Product Elements:
Hyoscyamine sulfate hyoscyamine sulfate water hyoscyamine sulfate hyoscyamine
Indications and Usage:
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 parti
Read more...al 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.
Warnings:
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 sign
Read more...s and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Dosage and Administration:
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 th
Read more...e 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.
Contraindications:
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:
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.
Overdosage:
Overdosage 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 ld 50 for hyoscyamine is 375 mg/kg. hyoscyamine sulfate injection, usp is dialyzable.
Description:
Description hyoscyamine sulfate injection, usp is a sterile solution containing 0.5 mg hyoscyamine sulfate per ml in water for injection. hyoscyamine sulfate injection, usp is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. the empirical formula is (c 17 h 23 no 3 ) 2 â¢h 2 so 4 â¢2h 2 0 and the molecular weight is 712.85. chemically, it is benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(s)-endo]-, sulfate (2:1), dihydrate with the following structure: the 1 ml vials contain as inactive ingredients: water for injection, ph is adjusted with hydrochloric acid when necessary. structure
Clinical Pharmacology:
Clinical pharmacology hyoscyamine sulfate injection, usp inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. these peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. it is completely devoid of any action in the autonomic ganglia. hyoscyamine sulfate injection, usp inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. hyoscyamine sulfate injection, usp also controls excessive pharyngeal, tracheal and bronchial secretions. hyoscyamine sulfate injection, usp disappears rapidly from the blood and is distributed throughout the entire body. the half-life of hyoscyamine sulfate injection, usp is 31/2 hours. hyoscyamine sulfate injection, usp is partly hydrolyzed to tropic acid and tro
Read more...pine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. only traces of this drug are found in breast milk. hyoscyamine sulfate injection, usp passes the blood brain barrier and the placental barrier.
How Supplied:
How supplied hyoscyamine sulfate injection usp (hyoscyamine sulfate injection usp, 0.5 mg/ml), is available in 1 ml vials. 1 ml vials â box of 5 ndc 54288-111-05 store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. also available as: product dosage strength package size ndc hyoscyamine sulfate injection, usp 0.5 mg/ml 5 vials (1 ml each) 54288-111-05
Package Label Principal Display Panel:
Principal display panel â 0.5 mg/ml ndc 54288-111-01 hyoscyamine sulfate injection, usp 0.5 mg hyoscyamine sulfate, usp per ml in water for injection. 5 vials (1 ml each) rx only dosage and administration: see package insert for further information. store at 25°c (77°f), excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. distributed by: bpi labs llc 12393 belcher rd s largo fl 33773 r-1907 li01i carton: ndc 54288-111-05 hyoscyamine sulfate injection, usp 0.5 mg hyoscyamine sulfate, usp per ml in water for injection. rx only vial carton