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hyoscyamine sulfate
Overview
What is NuLev?
Each round, white, peppermint flavored tablet can be chewed or placed on tongue for disintegration and contains 0.125 mg of hyoscyamine sulfate USP.
Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (CHNO)•HSO•2HO 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), dehydrate with the following structure:
Inactive ingredients include: lactose monohydrate, magnesium stearate, mannitol USP, peppermint flavor, starch, stearic acid.
What does NuLev look like?
What are the available doses of NuLev?
Sorry No records found.
What should I talk to my health care provider before I take NuLev?
Sorry No records found
How should I use NuLev?
Dosage may be adjusted according to the conditions and severity of symptoms. NuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) may be chewed or placed on tongue and allowed to disintegrate. Tablets may be taken with or without water.
What interacts with NuLev?
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.
What are the warnings of NuLev?
Array
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, NuLev 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, shortterm 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.
What are the precautions of NuLev?
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 drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.
Information for Patients
Like other anticholinergic agents, NuLev 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 NuLev 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.
Drug Interactions
Additive adverse effects resulting from cholinergic blockade may occur when NuLev 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 hyoscyamine sulfate. Administer NuLev before meals; antacids after meals.
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 hyoscyamine sulfate; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem.
Pregnancy-Pregnancy Category C
Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NuLev should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when NuLev is administered to a nursing woman.
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.
What are the side effects of NuLev?
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.
What should I look out for while using NuLev?
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.
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, NuLev 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, shortterm 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.
What might happen if I take too much NuLev?
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.
In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.
How should I store and handle NuLev?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USANuLev Chewable Melt (Hyoscyamine Sulfate tablets, 0.125 mg) are round, white, peppermint flavored tablets with "AP" debossed on one side and “nu” debossed on the opposite side.Bottles of 100 tablets NDC 68220-118-10Dispense in tight, light-resistant containers as defined in the USP/NF, with a child-resistant closure.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CALL A POISON CONTROL CENTER IMMEDIATELY.Manufactured for:ALAVEN PHARMACEUTICAL LLCMarietta, GA 30062www.alavenpharm.comFor Medical InquiriesCall toll free 1-888-317-000104/2009500384Printed in USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hyoscyamine sulfate 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. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions.
Hyoscyamine sulfate is absorbed totally and completely by oral administration. Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3½ hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine 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 passes the blood brain barrier and the placental barrier.
Non-Clinical Toxicology
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.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, NuLev 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, shortterm 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.
Additive adverse effects resulting from cholinergic blockade may occur when NuLev 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 hyoscyamine sulfate. Administer NuLev before meals; antacids after meals.
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 drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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