Source: FDA, National Drug Code (US) Revision Year: 2021
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.
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.
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.
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.
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.
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.
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.
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation.
Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 to 200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.
In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate Injection, USP is dialyzable.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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