Bactrim forte tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sulfamethoxazole, trimethoprim

Available from:

F. Hoffmann-La Roche Ltd.

ATC code:

J01EE01

INN (International Name):

sulfamethoxazole, trimethoprim

Dosage:

800mg+ 160mg

Pharmaceutical form:

tablets

Units in package:

(10/1x10/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-02-22

Patient Information leaflet

Patients receiving sulfonylurea derivatives (e.g. glibenclamide,
gliclazide, glipizide,
chlorpropamide and tolbutamide) or repaglinide, rosiglitazone or
pioglitazone should be monitored
regularly for hypoglycemia.
Sulfonamides, including sulfamethoxazole, can displace methotrexate
from plasma protein binding
sites and impair its renal transport, thus increasing the
concentration of free methotrexate and
potentially enhancing its effect and hematological side effects.
Coadministration of Bactrim and
methotrexate is not recommended.
Co-trimoxazole may influence the required dose of oral antidiabetic
agents.
Like other antibiotics, Bactrim can reduce the efficacy of oral
contraceptives. Female patients
should therefore be advised to take additional contraceptive measures
during Bactrim treatment.
OBSERVED INTERACTIONS
An increased incidence of thrombocytopenia with purpura has been
observed in elderly patients
concurrently receiving certain diuretics, primarily thiazides.
Platelets should therefore be
monitored regularly in patients using diuretics.
Coadministration with co-trimoxazole may increase systemic exposure to
drugs metabolised
primarily by CYP2C9, e.g. coumarins (warfarin, acenocoumarol,
phenprocoumon), phenytoin and
sulfonylurea derivatives (glibenclamide, gliclazide, glipizide,
chlorpropamide and tolbutamide).
Coagulation should be monitored in patients treated with coumarins.
Reversible deterioration of renal function has been observed in
patients treated with
co-trimoxazole and ciclosporin following renal transplantation.
Cases of pancytopenia have been reported in patients given the
combination of trimethoprim and
methotrexate (see
_Warnings and precautions_
). Trimethoprim has a low affinity for human
dihydrofolate reductase, but may increase the side effects of
methotrexate, especially in the
presence of risk factors such as old age, hypoalbuminemia, impaired
renal function and decreased
bone marrow reserve, and in patients receiving high doses of
methotrexate.
At-risk patients should be treated wit

Summary of Product characteristics

January 2018 Summary of Product Characteristics
Ro 06-2580 Bactrim oral
January 2018
1
BACTRIM
®
Sulfamethoxazole + trimethoprim
COMPOSITION
_Active substances_:
Trimethoprim (TM) and sulfamethoxazole (SMZ). The combination of the
two active
substances TM and SMZ has established itself under the name
co-trimoxazole.
_Excipients_:_ _
_Bactrim tablets_:
Excipients for tablets.
_Bactrim Forte tablets_:_ _
Excipients for tablets.
_Bactrim syrup for children_:_ _
Flavouring agents: ethyl vanillin, vanillin and others; preservatives:
E216, E218;
excipients for suspension.
PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
_Bactrim tablets_:_ _
White scored tablets, 80 mg TM and 400 mg SMZ.
_Bactrim Forte tablets_:_ _
Beige-white scored tablets, 160 mg TM and 800 mg SMZ.
_Bactrim syrup for children_:_ _
Oral suspension, 40 mg TM and 200 mg SMZ/5 ml.
INDICATIONS AND POTENTIAL USES
Infections due to co-trimoxazole-sensitive organisms, such as:
Upper and lower respiratory tract and ear infections: acute
exacerbations of chronic
bronchitis, bronchiectasis, pneumonia (including _ Pneumocystis
jirovecii_ pneumonia),
sinusitis, otitis media.
Urogenital infections: acute and chronic cystitis, pyelonephritis,
urethritis, prostatitis.
Gastrointestinal infections including typhoid and paratyphoid fever
(including treatment
of chronic carriers) and cholera (as an adjunct to fluid and
electrolyte replacement).
January 2018 Summary of Product Characteristics
Ro 06-2580 Bactrim oral
January 2018
2
Other bacterial infections due to sensitive organisms: acute
brucellosis, nocardiosis,
mycetoma
(except
when
caused
by
true
fungi),
South
American
blastomycosis
_(Paracoccidioides brasiliensis)_.
In osteomyelitis as a last-line drug (e.g. when vancomycin is
contraindicated), for
multiresistant organisms shown to be sensitive to co-trimoxazole.
Official recommendations on the appropriate use of antibiotics should
be followed,
especially usage recommendations to prevent the increase in antibiotic
resistance.
DOSAGE AND ADMINISTRATI