SULFAMETHOXAZOLE AND TRIMETHOPRIM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

INN（国際名）:

SULFAMETHOXAZOLE

構図:

SULFAMETHOXAZOLE 800 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. 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. 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 tablets 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. 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 tablets could offer some advantage over the use of a single antimicrobial agent. 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. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli. Sulfamethoxazole and trimethoprim tablets are 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 ).

製品概要:

Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg are white to off-white oval, beveled edge uncoated tablets, debossed with “H 49” on one side and deep break line on other side. NDC: 71335-0762-1: 20 Tablets in a BOTTLE NDC: 71335-0762-2: 14 Tablets in a BOTTLE NDC: 71335-0762-3: 10 Tablets in a BOTTLE NDC: 71335-0762-4: 28 Tablets in a BOTTLE NDC: 71335-0762-5: 40 Tablets in a BOTTLE NDC: 71335-0762-6: 6 Tablets in a BOTTLE NDC: 71335-0762-7: 60 Tablets in a BOTTLE NDC: 71335-0762-8: 30 Tablets in a BOTTLE NDC: 71335-0762-9: 13 Tablets in a BOTTLE NDC: 71335-0762-0: 21 Tablets in a BOTTLE Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

認証ステータス:

Abbreviated New Drug Application

製品の特徴

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM TABLET
BRYANT RANCH PREPACK
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM 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 and
160 mg trimethoprim; in tablets, each containing 400 mg
sulfamethoxazole and 80 mg
trimethoprim for oral administration.
Sulfamethoxazole is _N_ -(5-methyl-3-isoxazolyl) sulfanilamide; the
molecular formula is
C
H
N O S. It is a white to off-white, practically odorless, crystalline
powder, 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 or cream-colored crystals or crystalline powder
with
a molecular weight of 290.3 and the following structural formula:
1
10
11
3
3
14
18
4
3
INACTIVE INGREDIENTS: Docusate sodium, magnesium stearate,
pregelatinized starch
(maize), sodium benzoate, 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