SULFADIAZINE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SULFADIAZINE (UNII: 0N7609K889) (SULFADIAZINE - UNII:0N7609K889)

Dostupno od:

Eon Labs, Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

sulfADIAZINE Tablets, USP are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli , Klebsiella species, Enterobacter species, Staphylococcus aureus , Proteus mirabilis and P. vulgaris . Sulfadiazine should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful. Toxoplasmosis encephalitis in patients with and without acquired immunodeficiency syndrome, as adjunctive therapy with pyrimethamine. Malaria due to chloroquine-resistant strains of Plasmodium falciparum , when used as adjunctive therapy. Prophylaxis of meningococcal meningitis when sulfonamide-sensitive group A strains are known to prevail in family groups or larger closed populations (the prophylactic usefulness of sulfonamides

Proizvod sažetak:

sulfADIAZINE Tablets, USP for oral administration are available as 500 mg White, unscored, capsule-shaped tablets, debossed “E 757” on one face and supplied as: NDC 0185-0757-30 bottles of 30 NDC 0185-0757-01 bottles of 100 NDC 0185-0757-10 bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for Sandoz Inc. Princeton, NJ 08540 Manufactured by Epic Pharma, LLC Laurelton, NY 11413 OS7190 Rev. 06/2020 MF0757REV06/20

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

SULFADIAZINE- SULFADIAZINE TABLET
EON LABS, INC.
----------
SULFADIAZINE TABLETS, USP
RX ONLY
DESCRIPTION
Sulfadiazine is an oral sulfonamide antibacterial agent.
Each tablet, for oral administration, contains 500 mg sulfadiazine. In
addition, each tablet
contains the following inactive ingredients: croscarmellose sodium,
docusate sodium,
microcrystalline cellulose, povidone, sodium benzoate, sodium starch
glycolate and
stearic acid.
Sulfadiazine occurs as a white or slightly yellow powder. It is
odorless or nearly so and
slowly darkens on exposure to light. It is practically insoluble in
water and slightly soluble
in alcohol. The chemical name of sulfadiazine is N
-2-pyrimidinylsulfanilamide. The
molecular formula is C
H
N O S. It has a molecular weight of 250.27. The structural
formula is shown below:
Most sulfonamides slowly darken on exposure to light.
CLINICAL PHARMACOLOGY
The systemic sulfonamides are bacteriostatic agents having a similar
spectrum of
activity. Sulfonamides competitively inhibit bacterial synthesis of
folic acid
(pteroylglutamic acid) from aminobenzoic acid. Resistant strains are
capable of utilizing
folic acid precursors or preformed folic acid.
Sulfonamides exist in the blood in 3 forms - free, conjugated
(acetylated and possibly
others) and protein bound. The free form is considered to be the
therapeutically active
one.
Sulfadiazine given orally is readily absorbed from the
gastrointestinal tract. After a single
2 g oral dose, a peak of 6.04 mg/100 mL is reached in 4 hours; of
this, 4.65 mg/100 mL
is free drug.
When a dose of 100 mg/kg of body weight is given initially and
followed by 50 mg/kg
every 6 hours, blood levels of free sulfadiazine are about 7 mg/100mL.
Protein binding is
38% to 48%. Sulfadiazine diffuses into the cerebrospinal fluid; free
drug reaches 32% to
65% of blood levels and total drug 40% to 60%.
Sulfadiazine is excreted largely in the urine, where concentrations
are 10 to 25 times
1
10
10
4
2
greater than serum levels. Approximately 10% of a single oral dose is
excret