Oscimin Sublingual Tablet

Name: Oscimin Sublingual Tablet

Oscimin Sublingual Tablet - Clinical Pharmacology

Hyoscyamine has actions similar to those of atropine, but is more potent in both its central and peripheral effects.

This product inhibits gastrointestinal propulsive motility and decreases gastric acid secretions. This product controls excessive pharyngeal, tracheal, and bronchial secretion.

This product is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, this product disappears rapidly from the blood and is distributed throughout the entire body. The majority of hyoscyamine sulfate is excreted in the urine unchanged within the first 12 hours and only traces of hyoscyamine sulfate are found in the breast milk.

Indications and Usage for Oscimin Sublingual Tablet

This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.

This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.

Contraindications

Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age.

Warnings

Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.

Overdosage

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation.

Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a d degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100- 200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD50 for hyoscyamine is 375 mg/kg. Hyoscyamine is dialyzable.

Principal display panel

Figure 2: Container label

OSCIMIN 
hyoscyamine sulfate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68047-253
Route of Administration SUBLINGUAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
MANNITOL  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 6mm
Flavor PEPPERMINT Imprint Code LL;253
Contains     
Packaging
# Item Code Package Description
1 NDC:68047-253-01 100 TABLET, ORALLY DISINTEGRATING (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/03/2011
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE
Revised: 08/2011   Larken Laboratories, Inc.
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