Levbid also known as Hyoscyamine Sulfate is a human prescription drug labeled by 'Alaven Pharmaceutical Llc'. National Drug Code (NDC) number for Levbid is 68220-115. This drug is available in dosage form of Tablet, Extended Release. The names of the active, medicinal ingredients in Levbid drug includes Hyoscyamine Sulfate - .375 mg/1 . The currest status of Levbid drug is Active.

Levbid hyoscyamine sulfate hyoscyamine sulfate hyoscyamine anhydrous dibasic calcium phosphate ethylcellulose, unspecified lactose monohydrate magnesium stearate microcrystalline cellulose stearic acid ap;115

Drug interactions: additive adverse effects resulting from cholinergic blockade may occur when levbid ® is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (mao) inhibitors, tricyclic antidepressants or some antihistamines. antacids may interfere with the absorption of levbid ® .

Indications and usage: levbid ® is effective as adjunctive therapy in the treatment of peptic ulcer. it can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). levbid ® is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity Read more...

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, levbid ® may produce drowsiness, dizziness 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 including hyoscyamine sulfate. cns signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. these cns s Read more...

General: use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. use with caution in patients with hiatal hernia associated with reflux esophagitis.

Dosage and administration: dosage may be adjusted according to the conditions and severity of symptoms. adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. do not crush or chew tablets. do not exceed 4 tablets in 24 hours.

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.

Adverse reactions: all of the following adverse reactions have been reported with hyoscyamine sulfate. adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; 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); short-term memory loss; hallucinations; and decreased sweating.

Drug interactions: additive adverse effects resulting from cholinergic blockade may occur when levbid ® is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (mao) inhibitors, tricyclic antidepressants or some antihistamines. antacids may interfere with the absorption of levbid ® .

Pregnancy – pregnancy category c: animal reproduction studies have not been conducted with levbid ® . it is also not known whether levbid ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. levbid ® should be given to a pregnant woman only if clearly needed.

Geriatric use: reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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 (100-200 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. levbid ® is dialyzable.

Description: levbid ® extended-release tablets contain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. hyoscyamine sulfate is one of the principal anticholinergic/ antispasmodic components of belladonna alkaloids. the empirical formula is (c 17 h 23 no 3 )2•h 2 so 4 •2h 2 o 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: each levbid ® extended-release tablet also contains as inactive ingredients: calcium phosphate dibasic, ethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and stearic acid. chemical structure

Clinical pharmacology: levbid ® 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, the cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. at therapeutic doses, it is completely devoid of any action on autonomic ganglia. levbid ® inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. levbid ® also controls excessive pharyngeal, tracheal, and bronchial secretions. hyoscyamine sulfate is absorbed totally and completely by oral administration. once absorbed, it disappears rapidly from the blood and is distributed throughout the entire body: the half-life is 2 to 3 ½ hours. hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the Read more...

Carcinogenesis, mutagenesis, impairment of fertility: no long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of levbid ® ; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem.

How supplied: levbid ® (hyoscyamine sulfate 0.375 mg) extended-release tablets are white, capsule-shaped tablets. they are coded ap on one side and 115 on the other. bottles of 100 ndc 68220-115-10 store at controlled room temperature 20°-25°c (68°- 77°f); excursions permitted to 15°-30°c (59°- 86°f). please refer to current usp. dispense in tight, light-resistant containers as defined in usp/nf with a child-resistant closure. keep out of reach of children also available as: levsin ® dosage strength package size ndc tablets 0.125 mg 100 68220-112-10 tablets 0.125 mg 500 68220-112-50 sub-lingual tablets 0.125 mg 100 68220-113-10 sub-lingual tablets 0.125 mg 500 68220-113-50 elixir 0.125 mg/5 ml pint 0091-4532-16 drops 0.125 mg/ml 15ml 0091-4538-15 injection 0.5 mg/ml box of 5-1 ml 0091-1536-05 levsinex ® timecaps ™ 0.375 mg 100 0091-3537-01 levsinex ® timecaps ™ 0.375 mg 500 0091-3537-05 levbid ® extended-release tablets 0.375 mg 100 6822 Read more...

Information for patients: like other anticholinergic agents, levbid ® may produce drowsiness, dizziness, 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. use of levbid ® may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution. tablets may not completely disintegrate and may be excreted by some patients.

Principal display panel – 0.375 mg ndc 68220- 115 -10 levbid ® extended-release tablets (hyoscyamine sulfate, 0.375 mg) rx only alaven ® pharmaceutical llc 100 tablets for medical inquiries call 1-888-317-0001 usual dosage: adults and pediatric patients 12 years of age and older: 1 to 2 tablets every 12 hours. see package insert for further information. store at controlled room temperature 20°- 25°c (68° - 77°f); brief excursions permitted to 15°- 30°c (59°- 86°f). please refer to current usp. dispense in tight, light-resistant containers as defined in usp/nf with a child-resistant closure. mfg. for: alaven pharmaceutical llc 2260 northwest parkway marietta, ga 30067 www.alavenpharm.com 400633-08 rev 04/2017 levbid extended-release tablets 0.375 mg bottle label