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scolopamine transdermal system

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Overview

What is Scopolamine Trandermal System?

The scopolamine transdermal system is a circular flat patch designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.3 mg of scopolamine base. Scopolamine is α -(hydroxymethyl) benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo [3.3.1.0] non-7-yl ester. The empirical formula is CHNO and its structural formula is:

Scopolamine is a white to almost white, crystalline powder that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a film 0.2 mm thick and 2.5 cm, with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored, aluminized, polyester film; (2) a drug reservoir of scopolamine, crospovidone, isopropyl palmitate, light mineral oil, and polyisobutylene; (3) an ethylene vinyl acetate copolymer membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of crospovidone, isopropyl palmitate, light mineral oil, polyisobutylene, and scopolamine. A protective peel strip of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The inactive components, crospovidone (3.63 mg), isopropyl palmitate (1.81 mg), light mineral oil (11.42 mg) and polyisobutylene (16.83 mg), are not released from the system.

Cross section of the system:



What does Scopolamine Trandermal System look like?



What are the available doses of Scopolamine Trandermal System?

Continuous release, circular, flat, tan colored patch (1.3 mg scopolamine)

What should I talk to my health care provider before I take Scopolamine Trandermal System?

How should I use Scopolamine Trandermal System?

Scopolamine transdermal system is indicated in adults for prevention of nausea and vomiting associated with motion sickness.

Each scopolamine transdermal system is formulated to deliver approximately 1 mg of scopolamine over 3 days. Only one patch should be worn at any time.

The patch should be applied only to the skin in the postauricular (hairless area behind one ear) area.

Handling

After the patch is applied on the dry skin behind the ear, the hands should be washed thoroughly with soap and water and dried. Upon removal, the patch should be discarded. To prevent any traces of scopolamine from coming into direct contact with the eyes, after administration of the patch, the hands and the application site should be washed thoroughly with soap and water and dried.


What interacts with Scopolamine Trandermal System?

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What are the warnings of Scopolamine Trandermal System?

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What are the precautions of Scopolamine Trandermal System?

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What are the side effects of Scopolamine Trandermal System?

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What should I look out for while using Scopolamine Trandermal System?

Scopolamine transdermal system is contraindicated in the following populations:


What might happen if I take too much Scopolamine Trandermal System?

Because strategies for the management of drug overdose continually evolve, it is strongly recommended that a poison control center be contacted to obtain up-to-date information regarding the management of scopolamine transdermal system overdose. The prescriber should be mindful that antidotes used routinely in the past may no longer be considered optimal treatment.

For example, physostigmine, used more or less routinely in the past, is seldom recommended for the routine management of anticholinergic syndromes.

Until up-to-date authoritative advice is obtained, routine supportive measures should be directed to maintaining adequate respiratory and cardiac function.

The signs and symptoms of anticholinergic toxicity 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. These symptoms can be severe and may require medical intervention.

In cases of toxicity remove the patch. Serious symptomatic cases of overdosage involving multiple patch 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 patches from the skin and the mouth. If there is evidence of patch ingestion, gastric lavage, endoscopic removal of swallowed patches, 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.

The 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. Obtaining a careful history is crucial to making the correct diagnosis.


How should I store and handle Scopolamine Trandermal System?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information The scopolamine transdermal system is a tan-colored circular patch, 2.5 cm, on a clear, oversized, square peel strip, which is removed prior to use.Each scopolamine transdermal system contains 1.3 mg of scopolamine and is formulated to deliver approximately 1 mg of scopolamine over 3 days.Scopolamine transdermal system is available in packages of four, ten and twenty four patches. Each patch is foil wrapped. Patient instructions are included. • 1 Package (4 patches) NDC 45802--84• 1 Package (10 patches) NDC 45802--46• 1 Package (24 patches) NDC 45802--62StorageStore at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].HandlingSince scopolamine can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes, patients should be strongly advised to wash their hands thoroughly with soap and water immediately after handling the patch. In addition, it is important that used patches be disposed of properly to avoid contact with children or pets.[see Dosage and Administration (2), Warnings and Precautions (5.2), and Patient Counseling Information


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Scopolamine, a belladonna alkaloid, is an anticholinergic agent. 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.

Non-Clinical Toxicology
Scopolamine transdermal system is contraindicated in the following populations:

See for clinically significant drug interactions with diclofenac.

Patients currently being treated for Open Angle Glaucoma

Glaucoma therapy in patients with open angle glaucoma should be monitored and may need to be adjusted during scopolamine transdermal system use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure.

Patients should be advised to remove the patch immediately and promptly contact a physician in the event that they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes, accompanied by dilated pupils).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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