COGENTIN Solution for Injection 1 mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
BENZATROPINE MESILATE
Available from:
Merck Sharp and Dohme Limited
Dosage:
1 mg Milligram
Pharmaceutical form:
Solution for Injection
Authorization date:
1979-04-01
Summary of Product characteristics
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Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Cogentin 1mg/ml Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sterile injection of ‘Cogentin’ contains 1.0 mg/ml benzatropine mesilate. (2mg per 2ml ampoule)
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear, colourless, sterile solution for injection.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
‘Cogentin’ is an anti-parkinsonian agent with powerful anticholinergic effects.
It is indicated for symptomatic treatment of all types of ‘classical’ parkinsonism including arteriosclerotic,
post-encephalitic, and idiopathic parkinsonism, and of extrapyramidal reactions induced by phenothiazines or
reserpine. It is not recommended for use in tardive dyskinesia
4.2 Posology and method of adminstration
‘Cogentin’ Injection is only to be used in an emergency or when a patient is unable to swallow tablets.
As ‘Cogentin’ is cumulative in action, treatment should begin with a low dosage, which can be increased by amounts of
0.5 mg at intervals of five to six days, to the smallest dosage necessary for optimal relief without excessive
side-effects. Maximum dosage, 6 mg a day.
‘Cogentin’ Injection may be used intramuscularly or intravenously in emergencies, or for patients unable to swallow
tablets. (As there is no significant difference in time of onset&#
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