SULFAMETHOXAZOLE AND TRIMETHOPRIM suspension

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:

Aurobindo Pharma Limited

INN (International Adı):

SULFAMETHOXAZOLE

Kompozisyon:

SULFAMETHOXAZOLE 200 mg in 5 mL

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 oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is 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 oral suspension 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 oral suspension 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 Oral Suspension, USP contains 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL). Available as a pink, cherry-flavored syrup suspension.          50 mL Bottle                NDC 65862-496-50          100 mL Bottle              NDC 65862-496-01          473 mL Bottle              NDC 65862-496-47 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature] and protect from light. SHAKE WELL BEFORE USING. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SULFAMETHOXAZOLE AND TRIMETHOPRIM - SULFAMETHOXAZOLE AND
TRIMETHOPRIM SUSPENSION
AUROBINDO PHARMA LIMITED
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
sulfamethoxazole and trimethoprim oral suspension and other
antibacterial drugs,
sulfamethoxazole and trimethoprim oral suspension should be used only
to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic
antibacterial
combination product containing 200 mg sulfamethoxazole and 40 mg
trimethoprim in
each teaspoonful (5 mL).
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
Each teaspoonful (5 mL) of the oral suspension contains 200 mg
sulfamethoxazole and
40 mg trimethoprim as well as the following inactive ingredients:
alcohol 0.04% (v/v),
carboxymethylcellulose sodium, citric acid anhydrous, colloidal
silicon dioxide, FD&C Red
#40, flavour cherry #557, glycerin, methyl paraben, microcrystalline
cellulose and
carboxymethylcellulose sodium, polysorbate 80, purified water,
saccharin sodium,
sodium benzoate, and sorbitol solution.
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 -