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Sulfadiazine
Overview
What is Sulfadiazine?
Sulfadiazine is an oral sulfonamide anti-bacterial 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 CHNOS. It has a molecular weight of 250.27. The structural formula is shown below:
Most sulfonamides slowly darken on exposure to light.
What does Sulfadiazine look like?
What are the available doses of Sulfadiazine?
Sorry No records found.
What should I talk to my health care provider before I take Sulfadiazine?
Sorry No records found
How should I use Sulfadiazine?
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: , species, species, , and . 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 , 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
, when used concomitantly with adequate doses of penicillin.
Prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin.
H.
influenzae
IMPORTANT NOTES
In vitro
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.
SYSTEMIC SULFONAMIDES ARE CONTRAINDICATED IN INFANTS UNDER 2 MONTHS OF AGE except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis.
What interacts with Sulfadiazine?
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.
What are the warnings of Sulfadiazine?
Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.
The sulfonamides should be used for the of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.
Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias.
The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.
The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.
What are the precautions of Sulfadiazine?
General
Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma.
Hemolysis may occur in individuals deficient in glucose-6-phosphate dehydrogenase. This reaction is dose related.
Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.
Information for Patients
Patients should be instructed to drink an eight ounce glass of water with each dose of medication and at frequent intervals throughout the day. Caution patients to report promptly the onset of sore throat, fever, pallor, purpura or jaundice when taking this drug, since these may be early indications of serious blood disorders.
Laboratory Tests
Complete blood counts and urinalyses with careful microscopic examinations should be done frequently in patients receiving sulfonamides.
Drug Interactions
Administration of a sulfonamide may increase the effect of oral anticoagulants and methotrexate, probably by displacement of these drugs from binding sites on plasma albumin. Potentiation of the action of sulfonylurea hypoglycemic agents, thiazide diuretics and uricosuric agents may also be noted. This may also be due to displacement of the drugs from albumin or a pharmacodynamic mechanism may play a role. Conversely, agents such as indomethacin, probenecid and salicylates may displace sulfonamides from plasma albumin and increase the concentrations of free drug in plasma.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The sulfonamides bear certain chemical similarities to some goitrogens. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in rats.
Pregnancy
Nursing Mothers
Sulfadiazine is contraindicated for use in nursing mothers because the sulfonamides cross the placenta, are excreted in breast milk and may cause kernicterus.
Because of the potential for serious adverse reactions in nursing infants from sulfadiazine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. See
Pediatric Use
Sulfadiazine is contraindicated in infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). See and
What are the side effects of Sulfadiazine?
Blood Dyscrasias
Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia.
Allergic Reactions
Erythema multiforme (Stevens-Johnson syndrome), generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills.
Gastrointestinal Reactions
Nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis.
C.N.S. Reactions
Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia.
Renal
Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted.
Miscellaneous Reactions
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Goiter production, diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents.
What should I look out for while using Sulfadiazine?
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.
The sulfonamides should be used for the of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.
Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias.
The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.
The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.
What might happen if I take too much Sulfadiazine?
Sorry No Records found
How should I store and handle Sulfadiazine?
Store Temozolomide Capsules at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918SulfADIAZine Tablets USP for oral administration are available as:500 mg:ENDC 0185-0757-30 bottles of 30NDC 0185-0757-01 bottles of 100NDC 0185-0757-10 bottles of 1000Storage: 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .Manufactured forSandoz Inc.Princeton, NJ 08540Manufactured byEpic Pharma, LLCLaurelton, NY 11413OS7190Rev. 03/12MF0757REV03/12MG #16918
Clinical Information
Chemical Structure
No Image foundClinical 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 greater than serum levels. Approximately 10% of a single oral dose is excreted in the first 6 hours, 50% within 24 hours and 60% to 85% in 48 to 72 hours. Of the amount excreted in the urine, 15% to 40% is in the acetyl form.
Non-Clinical Toxicology
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.
The sulfonamides should be used for the of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.
Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias.
The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.
The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.
The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salex is not known.
Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma.
Hemolysis may occur in individuals deficient in glucose-6-phosphate dehydrogenase. This reaction is dose related.
Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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