Mestinon Dragees 60mg

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

PYRIDOSTIGMINE BROMIDE

可用日期:

A. MENARINI SINGAPORE PTE. LTD.

INN（国际名称）:

PYRIDOSTIGMINE BROMIDE

每包单位数:

20 Tablet Tablets; 150Tablet Tablets

厂商:

LABIANA PHARMACEUTICALS SLU

资料单张

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
MESTINON DRAGEES TABLET
_Pyridostigmine Bromide (60mg)_
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Mestinon is used for
2.
How Mestinon works
3.
Before you use Mestinon
4.
How to use Mestinon
5.
While
you
are
taking
Mestinon
6.
Side effects
7.
Storage
and
Disposal
of
Mestinon
8.
Product Description
9.
Manufacturer
10.
Product Registration holder
WHAT MESTINON IS USED FOR
Mestinon is used for the treatment of
myasthenia gravis. This is a condition
whereby you have muscle weakness and
tiredness especially on repeated use.
HOW MESTINON WORKS
MESTINON belongs to a group of
medicines called cholinergic
antimyasthenics. It works by preventing
the breakdown of a chemical called
acetylcholine. This chemical is needed
to stimulate muscle movement.
BEFORE YOU USE MESTINON
-
_Taking other medicines_
_ _
_ _
Tell your doctor if you have or have
had
any
of
the
following
medical
medical conditions (ie: kidney problem)
or
taking
any
other
medicines,
including
medicines
obtained
without a prescription.
Some medicines and Mestinon
may interfere with each other. These
include:
• muscle relaxants
• atropine contained in medicines
for travel sickness and stomach
cramps, or use in surgery
(injection) or used as an antidote
to insecticide poisoning (tablets)
Your doctor or pharmacist may have
more information on medicines to be
careful with or to avoid while taking
medication.
_- Pregnancy and Lactation_
_ _
The safety of Mestinon for use during
pregnancy has not been established.
Hence, it should only be used strictly
as directed by your doctor.
Since
it
is
not
known
whether
the
active ingredient in MESTINON
passes into breast milk, nursing mothers
are advised to refrain from breast
feeding their babies during treatment.
Your doctor can advise you of the
risks and benefits of taking
MESTINON while you are pregnant
or breast feeding.
Ask your doctor or pharmacisr for
advice before taking any medicine.
HOW TO USE MESTINON
-
_How much to use _
When using Mestinon, it is important

产品特点

Mestinon
®
Pyridostigmine Bromide
Information for Physicians
Mestinon
®
Dragées 60 mg
Mestinon
®
Tablet 10 mg
MESTINON
®
Pyridostigmine Bromide
Vagotonic, antimyasthenic
COMPOSITION
Tablets 10 mg: round biconvex tablets, white to off white coloured and
odourless. Dragées (sugar-coated tablets)
60 mg: round biconvex sugar-coated tablets, orange-white or pale
orange coloured.
PROPERTIES AND EFFECTS
Pyridostigmine, the active ingredient of Mestinon
®
is a cholinesterase inhibitor. It is characterized by the gentle
onset, smooth course, comparatively long duration and gradual decline
of its cholinergic action. Pyridostigmine has
an antagonistic effect on non-depolarising muscle relaxants only. It
has a synergistic effect on depolarizing muscle
relaxants.
PHARMACOKINETICS
_Absorption_
Pyridostigmine, like other medicines of the same type, is not fully
absorbed from the intestinal tract. Bioavailability
following oral administration is 3 - 8 %. Considerably higher doses
are therefore required for oral as opposed to
parenteral administration.
_Distribution_
Peak plasma concentrations were reached in the fasting state
approximately 1.5 - 2 hours after administration of
120 mg pyridostigmine. The increase in active ingredient is delayed
when taken with food. The distribution volume
averages 1.4 L/kg body weight. Pyridostigmine is not noticeably bound
to plasma proteins and does not cross the
blood-brain barrier. Blood plasma levels of 20 - 60 ng/ml are required
in order to obtain the desired therapeutic
effect with myasthenia gravis.
_Metabolism_
Pyridostigmine is metabolized to 3-hydroxy-N-methylpyridine and other
unidentified metabolites.
_Elimination_
Mean values of around 1.5 hours are given for the elimination half
life. This can, however, be prolonged up to three
times over in individual cases. Mean plasma clearance in healthy
volunteers is given as 0.36 - 0.65 L/kg/h. No
confirmed data are available regarding the potential accumulation of
unchanged pyridostigmine or active
metabolites. Since the dosage must,