Ed Spaz

Hyoscyamine is a prescription medication used to used to control symptoms associated with disorders of the gastrointestinal (GI) tract.

Hyoscyamine is also used in the treatment of bladder spasms, peptic ulcer disease, diverticulitis, colic, and irritable bowel syndrome. Hyoscyamine may also be used to treat rhinitis.

Hyoscyamine belongs to a group of drugs called Belladonna alkaloids. Hyoscyamine help by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid.

Hyoscyamine comes as a tablet, an orally disintegrating tablet, an extended-release (long-acting) capsule, an elixir, and a solution to take by mouth.

The tablets and liquid are usually taken three or four times a day.

The extended-release capsules are usually taken twice a day.

• Do not chew, divide, or break hyoscyamine extended-release capsules. Swallow hyoscyamine capsules whole.

Common side effects of hyoscyamine include drowsiness, dizziness, dryness of the mouth, urinary retention, and blurred vision.

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

Ed Spaz is part of the drug class:

• Belladonna alkaloids, tertiary amines

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• kidney function
• weight (children)

The maximum dose of hyoscyamine in adults is 1.5 mg/day, given in divided doses.

The maximum dose of hyoscyamine in children (2-12 years old) is 0.75 mg/day, given in divided doses.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor's instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor's instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

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.

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.

Hyoscyamine sulfate orally disintegrating tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration.

Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The molecular formula is (C17H23NO3)2•H2SO4•2H2O 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), dihydrate with the following structural formula:

Each tablet also contains as inactive ingredients: mannitol, croscarmellose sodium and magnesium stearate.

Ed-Spaz Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg are white, round, flat beveled edge tablets debossed "634" on one side and a score line on other side.

Bottles of 100 NDC 0485-0082-01

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.

Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:
Belcher Pharmaceuticals, Inc.
6911 Bryan Dairy Road
Largo, FL 33777

Manufactured for:
Edwards Pharmaceutical, Inc.
111 W. Mulberry St.
Ripley, MS 38663

May 2010
L18I
R-0510

NDC 0485-0082-01

Ed-Spaz
Hyoscyamine Sulfate Orally
Disintegrating
Tablets

0.125 mg

100 Tablets

Rx only