Levsin

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.

Measures to be taken are immediate lavage of the stomach and injection of 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, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

In rats, the LD50 for hyoscyamine is 375 mg/kg. Levsin® (hyoscyamine) is dialyzable.

• Alaven Pharmaceutical LLC

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• Meda Pharmaceuticals, Inc.

• Quality Care Pharmaceuticals

• Schwarz Pharma Inc.

Levsin is part of the drug class:

• Belladonna alkaloids, tertiary amines

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Hyoscyamine falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Hyoscyamine should be given to a pregnant woman only if clearly needed.

If you take too much hyoscyamine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Do not take hyoscyamine if you are allergic to it, 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 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.

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 and myocardial ischemia.

Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.

Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; 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); and decreased sweating.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6612 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

Measures to be taken are immediate lavage of the stomach and injection of 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, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 to 200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

In rats, the LD50 for hyoscyamine is 375 mg/kg. Levsin® is dialyzable.

Applies to hyoscyamine: oral conventional tablets and sublingual tablets, oral extended-release capsules and tablets, oral oral solution and elixir, oral orally disintegrating tablets, parenteral injection

Side effects include:

Most adverse effects are manifestations of pharmacologic effects at muscarinic-cholinergic receptors and usually are reversible when therapy is discontinued.

Severity and frequency of adverse effects are dose related and individual intolerance varies greatly; adverse effects occasionally may be obviated by a reduction in dosage but this also may eliminate potential therapeutic effects.

Adverse effects include dry 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, mental confusion and/or excitement (especially in geriatric patients), short-term memory loss, hallucinations, and decreased sweating.

Do not take Levsin 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 Levsin, 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 Levsin. Antacids can make it harder for your body to absorb this medicine. If you use an antacid, take it after you have taken this medicine 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 this medicine.

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

Tell your doctor about all other medicines you use, especially:

• amantadine (Symmetrel);

• haloperidol (Haldol);

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.