Levsin SL

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.

Levsin®/SL 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®/SL 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.

In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, Levsin®/SL 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.

Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the 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; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.

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®/SL is dialyzable.

Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

• It is used to slow the speed in the stomach and GI (gastrointestinal) tract.
• It is used to treat loose stools (diarrhea).
• It is used to treat GI (gastrointestinal) ulcers.
• It is used to treat irritable bowel syndrome.
• It is used to treat muscle spasms of the GI (gastrointestinal) tract, gallbladder system, or urinary system.
• It is used to treat a runny nose.
• It is used to treat Parkinson's disease.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to hyoscyamine or any other part of Levsin/SL (hyoscyamine sublingual tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Bowel block, bleeding problems, diarrhea, enlarged colon, glaucoma, heart problems, myasthenia gravis, slow-moving GI (gastrointestinal) tract, a swallowing tube (esophagus) that is not normal, ulcerative colitis, or trouble passing urine.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Levsin/SL with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take 30 to 60 minutes before meals.
• Do not take antacids at the same time as Levsin/SL. Ask your doctor if you have a question about how to take antacids with this medicine.
• Place tablet under the tongue and let melt.
• Some tablets may also be chewed or swallowed whole. Check with your pharmacist if you have questions about how to take Levsin/SL.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Levsin/SL (hyoscyamine sublingual tablets) is used on an as needed basis. Do not use more often than told by the doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.