Bactrim forte tablets film-coated

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 film-coated

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-12

Patient Information leaflet

In elderly patients or patients with renal impairment, hematological
changes indicative of folic
acid deficiency may occur. These can be reversed by folinic acid
therapy.
Caution is indicated in patients with an additional risk factor for
folic acid deficiency, e.g.
treatment with phenytoin or other folic acid antagonists,
malnutrition.
Coadministration of Bactrim and phenytoin is not recommended (see
_Interactions_
).
Cases of pancytopenia have been reported in patients given the
combination of trimethoprim and
methotrexate. Coadministration of Bactrim and methotrexate is not
recommended (see
_Interactions_
).
“Slow acetylators” may be at increased risk of idiosyncratic
reactions to sulfonamides.
INTERACTIONS
PHARMACOKINETIC INTERACTIONS
Trimethoprim is an inhibitor of the Organic Cation Transporter 2
(OCT2) and a weak inhibitor of
CYP2C8. Sulfamethoxazole is a weak inhibitor of CYP2C9.
Increased digoxin blood levels can occur with concomitant
co-trimoxazole therapy, especially in
elderly patients.
When administered at the standard doses, co-trimoxazole prolonged
phenytoin half-life by 39% and
decreased phenytoin clearance by 27%. Coadministration of Bactrim and
phenytoin is not
recommended. If coadministration is absolutely essential, patients
receiving phenytoin should be
observed for signs of phenytoin toxicity, and phenytoin serum
concentrations should be monitored.
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 r

Summary of Product characteristics

November 2018
Product Information EFA
Ro 06-2580
Bactrim oral
November 2018
Product Information EFA
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).
November 2018
Product Information EFA
Ro 06-2580
Bactrim oral
November 2018
Product Information EFA
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
resis