SULFADIAZINE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

EPIC PHARMA, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 when group B or C infections are prevalent is not proved and may be harmful in closed population groups). Meningococcal meningitis, when the organism has been demonstrated to be susceptible. Acute otitis media due to Haemophilus influenzae, when used concomitantly with adequate doses of penicilin. Prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin. H. influenzae meningitis, as adjunctive therapy with parental streptomycin. IMPORTANT NOTES In vitro sulfonamide susceptibility tests are not always reliable. The test must be carefully coordinated with bacteriologic and clinical response. When the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the culture media. Currently, the increasing frequency of resistant organisms limits the usefulness of antibacterial agents, including the sulfonamides, especially in the treatment of recurrent and complicated urinary tract infections. Wide variation in blood levels may result with identical doses. Blood levels should be measured in patients receiving sulfonamides for serious infections. Free sulfonamide blood levels of 5 mg to 15 mg per 100 mL may be considered therapeutically effective for most infections and blood levels of 12 mg to 15 mg per 100 mL may be considered optimal for serious infections. Twenty mg per 100 mL should be the maximum total sulfonamide level, since adverse reactions occur more frequently above this level. Sulfadiazine is contraindicated in the following circumstances: Hypersensitivity to sulfonamides. In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). In pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

Resumo do produto:

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 42806-757-60 bottles of 60 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 Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 06-2023-00 MF757REV06/23 OS0006

Status de autorização:

Abbreviated New Drug Application

Características técnicas

SULFADIAZINE- SULFADIAZINE TABLET
EPIC PHARMA, LLC
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SULFADIAZINE TABLETS, USP
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
1
10
10
4
2
65% of blood levels and total drug 40% to 60%.
Sulfadiazine is excreted largely in the urine, where concentrations
are 10 to 25 times
greater than serum levels. Approximately 10% of a single oral dose is
excreted i