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:

H.J. Harkins Company, Inc.

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. 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 otit

Ürün özeti:

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. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. 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). To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rx only

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SULFAMETHOXAZOLE AND TRIMETHOPRIM - SULFAMETHOXAZOLE AND
TRIMETHOPRIM SUSPENSION
H.J. HARKINS COMPANY, INC.
----------
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 is a synthetic antibacterial
combination product containing 200 mg
sulfamethoxazole and 40 mg trimethoprim per 5 mL 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 is:
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. It has the following structural formula is:
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 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
1
10
11
3
3
14
18
4
3
flavor.
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.