COTRIM 480MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SULPHAMETHOXAZOLE; TRIMETHOPRIM

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

SULPHAMETHOXAZOLE; TRIMETHOPRIM

Unit dalam pakej:

1000 Tablets; 500 Tablets

Dikeluarkan oleh:

MEDOCHEMIE LTD (Factory AZ)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
COTRIM TABLET
Sulphamethoxazole /Trimethoprim (400mg/80mg, 800mg/160mg)
1
WHAT IS IN THIS LEAFLET
1.
What Cotrim is used for
2.
How Cotrim works
3.
Before you use Cotrim
4.
How to use Cotrim
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Cotrim
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT COTRIM IS USED FOR
Cotrim may be used to treat:
-
Repiratory tract infections
-
Ear and sinus infections
-
Urinary tract and prostates infection
-
Digestive tract infections
-
Skin infections
HOW COTRIM WORKS
Cotrim
contains
sulphamethoxazole
and trimethoprim; or commonly known
as Cotrimoxazole.
Cotrimoxazole is an antibiotic that kills
bacteria causing infection.
BEFORE YOU USE COTRIM
_When you must not use it _
Do not take Cotrim:
-
if you are allergic to sulphonamides,
Cotrimoxazole
and
any
of
the
ingredients in the product
-
if you have severe liver damage
-
if you have severe kidney damage or
disease
_Before you start to use it _
Tell your doctor or pharmacist if you:
-
have
a
history
of
severe
allergic
reactions or asthma
-
have
liver,
kidney
disease,
or
any
blood disorder (including porphyria)
-
have
a
protein
disorder
called
phenylketonuria
-
have
glucose-6-phosphate
dehydrogenase (G6PD) deficiency
-
have high potassium or low sodium
level
-
hav genetic disorders related to sugar
intolerance
_ _
_Pregnancy and Lactation _
If you are pregnant or trying for a baby
or
breastfeeding,
ask
your
doctor
or
pharmacist
for
advice
before
taking
Cotrim. Cotrimoxazole should not be
taken during pregnancy, particularly in
first trimester and also near the time of
delivery,
unless
clearly
necessary.
If
used during pregnancy, you must take
folate as supplementation.
Cotrimoxazole
is
secreted
into
breastmilk in small amounts. Therefore,
cotrimoxazole should not be used when
you are breastfeeding.
_ _
_Taking other medicines _
Tell your doctor or pharmacist if you
are taking:
-
rifampicin (to treat tuberculosis)
-
a

Ciri produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cotrim 480mg Tablet
Cotrim DS 960mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cotrim tablet contains sulphamethoxazole 400mg and trimethoprim
80mg.
Each Cotrim DS tablet contains sulphamethoxazole 800mg and
trimethoprim 160mg.
The approved name for this combination is cotrimoxazole.
Excipient with known effect: lactose monohydrate. Each 960mg tablet
contains 20mg lactose monohydrate
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Cotrim 480mg Tablet: White, round, flat scored tablets embossed
“MC” with diameter of 12.7mm
Cotrim DS 960mg Tablet: White, capsule shaped, scored tablets,
embossed “MC”, size 17.5mm x 8mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Respiratory infections including acute and chronic bronchitis
(treatment and prophylaxis), also bronchiectasis, lung abscess,
lobar and broncho-pneumonia.
Pneumocystis carinii pneumonitis, sinusitis and otitis media.
Urinary tract infections, including urethritis, cystitis, pyelitis,
pyelonephritis and prostates.
Gastro-intestinal tract infections caused by salmonella typhii and
paratyphi, including the chronic carrier state; bacillary
dysentery and cholera (as an adjuvant to fluid and electrolyte
replacement).
Skin infections, including pyoderma, abscesses and wound infections,
septicaemia, gonorrhoea
Other infections caused by a wide range of pathogenic bacteria
including acute and chronic osteomyelitis, acute brucellosis,
nocardiosis and actinomycetoma and in South American blastomycosis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Co-trimoxazole is used similarly to the sulphonamides but in a wider
variety of infections, in addition to urinary-tract and
lower respiratory tract infections.
Co-trimoxazole is usually given by mouth in a dose of 960mg
(trimethoprim 160mg and sulphamethoxazole 800mg) twice
daily for up to 14 days; 2.88g daily in 2 or 3 divided doses may be
given in severe infections. Lower doses are given for lon