INDICATIONS:
Benzhexol is used for the symptomatic control of all forms of Parkinsonism, including the postencephalitic arteriosclerotic, and idiopathic types. It favourably influences rigidity and akinesia in the majority of patients. Tremor is generally improved also, but in some instances of severe rigidity, the tremor may be accentuated when the rigidity is diminished. Benzhexol favourably effects mood and reduces salivation.

CONTRA-INDICATIONS:
Benzhexol hydrochloride should not be given to patients with closed-angle glaucoma or to patients with a narrow angle between the iris and the cornea since its use may increase the intra-ocular pressure. The drug is contra-indicated in patients suffering from a paralytic ileus.

DOSAGE AND DIRECTIONS FOR USE:
Dosage should be individualised. The initial dose should be low and then increased gradually especially in elderly patients. It is usually given in 3 or 4 divided doses daily before or with food. The initial dose of 1 or 2 mg a day is gradually increased to 6 to 10 mg a day according to the condition of the patient; for advanced cases, 15 mg or more may be needed daily.
Treatment should never be terminated suddenly and it is usual when changing from one drug to another, to withdraw the one in small amounts while gradually increasing the dose of the other.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
5 to 10% of patients cannot tolerate fully effective doses. Side-effects such as dry mouth and blurred vision are not uncommon. Dizziness, mild nausea or nervousness may be experienced by 30 to 50 per cent of patients on benzhexol.
The reactions may be less pronounced as treatment continues. Suppurative parotitis skin rashes dilation of the colon, paralytic ileus, and delusions and hallucinations occur rarely. Patients with arteriosclerosis or with idiosyncrasy may show mental confusion, agitation nausea and vomiting. Potential side-effects associated with the use of any atropine-like drugs include constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intra-ocular tension, weakness, and headache. Occasionally giddiness and staggering occurs. Large doses may cause cerebral stimulation.
When intolerable side-effects occur with doses that fail to control the motor symptoms of the disease, other drugs must be employed along with benzhexol, or the agents must be withdrawn. Caution should be observed when benzhexol is administered to patients with prostatic enlargement, coronary insufficiency, or cardiac failure. Tachycardia may result from vagal inhibition and induce angina of effort in patients with coronary heart disease. The effects of benzhexol and other parasympatholytics may be enhanced by the concomitant administration of other drugs with parasympatholytic properties, such as some antihistamines and phenothiazines and tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium.
In case of overdosage, treatment is symptomatic and supportive.

IDENTIFICATION:
Flat white bisected tablets with bevelled edges.

PRESENTATION:
Packs of 100 tablets.

STORAGE INSTRUCTIONS:
Store in a cool place below 25° C.
Keep container tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
K/5.4.1/251.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13.6.1978

                D016
       
                A & S PRINTERS.

Updated on this site: December 2000
Current: March 2005
Source: Hospital Pharmacy

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