Servira

Generic Name: phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide
Dosage Form: tablet, extended release

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Servira EXTENDED RELEASE TABLETS

Servira Description

Each Servira Extended Release tablet contains:
Phenobarbital, USP ........................................ 48.6 mg
(Warning: May be habit forming)
Hyoscyamine Sulfate, USP................................ 0.3111 mg
Atropine Sulfate, USP........................................ 0.0582 mg
Scopolamine Hydrobromide, USP .................... 0.0195 mg

Servira Extended Release Tablets are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: DC Yellow #10 Aluminum Lake, FDC Blue #1 Aluminum Lake, FDC Yellow #6 Aluminum Lake, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, PEG 3350, Polyvinyl Alcohol, Povidone, Silicon Dioxide, Stearic Acid, Talc, Titanium Dioxide.

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Servira - Clinical Pharmacology

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 for Servira

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:

For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

Contraindications

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.

Servira is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom phenobarbital produces restlessness and/or excitement.

Warnings

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Servira may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Phenobarbital may decrease the effect of anticoagulants and necessitate larger doses of the anticoagulant for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.

Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

Precautions

Use 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.

Carcinogenesis, Mutagenesis
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.

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 Servira is administered to a nursing mother.

Adverse Reactions

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.

Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Servira 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.

Overdosage

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.

How is Servira Supplied

Servira Extended Release Tablets are supplied as: green, round tablets debossed “256”, bottles of 100 tablets, NDC 49769-256-10.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured for:
Kylemore Pharmaceuticals
Suwanee, GA 30024
Rev 12/09

PACKAGING:

Servira Extended Release Tablet labeling:

Servira 
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-256
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 48.6 mg
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE .3111 mg
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE .0582 mg
SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE .0195 mg
Product Characteristics
Color green Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 256
Contains         
Packaging
# Item Code Package Description
1 NDC:49769-256-10 100 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2010 09/30/2011
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010
 
Kylemore Pharmaceuticals, LLC
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