Anaspaz

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.

Serious side effects have been reported with hyoscyamine. See the “Hyoscyamine Precautions” section.

Common side effects of hyoscyamine include the following:

• drowsiness
• dizziness or lightheadedness
• headache
• blurred vision
• flushing (feeling of warmth)
• dry mouth
• constipation
• difficulty urinating
• increased sensitivity to light

This is not a complete list of hyoscyamine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Take hyoscyamine exactly as prescribed.

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

Do not chew, divide, or break extended-release (long-acting) capsule. Swallow extended-release (long-acting) capsule whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of hyoscyamine at the same time.

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.

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; severe ulcerative colitis; toxic megacolon; myasthenia gravis; myocardial ischemia.

General:
Use with caution and only when clearly indicated in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

Information for Patients:
Anaspaz may produce drowsiness, dizziness or blurred vision. Patients should observe caution before operating a motor vehicle or other machinery or performing other tasks requiring mental alertness.

Use of Anaspaz may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.

Drug Interactions:
Additive adverse effects resulting from cholinergic blockade may occur when Anaspaz is administered concomitantly with other anti-muscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of Anaspaz; take Anaspaz before meals and antacids after meals.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
No long-term studies in animals have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of Anaspaz in either males or females.

Pregnancy-Pregnancy Category C:
Animal reproduction studies have not been conducted with Anaspaz. It is also not known whether Anaspaz can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Anaspaz should be given to a pregnant woman only if clearly needed.

Nursing Mothers:
Anaspaz is excreted in human milk. Caution should be exercised when Anaspaz is administered to a nursing woman.

Pediatric Use:
Safety and effectiveness in pediatric patients below the age of 2 have not been established.

Geriatric use:
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Anaspaz and observed closely.

Not all the following adverse reactions have been associated with Anaspaz, but have been reported for drugs in the same pharmacological class, with anticholinergic / antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy, urinary retention, tachycardia, palpitations, blurred vision, mydriasis, cycloplegia, increased intraocular pressure, dry eyes, headache, nervousness, drowsiness, dizziness, weakness, mental confusion and/or excitement (especially in geriatric patients), flushing, insomnia, fever, altered sense of taste, nausea, vomiting, dysphagia, heartburn, constipation, bloated feeling, suppression of lactation, impotence, and decreased sweating. Allergic reactions or drug idiosyncrasies such as anaphylaxis, urticaria and other dermal manifestations may also occur.

The signs and symptoms of overdose include headache, nausea, vomiting, dizziness, dry mouth, difficulty in swallowing, dilated pupils, blurred vision, urinary retention, hot dry and flushed skin, tachycardia, hypertension, hypotension, respiratory depression, CNS stimulation, fever, ataxia, excitation, lethargy, stupor, coma, and paralysis (with large overdoses). General measures such as emesis or gastric lavage and administration of activated charcoal should be undertaken immediately. Supportive therapy is given as needed, including artificial respiration if required. Physostigmine may be given by intravenous injection to reverse severe anticholinergic symptoms.

The LD50 for hyoscyamine in rats is 375 mg/kg.

Hyoscyamine sulfate is dialyzable.

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 Anaspaz) 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 Anaspaz) 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 Anaspaz) 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 Anaspaz) on the CNS.[Ref]

Ocular

Ocular side effects due to the anticholinergic activity of hyoscyamine (the active ingredient contained in Anaspaz) 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 Anaspaz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.