Nulev

Name: Nulev

Nulev Precautions

Serious side effects have been reported with hyoscyamine including the following:

  • Diarrhea
  • Skin rash
  • Eye pain
  • Fast or irregular heartbeat
  • Psychosis has been reported in sensitive individuals given hyoscyamine sulfate. Tell your doctor if you notice any of these signs or symptoms:
    • confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, and/or agitation
  • Hyoscyamine sulfate may decrease sweating and result fever or heat stroke. Patients with a fever or those who may be exposed to elevated environmental temperatures should use caution.

If you experience any of these symptoms, call your doctor immediately:

Hyoscyamine can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how hyoscyamine affects you.

Talk to your doctor about the risks and benefits of taking hyoscyamine if you are 65 years of age or older. Older adults should not usually take hyoscyamine because it is not as safe and may not be as effective as other medications that can be used to treat the same condition.

Do not take hyoscyamine if you:

  • are allergic to hyoscyamine or to any of its ingredients
  • have glaucoma
  • have obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy)
  • have obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis)
  • have paralytic ileus
  • intestinal issues
  • unstable cardiovascular status in acute hemorrhage
  • have severe ulcerative colitis
  • have toxic megacolon complicating ulcerative colitis
  • have myasthenia gravis

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking NuLev (hyoscyamine)?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Uses of NuLev

  • It is used to slow the speed in the stomach and GI (gastrointestinal) tract.
  • It is used to treat loose stools (diarrhea).
  • It is used to treat GI (gastrointestinal) ulcers.
  • It is used to treat irritable bowel syndrome.
  • It is used to treat muscle spasms of the GI (gastrointestinal) tract, gallbladder system, or urinary system.
  • It is used to treat a runny nose.
  • It is used to treat Parkinson's disease.
  • It may be given to you for other reasons. Talk with the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

For Healthcare Professionals

Applies to hyoscyamine: compounding powder, injectable solution, oral capsule extended release, oral liquid, oral solution, oral spray, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release, sublingual tablet

Cardiovascular

Cardiovascular side effects have included tachycardia, premature ventricular depolarizations, and ventricular tachycardia.[Ref]

Gastrointestinal

Gastrointestinal side effects due to the anticholinergic effects of hyoscyamine (the active ingredient contained in NuLev) have commonly included dry mouth and mucous membranes. Other reported side effects include delayed gastric emptying time, reduced gastric acid secretion, constipation, and gastroesophageal reflux.[Ref]

General

Hyoscyamine (the active ingredient contained in NuLev) toxicity (anticholinergic side effects) often presents as fever, tachycardia, agitation, and dry skin/mucous membranes.[Ref]

Genitourinary

Genitourinary complications include urinary retention (due to anticholinergic effects on the urinary sphincter), which is common and dose-related, and impotence in male patients.[Ref]

Hypersensitivity

Hypersensitivity reactions to hyoscyamine (the active ingredient contained in NuLev) are rare. Reactions can include urticaria, eczema, papillary hyperplasia, mucopurulent discharge, eosinophilia, pruritus, edema, hypotension, abdominal pain, tachypnea, nausea and vomiting.[Ref]

Nervous system

Nervous system side effects have included lethargy and somnolence. Higher doses may be associated with mental confusion and/or excitement. The elderly appear to be more prone to the anticholinergic effects of hyoscyamine (the active ingredient contained in NuLev) on the CNS.[Ref]

Ocular

Ocular side effects due to the anticholinergic activity of hyoscyamine (the active ingredient contained in NuLev) have included inhibition of the iris sphincter muscle (possibly resulting in mydriasis), follicular conjunctivitis, and inhibition of the ciliary muscle (which can produce blurred vision). All muscarinic antagonists can precipitate glaucoma.[Ref]

Endocrine

Endocrine side effects have included inhibition of exocrine sweat glands. This is usually not clinically significant except when perspiration becomes a major factor in body temperature control.[Ref]

Some side effects of NuLev may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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