SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

SULFAMETHOXAZOLE (UNII: JE42381TNV) (SULFAMETHOXAZOLE - UNII:JE42381TNV), TRIMETHOPRIM (UNII: AN164J8Y0X) (TRIMETHOPRIM - UNII:AN164J8Y0X)

Mevcut itibaren:

Amneal Pharmaceuticals of New York LLC

INN (International Adı):

SULFAMETHOXAZOLE

Kompozisyon:

SULFAMETHOXAZOLE 400 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli , Klebsiella species, Enterobacter species, Morganella morganii , Proteus mirabilis and Proteus vulgaris . It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli . Sulfamethoxazole and trimethoprim is contraindicated in the following situations: - known hypersensitivity to trimethoprim or sulfonamides - history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides - documented megaloblastic anemia due to folate deficiency - pediatric patients less than 2 months of age - marked hepatic damage - severe renal insufficiency when renal function status cannot be monitored - concomitant administration with dofetilide (see PRECAUTIONS ).

Ürün özeti:

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim Tablets USP, DS (double strength) 800 mg/160 mg, are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. They are available as follows: Bottles of 10:                   NDC 53746-272-11 Bottles of 24:                   NDC 53746-272-24 Bottles of 100:                 NDC 53746-272-01 Bottles of 250:                 NDC 53746-272-02 Bottles of 500:                 NDC 53746-272-05 Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg, are supplied as white, round, bisected tablets debossed “IP” over “271” on one side. They are available as follows: Bottles of 50:                   NDC 53746-271-50 Bottles of 100:                 NDC 53746-271-01 Bottles of 500:                 NDC 53746-271-05 Bottles of 1000:               NDC 53746-271-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS AND DOUBLE STRENGTH TABLETS,
USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
sulfamethoxazole and trimethoprim tablets and other antibacterial
drugs,
sulfamethoxazole and trimethoprim tablets should be used only to treat
or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Sulfamethoxazole and trimethoprim is a synthetic antibacterial
combination product
available in DS (double strength) tablets, each containing 800 mg
sulfamethoxazole, USP
and 160 mg trimethoprim, USP; in tablets, each containing 400 mg
sulfamethoxazole,
USP and 80 mg trimethoprim, USP for oral administration.
Sulfamethoxazole is _N_ -(5-methyl-3-isoxazolyl) sulfanilamide; the
molecular formula is
C
H
N O S. It is an almost white, odorless, tasteless compound with a
molecular
weight of 253.28 and the following structural formula:
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the
molecular
formula is C
H
N O . It is a white to light yellow, odorless, bitter compound with a
molecular weight of 290.3 and the following structural formula:
1
10
11
3
3
14
18
4
3
INACTIVE INGREDIENTS: Magnesium stearate, povidone, pregelatinized
starch and
sodium starch glycolate.
CLINICAL PHARMACOLOGY
Sulfamethoxazole and trimethoprim is rapidly absorbed following oral
administration.
Both sulfamethoxazole and trimethoprim exist in the blood as unbound,
protein-bound
and metabolized forms; sulfamethoxazole also exists as the conjugated
form.
Sulfamethoxazole is metabolized in humans to at least 5 metabolites:
the N -acetyl-, N -
hydroxy-, 5-methylhydroxy-, N -acetyl-5-methylhydroxy-
sulfamethoxazole metabolites,
and an N-glucuronide conjugate. The formulation of N -hydroxy
metabolite is mediated
_via _CYP2C9.
Trimethoprim is metabolized _in vitro _to 11 different metabolites, of
which, fi