Benzatropine Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Benzatropine mesilate 1 mg/mL

Available from:

Phebra NZ Limited

Dosage:

2 mg/2mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Benzatropine mesilate 1 mg/mL Excipient: Sodium chloride Water for injection

Prescription type:

Prescription

Therapeutic indications:

Benzatropine Injection is recommended for all forms of parkinsonism including arteriosclerotic, post-encephalitic, idiopathic, as well as medicine-induced extrapyramidal disorders (except tardive dyskinesia). It can be effective at any stage of the disease, even when a patient has become bedridden. Benzatropine Injection often is helpful in patients who have become unresponsive to other agents. Benzatropine Injection is a powerful anticholinergic agent which is mainly effective in relieving tremor and rigidity. Therapy is directed toward control of disturbing symptoms to permit the patient maximum integration of function with minimum discomfort. In non-medicine-induced parkinsonism, partial control of symptoms is usually achieved.

Product summary:

Package - Contents - Shelf Life: Vial, glass, (Type I), closed with a rubber stopper and flip-off seal, 2 mL fill - 5 dose units - 36 months from date of manufacture stored at or below 30°C protect from light. Do not freeze. - Vial, glass, (Type I), closed with a rubber stopper and flip-off seal, 2 mL fill - 10 dose units - 36 months from date of manufacture stored at or below 30°C protect from light. Do not freeze.

Authorization date:

2018-05-02

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet_ Benzatropine Injection v 2.0/Apr 2021
Page 1 of 7
1.
PRODUCT NAME
Benzatropine Injection (1 mg/mL), solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL of Benzatropine Injection contains 2 mg of benzatropine
mesilate.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benzatropine Injection is recommended for all forms of parkinsonism
including arteriosclerotic, post- encephalitic,
idiopathic, as well as medicine-induced extrapyramidal disorders
(except tardive dyskinesia). It can be effective
at any stage of the disease, even when a patient has become bedridden.
Benzatropine Injection often is helpful
in patients who have become unresponsive to other agents. Benzatropine
Injection is a powerful anticholinergic
agent which is mainly effective in relieving tremor and rigidity.
Therapy is directed toward control of disturbing
symptoms to permit the patient maximum integration of function with
minimum discomfort. In non-medicine-
induced parkinsonism, partial control of symptoms is usually achieved.
4.2
DOSE AND METHOD OF ADMINISTRATION
Benzatropine Injection is available as an injection for intravenous
and intramuscular use. Each millilitre of the
injection contains:
•
Benzatropine mesilate
1.0 mg
•
Sodium chloride
9.0 mg
•
Water for injections q.s
1.0 mL
Because Benzatropine Injection is cumulative in action, therapy should
be initiated with a small dose which then
can be increased gradually at five- or six-day intervals. Increases in
dosage should be made in increments of 0.5
mg, to a maximum of 6 mg.
The injection is especially useful for psychotic patients with acute
dystonic reactions or other reactions that make
oral medication difficult or impossible.
There is no significant difference in the onset of effect following
intravenous or intramuscular injection. Improvement
is noticeable within a few minutes after injection.
In emergency situations, when the patien