Isopto Hyoscine

Scopolamine is a prescription medication used to prevent the nausea and vomiting of motion sickness. 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.

Scopolamine belongs to a group of drugs called anticholinergic medications, which help block the activity of certain nerve fibers in the brain that would otherwise trigger the sensation of nausea or vomiting

This medication comes in patch form and is applied behind the ear once every three days.

Common side effects of scopolamine include dry mouth, blurry vision, dizziness, and drowsiness. Do not drive or operate heavy machinery until you know how scopolamine affects you.

Scopolamine is a prescription medication used to prevent the nausea and vomiting of motion sickness for up to 3 days. 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• A-S Medication Solutions LLC

• Alcon Laboratories, Inc.

• Alcon Laboratories, Ophthalmic Div.

• Physicians Total Care, Inc.

• Southwood Pharm., Inc.

Serious side effects have been reported with scopolamine. See the “Scopolamine Precautions” section.

Common side effects of scopolamine include the following:

• dry mouth
• blurry vision
• drowsiness
• dizziness
• disorientation
• memory disturbances
• restlessness
• hallucinations
• confusion
• difficulty urinating
• skin rashes or redness
• temporary changes in heart rate such as palpitations

This is not a complete list of scopolamine side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alcohol
• barbiturates such as secobarbital (Seconal), amobarbital (Amytal), pentobarbital (Nembutal), butabarbital (Butisol), and phenobarbital (Luminal)
• antipsychotics such as haloperidol (Haldol), clozapine (Clozaril), and risperidone (Risperdal)
• antihistamines such as meclizine (Antivert, Bonine, Dramamine, Verticalm), diphenhydramine (Benadryl), desloratadine (Clarinex), olopatadine (Pataday, Patanol), and azelastine (Astelin, Astepro)
• other anticholinergics such as atropine (Atropen, Sal-Tropine, Ocu-Tropine), oxybutynin (Ditropan), hyoscyamine (Levsinex), solifenacin (Vesicare), and trospium (Sanctura)
• benzodiazepines such as alprazolam (Xanax), diazepam (Valium), temazepam (Restoril), and triazolam (Halcion)
• monoamine oxidase (MAO) blockers such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) or tranylcypromine (Parnate)
• muscle relaxants such as carisoprodol (Soma), dantrolene (Dantrium), metaxalone (Skelaxin), cyclobenzaprine (Flexeril, Amrix), tizanidine (Zanaflex), and methocarbamol (Robaxin)

This is not a complete list of scopolamine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with scopolamine including the following:

• 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.
• drug withdrawal/post-removal symptoms: Symptoms such as dizziness, nausea, vomiting, headache, and disturbances of equilibrium have been reported by some people following stopping use of the scopolamine 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.
• skin burn. This has been reported at the patch site in several patients wearing aluminized transdermal systems during a Magnetic Resonance Imaging (MRI) scan. Because scopolamine contains aluminum, it is recommended to remove the system before undergoing an MRI.

Scopolamine can cause blurry vision, dizziness, and drowsiness. Do not drive or operate heavy machinery until you know how scopolamine affects you.

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.

Scopolamine should not be used in children. The safety of its use in children has not been determined. Children and the elderly may be particularly sensitive to the effects of scopolamine.

Do not take scopolamine if you:

• are allergic to scopolamine or to any of its ingredients
• are allergic to medications that contain belladonna alkaloids such as Donnatal tablets and elixir, PB Hyos elixir, Quadrapax elixir, Lomotil, atropine (Atropen, Sal-Tropine, Ocu-Tropine), and hyoscyamine (Levsinex)
• have angle-closure (narrow angle) glaucoma

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of scopolamine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking scopolamine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to scopolamine or to any of its ingredients
• are allergic to medications that contain belladonna alkaloids such as Donnatal tablets and elixir, PB Hyos elixir, Quadrapax elixir, Lomotil,  atropine (Atropen, Sal-Tropine, Ocu-Tropine), and hyoscyamine (Levsinex)
• have (or have had) glaucoma (increased pressure in the eyeball) or a predisposition to glaucoma
• have (or have had) any metabolic, heart, liver, kidney, or other serious medical conditions
• are scheduled for Magnetic Resonance Imaging (MRI) scan
• have any obstruction of the stomach or intestine
• have any trouble urinating due to prostate enlargement or any bladder obstruction
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Scopolamine falls into category C. In animals studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with scopolamine, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Scopolamine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from this medication, a choice should be made whether to stop nursing or to stop use of scopolamine. The importance of the drug to the mother should be considered.

Take scopolamine exactly as prescribed.

This medication comes in patch form and is applied behind the ear once every three days. Wear only one patch at a time.

Alcohol may intensify some of the side effects of this medication.

Scopolamine should not be used in children. The safety of its use in children has not been determined. Children and the elderly may be particularly sensitive to the effects of scopolamine.

If the patch is to be worn for motion sickness, place behind your ear several hours before you travel.

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.

How to apply the patch:

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.

1. For the prevention of motion sickness, plan to apply one scopolamine 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.
2. 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.
3. Cut along dotted line to open the pouch and then remove the patch.
4. Remove the clear plastic six-sided backing from the round patch. Try not to touch the adhesive surface on the patch with your hands.
5. Firmly apply the adhesive surface (metallic side) to the dry area of skin behind the ear so that the tan-colored side is showing. Make good contact, especially around the edge. Once you have placed the patch behind your ear, do not move it for as long as you want to use it (e.g., up to 3 days for prevention of motion sickness).
6. Important: After the patch is in place, be sure to wash your hands thoroughly with soap and water to remove any scopolamine. 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.
7. 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.
8. 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.
9. 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.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of scopolamine at the same time.

Take scopolamine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The scopolamine dose your doctor recommends will be based on the condition being treated.

The recommended dose range for 1 patch worn for up to 3 days. Wear only one patch at a time. Remove old patch before replacing with a new one.

If you take too much scopolamine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store scopolamine at room temperature between 20°C and 25°C (68°F and 77°F) until you are ready to use it.

Keep this and all medicines out of the reach of children.