Hyoscyamine

Levsin® (hyoscyamine) is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Levsin® (hyoscyamine) is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.

Levsin® (hyoscyamine) inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Levsin® (hyoscyamine) inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Levsin® (hyoscyamine) also controls excessive pharyngeal, tracheal and bronchial secretions.

Levsin® (hyoscyamine) is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, Levsin® (hyoscyamine) disappears rapidly from the blood and is distributed throughout the entire body. The half-life of Levsin® (hyoscyamine) is 2 to 3½ hours. Levsin® (hyoscyamine) is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk. Levsin® (hyoscyamine) passes the blood brain barrier and the placental barrier.

Like other anticholinergic agents, Levsin® (hyoscyamine) may produce drowsiness, dizziness, or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

Use of Levsin® (hyoscyamine) 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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of hyoscyamine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking hyoscyamine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to hyoscyamine or to any of its ingredients
• have or had glaucoma
• have or had heart, lung, liver, or kidney disease
• have congestive heart failure or cardiac arrhythmias
• have a urinary tract or intestinal obstruction
• have an enlarged prostate
• have ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum)
• have myasthenia gravis.
• have hyperthyroidism
• have hypertension
• are having surgery, including dental surgery. Tell your doctor or dentist that you take hyoscyamine.
• are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking hyoscyamine, call your doctor.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;

• an enlarged prostate or problems with urination;

• intestinal blockage;

• severe ulcerative colitis, or toxic megacolon;

• glaucoma; or

• myasthenia gravis.

To make sure you can safely take hyoscyamine, tell your doctor if you have any of these other conditions:

• heart disease, congestive heart failure;

• a heart rhythm disorder;

• high blood pressure;

• overactive thyroid; or

• hiatal hernia with GERD (gastroesophageal reflux disease).

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

(hye oh SYE a meen)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Elixir, Oral, as sulfate:

Hyosyne: 0.125 mg/5 mL (473 mL) [contains alcohol, usp; lemon flavor]

Generic: 0.125 mg/5 mL (473 mL)

Solution, Injection, as sulfate:

Levsin: 0.5 mg/mL (1 mL [DSC]) [contains benzyl alcohol]

Solution, Injection, as sulfate [preservative free]:

Levsin: 0.5 mg/mL (1 mL)

Solution, Oral, as sulfate:

Hyosyne: 0.125 mg/mL (15 mL) [lemon flavor]

Generic: 0.125 mg/mL (15 mL)

Tablet, Oral, as sulfate:

Levsin: 0.125 mg

Oscimin: 0.125 mg [peppermint flavor]

Generic: 0.125 mg

Tablet Disintegrating, Oral, as sulfate:

Anaspaz: 0.125 mg [scored]

Ed-Spaz: 0.125 mg [scored]

NuLev: 0.125 mg [peppermint flavor]

Oscimin: 0.125 mg [peppermint flavor]

Symax FasTabs: 0.125 mg [DSC]

Generic: 0.125 mg

Tablet Extended Release, Oral, as sulfate:

Symax Duotab: 0.375 mg [contains brilliant blue fcf (fd&c blue #1)]

Tablet Extended Release 12 Hour, Oral, as sulfate:

Levbid: 0.375 mg

Oscimin SR: 0.375 mg

Symax-SR: 0.375 mg [scored]

Generic: 0.375 mg

Tablet Sublingual, Sublingual, as sulfate:

HyoMax-SL: 0.125 mg [DSC]

Levsin/SL: 0.125 mg

Oscimin: 0.125 mg [peppermint flavor]

Symax-SL: 0.125 mg [mint flavor]

Generic: 0.125 mg

• Anticholinergic Agent

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.