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warnings
WARNINGS SECTION Administration of Seromycin should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of CNS toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo, paresis, or dysarthria. The toxicity of Seromycin is closely related to excessive blood levels (above 30 μg/mL), as determined by high dosage or inadequate renal clearance. The ratio of toxic dose to effective dose in tuberculosis is small. The risk of convulsions is increased in chronic alcoholics. Patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.
ADVERSE REACTIONS SECTION Most adverse reactions occruing during therapy with Seromycin® involve the nervous system or are manifestitations of drug hypersensitivity. The following side effects have been observed in patients receiving Seromycin®: Nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) - Convulsions - Drowsiness and somnolence - Headache - Tremor - Dysarthria - Vertigo - Confusion and disorientation with loss of memory - Psychoses, possibly with suicidal tendencies - Character changes - Hyperirritability - Aggression - Paresis - Hyperreflexia - Paresthesia - Major & minor (localized) clonic seizures - Coma Cardiovascular: Sudden development of congestive heart failure in patients receiving 1 to 1.5 g of Seromycin® daily has been reported Allergy (apparently not related to dosage) Skin rash Miscellaneous: Elevated serum transaminase, especially in patients with preexisting liver disease