OXYBUTYNIN CHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

OXYBUTYNIN CHLORIDE

Composition:

OXYBUTYNIN CHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxybutynin Chloride Tablets USP are 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 urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

Product summary:

Oxybutynin Chloride Tablets USP are available as follows: 5 mg – Very pale blue, round, biconvex, scored tablets. Debossed with PLIVA 456 on one side and scored on the other side. Available in bottles of 100 (NDC 50111-456-01), 500 (NDC 50111-456-02), and 1000 (NDC 50111-456-03) tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
OXYBUTYNIN CHLORIDE TABLETS USP
456
RX ONLY
DESCRIPTION
Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex,
scored, debossed tablets
containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin
chloride, USP is d,l (racemic) 4-
diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The
structural formula appears
below:
C
H NO •HCl M.W. 393.9
Oxybutynin chloride, USP is a white crystalline solid. It is readily
soluble in water and acids, but
relatively insoluble in alkalis.
Oxybutynin Chloride Tablets USP also contain calcium stearate,
microcrystalline cellulose, anhydrous
lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake.
Oxybutynin Chloride Tablets USP are for oral administration.
Meets USP Dissolution Test 2.
Therapeutic Category: Antispasmodic, anticholinergic.
CLINICAL PHARMACOLOGY
Oxybutynin chloride exerts a 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.
22
31
3
Antimuscarinic activity resides predominately in the R-isomer. A
metabolite, desethyloxybutynin, has
pharmacological activity similar to that of oxybutynin in _in vitro_
studies.
PHARMACOKINETICS
_Absorption_
Following or