Benztrop

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Benzatropine mesilate 2mg

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Benzatropine mesilate 2 mg

Dosage:

2 mg

Pharmaceutical form:

Tablet

Composition:

Active: Benzatropine mesilate 2mg Excipient: Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch

Units in package:

Bottle, plastic, HDPE bottle with PP closure, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fine Chemicals Corporation (Pty) Limited

Therapeutic indications:

BENZTROP tablets are indicated for the treatment of all forms of Parkinsonism and the treatment of extrapyramidal reactions (except tardive dyskinesia) due to neuroleptic drugs.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with PP closure - 60 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2003-05-29

Summary of Product characteristics

Page 1 of 6
NEW ZEALAND DATA SHEET
1.
BENTROP TABLET
Benztrop tablet 2mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benztrop 2mg: Each tablet contains 2mg of benzatropine mesilate.
Excipients with known effect:
Maize starch, lactose, microcrystalline cellulose, and magnesium
stearate.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
BENZTROP 2 mg tablets are round, flat-faced, cross-scored on one side
and embossed “PMS-2”
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BENZTROP tablets are indicated for the treatment of all forms of
Parkinsonism and the treatment
of extrapyramidal reactions (except tardive dyskinesia [see
Contraindications and Warnings and
Precautions]) due to neuroleptic drugs.
4.2
DOSE AND METHOD OF ADMINISTRATION
Benzatropine action is cumulative and therapy should be initiated with
a small dose, which can be
increased gradually at five- or six-day intervals, to a maximum of 6
mg.
Dose equivalence when the tablet is quartered has not been
established. This product is not able to
deliver all approved dose regimens.
Some patients experience greatest relief when taking the entire dose
at bedtime; others react more
favourably to divided doses, two to four times a day.
The long duration of action of BENZTROP makes it particularly suitable
for administration at
bedtime when the effects may persist throughout the night. Therefore,
BENZTROP enables the
patient to turn in bed more easily and to rise in the morning.
When BENZTROP is started, therapy with other agents in Parkinsonism
should not be terminated
abruptly but reduced or discontinued gradually. Many patients obtain
the greatest relief with a
combination of BENZTROP and other drugs.
BENZTROP may be used concomitantly with SINMET* (carbidopa/ levodopa,
MSD), or with
levodopa in which case periodic dosage adjustment may be required in
order to maintain optimum
response.
Page 2 of 6
Arteriosclerotic, Idiopathic and Postencephalitic Parkinsonism
The usual daily dose of benzatropine is 1 mg to