2 f e 1 o g sulfate; LANN-NP_41897 / pa # any anticholinergic arx) l 1101-2 # 12/16/2019 09:59 AM / NP Item 473ML Insert (Si & b​ ean 10-1101 CG j WARNINGS PRECAUTIONS 6.5 pt​ CONTRAINDICATIONS ith 2D 15 ML w Hyosyne Drops 09:59 AM ileostomy or colostomy. inappropriate In and this possibly instance, harmful. treatment Like other with anticholinergic this agents, drug Hyoscyamine would be early symptom of incomplete intestinal obstruction, especially in patients with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an some antihistamines. some Antacids may interferehyoscyamine with sulfate before meals; antacids after meals. the absorption of hyoscyamine sulfate. of Fertility: Mutagenesis, Carcinogenesis, Impairment Administer No long-term studiescarcinogenic, in mutagenic animals or have impairment of been fertility performed potential to of hyoscyamine determine the gravis. In the presence of high environmental temperature, heat prostration can occur with hyoscyamine sulfate ishaloperidol, amantadine, administered concomitantly withphenothiazines, other monoamine antimuscarinics, oxidase (MAO) inhibitors, tricyclic antidepressants or and renal disease. Investigate any tachycardia before giving ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia fever or heatenvironmental temperatures stroke; should use caution. febrile patients or those whoInteractions: Drug may be exposedAdditive to adverse elevated effects resulting from cholinergic blockade may occur when insomnia, agitation andand mannerisms, symptoms and usually inappropriatedrug. resolve affect. within These 12 CNS to signs 48 hours after discontinuation ofGeneral: the Use with cautioncoronary in heart patients with: disease, autonomic congestive heart neuropathy, failure, hyperthyroidism, cardiac arrythmias, hypertension, debilitated patients; unstable cardiovascular status in acute hemorrhage; severe other machinery or to perform hazardous work while taking this drug. Use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, signs and symptoms includehallucinations, confusion, dysarthria, disorientation, ataxia, short coma, term euphoria, memory decreased loss, anxiety, fatigue, achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or dizziness or blurredengage vision. in In activities requiring this mental event, alertness the such patient as operating should a be motor vehicle warned or not to such as operatingwork a while taking motor this drug. vehicle or other machineryPsychosis has or been to reported in perform sensitive hazardous individuals given anticholinergic drugs. CNS and tremors andused in to the therapy control of poisoning by anticholinesterase agents. associated sialorrhea and hyperhidrosis. May be Glaucoma; obstructive uropathyprostatic (for hypertrophy); example, obstructive bladder disease neck of obstruction the due gastrointestinal to tract (as in demonstrable evidence of a problem.a of evidence demonstrable hernia associated with reflux esophagitis. Information for Patients: Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, patient should be warned not to engage in activities requiring mental alertness relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity however, years of marketing experience with hyoscyamine sulfate shows no drug since they may increase the heart rate. Use with caution in patients with hiatal sulfate may produce drowsiness, dizziness or blurred vision. In this event, the narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the flexure syndrome and neurogenic(elixir colon). and Also drops). used in Hyoscyamine the sulfate treatment is of indicated infant along colic with morphine or other 1.125 x 1.125)

• Rev. 12/19 folded: 2 F.P.O.

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3 Code

12/16/2019

NO 2 D 2 23 H 17 6.75 x 7.875 ( 10-1101 : atrioventricular node, and the Code

HYOSYNE ORAL DROPS Code 128 (Hyoscyamine Sulfate DESCRIPTION Oral Solution) Type: HYOSYNE ELIXIR HYOSYNE ELIXIR

INDICATIONS ANDINDICATIONS USAGE (Hyoscyamine Sulfate Elixir) CLINICAL PHARMACOLOGY CLINICAL HYOSYNE ORAL DROPS HYOSYNE (Hyoscyamine Sulfate Oral Solution) contain 0.125 mg LANN-NP_41897 also contain as inactive ingredients: Alcohol, citric acid, Lannett Company, Inc. (Hyoscyamine Sulfate Elixir) (Hyoscyamine ​ (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine also contain as inactive ingredients: Alcohol, citric acid, FD&C (Hyoscyamine Sulfate Oral Solution) (Hyoscyamine O and the molecular weight is 712.85. Chemically, it is benzeneacetic 2 ]-, sulfate (2:1), dihydrate with the following structure: ]-, sulfate (2:1), dihydrate with •2H α-(hydroxymethyl)-, 8-methyl-8- azabicyclo[3.2.1]oct-3-yl ester, endo 4 S)- SO 2 enterocolitis. enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute associated abdominal cramps. May be used in functional intestinal disorders to hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and ulcer. It can also be used to control gastric secretion, visceral spasm and the majority ofhours. the drug Only is tracesplacental barrier. the and barrier brain blood the passes excreted of in this the drug urine are unchanged found within in the breast first milk. 12 Hyoscyamine Hyoscyamine sulfate sulfate is effective as adjunctive therapy in the treatment of peptic distributed throughout the entire body.1/2 The hours. half-life Hyoscyamine of hyoscyamine sulfate sulfate is is partly 2 hydrolyzed to 3 to tropic acid and tropine but Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is muscle, cardiac muscle, the sinoatrial node, the Hyoscyamine sulfate is absorbed totally and completely by oral administration. neurogenic bladder and neurogenic bowel disturbances (including the splenic cholinergic receptors are present in the autonomic effector cells of the smooth excessive pharyngeal, tracheal pharyngeal, excessive bronchial and secretions. respond to acetylcholine but lack cholinergic innervation. These peripheral autonomic ganglia. Hyoscyaminemotility sulfate and inhibits gastrointestinal decreases propulsive gastric acid secretion. Hyoscyamine sulfate also controls syndrome (irritable colon,gastrointestinal spastic disorders. colon, Also mucous used colitis) as and adjunctive functional therapy in the treatment of innervated by postganglionic cholinergic nerves and on smooth muscles that exocrine glands. At therapeutic doses, it is completely devoid of any action on H HYOSYNE ELIXIR Hyoscyamine sulfate iscomponents one of of belladonna the alkaloids. principal anticholinergic/antispasmodic The empirical formula is (C HYOSYNE ORAL DROPS hyoscyamine sulfate per mLadministration. oral for alcohol v/v 5% with sulfate5 per mL20% with administration. oral v/v alcohol for red #40, FD&C yellowcitrate, sorbitol solution, and sucrose. #6, flavor, glycerin, purified water, sodium benzoate, sodium HYOSYNE ORAL DROPS HYOSYNE ELIXIR FD&C red #40, FD&Csorbitol solution, sucrose, and water. yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, Hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures acid, [3( Pregnancy - Pregnancy Category C: Body Weight Usual Dose Do Not Exceed Animal reproduction studies have not been conducted with hyoscyamine sulfate. It In 24 Hours is also not known whether hyoscyamine sulfate can cause fetal harm when 3.4 kg (7.5 lb.) 4 drops 24 drops administered to a pregnant woman or can affect reproduction capacity. 5 kg (11 lb.) 5 drops 30 drops Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed. 7 kg (15 lb.) 6 drops 36 drops 10 kg (22 lb.) 8 drops 48 drops Nursing Mothers: Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when Package of Hyoscyamine Sulfate Oral Drops is accompanied with a dropper having hyoscyamine sulfate is administered to a nursing woman. markings of 3, 4, 5 DROPS, and 0.25 mL. The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate Geriatric Use: (mg) for each marking are as follows: 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 Marking on Approximate Equivalent Amount Dropper range, reflecting the greater frequency of decreased hepatic, renal, or cardiac Hyoscyamine Sulfate Oral Hyoscyamine Sulfate function, and of concomitant disease or other drug therapy. Drops Solution (mL) (mg) 3 DROPS 0.08 mL 0.01 mg 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. 4 DROPS 0.11 mL 0.01375 mg Because elderly patients are more likely to have decreased renal function, care 5 DROPS 0.14 mL 0.0175 mg should be taken in dose selection, and it may be useful to monitor renal function. 0.25 mL 0.25 mL 0.03125 mg

ADVERSE REACTIONS All of the following adverse reactions have been reported with hyoscyamine sulfate. HYOSYNE ELIXIR Adverse reactions may include dryness of the mouth; urinary hesitancy and (Hyoscyamine Sulfate Elixir) retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular Dosage may be adjusted according to the conditions and severity of tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; symptoms. Measure dosage very carefully. dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; Adults and pediatric patients 12 years of age and older: 1 to 2 teaspoonfuls abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours. other dermal manifestations; ataxia; speech disturbance; some degree of mental Pediatric patients 2 to under 12 years of age: Please see the following confusion and/or excitement (especially in elderly persons); short-term memory dosage guide is based on body weight. The doses may be repeated every loss; hallucinations; and decreased sweating. four hours or as needed. Do not exceed 6 teaspoonfuls in 24 hours.

OVERDOSAGE Body Weight Usual Dose The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in 10 kg (22 lb.) 1/4 teaspoon (1.25 mL) swallowing, and CNS stimulation. 20 kg (44 lb.) 1/2 teaspoonful (2.5 mL) 40 kg (88 lb.) 3/4 teaspoonful (3.75 mL) Measures to be taken are immediate lavage of the stomach and injection of 50 kg (110 lb.) 1 teaspoonful (5 mL) 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, HOW SUPPLIED hypothermic blanket). Excitement to a degree which demands attention may be HYOSYNE ORAL DROPS (Hyoscyamine Sulfate 0.125 mg per mL) is orange managed with sodium thiopental 2% solution given slowly intravenously or chloral colored, flavored, and contains 5% alcohol. It is supplied in a 15 mL bottle with a hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of calibrated dropper (NDC 54838-506-15). progression of the curare-like effect to paralysis of the respiratory muscles, HYOSYNE ELIXIR (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, artificial respiration should be instituted and maintained until effective flavored, and contains 20% alcohol. It is supplied in a pint (473 mL) bottle (NDC respiratory action returns. 54838-511-80).

In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) dialyzable. [See USP Controlled Room Temperature].

DOSAGE AND ADMINISTRATION Rx only. HYOSYNE ORAL DROPS Distributed by: (Hyoscyamine Sulfate Oral Solution) Lannett Company, Inc. Dosage may be adjusted according to the conditions and severity of Philadelphia, PA 19136 symptoms. Measure dosage very carefully. Rev. 12/19 10-1101 Adults and pediatric patients 12 years of age and older: 1 to 2 mL every four CG#1101-2 hours or as needed. Do not exceed 12 mL in 24 hours. Pediatric patients 2 to under 12 years of age: 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours. Pediatric patients under 2 years of age: The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed.

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