BENZATROPINE PHEBRA SOLUTION FOR INJECTION 2 MG2 ML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Benzatropine mesilate

Available from:

PHEBRA (SE ASIA) PTE. LTD.

ATC code:

N04AC01

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Benzatropine mesilate 2.0 mg/2ml

Administration route:

INTRAVENOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Phebra Pty Ltd

Authorization status:

ACTIVE

Authorization date:

2021-06-03

Summary of Product characteristics

PRODUCT INFORMATION
Pack Insert – Benzatropine Injection (AU-NZ-SG)
Page 1 of 10
PiINJ187/197
.
03
BENZATROPINE INJECTION
(BENZATROPINE MESILATE)
1
NAME OF THE MEDICINE
Benzatropine mesilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzatropine Injection is available as 2 mg in 2 mL vials.
Benzatropine Injection contains benzatropine mesilate as the active
ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Benzatropine Injection, 2 mg in 2 mL, clear, colourless, particle free
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Benzatropine Injection is recommended for all forms of parkinsonism -
including arteriosclerotic, post-encephalitic,
idiopathic, as well as drug-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-drug-induced parkinsonism, partial control of symptoms is
usually achieved.
4.2
D
OSE 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.
PRODUCT INFORMATION
BENZATROPINE INJECTION
Pack Insert– Benzatropine Injection (AU-SG-NZ)
Page 2 of 10
PiINJ187/197
.
03
The injection is especially useful for psychotic patients with acute
dystonic rea