 Your Prescription to Prevent Motion Sickness |
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Prescribing Information
Description The hydrobromide of an alkaloid, l-scopolamine (hyoscine), this compound combines the base (scopine) with D-tropic acid. Obtained from plants of the Solanaceae family, it is one of the belladonna alkaloids related to atropine. It is freely soluble in water (1:1.5) and soluble in alcohol (1:20). Scopolamine, an anticholinergic drug, is a primary central depressant with marked sedative and tranquilizing properties; like atropine, it is a mydriatic. Scopolamine hydrobromide occurs as colorless or white crystals or as white granular powder. It is odorless and slightly efflorescent in dry air. Each soluble tablet contains 0.4 mg scopolamine hydrobromide 3H2O. The chemical name of scopolamine hydrobromide is [6 beta, 7 beta-epoxy-1 alpha H, 5 alpha H-tropan-3 alpha-ol(-)-tropate (ester) hydrobromide; hyoscine hydrobromide]. Clinical Pharmacology The official variety of levoscopolamine is paralyzant to peripheral ends of the parasympathetic nerves, acting in this respect like atropine, although less powerfully. It dilates the pupil, causes dryness of the throat and skin, accelerates heart action, etc. As a mydriatic, it is much quicker and less lasting in its effects than atropine and is used to paralyze accommodation in correcting errors of refraction. It differs strikingly from atropine, however, in that it does not stimulate the medullary centers and therefore does not increase respiration or elevate blood pressure; also, it frequently appears to act as a cerebral depressant and tends to promote sleep. In some persons, the sleep it produces is attended with a kind of low muttering delirium recalling the mental confusion seen in atropine poisoning; this effect may be observed in a patient with pain. A striking effect of large doses of scopolamine is the loss of memory for events which happened while the patient was under the influence of the drug. It has been reported that scopolamine has slight analgesic properties and greatly as morphine or urethan. In large doses, it is depressant to the respiratory center and, apparently, also in some degree to motor ganglia of the spinal cord. Indications and Usage SCOPACE is used as an anticholinergic central-nervous system depressant; in the symptomatic treatment of postencephalitic parkinsonism and paralysis agitans; in spastic states; and, locally as a substitute for atropine in ophthalmology. SCOPACE inhibits excessive motility and hypertonus of the gastrointestinal tract in such conditions as the irritable colon syndrome, mild dysentery, diverticulitis, pylorospasm, and cardiospasm. It may also prevent motion sickness. Warnings 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. Contraindications Scopolamine is contraindicated in the presence of narrow-angle glaucoma, prostatic hypertrophy, and pyloric obstruction. It should not be administered to patients with impaired renal or hepatic function, to those who have an idiosyncrasy to anticholinergic drugs, or to those who are allergic to scopolamine, bromide, or hydrobromide. Precautions General Precautions- Use with caution in patients with cardiac disease and in the elderly. Usage in Pregnancy-Pregnancy Category C- Animal reproductions studies have not bee conducted with scopolamine hydrobromide. It is also not known whether the Scopace can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Scopolamine hydrobromide should be given to a pregnant woman only if clearly needed. Nursing Mothers-It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when scopolamine hydrobromide is administered to a nursing woman. Usage in Children-Safety and effectiveness in children have not been established. Drug Interactions Scopolamine should be used with care in patients taking drugs, including alcohol, capable of causing CNS effects. Special attention should be given to drugs having anticholinergic properties, e.g. belladonna alkaloids, antihistamines (including meclizine), and antidepressants. Adverse Reactions Side effects are similar to those of atropine i.e., dry mouth, flushing, tachycardia, mydriasis, blurred vision, or urinary retention by taking Scopace. Dryness of the mouth (xerostomia) should be avoided as it may cause tooth decay or other dental problems over time. In susceptible individuals, there may be dryness of the skin and other signs and symptoms typical of anticholinergic drugs. Many persons are excessively susceptible to scopolamine, and toxic symptoms may occur; such symptoms are often very alarming. There are marked disturbances of the intellect, ranging from complete disorientation to an active delirium resembling that encountered in atropine poisoning. Many cases present marked somnolence, but in others this may be lacking. At times the pupils are dilated, the pulse rate is accelerated, and there is dryness of the mouth with a husky quality of the voice apparently due to laryngeal paralysis; these symptoms are often absent or very mild. Overdosage In addition to the adverse reactions listed above, overdoses may cause delirium, fever, stupor, coma, respiratory failure, and death. The antidote is physostigmine, which may be given in repeated doses if the patient lapses into coma again within one to two hours. Scopolamine (Scopace) occasionally acts as an excitant that may cause delirium, especially in painful conditions. Administration and Dosage The dosage range for scopolamine is 0.4 to 0.8 mg. The dosage may be cautiously increased in parkinsonism and spastic states. How Supplied SCOPACE Tablets Rx Only. Store at controlled room temperature 15 -30 degrees C (59-86 degrees F).
(V. 0207) |
