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atropine sulfate and
scopolamine hydrobromide tablet, extended release
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----------SERVIRA EXTENDED RELEASE TABLETS
Each Servira Extended Release tablet contains:
This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.
INDICATIONS AND USAGE
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as "possibly" effective:
Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.
In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).
PRECAUTIONSUse with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.
Theoretically, with overdosage, a curare-like action may occur.
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy Category C
Animal reproduction studies have not been conducted with Servira. It is not known whether Servira can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Servira should be given to a pregnant woman only if clearly needed.
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 Servira is administered to a nursing mother.
Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug.
DOSAGE AND ADMINISTRATION
The dosage of Servira should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The usual dose is one tablet every twelve (12) hours. If indicated, one tablet every eight (8) hours may be given.
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils; hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, CNS stimulation. Treatment should mconsist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be added.
Servira Extended Release Tablets are supplied as: green, round tablets debossed “256”, bottles of 100 tablets, NDC 49769-256-10.
Revised: 01/2010 Kylemore Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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