OXYBUTYNIN CHLORIDE SYRUP, USP 5 mg/5 mL

Chemically, oxybutynin chloride is 4-(Diethylamino)-2-butynyl (±)-α-phenylcyclohexaneglycolate hydrochloride. The molecular formula of oxybutynin chloride is C₂₂H₃₁NO₃•HCl. The structural formula appears below:

Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.96. It is readily soluble in water and acids, but relatively insoluble in alkalis.

Each 5 mL, for oral administration, contains 5 mg of oxybutynin chloride. In addition, the following inactive ingredients are present: Artificial raspberry flavor; citric acid, USP; D&C Yellow No. 10; FD&C Blue No. 1; glycerin, USP; liquid sugar; methylparaben, NF; propylene glycol, USP; sodium citrate, USP and sorbitol solution, USP.

Therapeutic Category: Antispasmodic, anticholinergic.

Oxybutynin chloride exerts direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride exhibits only one fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Oxybutynin chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin chloride increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin chloride thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.

Oxybutynin chloride was well tolerated in patients administered the drug in controlled studies of 30 days duration and in uncontrolled studies in which some patients received the drug for 2 years. Pharmacokinetic information is not currently available.

Oxybutynin chloride syrup is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (ie, urgency, frequency, urinary leakage, urge incontinence, dysuria).

Oxybutynin chloride is contraindicated in patients with untreated angle closure glaucoma and in patients with untreated narrow anterior chamber angles since anticholinergic drugs may aggravate these conditions.

It is also contraindicated in partial or complete obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis, and myasthenia gravis. It is contraindicated in patients with obstructive uropathy and in patients with unstable cardiovascular status in acute hemorrhage.

Oxybutynin chloride is contraindicated in patients who have demonstrated hypersensitivity to the product.

Oxybutynin chloride, when administered in the presence of a high environmental temperature, can cause heat prostration (fever and heat stroke 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 oxybutynin chloride would be inappropriate and possibly harmful.

Oxybutynin chloride may produce drowsiness or blurred vision. The patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Alcohol or other sedative drugs may enhance the drowsiness caused by oxybutynin chloride.

Oxybutynin chloride should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease. Oxybutynin chloride may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, and prostatic hypertrophy.

Administration of oxybutynin chloride to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease.

Following administration of oxybutynin chloride, the symptoms that can be associated with the use of other anticholinergic drugs may occur:

Cardiovascular: Palpitations, tachycardia, vasodilatation

Dermatologic: Decreased sweating, rash

Gastrointestinal/Genitourinary: Constipation, decreased gastrointestinal motility, dry mouth, nausea, urinary hesitance and retention

Nervous System: Asthenia, dizziness, drowsiness, hallucinations, insomnia, restlessness

Ophthalmic: Amblyopia, cycloplegia, decreased lacrimation, mydriasis

Other: Impotence, suppression of lactation

The symptoms of overdosage with oxybutynin chloride may be any of those seen with other anticholinergic agents. Symptoms may include signs of central nervous system excitation (eg, restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, nausea, vomiting, tachycardia, hypotension or hypertension, respiratory failure, paralysis, and coma. In the event of an overdose or exaggerated response, treatment should be symptomatic and supportive. Maintain respiration and induce emesis or perform gastric lavage (emesis is contraindicated in precomatose patients, convulsive or psychotic state). Activated charcoal may be administered as well as a cathartic. Physostigmine may be considered to reverse symptoms of anticholinergic intoxication. Hyperpyrexia may be treated symptomatically with ice bags or other cold applications and sponges.

Oxybutynin Chloride Syrup, USP 5 mg/5 mL is a light aqua, raspberry-flavored liquid supplied in 1 Pint (473 mL) bottles.

Pharmacist: Dispense in tight, light-resistant container as defined in the USP.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Rx Only

Product No.: 8092

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8092-16

REV. 07-18

MGP

NDC 60432-092-16

OXYBUTYNIN CHLORIDE

SYRUP, USP

5 mg/5 mL

Each teaspoonful (5 mL) contains:

5 mg oxybutynin chloride

DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED

FOR YOUR PROTECTION" IS BROKEN OR MISSING.

BULK CONTAINER —

NOT FOR HOUSEHOLD USE

Rx Only

NET: 1 Pint (473 mL)