Scopolamine

What is Scopolamine?

• Scopolamine (Transderm Scop) transdermal system is an anticholinergic used to prevent nausea and vomiting caused by motion sickness or medications used during surgery.

Scopolamine

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Scopolamine molecule ball

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Scopolamineanticholinergic

What are the uses of this medicine?

Scopolamine (Transderm Scop) transdermal system is a prescription medicine used for adults to help prevent:

• nausea and vomiting from motion sickness
• nausea and vomiting from anesthesia or taking opioid pain medicines after surgery

How does this medicine work?

• Scopolamine, a belladonna alkaloid, is an anticholinergic.
• Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation.
• It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center.
• Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• angle closure glaucoma.
• hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system.

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.

Be sure to mention any of the following:

• antihistamines such as meclizine (Antivert, Bonine, others); medications for anxiety, irritable bowel disease, motion sickness, pain, Parkinson's disease, seizures or urinary problems
• muscle relaxants
• sedatives
• sleeping pills
• tranquilizers
• tricyclic antidepressants such as desipramine (Norpramin), clomipramine (Anafranil), imipramine (Tofranil), and trimipramine (Surmontil).

Is this medicine FDA approved?

• Initial U.S. Approval: 1979

How should this medicine be used?

Recommended dosage:

Recommended Adult Dosage: Motion Sickness:

• Apply one transdermal system to the hairless area behind one ear at least 4 hours before antiemetic effect is required for use up to 3 days.
• If therapy for more than 3 days is required, remove the first transdermal system and apply a new transdermal system behind the other ear.

PONV:

• For surgeries other than cesarean section, apply one transdermal system behind the ear the evening before surgery and remove 24 hours following surgery.

Administration:

• Scopolamine comes as a patch to be placed on the hairless skin behind your ear.
• When used to help prevent nausea and vomiting caused by motion sickness, apply the patch at least 4 hours before its effects will be needed and leave in place for up to 3 days.
• If treatment is needed for longer than 3 days to help prevent nausea and vomiting caused by motion sickness, remove the current patch and apply a new patch behind the other ear.
• When used to prevent nausea and vomiting from medications used with surgery, apply the patch as directed by your doctor and leave it in place for 24 hours after your surgery.
• Each scopolamine transdermal system is formulated to deliver in vivo approximately 1 mg of scopolamine over 3 days.
• Only wear one transdermal system at any time.
• Do not cut the transdermal system.
• Apply the transdermal system to the skin in the postauricular area (hairless area behind one ear).
• After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands.
• If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear.
• Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets or others.

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

This medicine is available in fallowing doasage form:

• As Transdermal system: 1 mg/3 days

This medicine is available in fallowing brand namesː

• Transderm Scop

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry mouth
• blurred vision or eye problems
• feeling sleepy or drowsy
• disorientation (confusion)
• dizziness
• feeling agitated or irritable
• pharyngitis (sore throat)

Scopolamine transdermal system may cause serious side effects, including:

• angle closure glaucoma
• worsening of seizures
• an unusual reaction called acute psychosis
• worsening of your preeclampsia during pregnancy
• difficulty urinating
• difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting
• withdrawal symptoms after removing scopolamine transdermal system after using it for several days
• temporary increase in the size of your pupil and blurry vision

What special precautions should I follow?

• You should not drink alcohol while using scopolamine transdermal system. It can increase your chances of having serious side effects.
• You should not drive, operate heavy machinery, or do other dangerous activities until you know how scopolamine transdermal system affects you.
• You should be careful if you use scopolamine transdermal system while you participate in watersports because you may feel lost or confused (disoriented).
• Limit contact with water while swimming and bathing because scopolamine transdermal system may fall off. If scopolamine transdermal system falls off, throw it away and apply a new one on the hairless area behind your other ear.
• The mydriatic effect of scopolamine may cause an increase in intraocular pressure resulting in acute angle closure glaucoma. Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop.
• Scopolamine has been reported to exacerbate psychosis. Also, monitor patients for new or worsening psychiatric symptoms during concomitant treatment with other drugs that are associated with similar psychiatric effects.
• Seizures and seizure-like activity have been reported in patients receiving scopolamine.
• Scopolamine can cause drowsiness, disorientation, and confusion. Discontinue scopolamine transdermal system if signs or symptoms of cognitive impairment develop. Scopolamine transdermal system is not approved for use in pediatric patients.
• Eclamptic seizures have been reported in pregnant women with severe preeclampsia soon after injection of intravenous and intramuscular scopolamine. Avoid use of scopolamine transdermal system in patients with severe preeclampsia.
• Scopolamine, due to its anticholinergic properties, can decrease gastrointestinal motility and cause urinary retention. Discontinue scopolamine transdermal system in patients who develop difficulty in urination.
• Discontinuation of scopolamine transdermal system, usually after several days of use, may result in withdrawal symptoms, such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia and hypotension. Instruct patients to seek medical attention if they experience severe symptoms.
• Scopolamine can cause temporary dilation of the pupils resulting in blurred vision if it comes in contact with the eyes. Advise patients to wash their hands thoroughly with soap and water and dry their hands immediately after handling the transdermal system.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias.

• The signs and symptoms of overdose/toxicity due to scopolamine should be carefully distinguished from the occasionally observed syndrome of withdrawal.
• Although mental confusion and dizziness may be observed with both acute toxicity and withdrawal, other characteristic findings differ: tachyarrhythmias, dry skin, and decreased bowel sounds suggest anticholinergic toxicity, while bradycardia, headache, nausea and abdominal cramps, and sweating suggest post-removal withdrawal.

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.
• In cases of toxicity remove the scopolamine transdermal system.
• Serious symptomatic cases of overdosage involving multiple transdermal system applications and/or ingestion may be managed by initially ensuring the patient has an adequate airway and supporting respiration and circulation.
• This should be rapidly followed by removal of all transdermal systems from the skin and the mouth.
• If there is evidence of transdermal system ingestion, endoscopic removal of swallowed transdermal systems, or administration of activated charcoal should be considered, as indicated by the clinical situation.
• In any case where there is serious overdosage or signs of evolving acute toxicity, continuous monitoring of vital signs and ECG, establishment of intravenous access, and administration of oxygen are all recommended.

Can this medicine be used in pregnancy?

• Scopolamine use in pregnant women have not identified a drug associated risk of major birth defects, miscarriage, or adverse fetal outcomes.
• Avoid use of scopolamine transdermal system in pregnant women with severe preeclampsia because eclamptic seizures have been reported after exposure to scopolamine.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: scopolamine

• Inactive ingredients: peach-colored polyethylene/polyester film, polypropylene, povidone and silicone adhesive. The brown imprinting ink contains acrylic polymers, carbon black, iron oxides (red and yellow), polydimethylsiloxane, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and triethanolamine.

Who manufactures and distributes this medicine?

Manufactured for:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

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

• Store scopolamine transdermal system at room temperature between 68°F and 77°F (20ºC and 25ºC) until you are ready to use it.
• Store scopolamine transdermal system in an upright position.
• Do not bend or roll scopolamine transdermal system.

anticholinergic agents

• Aclidinium
• Atropine
• Homatropine
• Darifenacin
• Dicyclomine
• Fesoterodine
• Flavoxate
• Glycopyrrolate
• Hyoscyamine
• Ipratropium
• Mepenzolate
• Methscopolamine
• Oxybutynin
• Propantheline
• Scopolamine
• Solifenacin
• Tiotropium
• Tolterodine
• Trospium

• Dailymed label info on Scopolamine
• FDA Scopolamine

Scopolamine Resources
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