SULFAMETHOXAZOLE AND TRIMETHOPRIM- sulfamethoxazole and trimethoprim tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Produkta apraksts Produkta apraksts (SPC)
31-01-2013

Aktīvā sastāvdaļa:

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

Pieejams no:

Glenmark Generics Inc. USA

SNN (starptautisko nepatentēto nosaukumu):

SULFAMETHOXAZOLE

Kompozīcija:

SULFAMETHOXAZOLE 400 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP 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 Ot

Produktu pārskats:

Sulfamethoxazole and Trimethoprim Tablets USP are supplied as follows: Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) (white to off-white, oval shaped, uncoated tablets with ‘G340’ debossed on one side and breakline on the other side) containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP – bottles of 100 (NDC 68462-340-01) and 500 (NDC 68462-340-05). Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg (white to off-white, round, standard biconvex, uncoated tablets with ‘G339’ debossed on one side and breakline on the other side) containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP – bottles of 100 (NDC 68462-339-01) and 500 (NDC 68462-339-05).

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                SULFAMETHOXAZOLE AND TRIMETHOPRIM- SULFAMETHOXAZOLE AND TRIMETHOPRIM
TABLET
GLENMARK GENERICS INC. USA
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP, 800 MG/160 MG (DOUBLE
STRENGTH) AND 400
MG/80 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
sulfamethoxazole and trimethoprim tablets USP and other antibacterial
drugs, sulfamethoxazole and
trimethoprim tablets USP should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Sulfamethoxazole and trimethoprim tablets USP are a synthetic
antibacterial combination product
available in double strength (DS) 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 USP 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 USP 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
290.32 and the following structural formula:
INACTIVE INGREDIENTS: colloidal silicon dioxide, docusate sodium,
magnesium stearate, pregelatinized
starch, sodium benzoate, sodium starch glycolate and talc.
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-
1
10
11
3
3
14
18
4
3
least 5 metabolites: the N -acetyl-, N -hydroxy-, 5-methylhydroxy-, N
-acetyl-5-methylhydroxy-
sulfamethoxazole metabo
                                
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