NEOSTIGMINE JN neostigmine methylsulfate 0.5 mg/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

neostigmine methylsulfate, Quantity: 500 microgram

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; monobasic sodium phosphate; dibasic sodium phosphate dodecahydrate; water for injections

Administration route:

Subcutaneous, Intramuscular, Intravenous

Units in package:

10 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Neostigmine is indicated for:,? Reversal of the effects of non-depolarising neuromuscular blocking agents.,? 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.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: PE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-31

Patient Information leaflet

NEOSTIGMINE
INJECTION B.P.
_Neostigmine Methylsulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Neostigmine Injection. It does not
contain all the information that is
known about Neostigmine Injection.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you being given
Neostigmine Injection against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT NEOSTIGMINE IS
FOR
Neostigmine Injection increases
movement of the muscles in the
body.
It can be used:
•
to reverse the effects of medicines
which are used to stop muscles
moving;
•
to activate the muscles in the
bladder, stomach and intestines
following surgery;
•
for myasthenia gravis.
Neostigmine Injection is known as a
cholinesterase inhibitor. It works by
stopping a chemical called
acetylcholine, which stimulates
muscle movement, from breaking
down.
Your doctor will have explained why
you are being treated with
Neostigmine Injection.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
Neostigmine Injection is not
addictive.
BEFORE YOU ARE GIVEN
NEOSTIGMINE
You may already have been given
Neostigmine Injection. Your doctor
will have considered the situation
carefully and decided to use it.
However, if any of the following
applies to you, tell your doctor
immediately.
_WHEN YOU MUST NOT USE IT_
YOU SHOULD NOT BE GIVEN
NEOSTIGMINE INJECTION IF YOU ARE
PREGNANT OR BREASTFEEDING UNLESS
YOUR DOCTOR SAYS SO. ASK YOUR
DOCTOR ABOUT THE RISKS AND BENEFITS
INVOLVED.
It may make your baby arrive early if
you are given it in the last weeks
before your baby is due.
Your baby can take in

Summary of Product characteristics

1 of 8
AUSTRALIAN PRODUCT INFORMATION
NEOSTIGMINE INJECTION BP
(NEOSTIGMINE METHYLSULFATE)
1
NAME OF THE MEDICINE
Neostigmine methylsulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL sterile solution of pH 4.5 – 6.5 containing 0.5 mg of
neostigmine methylsulfate.
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
Injection solution. Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neostigmine is indicated for:
•
Reversal of the effects of non-depolarising 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 Injection BP can be given as an intramuscular (IM),
intravenous (IV) or subcutaneous
(SC) injection. The following doses are approximately equivalent in
effect: 0.5 mg IV = 1.0 - 1.5
mg IM or SC.
When Neostigmine Injection BP is given, a syringe of atropine sulfate
should be available to
counteract severe cholinergic reactions, if they occur. Do not mix
atropine with other drugs in the
same syringe as compatibility data are not available.
Neostigmine Injection BP in ampoules contains no antimicrobial agent.
It should be used once and
any residue discarded.
ANTAGONIST TO NONDEPOLARISING NEUROMUSCULAR BLOCKADE
Usually, reversal of neuromuscular blockade with Neostigmine Injection
BP should not be
attempted until spontaneous recovery from paralysis is evident. It is
recommended that the patient
2 of 8
be well ventilated and patent airway maintained until complete
recovery of normal respiration is
affirmed.
_ADULTS _
A single dose of neostigmine 0.5 to 2.5 mg (0.05 - 0.07 mg/kg) to be
administered s