Monograph Details
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Gastrointestinal Tract
> Hyperacidity, GERD, and ulcers
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NULEV |
| Manufacturer |
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Schwarz Pharma, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Anticholinergic. |
| Generic Name |
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Hyoscyamine sulfate 0.125mg; orally-disintegrating tabs; mint flavor; contains phenylalanine. |
| Indications |
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Adjunct in irritable bowel syndrome, peptic ulcer, spastic or functional GI disorders, neurogenic bowel disorders, colic. |
| Adults and Children |
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<2yrs: not recommended. 2–12yrs: ½–1 tab every 4 hrs or as needed; max 6 tabs/day. ≥12yrs: 1–2 tabs every 4 hrs or as needed; max 12 tabs/day. Dissolve on tongue; swallow with or without water. |
| Contraindications |
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Glaucoma. GI or urinary tract obstruction. Paralytic ileus. Intestinal atony in elderly or debilitated. Unstable cardiovascular status in acute hemorrhage. Severe ulcerative colitis. Toxic megacolon. Myasthenia gravis. |
| Precautions |
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High environmental temperature. Fever. Diarrhea: exclude partial GI obstruction. Autonomic neuropathy. Hyperthyroidism. Cardiovascular disease. Hypertension. CHF. Arrhythmias. Tachycardia. Renal disease. Hiatal hernia with reflux esophagitis. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Additive effects with other anticholinergics, amantadine, haloperidol, phenothiazines, MAOIs, tricyclic antidepressants, antihistamines. Antacids may inhibit absorption. |
| Adverse Reactions |
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Anticholinergic effects (e.g., drowsiness, dizziness, blurred vision, urinary hesitancy, palpitations, mydriasis, dry mouth), nausea, taste loss, impotence, rash, confusion, psychosis. |
| How Supplied |
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Tabs—100 |
| Additional Resources |
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• Related Prescribing Note |
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