BENZATROPINE INJECTION benzatropine mesilate 2mg in 2 mL, vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

benzatropine mesilate, Quantity: 1 mg/mL

Available from:

Phebra Pty Ltd

INN (International Name):

benzatropine mesilate

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

10 & 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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 antichlolinergic 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.

Product summary:

Visual Identification: A clear particle free solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-07-18

Patient Information leaflet

Benzatropine Injection
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Version 0_2_
BENZATROPINE INJECTION
Contains benzatropine mesilate 2 mg in 2 mL
BENZ-troe-peen
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Benzatropine
Injection. It does not contain all the
available information. It does not take
the place of talking to your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given Benzatropine Injection
against the benefits they expect it will
have for you.
If you have any concerns about
being given this medicine, ask your
doctor.
Keep this leaflet in a safe place.
You may need to read it again.
What Benzatropine
Injection is used for
Benzatropine Injection is used to treat
some of the symptoms of
parkinsonism.
The symptoms of parkinsonism include
slow and unsteady movement, muscle
stiffness and shaking (tremors). If
untreated, parkinsonism can cause
difficulty in performing normal daily
activities.
Symptoms of parkinsonism can be
caused by certain diseases of the brain
affecting movement, such as
Parkinson’s disease. They can also be
caused by some medicines that are
used to treat certain mental conditions.
Benzatropine Injection is most helpful
in improving muscle stiffness and
shaking.
Benzatropine Injection belongs to a
group of medicines called
anticholinergics. It comes as an
injection.
Benzatropine Injection works by
blocking the effects of acetylcholine, a
naturally occurring chemical produced
by brain cells that can interfere with
the regions of the brain that control
muscle movement. In many patients,
this reduces the symptoms of shaking
and muscle stiffness.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription.
Before you are given
Benzatropine Injection
When you must not be given
it
You should not be given
Benzatropine Injection if you have
an allergy to:

any medicine contai

Summary of Product characteristics

PRODUCT INFORMATION
Australian Product Information – Benzatropine Injection
Page 1 of 8
Version 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
Australian Product Information – Benzatropine Injection
Page 2 of 8
Version 03
The injection is especially useful for psychotic patients with acute
dystonic re