RESPRIM trimethoprim/sulfamethoxazole 80 mg/400 mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

trimethoprim, Quantity: 80 mg; sulfamethoxazole, Quantity: 400 mg

Доступна з:

Alphapharm Pty Ltd

Фармацевтична форма:

Tablet, uncoated

Склад:

Excipient Ingredients: povidone; docusate sodium; magnesium stearate; sodium starch glycollate

Адміністрація маршрут:

Oral

Одиниць в упаковці:

20 (hospital only), 30 (hospital only), 10

Клас:

Medicine Registered

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

INDICATIONS AS AT 13 NOVEMBER 2000 : Upper and lower respiratory tract infections; renal and urinary tract infections; skin and wound infections; septicaemias and other infections caused by sensitive organisms.

Огляд продуктів:

Visual Identification: 11 mm flat bevelled edge white tablet, marked '80|400' on one side and 'R' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизація:

Registered

Дата Авторизація:

1991-09-20

інформаційний буклет

RESPRIM; RESPRIM
FORTE
_contains the active ingredients trimethoprim and sulfamethoxazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RESPRIM.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking RESPRIM against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT RESPRIM IS
USED FOR
RESPRIM contains the active
ingredients sulfamethoxazole and
trimethoprim, also known as co-
trimoxazole.
RESPRIM is used to treat infections
in different parts of the body caused
by bacteria.
RESPRIM belongs to a group of
medicines called antibiotics. There
are many different types of
medicines used to treat bacterial
infections. Sulfamethoxazole in
RESPRIM belongs to a group of
medicines known as sulfonamides.
Trimethoprim belongs to a group of
medicines known as the
benzylpyrimidines.
RESPRIM works by stopping the
growth of the bacteria that is causing
your infection.
RESPRIM will not work against
infections caused by viruses, such as
colds or flu.
RESPRIM has been prescribed for
your current infection. Another
infection later on may require a
different medicine.
Your doctor may have prescribed
RESPRIM for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RESPRIM
HAS BEEN PRESCRIBED FOR YOU.
RESPRIM is available only with a
doctor's prescription.
BEFORE YOU TAKE
RESPRIM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE RESPRIM IF:
•
YOU HAVE HAD AN ALLERGIC
REACTION TO TRIMETHOPRIM,
SULFAMETHOXAZOLE OR ANY OTHER
SULFONAMIDE (SULFUR) ANTIBIOTIC,
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tong

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION
RESPRIM
RESPRIM FORTE
_Sulfamethoxazole/Trimethoprim tablets _
1
NAME OF THE MEDICINE
Sulfamethoxazole/trimethoprim
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each RESPRIM tablet contains 400 mg of sulfamethoxazole and 80 mg of
trimethoprim as the active
ingredients. Each RESPRIM FORTE tablet contains 800 mg of
sulfamethoxazole and 160 mg of trimethoprim
as the active ingredients.
Excipients with known effect: sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RESPRIM
:
Sulfamethoxazole
400
mg
with trimethoprim 80
mg
tablet: 11 mm flat bevelled edge white tablet, marked
“80|400” on one side and “R” on the other side.
RESPRIM FORTE
:
Sulfamethoxazole 800 mg with trimethoprim 160 mg tablet:
19 mm x 9 mm oblong convex white tablet, marked “160|800” on one
side and “RF” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Upper and lower respiratory tract infections; renal and urinary tract
infections; skin and wound infections;
septicaemias and other infections caused by sensitive organisms.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
In acute infections, trimethoprim/sulfamethoxazole should be given for
at least 5 days or until the patient has
been symptom-free for 2 days.
ADULTS AND CHILDREN OVER 12 YEARS:
_Standard dosage: _
2 RESPRIM tablets or 1 RESPRIM FORTE tablet every 12 hours.
_For severe infections: _
3 RESPRIM tablets or 1½ RESPRIM FORTE tablets every 12 hours. This is
the
maximum daily dosage.
RESPRIM and RESPRIM FORTE – PRODUCT INFORMATION
2
The recommended dose for patients with documented
_Pneumocystis jirovecii _
pneumonitis is 20 mg/kg
trimethoprim and 100 mg/kg sulfamethoxazole per 24 hours given in
equally divided doses every six hours
for 14 days.
Attention should be paid to the folate status of the patient should
treatment be prolonged.
CHILDREN UNDER 12 YEARS (
see Section 4.3 CONTRAINDICATIONS
):
Alternative dosage form is available from other brands for use in
children under