SULFAMETHOXAZOLE AND TRIMETHOPRIM suspension

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Akorn Operating Company LLC

INN (Միջազգային անվանումը):

SULFAMETHOXAZOLE

Կազմը:

SULFAMETHOXAZOLE 200 mg in 5 mL

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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.

Ապրանքի ամփոփագիր:

Sulfamethoxazole and Trimethoprim Oral Suspension, USP is supplied in a purple grape-flavored suspension and in a pink cherry-flavored suspension containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL (teaspoonful) both packaged in 1 pint (473 mL) bottles. The grape-flavored suspension is also available in 20 mL unit dose. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container. Rx only REFERENCES All trademarks are the property of their respective owners. Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev. 823:12 08/22

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND
TRIMETHOPRIM SUSPENSION
AKORN OPERATING COMPANY LLC
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SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP
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 is a synthetic
antibacterial
combination product available for oral administration, with each
teaspoonful (5 mL)
containing 200 mg sulfamethoxazole and 40 mg trimethoprim.
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:
INACTIVE INGREDIENTS: alcohol 0.26%, methylparaben 0.1% and sodium
benzoate 0.1%
(added as preservatives), carboxymethylcellulose sodium, citric acid
(anhydrous),
glycerin, microcrystalline cellulose, polysorbate 80, purified water,
saccharin sodium, and
sorbitol. The light purple, grape flavored suspension contains the
following additional
1
10
11
3
3
14
18
4
3
inactive ingredients: FD&C Red No. 40, FD&C Blue No. 1 and natural and
artificial grape
flavor. The pink, cherry flavored suspension contains the following
additional inactive
ingredients: FD&C Red No. 40, FD&C Yellow No. 6 and artificial cherry
flavor.
CLINICAL PHARMACOLOGY
Sulfamethoxazole and trimethoprim oral suspension is rapidly absorbed
following oral
administration. Both sulfamethoxazole and trimethoprim exist in the
blood as unbound,
protein-bound and metabolized forms; sulfam