Neostigmine Methylsulphate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Neostigmine metilsulfate 2.5 mg/mL

Available from:

Juno Pharmaceuticals NZ Limited

INN (International Name):

Neostigmine metilsulfate 2.5 mg/mL

Dosage:

2.5 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Neostigmine metilsulfate 2.5 mg/mL Excipient: Dibasic sodium phosphate dodecahydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection

Units in package:

Polyamp, foil wrapped, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

DPx Fine Chemicals Austria GmbH & Co KG

Therapeutic indications:

· Reversal of the effects of nondepolarising neuromuscular blocking agents (e.g. tubocurarine, pancuronium etc.).

Product summary:

Package - Contents - Shelf Life: Polyamp, foil wrapped - 1 mL - 30 months from date of manufacture stored at or below 25°C - Polyamp, Duo Fit 50 x 1mL - 50 mL - 18 months from date of manufacture stored at or below 25°C

Authorization date:

1990-06-29

Summary of Product characteristics

Neostigmine Data Sheet 070918
NEW ZEALAND DATA SHEET
1.
PRODUCT
NAME
N
EOSTIGMINE
M
ETHYLSULFATE
I
NJECTION
B.P. Solution for injection 2.5 mg/mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL sterile solution of pH 4.5 – 6.5 containing 2.5 mg of
neostigmine methylsulfate.
Excipients with known effect: sodium chloride, monobasic sodium
phosphate, dibasic sodium
phosphate dodecahydrate.
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection. Clear, colourless, particle-free solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Reversal of the effects of nondepolarising neuromuscular blocking
agents (e.g.
tubocurarine, pancuronium, etc.)
•
Prophylaxis and treatment of post-operative intestinal atony and
urinary retention.
•
Treatment of myasthenia gravis during acute exacerbations, when the
condition is
severe or in neonates.
4.2
DOSE AND METHOD OF ADMINISTRATION
Neostigmine can be given as an intramuscular (IM), intravenous (IV) or
subcutaneous (SC)
injection.
When Neostigmine is given, a syringe of atropine sulfate should be
available to counteract
severe cholinergic reactions, if they occur. Do not mix atropine with
other medicines in the
same syringe as compatibility data are not available.
The presentations of N
EOSTIGMINE
Injection BP solution contain no antimicrobial agents. They
are intended for single use only and any solution remaining from an
opened container should
be discarded.
ANTAGONIST TO NONDEPOLARISING NEUROMUSCULAR BLOCKADE
Usually, reversal of neuromuscular blockade with Neostigmine should
not be attempted until
spontaneous recovery from paralysis is evident. It is recommended that
the patient be well
ventilated and patent airway maintained until complete recovery of
normal respiration is
affirmed.
Neostigmine Data Sheet 070918
2
ADULT
A single dose of Neostigmine 0.5 to 2.5 mg (0.05 – 0.07 mg/kg) to be
administered
simultaneously (in separate syringes) with atropine sulfate 0.6-1.2 mg
(0.02 to 0.03) mg/kg) by
slow IV injection over