Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other. Bottles of 100 tablets NDC 68220-113-10 Bottles of 500 tablets NDC 68220-113-50 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 0.125mg 100 68220-112-10 Tablets 0.125mg 500 68220-112-50 Sub-lingual Tablets 0.125mg 100 68220-113-10 Sub-lingual Tablets 0.125mg 500 68220-113-50 Elixir 0.125mg/5 mL Pint 0091-4532-16 Drops 0.125mg/mL 15mL 0091-4538-15 Injection 0.5mg/mL Box of 5-1mL 0091-1536-05 Levbid ® extended- 0.375mg 100 68220-115-10 release tablets 0.375mg 500 68220-115-50 Manufactured for: ALAVEN ® PHARMACEUTICAL LLC Marietta, GA 30067 Address medical inquiries to: Alaven Pharmaceutical LLC 2260 Northwest Parkway, Suite A Marietta, GA 30067 Or call toll free 1-888-317-0001; PRINCIPAL DISPLAY PANEL – 0.125 mg NDC 68220- 113 -10 Levsin /SL ® tablets (hyoscyamine sulfate tablets USP) 0.125 mg sublingual / chewable / oral Rx only ALAVEN PHARMACEUTICAL LLC 100 tablets For medical inquiries call 1-888-317-0001 Each tablet contains 0.125 mg hyoscyamine sulfate, USP. USUAL DOSAGE: See package insert for full prescribing information. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. 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. Mfg. for: Alaven Pharmaceutical LLC 2260 Northwest Parkway Marietta, GA 30067 www.alavenpharm.com 400646-08 Rev 04/2017 Levsin SL Tablets 0.125 mg Bottle Label
- HOW SUPPLIED: Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other. Bottles of 100 tablets NDC 68220-113-10 Bottles of 500 tablets NDC 68220-113-50 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 0.125mg 100 68220-112-10 Tablets 0.125mg 500 68220-112-50 Sub-lingual Tablets 0.125mg 100 68220-113-10 Sub-lingual Tablets 0.125mg 500 68220-113-50 Elixir 0.125mg/5 mL Pint 0091-4532-16 Drops 0.125mg/mL 15mL 0091-4538-15 Injection 0.5mg/mL Box of 5-1mL 0091-1536-05 Levbid ® extended- 0.375mg 100 68220-115-10 release tablets 0.375mg 500 68220-115-50 Manufactured for: ALAVEN ® PHARMACEUTICAL LLC Marietta, GA 30067 Address medical inquiries to: Alaven Pharmaceutical LLC 2260 Northwest Parkway, Suite A Marietta, GA 30067 Or call toll free 1-888-317-0001
- PRINCIPAL DISPLAY PANEL – 0.125 mg NDC 68220- 113 -10 Levsin /SL ® tablets (hyoscyamine sulfate tablets USP) 0.125 mg sublingual / chewable / oral Rx only ALAVEN PHARMACEUTICAL LLC 100 tablets For medical inquiries call 1-888-317-0001 Each tablet contains 0.125 mg hyoscyamine sulfate, USP. USUAL DOSAGE: See package insert for full prescribing information. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. 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. Mfg. for: Alaven Pharmaceutical LLC 2260 Northwest Parkway Marietta, GA 30067 www.alavenpharm.com 400646-08 Rev 04/2017 Levsin SL Tablets 0.125 mg Bottle Label
Overview
Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally. Levsin ® /SL 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, ~-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: Each tablet also contains as inactive ingredients: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid. Chemical Structure
Indications & Usage
Levsin ® /SL 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). Also used in the treatment of infant colic (elixir and drops). Levsin ® /SL 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 and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
Dosage & Administration
Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed. Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
Warnings & Precautions
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, Levsin ® /SL 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 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.
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 Levsin ® /SL 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 Levsin ® /SL. Administer Levsin ® /SL before meals; antacids after meals.
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