BACTRIM DS tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trimethoprim, Quantity: 160 mg; sulfamethoxazole, Quantity: 800 mg

Available from:

Echo Therapeutics Pty Ltd

INN (International Name):

Sulfamethoxazole,Trimethoprim

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Upper and lower respiratory tract infections, renal and urinary tract infections; genital tract infections; gastrointestinal tract infections; skin and wound infections; septicaemias and other infections caused by sensitive organisms.

Product summary:

Visual Identification: Oblong, biconvex, white to almost white tablets, scored on one side, marked "ROCHE 800 + 160" on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-07-08

Patient Information leaflet

BACTRIM DS BLISTER PACK CMI 2.00
1
BACTRIM
® DS TABLETS
pronounced BACK-TRIM
_contains the active ingredients sulfamethoxazole and trimethoprim _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BACTRIM DS
tablets. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BACTRIM
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BACTRIM IS
USED FOR
BACTRIM contains the active
ingredients sulfamethoxazole and
trimethoprim, also known as co-
trimoxazole.
BACTRIM is used to treat bacterial
infections in different parts of the
body.
BACTRIM belongs to a group of
medicines called antibiotics. There
are many different types of
medicines used to treat bacterial
infections. Sulfamethoxazole in
BACTRIM belongs to a group of
medicines known as sulfonamides.
Trimethoprim belongs to a group of
medicines known as the
benzylpyrimidines.
BACTRIM works by stopping the
growth of the bacteria causing the
infection.
BACTRIM does not work against
infections caused by viruses, such as
colds and flu.
BACTRIM has been prescribed for
your current infection. Another
infection later on may require a
different medicine.
Your doctor may have prescribed
BACTRIM for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY BACTRIM HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
BACTRIM
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BACTRIM IF:
•
YOU HAVE HAD AN ALLERGIC
REACTION TO SULFAMETHOXAZOLE,
TRIMETHOPRIM, ANY OTHER
SULFONAMIDE, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
•
skin rash
•
peeling of the skin
•
itching or hives
•
swelling of

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BACTRIM
® DS (SULFAMETHOXAZOLE/TRIMETHOPRIM)
Bactrim DS tabs PI 2.00
1
1.
NAME OF THE MEDICINE
Sulfamethoxazole/trimethoprim
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The tablets contain 800mg sulfamethoxazole and 160mg trimethoprim.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Bactrim DS tablets are oblong, biconvex, white to almost white, scored
on one side and
marked "BACTRIM 800 + 160" on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Upper and lower respiratory tract infections; renal and urinary tract
infections; genital tract
infections; gastrointestinal 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 Bactrim should be given for at least five days or
until the patient has been
symptom-free for two days.
Adults and children over 12 years of age
_Standard dosage. _
One Bactrim DS (double strength) tablet morning and evening after
meals.
Minimum dosage: half a Bactrim DS (double strength) tablet twice daily
(see below).
Maximum dosage (for particularly severe infections): One and a half
Bactrim DS (double
strength) tablets twice daily.
The recommended dose for patients with documented Pneumocystis
jirovecii pneumonitis is
20 mg/kg trimethoprim and 100 mg/kg sulfamethoxazole/24 hours given in
equally divided
doses every six hours for 14 days.
SPECIAL POPULATIONS
Renal impairment
The following dosage regimens are based on published information for
the administration of
Bactrim DS tablets to patients with reduced kidney function.
CRITERIA OF KIDNEY FUNCTION
(NON-PROTEIN NITROGEN IS
UNSUITABLE)
RECOMMENDED DOSAGE REGIMENS
CREATININE
CLEARANCE
ML/MIN
SERUM
1
CREATININE

MOL/L
ONE STANDARD DOSE FOR ADULTS = 1 BACTRIM DS TABLET
CONTAINING A TOTAL OF 160 MG TMP + 800 MG SMX
Bactrim DS tabs PI 2.00
2
Above 25
Men < 265
Women < 180
Dosage as for patients with normal kidney functions ie 1
sta