Scopolamine Transdermal Patch India
This skin patch is used to prevent nausea and vomiting caused by motion sickness or recovery from anesthesia and surgery. Scopolamine 1.5mg works by correcting the.
Each Transderm Scōp ® patch is formulated to deliver in-vivo approximately 1mg of scopolamine over 3 days. Only one patch should be worn at any time. Do not cut the patch. 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.
2.1 Initiation of Therapy Motion sickness. To prevent the nausea and vomiting associated with motion sickness, one Transderm Scōp patch (formulated to deliver approximately 1mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required. Post Operative Nausea and Vomiting. To prevent post operative nausea and vomiting, one Transderm Scōp patch should be applied the evening before scheduled surgery, except for caesarian section. For caesarian section surgery, to minimize exposure of the newborn baby to the drug, apply the patch one hour prior to caesarian section. 5.1 Open Angle Glaucoma 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 Transderm Scōp 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). 5.6 Specific Populations Pediatric A safe and effective dose has not been established in the pediatric population. Children are particularly susceptible to the side effects of belladonna alkaloids; including mydriasis, hallucinations, amyblyopia, and drug withdrawal syndrome. Neurologic and psychiatric adverse reactions, such as hallucinations, amblyopia and mydriasis have also been reported when one half or one quarter of a patch has been applied. Elderly Transderm Scōp should be used with caution in the elderly because of the increased likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome.
Clinical trials of Transderm Scop did not include sufficient number of subjects aged 65 years and older to determine if they respond differently from younger subjects. Renal and Hepatic Impaired Transderm Scōp should be used with caution in individuals with impaired renal or hepatic functions because of the increased likelihood of CNS effects. Transderm Scop has not been studied in these populations.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Motion Sickness In motion sickness clinical studies of Transderm Scōp, the most frequent adverse reaction was dry mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug. Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed. Post-Operative Nausea and Vomiting In a total of five clinical studies in which Transderm Scōp was administered perioperatively to a total of 461 patients where safety was assessed, dry mouth was the most frequently reported adverse drug reaction, which occurred in approximately 29% of patients on drug.
Dizziness was reported by approximately 12% of patients on drug. Other adverse drug reactions reported from these studies, with a frequency of ≥3% of patients treated with Transderm Scop and with a frequency higher than placebo were, in descending order: somnolence, urinary retention, agitation/restlessness, visual impairment, confusion, mydriasis and pharyngitis (see Table 6.1). 6.2 Postmarketing Experience The following adverse drug reactions, further to those reported from clinical trials, have been identified during postapproval use of Transderm Scop. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to confirm a definite causal relationship.
In worldwide marketing with Transderm Scōp, the following adverse drug reactions were reported by body system. Psychiatric disorders: acute psychosis including: hallucinations disorientation, and paranoia. Nervous system disorders: headache, amnesia, coordination abnormalities, speech disorder, disturbance in attention, restlessness. General disorders and administration site conditions: application site burning. Eye disorders: dry eyes, eye pruritis, angle closure glaucoma, amblyopia, eyelid irritation. Skin and subcutaneous tissue disorders: rash generalized, skin irritation, erythema. Renal and urinary disorders: dysuria.
Ear and Labyrinth Disorders: vertigo. 6.3 Drug Withdrawal/Post-Removal Symptoms Symptoms such as dizziness, nausea, vomiting, abdominal cramps, sweating, headache mental confusion, muscle weakness, bradycardia and hypotension may occur following abrupt discontinuation of anticholinergic drugs such as Transderm Scōp. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scōp system.
These symptoms usually do not appear until 24 hours or more after the patch has been removed. These symptoms can be severe and may require medical intervention. Some symptoms may be related to adaptation from a motion environment to a motion-free environment. These symptoms can be severe and may require medical intervention. The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying. Scopolamine should be used with caution in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol. Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
In vitro studies indicated that the potential for scopolamine to alter the pharmacokinetics of other concomitant medications through inhibition of CYP 1A2, 2C8, 2C9, 2C19, 2D6 and 3A4 or induction of CYP 1A2 and 3A4 is low; however, in vivo studies have not been conducted. 8.1 Pregnancy Pregnancy Category C Based on data from one prospective study of Transderm Scōp in cesarean delivery, the rate of newborn adverse events in both the Transderm Scōp and placebo groups were the same.
The rates were 10.5% (12 events in 114 newborns) in both treatment groups. None of these events were considered life threatening or drug related.
Jaundice was the only adverse event occurring more frequently with Transderm Scōp than placebo: 9 events (7.9%) versus 2 events (1.8%) (p=0.031). Jaundice, a common occurrence in newborns, resolved with ultraviolet light and did not prolong the hospital stay. There are no adequate and well-controlled studies of Transderm Scōp use during pregnancy.
In animal reproduction studies, when pregnant rats and rabbits received scopolamine hydrobromide by daily intravenous injection, no adverse effects were observed in rats. An embryotoxic effect was observed in rabbits at doses producing plasma levels approximately 100 times the levels achieved in humans using a transdermal system. Transderm Scōp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and the mother. 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 Transderm Scōp ® patch 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.
Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scōp system is a film 0.2 mm thick and 2.5 cm 2, 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, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of 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, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system. Cross section of the system.
12.1 Mechanism of Action 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. 12.3 Pharmacokinetics The pharmacokinetics of scopolamine delivered via the system are due to the characteristics of both the drug and dosage form.
The system is formulated to deliver in-vivo approximately 1 mg of scopolamine at an approximately constant rate to the systemic circulation over 3 days. Upon application to the postauricular skin, an initial priming dose of scopolamine is released from the adhesive layer to saturate skin-binding sites. The subsequent delivery of scopolamine to the blood is determined by the rate controlling membrane and is designed to produce stable plasma levels in a therapeutic range. Following removal of the used system, there is some degree of continued systemic absorption of scopolamine bound in the skin layers. Absorption Scopolamine is well absorbed percutaneously. Following application to the skin behind the ear, circulating plasma levels are detected within 4 hours with peak levels being obtained, on average, within 24 hours.
The average plasma concentration produced is 87 pg/mL (0.28 nM) for free scopolamine and 354 pg/mL for total scopolamine (free + conjugates). Distribution The distribution of scopolamine is not well characterized. It crosses the placenta and the blood brain barrier and may be reversibly bound to plasma proteins. Metabolism and Excretion The exact elimination pattern of scopolamine has not been determined. Following patch removal, plasma levels of scopolamine decline in a log linear fashion with an observed half-life of 9.5 hours.
Less than 10% of the total dose is excreted in the urine as the parent drug and metabolites over 108 hours. Scopolamine is extensively metabolized and conjugated with less than 5% of the total dose appearing unchanged in the urine. The enzymes responsible for metabolizing scopolamine are unknown. Drug Interaction An in vitro study using human hepatocytes examined the induction of CYP1A2 and CYP3A4 by scopolamine. Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymes at the concentrations up to 10 nM. In an in vitro study using human liver microsomes which evaluated the inhibition of CYP1A2, 2C8, 2C9, 2C19, 2D6 and 3A4, scopolamine did not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1 mcM.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been conducted to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated. Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system). However, fertility studies in male animals were not performed.
14.2 Post-Operative Nausea and Vomiting In two pivotal clinical efficacy studies in 391 adult female patients undergoing cesarean section or gynecological surgery with anesthesia and opiate analgesia, 66% of those treated with Transderm Scōp ® (compared to only 46% of those receiving placebo) reported no retching/vomiting within the 24-hour period following administration of anesthesia/opiate analgesia. When the need for additional antiemetic medication was assessed during the same period, there was no need for medication in 76% of patients treated with Transderm Scōp as compared to 59% of placebo-treated patients. The Transderm Scōp ® system is a tan-colored circular patch, 2.5 cm 2, on a clear, oversized, hexagonal peel strip, which is removed prior to use. Each Transderm Scōp system contains 1.5 mg of scopolamine and is formulated to deliver in-vivo approximately 1 mg of scopolamine over 3 days. Transderm Scōp is available in packages of four patches. Each patch is foil wrapped.
Patient instructions are included. 1 Package (4 patches) NDC 0067-4345-04 Storage The system should be stored at controlled room temperature between 20°C-25°C (68°F-77°F).
Handling Since 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.
, and ). See FDA-approved patient labeling (Patient Information) Please read this instruction sheet carefully before opening the system package. Transderm Scōp ® Transdermal System Generic Name: scopolamine, pronounced skoe-POL-a-meen. Elderly patients should be informed that Transderm Scōp may cause a greater likelihood of CNS effects, such as hallucinations, confusion, dizziness and drug withdrawal syndrome and to seek immediate medical care if they become confused, disoriented or dizzy while wearing the patch or after removing.
Patients should be informed that since Transderm Scōp may cause drowsiness, disorientation and confusion they should avoid engaging in activities that require mental alertness such as driving a motor vehicle or operating dangerous machinery. Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of Transderm Scop. Because of the possibility of drowsiness, disorientation and confusion, patients should be informed that they should avoid drinking alcohol. PATIENT INFORMATION Transderm Scōp®, pronounced tran(t)s-derm skōp (scopolamine) transdermal system patch Read this Patient Information before you start using Transderm Scōp® and each time you get a refill.
There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is Transderm Scōp ®? The Transderm Scōp® patch is a prescription medicine used for adults to:. help prevent nausea and vomiting from motion sickness.
help prevent nausea and vomiting from anesthesia or taking opioid pain medicines after surgery It is not known if Transderm Scōp® is safe or effective in children. Who should not use Transderm Scōp ®? Do not use Transderm Scōp ® if you:. have an eye problem called angle closure glaucoma. if you are allergic to any of the ingredients in Transderm Scōp® or other medicines called belladonna alkaloids. See the end of this leaflet for a list of the ingredients in Transderm Scōp®.
Ask your doctor if you are not sure. What should I tell my doctor before using Transderm Scōp ®? Before you use Transderm Scōp®, tell your doctor if you:. are scheduled to have a gastric secretion test. have glaucoma (increased pressure in the eye). have liver or kidney problems. have problems with your stomach or intestines.
have trouble urinating. have a history of seizures or psychosis. have any other medical conditions. are pregnant or plan to become pregnant. It is not known if Transderm Scōp® can harm your unborn baby. are breast-feeding or plan to breast-feed. Transderm Scōp® can pass into your breast milk and may harm your baby.
Talk to your doctor about the best way to feed your baby if you use Transderm Scōp®. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Transderm Scōp® may affect the way other medicines work, and other medicines may affect how Transderm Scōp® works. Medicines that you take by mouth may not be absorbed well while you use Transderm Scōp®. Especially tell your doctor if you take:. a sedative or tranquilizer (medicines that make you sleepy).
an antidepressant medicine. an anticholinergic medicine, such as an allergy or cold medicine, a medicine to treat bladder or bowel spasms, certain asthma medicines, or other medicines for motion sickness. Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take.
Keep a list of them and show it to your doctor or pharmacist when you get a new medicine. How should I use Transderm Scōp ®? Use Transderm Scōp ® exactly as your doctor tells you to use it.
Transderm Scōp ® is a tan-colored circle shaped patch. Wear only one patch at any time. Do not cut the patch. To help prevent nausea and vomiting from motion sickness:. Apply one Transderm Scōp® patch to your skin on a hairless area behind one ear at least 4 hours before the activity to prevent nausea and vomiting. If the treatment is needed for longer than 3 days, remove the patch from the hairless area behind your ear. Get a new Transderm Scōp® patch and place it on the hairless area behind your other ear.
To help prevent nausea and vomiting after surgery:. Follow your doctor’s instructions about when to apply Transderm Scōp® before your scheduled surgery. The Transderm Scōp® patch should be left in place for 24 hours after surgery.
After 24 hours the patch should be removed and thrown away. Apply Transderm Scōp® as follows: Inside the Transderm Scōp® package, you will find one Transderm Scōp® patch. A tan colored patch with a metallic (silver) sticky surface is adhered to a clear disposable backing (See Figure 1). After removing the patch, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Note that the used patch will still contain some of the active ingredient after use. To avoid accidental contact or ingestion by children or pets, fold the used patch in half with the sticky side together. Dispose in the trash out of the reach of children and pets.
If you use too much Transderm Scōp®, call your doctor or local poison control center, or go to the nearest hospital emergency room right away. What should I avoid while using Transderm Scōp ®?. You should not drink alcohol while using Transderm Scōp®. 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 Transderm Scōp® affects you. You should not use Transderm Scōp® during a Magnetic Resonance Imaging scan (MRI). Remove Transderm Scōp® patch before undergoing an MRI; it can cause your skin to burn.
You should be careful if you use Transderm Scōp® while you participate in watersports because you may feel lost or confused (disoriented). Limit contact with water while swimming and bathing because the Transderm Scōp® patch may fall off. If the patch falls off, throw it away and apply a new one on the hairless area behind your other ear. What are the possible side effects of Transderm Scōp ®? Transderm Scōp ® may cause serious side effects, including:.
angle closure glaucoma. If you have open angle glaucoma and use Transderm Scōp®, remove the patch and call a doctor right away if you get pain and reddening of your eyes with an increase in the size of your pupil (the small dark circle in the eye). temporary increase in the size of your pupil and blurry vision, especially if Transderm Scōp® comes in contact with your eyes. difficulties in urinating. difficulties in food passing from the stomach to the small intestines, which may cause abdominal pain, nausea or vomiting.
worsening of seizures. Tell your doctor about any worsening of seizures while using Transderm Scōp®. an unusual reaction called acute psychosis: Tell your doctor if you have any of these symptoms:. confusion.
agitation. rambling speech. hallucinations (seeing or hearing things that are not there). paranoid behaviors and delusions (false belief in something). skin burns at the site of the patch.
This can happen during a medical test called a Magnetic Resonance Imaging scan (MRI). Transderm Scōp® contains aluminum and should be removed from your skin before you have an MRI.
The most common side effects of using Transderm Scōp® include:. dry mouth. drowsiness. disorientation (confusion). blurred vision.
pharyngitis. memory trouble. dizziness. restlessness.
agitation. problems urinating. skin rashes or redness, application site burning.
dry itchy, or reddened whites of the eyes, and eye pain Symptoms when removing Transderm Scōp ®. Some people may have certain symptoms 24 hours or more after removing Transderm Scōp®. These symptoms may include:. dizziness. nausea. vomiting.
headache. problems with balance and walking. decrease in blood pressure.
muscle weakness. decrease in heart rate Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Transderm Scōp®. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may reports side effects to FDA at 1-800-FDA-1088.
How should I store Transderm Scōp®?. Store Transderm Scōp® at room temperature between 68°F and 77°F (20°C and 25°C) until you are ready to use it. Keep Transderm Scōp® and all medicines out of reach of children.
General Information about Transderm Scōp ® Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Transderm Scōp® for a condition for which it was not prescribed. Do not give Transderm Scōp® to other people, even if they have the same symptoms you have. It may harm them. This patient information leaflet summarizes the most important information about Transderm Scōp®.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Transderm Scōp® that is written for the health professionals. For more information, go to www. Transdermscop.com or call 1-800-452-0051. What are the ingredients in the Transderm Scōp ® patch? Active ingredient: Scopolamine Inactive ingredients: light mineral oil and polyisobutylene and aluminized polyester film Manufactured by: ALZA Corporation Vacaville, CA 95688 Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ ©2013.
Scopolamine is a viscous liquid that has a molecular weight of 303.35 and a pKa of 7.55-7.81. The Transderm Scōp system is a film 0.2 mm thick and 2.5 cm 2, 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, light mineral oil, and polyisobutylene; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) an adhesive formulation of 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, light mineral oil (12.4 mg) and polyisobutylene (11.4 mg), are not released from the system. Cross section of the system. Pharmacology The sole active agent of Transderm Scōp is scopolamine, a belladonna alkaloid with well-known pharmacological properties.
It is an anticholinergic agent which 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 1,2. 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 2.
Pharmacokinetics Scopolamine’s activity is due to the parent drug. The pharmacokinetics of scopolamine delivered via the system are due to the characteristics of both the drug and dosage form. The system is programmed to deliver in-vivo approximately 1.0 mg of scopolamine at an approximately constant rate to the systemic circulation over 3 days. Upon application to the post-auricular skin, an initial priming dose of scopolamine is released from the adhesive layer to saturate skin binding sites. The subsequent delivery of scopolamine to the blood is determined by the rate controlling membrane and is designed to produce stable plasma levels in a therapeutic range.
Following removal of the used system, there is some degree of continued systemic absorption of scopolamine bound in the skin layers. Absorption: Scopolamine is well-absorbed percutaneously. Following application to the skin behind the ear, circulating plasma levels are detected within 4 hours with peak levels being obtained, on average, within 24 hours. The average plasma concentration produced is 87 pg/mL for free scopolamine and 354 pg/mL for total scopolamine (free + conjugates).
Distribution: The distribution of scopolamine is not well characterized. It crosses the placenta and the blood brain barrier and may be reversibly bound to plasma proteins. Metabolism: Although not well characterized, scopolamine is extensively metabolized and conjugated with less than 5% of the total dose appearing unchanged in the urine. Elimination: The exact elimination pattern of scopolamine has not been determined. Following patch removal, plasma levels decline in a log linear fashion with an observed half-life of 9.5 hours. Less than 10% of the total dose is excreted in the urine as parent and metabolites over 108 hours.
Clinical Results: In 195 adult subjects of different racial origins who participated in clinical efficacy studies at sea or in a controlled motion environment, there was a 75% reduction in the incidence of motion-induced nausea and vomiting 3. In two pivotal clinical efficacy studies in 391 adult female patients undergoing cesarean section or gynecological surgery with anesthesia and opiate analgesia, 66% of those treated with Transderm Scōp (compared to only 46% of those receiving placebo) reported no retching/vomiting within the 24-hour period following administration of anesthesia/opiate analgesia. When the need for additional antiemetic medication was assessed during the same period, there was no need for medication in 76% of patients treated with Transderm Scōp as compared to 59% of placebo-treated patients 4, 5.
Glaucoma therapy in patients with chronic open-angle (wide-angle) glaucoma should be monitored and may need to be adjusted during Transderm Scōp use, as the mydriatic effect of scopolamine may cause an increase in intraocular pressure. Transderm Scōp should not be used in children and should be used with caution in the elderly. See PRECAUTIONS. Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, patients should be warned of the possibility and cautioned against engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery. Rarely, idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine. The most serious of these that have been reported are: acute toxic psychosis, including confusion, agitation, rambling speech, hallucinations, paranoid behaviors, and delusions.
General Scopolamine should be used with caution in patients with pyloric obstruction or urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or antimuscarinic drug to patients suspected of having intestinal obstruction. Transderm Scōp should be used with caution in the elderly or in individuals with impaired liver or kidney functions because of the increased likelihood of CNS effects.
Caution should be exercised in patients with a history of seizures or psychosis, since scopolamine can potentially aggravate both disorders. Skin burns have been reported at the patch site in several patients wearing an aluminized transdermal systems during a Magnetic Resonance Imaging scan (MRI). Because Transderm Scōp ® contains aluminum, it is recommended to remove the system before undergoing an MRI. Information for Patients Since 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. Patients should be advised to remove the patch immediately and promptly contact a physician in the unlikely event that they experience symptoms of acute narrow-angle glaucoma (pain and reddening of the eyes, accompanied by dilated pupils). Patients should also be instructed to remove the patch if they develop any difficulties in urinating. Patients who expect to participate in underwater sports should be cautioned regarding the potentially disorienting effects of scopolamine. A patient brochure is available. Drug Interactions The absorption of oral medications may be decreased during the concurrent use of scopolamine because of decreased gastric motility and delayed gastric emptying. Scopolamine should be used with care in patients taking other drugs that are capable of causing CNS effects such as sedatives, tranquilizers, or alcohol.
Special attention should be paid to potential interactions with drugs having anticholinergic properties; e.g., other belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been completed to evaluate the carcinogenic potential of scopolamine. The mutagenic potential of scopolamine has not been evaluated.
Fertility studies were performed in female rats and revealed no evidence of impaired fertility or harm to the fetus due to scopolamine hydrobromide administered by daily subcutaneous injection. Maternal body weights were reduced in the highest-dose group (plasma level approximately 500 times the level achieved in humans using a transdermal system). Pregnancy Category C Teratogenic studies were performed in pregnant rats and rabbits with scopolamine hydrobromide administered by daily intravenous injection. No adverse effects were recorded in rats. Scopolamine hydrobromide has been shown to have a marginal embryotoxic effect in rabbits when administered by daily intravenous injection at doses producing plasma levels approximately 100 times the level achieved in humans using a transdermal system.
During a clinical study among women undergoing cesarean section treated with Transderm Scōp in conjunction with epidural anesthesia and opiate analgesia, no evidence of CNS depression was found in the newborns. There are no other adequate and well-controlled studies in pregnant women. Other than in the adjunctive use for delivery by cesarean section, Transderm Scōp should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. The adverse reactions for Transderm Scōp are provided separately for patients with motion sickness and with post-operative nausea and vomiting. Motion Sickness: In motion sickness clinical studies of Transderm Scōp, the most frequent adverse reaction was dryness of the mouth. This occurred in about two thirds of patients on drug. A less frequent adverse drug reaction was drowsiness, which occurred in less than one sixth of patients on drug.
Transient impairment of eye accommodation, including blurred vision and dilation of the pupils, was also observed. Post-operative Nausea and Vomiting: In a total of five clinical studies in which Transderm Scōp was administered perioperatively to a total of 461 patients and safety was assessed, dry mouth was the most frequently reported adverse drug experience, which occurred in approximately 29% of patients on drug. Dizziness was reported by approximately 12% of patients on drug 6. Postmarketing and Other Experience: In addition to the adverse experiences reported during clinical testing of Transderm Scōp, the following are spontaneously reported adverse events from postmarketing experience. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of Transderm Scōp in their causation cannot be reliably determined: acute angle-closure (narrow-angle) glaucoma; confusion; difficulty urinating; dry, itchy, or conjunctival injection of eyes; restlessness; hallucinations; memory disturbances; rashes and erythema; and transient changes in heart rate.
Drug Withdrawal/Post-Removal Symptoms: Symptoms such as dizziness, nausea, vomiting, and headache occur following abrupt discontinuation of antimuscarinics. Similar symptoms, including disturbances of equilibrium, have been reported in some patients following discontinuation of use of the Transderm Scōp system. These symptoms usually do not appear until 24 hours or more after the patch has been removed. Some symptoms may be related to adaptation from a motion environment to a motion-free environment.
More serious symptoms including muscle weakness, bradycardia and hypotension may occur following discontinuation of Transderm Scōp. 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 Transderm Scōp patch 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.
Most cases of toxicity involving the use of the product will resolve with simple removal of 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 (see Drug Withdrawal/Post Removal Symptoms).
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.
Initiation of Therapy: To prevent the nausea and vomiting associated with motion sickness, one Transderm Scōp patch (programmed to deliver approximately 1.0 mg of scopolamine over 3 days) should be applied to the hairless area behind one ear at least 4 hours before the antiemetic effect is required. To prevent post operative nausea and vomiting, the patch should be applied the evening before scheduled surgery. To minimize exposure of the newborn baby to the drug, apply the patch one hour prior to cesarean section.
Only one patch should be worn at any time. Do not cut the patch.
Handling: After the patch is applied on 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, the hands and the application site should be washed thoroughly with soap and water and dried. (A patient brochure is available). Continuation of Therapy: Should the patch become displaced, it should be discarded, and a fresh one placed on the hairless area behind the other ear.
For motion sickness, if therapy is required for longer than 3 days, the first patch should be removed and a fresh one placed on the hairless area behind the other ear. For perioperative use, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded. The Transderm Scōp system is a tan-colored circular patch, 2.5 cm 2, on a clear, oversized, hexagonal peel strip, which is removed prior to use. Each Transderm Scōp system contains 1.5 mg of scopolamine and is programmed to deliver in-vivo approximately 1.0 mg of scopolamine over 3 days.
Transderm Scōp is available in packages of four patches. Each patch is foil wrapped. Patient instructions are included. 1 Package (4 patches) NDC -1 The system should be stored at controlled room temperature between 20°C-25°C (68°F-77°F). McEvoy, G.K.
(ed.); AHSF Drug Information; American Society of Hospital Pharmacists, Bethesda, MD, pp. 608-611 (1990). Gilman, A.G.
Et al (ed.); The Pharmacological Basis of Therapeutics (8th Ed.); Pergamon Press, New York, NY, pp. 150-165 (1990). Pharmacokinetic Clinical data on file. Kotelko, D.M. Et al; “Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine”, Anesthesiology 71(5): 675-678 (1989).
Bailey, P.L. Et al; “Transdermal scopolamine reduces nausea and vomiting after outpatient laparoscopy”, Anesthesiology 72(6): 977-980 (1990). Clinical safety data on file.
Scopolamine Transdermal Patch Dose
Mfd by: ALZA Corporation Mountain View, CA 94043 Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ ©2006 42013C Printed in U.S.A. 2/06) Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146. Transdermal Therapeutic System The Transderm Scōp system helps to prevent the nausea and vomiting of motion sickness for up to 3 days. It is a round adhesive patch that you place behind your ear several hours before you travel. It also helps to prevent the nausea and vomiting associated with the use of anesthesia and certain analgesics used during or after many types of surgery.
If the patch is to be used in conjunction with scheduled surgery, it is applied the evening before surgery. For cesarean section, the patch is applied one hour prior to surgery to minimize exposure of the unborn child to the drug. Wear only one patch at any time. Be sure to wash your hands thoroughly with soap and water immediately after handling the patch, so that any drug that might get on your hands will not come into contact with your eyes. Avoid drinking alcohol while using Transderm Scōp.
Also, be careful about driving or operating any machinery while using the system because the drug might make you drowsy. DO NOT USE TRANSDERM SCŌP IF YOU ARE ALLERGIC TO SCOPOLAMINE. TRANSDERM SCŌP SHOULD NOT BE USED IN CHILDREN AND SHOULD BE USED WITH CAUTION IN THE ELDERLY. How the Transderm Scōp System Works A group of nerve fibers deep inside the ear helps people keep their balance.
For some people, the motion of ships, airplanes, trains, automobiles, and buses increases the activity of these nerve fibers. This increased activity causes the dizziness, nausea, and vomiting of motion sickness. People may have one, some, or all of these symptoms. Transderm Scōp contains the drug scopolamine, which helps reduce the activity of the nerve fibers in the inner ear. When a Transderm Scōp patch is placed on the skin behind one of the ears, scopolamine passes through the skin and into the bloodstream. One patch may be kept in place for 3 days if needed. It has been suggested that Transderm Scōp, when used to reduce nausea and vomiting associated with surgical anesthesia or analgesia, acts on the same nerve fibers that are affected when the product is taken for motion sickness.
Side Effects The most common side effect experienced by people using Transderm Scōp is dryness of the mouth. This occurs in about two thirds of the people. A less frequent side effect is drowsiness, which occurs in less than one sixth of the people.
Temporary blurring of vision and dilation (widening) of the pupils may occur, especially if the drug is on your hands and comes in contact with the eyes. On infrequent occasions, disorientation, memory disturbances, dizziness, restlessness, hallucinations, confusion, difficulty urinating, skin rashes or redness, temporary changes in heart rate such as palpitations, dry itchy, or reddened whites of the eyes, and eye pain have been reported. If these effects do occur, remove the patch and call your doctor. Since drowsiness, disorientation, and confusion may occur with the use of scopolamine, be careful driving or operating any dangerous machinery, especially when you first start using the drug system. In addition, if you plan to participate in underwater sports while wearing the patch, you should discuss with your doctor the potentially disorienting effects of scopolamine. Eye Effects: Temporary blurring of vision and dilation (widening) of the pupils may occur, especially if the drug is on your fingers or hands and comes into contact with the eyes.
Dry, itchy, or reddened whites of the eye and eye pain have been reported infrequently. In the unlikely event that you experience pain in the eye and reddened whites of the eye, which may be accompanied by widening of the pupil and blurred vision, remove the patch and consult your doctor promptly. Widening of the pupils and blurred vision without pain, or reddened whites of the eye, is usually temporary and not serious. Drug Withdrawal/Post-Removal Symptoms: Symptoms such as dizziness, nausea, vomiting, headache, and disturbances of equilibrium have been reported by some people following discontinuation of use of the Transderm Scōp patch. These symptoms have occurred most often in people who have used the patches for more than 3 days, and frequently do not appear until 24 hours or more after the patch has been removed.
These symptoms may be associated with adaptation from a motion environment to a motion-free environment. It is recommended that you consult with your doctor if these symptoms persist.
How to Use Transderm Scōp Transderm Scōp should be stored at controlled room temperature between 20°C and 25°C (68°F and 77°F) until you are ready to use it. For the prevention of motion sickness, plan to apply one Transderm Scōp patch at least 4 hours before you need it. If the patch is to be used in conjunction with scheduled surgery, it is applied the evening before surgery.
For cesarean section, the patch is applied one hour prior to surgery to minimize exposure of the unborn child to the drug. Wear only one patch at any time. Do not cut the patch. Select a hairless area of skin behind one ear, taking care to avoid any cuts or irritations. Wipe the area with a clean, dry tissue. Cut along dotted line to open the pouch and then remove the patch (Figure 1). Important: After the patch is in place, be sure to wash your hands thoroughly with soap and water to remove any scopolamine.
Scopolamine Transdermal Patch
If this drug were to come into contact with your eyes, it could cause temporary blurring of vision and dilation (widening) of the pupils (the dark circles in the center of your eyes). Unless accompanied by eye pain and reddened whites of the eyes (see Precautions), this is not serious and your pupils should return to normal. If the patch is being used to prevent the nausea and vomiting of motion sickness, remove the patch after 3 days and throw it away. (You may remove it sooner if you are no longer concerned about motion sickness).
If the patch is being used to prevent nausea and vomiting associated with anesthesia or analgesia, the patch should be kept in place for 24 hours following surgery at which time it should be removed and discarded. After removing the patch, be sure to wash your hands and the area behind your ear thoroughly with soap and water. Since the patch will still contain some active ingredient after use, and to avoid accidental contact or ingestion by children or pets, fold the used patch in half with the sticky side together and dispose in the trash out of the reach of children and pets. If you wish to control the nausea and vomiting of motion sickness for longer than 3 days, remove the first patch after 3 days and place a new one behind the other ear, repeating instructions 2 through 7.
Keep the patch dry, if possible, to prevent it from falling off. Limited contact with water, however, as in bathing or swimming, will not affect the system. In the unlikely event that the patch falls off, throw it away and put a new one behind the other ear. Please inform your doctor if you are taking other medications, including over-the-counter medications. This leaflet presents a summary of information about Transderm Scōp. If you would like more information or if you have any questions, ask your doctor or pharmacist.
A more technical leaflet is available, written for your doctor. If you would like to read the leaflet, ask your pharmacist to show you a copy. You may need the help of your doctor or pharmacist to understand some of the information.
By: ALZA Corporation Mountain View, CA 94043 Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ ©2006 42014C Printed in U.S.A. To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application.
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