HYOSCYAMINE SULFATE

INDICATIONS AND USAGE Hyoscyamine sulfate Injection, USP is effective as adjunctive therapy in the treatment of peptic ulcer. In acute episodes, Hyoscyamine sulfate Injection, USP can be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Parenterally administered Hyoscyamine sulfate Injection, USP is also effective in reducing gastrointestinal motility to facilitate diagnostic procedures such as endoscopy or hypotonic duodenography. Hyoscyamine sulfate Injection, USP may be used to reduce pain and hypersecretion in pancreatitis, in certain cases of partial heart block associated with vagal activity, and as an antidote for poisoning by anticholinesterase agents. In Anesthesia: Hyoscyamine sulfate Injection, USP is indicated as a pre-operative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. Hyoscyamine sulfate Injection, USP protects against the peripheral muscarinic effects such as bradycardia and excessive secretions produced by halogenated hydrocarbons and cholinergic agents such as physostigmine, neostigmine, and pyridostigmine given to reverse the actions of curariform agents. In Urology: Hyoscyamine sulfate Injection, USP may also be used intravenously to improve radiologic visibility of the kidneys. It is also indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic.

DOSAGE AND ADMINISTRATION The dose may be administered subcutaneously, intramuscularly, or intravenously without dilution. As with all parenteral drug products, Hyoscyamine sulfate injection, USP should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Gastrointestinal Disorders: The usual adult recommended dose is 0.5 to 1 mL (0.25 to 0.5 mg). Some patients may need only a single dose; others may require administration two, three, or four times a day at four hour intervals. Diagnostic Procedures: The usual adult recommended dose is 0.5 to 1 mL (0.25 to 0.5 mg) administered intravenously 5 to 10 minutes prior to the diagnostic procedure. Anesthesia: Adults and pediatric patients over 2 years of age: As a pre-anesthetic medication, the recommended dose is 5 µg (0.005 mg) per kg of body weight. This dose is usually given thirty to sixty minutes prior to the anticipated time of induction of anesthesia or at the time the pre-anesthetic narcotic or sedatives are administered. Hyoscyamine sulfate injection, USP may be used during surgery to reduce drug-induced bradycardia. It should be administered intravenously in increments of 0.25 mL and repeated as needed. To achieve reversal of neuromuscular blockade, the recommended dose is 0.2 mg (0.4 mL) Hyoscyamine sulfate injection USP for every 1 mg neostigmine or the equivalent dose of physostigmine or pyridostigmine.

WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, Hyoscyamine sulfate Injection, USP may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis and myocardial ischemia.

ADVERSE REACTIONS Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); and decreased sweating. To report SUSPECTED ADVERSE REACTIONS, contact BPI Labs, LLC, at (727-471-0850) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.