OXYBUTYNIN CHLORIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)

Available from:

Pharmaceutical Associates, Inc.

INN (International Name):

OXYBUTYNIN CHLORIDE

Composition:

OXYBUTYNIN CHLORIDE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (i.e., 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.

Product summary:

Oxybutynin Chloride Syrup USP (5 mg/5 mL) is a cherry flavored, blue liquid supplied in bottles of 16 fluid ounces (473 mL) (NDC 0121- 0671-16) and 5 mL Unit Dose Cups (NDC 0121-0671-05). 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE SYRUP
PHARMACEUTICAL ASSOCIATES, INC.
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OXYBUTYNIN CHLORIDE
SYRUP USP
DESCRIPTION
Chemically, oxybutynin chloride is d,l (racemic)
4-diethylamino-2-butynyl phenylcyclohexylglycolate
hydrochloride. The molecular formula of oxybutynin chloride is C
H NO •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 of oxybutynin chloride syrup, for oral administration,
contains 5 mg oxybutynin chloride with
inactive ingredients citric acid, FD&C Green No. 3, glycerin,
methylparaben, cherry flavor, sodium
citrate, sorbitol, sucrose, and water.
Therapeutic Category: Antispasmodic, anticholinergic.
CLINICAL PHARMACOLOGY
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 of the
patients received the drug for 2 years.
Pharmacokinetic information is not currently available.
INDICATIONS AND USAGE
Oxybutynin chloride syrup is indicated for the relief o