SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH- sulfamethoxazole and trimethoprim tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

New Horizon Rx Group, LLC

INN (International Name):

SULFAMETHOXAZOLE

Composition:

SULFAMETHOXAZOLE 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 the 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. Ac

Product summary:

Sulfamethoxazole and Trimethoprim Tablets, USP are supplied as follows: Sulfamethoxazole and Trimethoprim DS (double strength) Tablets, USP, 800 mg/160 mg, are supplied as white, oval, bisected tablets debossed “IP” bisect “272” on one side. They are available as follows: Bottles of 20:           NDC 58517-140-20 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. REFERENCES Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 Manufactured By: Amneal Pharmaceuticals Hauppauge, NY 11788 Rev. 11/13

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH- SULFAMETHOXAZOLE
AND TRIMETHOPRIM TABLET
NEW HORIZON RX GROUP, LLC
----------
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS, USP
DESCRIPTION
Sulfamethoxazole and trimethoprim is a synthetic antibacterial
combination product available in DS
(double strength) 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 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 290.3.
It has the following structural formula:
INACTIVE INGREDIENTS: Magnesium stearate, povidone, pregelatinized
starch 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. The metabolism of
sulfamethoxazole occurs
predominately by N -acetylation, although the glucuronide conjugate
has been identified. The principal
1
10
11
3
3
14
18
4
3
4
metabolites of trimethoprim are the 1- and 3-oxides and the 3'- and
4'-hydroxy derivatives. The free
forms of sulfamethoxazole and trimethoprim are considered to be the
therapeutically active forms.
Approximately 70% of sulfamethoxazole and 44% of trimethoprim are
bound to plasma proteins. The
presence of 10 mg percent of sulfamethoxazole in plasma decreases the
protein binding of trimethoprim
by an insignificant degree; trimethoprim does not influence the
protein binding of sulfamethoxazole.
Peak blood levels for the individual components