Formoterol Neutec 12mcg Capsair Hard Capsule Inhalation Powder

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Formoterol Fumarate Dihydrate

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

Formoterol Fumarate Dihydrate

Unit dalam pakej:

60 Capsules

Dikeluarkan oleh:

Neutec Inhaler Ilac Sanayi ve Ticaret A.S.,

Risalah maklumat

FORMOTEROL NEUTEC 12MCG CAPSAIR HARD CAPSULE INHALATION POWDER
Formoterol Fumarate Dihydrate (12 mcg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Formoterol _
_Neutec _
_12 _
_mcg _
_Capsair _
is used for
2.
How
_Formoterol _
_Neutec _
_12 _
_mcg _
_Capsair _
works
3.
Before you use
_Formoterol Neutec _
_12 mcg Capsair_
4.
How to use
_Formoterol Neutec 12 _
_mcg Capsair_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Formoterol _
_Neutec 12 mcg Capsair_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
_FORMOTEROL _
_NEUTEC _
_12 _
_MCG _
_CAPSAIR _IS USED FOR
•
Prophylaxis
and
treatment
of
bronchoconstriction
(tightening
of
the muscle surrounding the airways)
in patients with asthma.
_ _
•
Prophylaxis
of
bronchospasm
(tightening
of
the
muscle
surrounding
the
airways
in
lungs)
induced by inhaled allergens, cold
air, or exercise.
_ _
•
Prophylaxis
and
treatment
of
bronchoconstriction in patients with
obstructive airways disease (Chronic
Obstructive
Pulmonary
Disease
-
COPD) including chronic bronchitis
(inflammation
of
the
breathing
tubes)
and
emphysema
(lung
problem
that
causes
shortness
of
breath). Formoterol Neutec has been
shown to improve quality of life in
COPD patients.
_ _
HOW
_FORMOTEROL _
_NEUTEC _
_12 _
_MCG _
_CAPSAIR _WORKS
Formoterol
is
a
potent
selective
β2-
adrenergic
stimulant.
It
works
by
relaxing the muscles in your airway. It
has rapid effect that are seen within 1-3
minutes till 12 hours after inhalation.
BEFORE YOU USE _FORMOTEROL NEUTEC 12 _
_MCG CAPSAIR _
-
_When you must not use it _
Do not take
_ Formoterol Neutec 12 mcg _
_Capsair _
if you are allergy to
_formoterol_
,
lactose or any other ingredients of this
medicine.
_Pregnancy and lactation _
Do not take
_Formoterol Neutec 12 mcg _
_Capsair _
if you are pregnant, trying to get
pregnant or think you may be pregnant
unless to control asthma in all stages of
pregnancy, and if the expected benefit to
the mother is greater

Ciri produk

FORMOTEROL NEUTEC 12MCG CAPSAIR HARD CAPSULE INHALATION POWDER
Each inhalation powder capsules contains 12 mcg Formoterol Fumarate
Dihydrate
_ _
PRODUCT DESCRIPTION
Cover; transparent
Body; in natural transparent capsule, white powder
PHARMACODYNAMICS
Pharmacotherapeutic group: Selective beta2-adrenergic agonist, ATC
code: R03AC13.
Formoterol is a potent selective β2-adrenergic stimulant. It exerts a
bronchodilator effect in patients
with reversible airways obstruction. The effect sets in rapidly
(within 1-3 minutes) and is still
significant 12 hours after inhalation.
Formoterol inhalation powder has been shown to be effective in
preventing bronchospasm induced
by exercise and methacholine. Formoterol has been shown to improve
symptoms and pulmonary
function and quality of life in the treatment of conditions associated
with COPD. Formoterol acts on
the reversible component of the disease.
PHARMACOKINETICS
Formoterol has a therapeutic dose range of 12 to 24 micrograms b.i.d.
Data on the plasma
pharmacokinetics of formoterol were collected after inhalation of
doses higher than the
recommended range and in COPD patients after inhalation of therapeutic
doses. Urinary excretion of
unchanged formoterol, used as an indirect measure of systemic
exposure, correlates with plasma
drug disposition data. The elimination half-lives calculated for urine
and plasma are similar.
ABSORPTION
Following inhalation of a single 120 microgram dose of formoterol
fumarate, formoterol was rapidly
absorbed into plasma, reaching a maximum concentration of 266 pmol/l
within 5 minutes of
inhalation. In COPD patients treated for 12 weeks with formoterol
fumarate 12 or 24 micrograms
b.i.d. the plasma concentrations of formoterol ranged between 11.5 and
25.7 pmol/L and 23.3 and
50.3 pmol/L respectively at 10 minutes, 2 hours and 6 hours post
inhalation.
The cumulative urinary excretion of formoterol and/or its (R,R) and
(S,S)-enantiomers, after
inhalation of dry powder (12-96 micrograms) or aerosol formulations
(12-96 micrograms), showed
that ab