Scopolamine (transdermal route)


    Brand Name

    US Brand Name

    Transderm Scop

    Canadian Brand Name

    Transderm-V


    Description

    Scopolamine transdermal patch is used to prevent nausea and vomiting after anesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness.

    Scopolamine belongs to the group of medicines called anticholinergics. It works on the central nervous system (CNS) to create a calming effect on the muscles in the stomach and bowels (gut).

    This medicine is available over-the-counter (OTC) or with a doctor's prescription.

    This product is available in the following dosage forms:

    • Patch, Extended Release

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of scopolamine transdermal patch in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies on the relationship of age to the effects of scopolamine transdermal patch have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of scopolamine transdermal patch in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, or unwanted effects (including hallucinations, confusion, dizziness), which may require caution in patients receiving scopolamine transdermal patch.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Potassium Citrate

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Aclidinium
    • Alfentanil
    • Alprazolam
    • Amantadine
    • Amifampridine
    • Amitriptyline
    • Amobarbital
    • Amoxapine
    • Anileridine
    • Atropine
    • Baclofen
    • Belladonna
    • Benzhydrocodone
    • Benztropine
    • Biperiden
    • Bromazepam
    • Brompheniramine
    • Buprenorphine
    • Bupropion
    • Buspirone
    • Butabarbital
    • Butorphanol
    • Calcium Oxybate
    • Carbinoxamine
    • Carisoprodol
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorpheniramine
    • Chlorpromazine
    • Chlorzoxazone
    • Clemastine
    • Clidinium
    • Clobazam
    • Clomipramine
    • Clonazepam
    • Clorazepate
    • Clozapine
    • Codeine
    • Cyclobenzaprine
    • Cyclopentolate

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Glaucoma, narrow-angle—Should not be used in patients with this condition.
    • Glaucoma, open-angle (wide-angle) or
    • Increased pressure in the eye or
    • Problems with urination (eg, urinary tract blockage or trouble urinating) or
    • Psychosis (mental illness), history of or
    • Seizures, history of or
    • Stomach or bowel blockage—Use with caution. May make these conditions worse.
    • Liver disease or
    • Kidney disease—Use has not been studied in patients with these conditions.

    Proper Use

    Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

    This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, breasts, or genital area. Do not use it on skin areas that have cuts, scrapes, burns, scars, on irritated skin, or on recently shaved skin. If it does get on these areas, rinse it off right away.

    To use the Transderm Scop® patch:

    • Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
    • Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
    • Apply the patch to a clean, dry, and intact skin area behind your ear. Choose an area with little or no hair and free of scars, cuts, pain, tenderness, or irritation.
    • Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
    • The patch should stay in place even during showering, bathing, or swimming. Apply a new patch behind the other ear if the first one becomes too loose or falls off.
    • Only one patch should be used at any time.
    • Remove the patch after 3 days. If treatment is to be continued for more than 3 days, remove the first patch and apply a new one behind the opposite ear.

    To use the scopolamine extended-release skin patch:

    • Wash your hands with soap and water before and after applying the patch.
    • Cut the package along the dashed line to open. Remove the clear plastic backing from the tan-colored round patch.
    • Do not touch the metallic adhesive (sticky) side of the patch with your hands. Apply the patch to clean, dry skin behind your ear. The imprinted, tan colored side of the patch should be facing up.
    • If the patch falls off, put on a new patch.
    • Remove the patch after 3 days and put on a new patch. After you remove the old patch, fold it in half with sticky sides together.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For transdermal dosage form (patch):
      • For prevention of nausea and vomiting after anesthesia, narcotic pain medicine, and surgery:
        • Adults—Apply one patch behind the ear the evening before surgery. Leave it in place for 24 hours.
        • Children—Use is not recommended.
      • For prevention of nausea and vomiting from motion sickness:
        • Adults—Apply one patch behind the ear at least 4 hours before the effect is needed, for up to 3 days.
        • Children—Use is not recommended.

    Missed Dose

    If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

    Do not bend or roll the scopolamine extended-release skin patch.


    Precautions

    Your doctor may want to check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to use it.

    This medicine may increase the pressure in the eye, which may lead to acute angle-closure glaucoma. Check with your doctor right away if you have eye pain or discomfort, blurred vision, or halos around lights.

    This medicine can temporarily increase the size of your pupil and cause blurry vision if it comes in contact with your eyes. It may also cause problems with urination. If any of these reactions occur, call your doctor right away.

    This medicine may cause drowsiness, dizziness, confusion, or trouble seeing clearly. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If you plan to participate in underwater sports, you may feel lost or confused (disoriented). Talk with your doctor if you have concerns.

    If you develop any unusual or strange thoughts and behavior while using scopolamine transdermal patch, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol. Other changes may be confusion, delusions, hallucinations (seeing, hearing, or feeling things that are not there), and unusual excitement, nervousness, or irritability.

    This medicine may cause seizures in pregnant women with severe preeclampsia (pregnancy with high blood pressure and high protein levels in the urine or organ problems). Talk to your doctor if you have concerns.

    Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. The patch contains aluminum, which can cause skin burns at the application site during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

    Scopolamine transdermal will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

    Scopolamine transdermal may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Agitation

    Less common

    • Bigger, dilated, or enlarged pupils (black part of the eye)
    • blurred vision or other changes in vision
    • confusion
    • increased sensitivity of the eyes to light

    Incidence not known

    • Burning feeling while urinating
    • delusions of persecution, mistrust, suspiciousness, or combativeness
    • difficulty in speaking
    • disturbance in attention
    • dry, itchy eyes
    • eyelid irritation
    • headache
    • loss of memory
    • poor coordination
    • problems with memory
    • restlessness
    • seeing, hearing, or feeling things that are not there

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Anxiety
    • blurred or loss of vision
    • change in consciousness
    • decrease in frequency of urination
    • decrease in urine volume
    • deep or fast breathing with dizziness
    • difficulty in passing urine (dribbling)
    • disturbed color perception
    • double vision
    • dry mouth
    • dry, flushed skin
    • fast, pounding, or irregular heartbeat or pulse
    • halos around lights
    • headache
    • irritability
    • loss of consciousness
    • nervousness
    • night blindness
    • numbness of the feet, hands, and around the mouth
    • overbright appearance of lights
    • painful urination
    • pounding in the ears
    • seizures
    • shaking
    • sleepiness
    • trouble with sleeping
    • tunnel vision
    • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Dizziness
    • dry mouth
    • sleepiness or unusual drowsiness

    Less common

    • Body aches or pain
    • cough
    • dryness or soreness of the throat
    • fever
    • hoarseness
    • stuffy or runny nose
    • tender, swollen glands in the neck
    • trouble in swallowing
    • voice changes

    More common

    • Burning feeling at the application site
    • feeling of constant movement of self or surroundings
    • itching, skin rash
    • lightheadedness
    • sensation of spinning

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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