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How Transderm-V Prevents Motion Sickness
In some people, motion of ships, airplanes, trains, automobiles and buses increasese activity of the nerve fibers of the inner ear, which are part of the body's balance mechanism. The result is motion sickness, which is characterized by dizziness, nausea and vomiting. A person suffering from motion sickness may experience one, all or any combination of these symptoms. Scopolamine is an effective medication for the prevention of nausea and vomiting because it reduces the activity of the nerve fibers in the inner ear and acts on the motion sickness centres in the brain.
Transderm-V is a small flexible adhesive disc. When placed behind the ear, it delivers scopolamine to the skin surface from where it is absorbed into the bloodstream over a prolonged period of up to 3 days.
Adults: To obtain optimum effect, Transderm-V should be applied to a dry, hairless area of post-auricular skin approximately 12 hours before the antiemetic effect is required. Only 1 disc should be worn at any time. Should the disc become displaced, it should be discarded and a fresh one placed on a different skin site.
Scopolamine provides protection over a 3 day period. If the disc is only needed for a shorter time, it should be removed at the end of the journey.
If therapy is required for longer periods, the first disc should be removed after 72 hours and a second disc applied behind the other ear. Usage is not recommended for periods exceeding six consecutive days. If you require usage for longer than six days, please consult your doctor.
Children: Scopolamine should not be used in children (see Precautions).
Transderm-V is designed to deliver in vitro 1 mg scopolamine at a constant rate over the 3 day functional lifetime. An initial priming dose of scopolamine, released from the adhesive layer of the system, saturates the skin binding sites for the drug and brings the plasma concentration to the required steady state level. Subsequently, there is continuous controlled release of scopolamine, from the drug reservoir through the rate-controlling membrane.
Handling: After the disc is applied on dry skin behind the ear, the hands should be washed thoroughly with soap and water, then dried. Once the disc has been affixed, it should not be touched again while it is being worn. Upon removal, the disc should be carefully discarded, and the hands and application site washed thoroughly with soap and water to prevent traces of scopolamine from coming in direct contact with the eyes. If scopolamine were to contact the eyes it could cause slight temporary blurring of vision and dilation of the pupils (sometimes in one eye only).
Known hypersensitivity to scopolamine or any components of the system.
Glaucoma or a predisposition to angle-closure glaucoma (see Warnings).
Warnings in Clinical States:
Occupational Hazards: Since drowsiness, disorientation and confusion may occasionally occur with the use of scopolamine, patients should be cautioned about engaging in activities that require mental alertness, such as driving a motor vehicle or operating dangerous machinery.
Potentially alarming idiosyncratic reactions may occur with ordinary therapeutic doses of scopolamine.
In patients with a history of possible raised intraocular pressure (pressure pain, blurred vision, glaucomatous halo), scopolamine should be employed only after ophthalmological examination excludes glaucoma (see Contraindications).
Scopolamine should be discontinued if it causes blurring of vision with pressure pain within the eye (see Contraindications).
Scopolamine should be used with caution in patients with dysuria, e.g., due to urinary bladder neck obstruction. Caution should be exercised when administering an antiemetic or antimuscarinic drug to patients suspected of having intestinal obstruction, e.g., pyloric stenosis.:
Scopolamine should be used with caution in the elderly or in individuals with impaired metabolic, liver or kidney functions.
In certain cases, especially in the elderly, confusional states and/or visual hallucinations may occur. Should this occur, scopolamine should be removed at once. If severe symptoms persist, appropriate countermeasures should be taken (see Overdose: Symptoms and Treatment).
In epileptic patients, isolated cases of increased seizure frequency have been reported.
Children: Children are particularly susceptible to the side effects of belladonna alkaloids. Transderm-V should not be used in children because it is not known whether the amount of scopolamine released could produce serious adverse effects in children.
Pregnancy: Scopolamine should be used during pregnancy only if the anticipated benefit justifies the potential risk to the mother and fetus.
Lactation: Scopolamine should not be administered to nursing mothers since it is excreted into breast milk.
Drug Interactions :
Scopolamine should be employed with caution in patients taking drugs which act on the CNS. This applies particularly to patients under treatment with drugs displaying anticholinergic properties, for example, belladonna alkaloids, antihistamines, antidepressants (tricyclics and MAO inhibitors), phenothiazines, amantadine and quinidine.
Any parasympatholytic or sympathomimetic agent or barbiturate should be administered with caution to persons wearing scopolamine.
Patients should refrain from consuming alcohol while using scopolamine. Alcohol may interfere with the metabolism of the drug and could thus cause plasma levels to become elevated, which could intensify the side effects.
Information for the Patient: 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 disc and to avoid touching the disc while in place behind the ear.
Patients should be advised to remove the disc and contact a physician promptly in the unlikely event that they experience symptoms of angle-closure glaucoma (pain in and reddening of the eyes accompanied by dilated pupils).
Patients should be instructed to remove the disc if they develop difficulty urinating.
Patients should be advised to refrain from consuming alcohol while using scopolamine.
Patients should be warned against driving a motor vehicle or operating dangerous machinery.
A patient leaflet is supplied with the discs.
Gastrointestinal: Frequent: transient dryness of the mouth.
Ophthalmic: Frequent: transient impairment of eye accommodation (cycloplegia), including blurred (near) vision and dilatation of the pupils (sometimes in one eye only), especially if traces of active substance on the hands enter the eyes. Occasional: irritation of the eyelids. Isolated cases: dilatation of the pupils may provoke acute glaucoma, especially angle-closure glaucoma.
CNS: Occasional: drowsiness. Rare: impairment of memory and concentration, restlessness, giddiness, dizziness, disorientation, confusion and hallucinations.
Dermatological: Occasional: local irritation of the skin. Isolated cases: generalized skin rash.
Genitourinary: Rare: disturbances of micturition (retention of urine).
Cardiovascular: Isolated cases: slight variations in blood pressure.
Adverse Effects after Withdrawal of Scopolamine: In certain instances, there have been complaints of transient dizziness, nausea, vomiting, headache and disturbances of balance following discontinuation of scopolamine, usually after several days of use.