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Basic Drug Info
Drug Name:Sulfadiazine
Manufacturer:Sandoz Inc.
Other Info:

 Initially, 2 to 4 g.

Maintenance, 2 to 4 g, divided into 3 to 6 doses, every 24 hours.



Clinical Trials:


Indications and Usage

Sulfadiazine tablets are indicated in the following conditions:ChancroidTrachomaInclusion conjunctivitisNocardiosisUrinary 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 sul fonamide-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 penicillin.Prophylaxis against recurrences of rheumatic fever, as an alternative to penicillin.H.

influenzae meningitis, as adjunctive therapy with parental streptomycin.IMPORTANT NOTESIn 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 to 15 mg per 100 mL may be considered therapeutically effective for most infections, and blood levels of 12 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.
Pyelonephritis -- Inflammation of the KIDNEY involving the renal parenchyma (the NEPHRONS); KIDNEY PELVIS; and KIDNEY CALICES. It is characterized by ABDOMINAL PAIN; FEVER; NAUSEA; VOMITING; and occasionally DIARRHEA.

Pyelitis -- Inflammation of the KIDNEY PELVIS and KIDNEY CALICES where urine is collected before discharge, but does not involve the renal parenchyma (the NEPHRONS) where urine is processed.

Cystitis -- Inflammation of the URINARY BLADDER, either from bacterial or non-bacterial causes. Cystitis is usually associated with painful urination (dysuria), increased frequency, urgency, and suprapubic pain.

Obstructive Uropathy --

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Toxoplasmosis, Cerebral -- Infections of the BRAIN caused by the protozoan TOXOPLASMA gondii that primarily arise in individuals with IMMUNOLOGIC DEFICIENCY SYNDROMES (see also AIDS-RELATED OPPORTUNISTIC INFECTIONS). The infection may involve the brain diffusely or form discrete abscesses. Clinical manifestations include SEIZURES, altered mentation, headache, focal neurologic deficits, and INTRACRANIAL HYPERTENSION. (From Joynt, Clinical Neurology, 1998, Ch27, pp41-3)

Acquired Immunodeficiency Syndrome -- An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.

Malaria -- A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.

Meningococcal meningitis -- A fulminant infection of the meninges and subarachnoid fluid by the bacterium NEISSERIA MENINGITIDIS, producing diffuse inflammation and peri-meningeal venous thromboses. Clinical manifestations include FEVER, nuchal rigidity, SEIZURES, severe HEADACHE, petechial rash, stupor, focal neurologic deficits, HYDROCEPHALUS, and COMA. The organism is usually transmitted via nasopharyngeal secretions and is a leading cause of meningitis in children and young adults. Organisms from Neisseria meningitidis serogroups A, B, C, Y, and W-135 have been reported to cause meningitis. (From Adams et al., Principles of Neurology, 6th ed, pp689-701; Curr Opin Pediatr 1998 Feb;10(1):13-8)

Acute Otitis Media --

Rheumatic Fever -- A febrile disease occurring as a delayed sequela of infections with group A hemolytic streptococci and characterized by multiple focal inflammatory lesions of the connective tissue structures, especially of the heart, blood vessels, and joints (polyarthritis), and by the presence of Aschoff bodies in the myocardium and skin. (Dorland, 27th ed)

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

Contraindications

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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Congenital Toxoplasmosis -- Prenatal protozoal infection with TOXOPLASMA gondii which is associated with injury to the developing fetal nervous system. The severity of this condition is related to the stage of pregnancy during which the infection occurs; first trimester infections are associated with a greater degree of neurologic dysfunction. Clinical features include HYDROCEPHALUS; MICROCEPHALY; deafness; cerebral calcifications; SEIZURES; and psychomotor retardation. Signs of a systemic infection may also be present at birth, including fever, rash, and hepatosplenomegaly. (From Adams et al., Principles of Neurology, 6th ed, p735)

Kernicterus -- A term used pathologically to describe BILIRUBIN staining of the BASAL GANGLIA; BRAIN STEM; and CEREBELLUM and clinically to describe a syndrome associated with HYPERBILIRUBINEMIA. Clinical features include athetosis, MUSCLE SPASTICITY or hypotonia, impaired vertical gaze, and DEAFNESS. Nonconjugated bilirubin enters the brain and acts as a neurotoxin, often in association with conditions that impair the BLOOD-BRAIN BARRIER (e.g., SEPSIS). This condition occurs primarily in neonates (INFANT, NEWBORN), but may rarely occur in adults. (Menkes, Textbook of Child Neurology, 5th ed, p613)

Warnings

The sulfonamides should not be used for the treatment 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.
Branded Drugs
The following US Branded drugs contain Sulfadiazine


SULFONAMIDES DUPLEX -- ELI LILLY AND CO


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