Levsin

DRUG DESCRIPTION

Levsin® tablets (hyoscyamine sulfate tablets USP) contain 0.125 mg hyoscyamine sulfate formulated for oral administration.

Levsin® (hyoscyamine) is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2•H2SO4•2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, a-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:

Levsin® (hyoscyamine sulfate) Structural Formula Illustration

Each tablet also contains as inactive ingredients: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid.

What are the possible side effects of hyoscyamine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

  • diarrhea;
  • confusion, hallucinations;
  • unusual thoughts or behavior;
  • fast, pounding, or uneven heart rate;
  • rash or flushing; or
  • eye pain.

Less serious side effects may include:

  • dizziness,...

Read All Potential Side Effects and See Pictures of Levsin »

What are the precautions when taking hyoscyamine (Levsin)?

Before taking hyoscyamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle type, untreated open-angle type), enlarged prostate, urinary blockage problems, certain stomach/intestinal problems (e.g., slow gut, blockage, severe ulcerative colitis, infection), heart problems due to severe bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: overactive thyroid, other...

Read All Potential Precautions of Levsin »


Levsin Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, blurred vision, dry mouth, vision problems, headache, trouble sleeping, constipation, flushing, dry skin, and decreased sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, unusual excitement), fast/irregular heartbeat, difficulty urinating, decreased sexual ability, loss of coordination, slurred speech, eye pain, vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hyoscyamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle type, untreated open-angle type), enlarged prostate, urinary blockage problems, certain stomach/intestinal problems (e.g., slow gut, blockage, severe ulcerative colitis, infection), heart problems due to severe bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: overactive thyroid, other heart problems (e.g., coronary heart disease, congestive heart failure, fast heartbeat, arrhythmias), high blood pressure, kidney disease, heartburn problems (acid reflux, hiatal hernia), certain nervous system problem (autonomic neuropathy), myasthenia gravis.

Contact lens wearers may need to use wetting eye drops since this medication can cause dry eyes.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug may increase the risk for heatstroke because it decreases sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for confusion and unusual excitement while using this drug.

Children may be more sensitive to the effects of this drug.

Hyoscyamine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.


Levsin Patient Information Including Side Effects

Brand Names: Anaspaz, Cystospaz, Hyospaz, Hyosyne, Levbid, Levsin, Levsin SL, Levsinex SR, Symax Duotab, Symax SL, Symax SR

Generic Name: hyoscyamine (Pronunciation: hye oh SYE a meen)

  • What is hyoscyamine (Levsin)?
  • What are the possible side effects of hyoscyamine?
  • What is the most important information I should know about hyoscyamine?
  • What should I discuss with my healthcare provider before taking hyoscyamine?
  • How should I take hyoscyamine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking hyoscyamine?
  • What other drugs will affect hyoscyamine?
  • Where can I get more information?

What is hyoscyamine (Levsin)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson's disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hyoscyamine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

  • diarrhea;
  • confusion, hallucinations;
  • unusual thoughts or behavior;
  • fast, pounding, or uneven heart rate;
  • rash or flushing; or
  • eye pain.

Less serious side effects may include:

  • dizziness, drowsiness, feeling nervous;
  • blurred vision, headache;
  • sleep problems (insomnia);
  • nausea, vomiting, bloating, heartburn, or constipation;
  • changes in taste;
  • problems with urination;
  • decreased sweating;
  • dry mouth; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hyoscyamine?

Do not take this medication if you are allergic to hyoscyamine, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

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 can cause side effects that may impair your vision, thinking, or reactions. Be careful if you drive or do anything that requires you to be awake and able to see clearly.

Avoid drinking alcohol. It can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Because hyoscyamine reduces sweating, it can increase your risk of heat stroke.

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