Hyoscyamine

What is Hyoscyamine?

• Hyoscyamine is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids used to control symptoms associated with disorders of the gastrointestinal (GI) tract.

Hyoscyamine

Hyoscyamine-from-xtal-3D-balls

Hyoscyamine chemical structure

What are the uses of this medicine?

Hyoscyamine is used:

• as adjunctive therapy in the treatment of peptic ulcer.
• to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps.
• functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis.
• as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders.
• as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances.
• 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.
• in the therapy of poisoning by anticholinesterase agents.

How does this medicine work?

• Hyoscyamine (hye" oh sye' a meen) is a derivative of natural alkaloid found in plants of the Solanacea family such as henbane (Hyoscyamus niger, for which it is named), jimson weed (Datura stramonium), tomatoes (Soanum lycopersicum) and deadly nightshade (Atropa belladonna).
• Hyoscyamine is the levorotary isomer of atropine and has potent anticholinergic, antimuscarinic activity.
• It has been used for decades as an antiemetic, antisecretory and antispasmotic agent in the treatment of nausea, motion sickness, allergic rhinitis, gastrointestinal spasm and hypermotility, functional bowel syndrome and hyperactive bladder.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• 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

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• amantadine (Symadine, Symmetrel), amitriptyline (Elavil), chlorpromazine (Thorazine), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), fluphenazine (Prolixin), haloperidol (Haldol), imipramine (Tofranil), medications containing belladonna (Donnatal), mesoridazine (Serentil), nortriptyline (Pamelor), perphenazine (Trilafon), phenelzine (Nardil), prochlorperazine (Compazine), promazine (Sparine), promethazine (Phenergan), protriptyline (Vivactil), thioridazine (Mellaril), tranylcypromine (Parnate), trifluoperazine (Stelazine), triflupromazine (Vesprin), trimeprazine (Temaril), and trimipramine (Surmontil).

• Antacids may interfere with hyoscyamine, making it less effective. Take hyoscyamine 1 hour before or 2 hours after antacids.

Is this medicine FDA approved?

• Despite having been used in clinical medicine for decades, hyoscyamine has not been formally approved for many of its common uses in the United States.

How should this medicine be used?

Recommended dosage:

• The recommended adult oral dose varies, but is generally 0.125 to 0.25 mg two to four times daily.

Pediatric patients 2 to under 12 years of age:

• 1/2 to 1 tablet 0.125 mg every four hours or as needed.
• Do not exceed 6 tablets in 24 hours.

Administration:

• Hyoscyamine comes as a tablet, an extended-release (long-acting) capsule, and a liquid 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.
• Swallow the extended-release tablets whole; do not split, chew, or crush them.
• Hyoscyamine controls symptoms associated with disorders of the GI tract, but it does not cure the disorders.
• Continue to take hyoscyamine even if you feel well. Do not stop taking hyoscyamine without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• Hyoscyamine is available as tablets, capsules, liquids, elixirs, powders, and solutions for injection in both prescription and over-the-counter forms.

This medicine is available in fallowing brand namesː

• ED-Spaz
• Cystospaz
• Hyomax
• Hyophen
• Hyosyne
• Levsin
• Oscimin

What side effects can this medication cause?

The most common side effects of this medicine 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
• fatigue
• dizziness
• insomnia
• nausea
• vomiting
• impotence
• suppression of lactation
• 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
• decreased sweating

What special precautions should I follow?

• Like other anticholinergic agents, hyoscyamine sulfate 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 hyoscyamine sulfate 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.
• Use with caution 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 drugs since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.
• Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when Hyoscyamine Sulfate Sublingual Tablets are administered to a nursing woman.
• 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.
• Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
• Consider 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.
• Ask your doctor about the safe use of alcohol during your treatment with hyoscyamine. Alcohol can make the side effects of this medication worse.
• Hyoscyamine has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Hyoscyamine Sulfate Sublingual Tablets should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of hyoscyamine sulfate have been established in pediatric patients over 2 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• hyoscyamine sulfate

Inactive ingredients:

• colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol and flavor.

Who manufactures and distributes this medicine?

Distributed by:

• County Line Pharmaceuticals, LLC
• Pine Brook, NJ USA

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20°-25°C (68°-77°F); excursion permitted to 15°-30°C (59°-86°F).
• Please refer to current USP.
• Dispense in tight, light-resistant containers with a child-resistant closure.

Urologic agents

• Overactive bladder syndrome agents - darifenacin, fesoterodine, flavoxate, hyoscyamine, mirabegron, oxybutynin, solifenacin, tolterodine, trospium

• Dailymed label info on Hyoscyamine
• FDA Hyoscyamine