OXYBUTYNIN CHLORIDE- oxybutynin chloride tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Preferred Pharmaceuticals Inc.

Designación común internacional (DCI):

OXYBUTYNIN CHLORIDE

Composición:

OXYBUTYNIN CHLORIDE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Oxybutynin chloride tablets 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.

Resumen del producto:

Oxybutynin Chloride Tablets USP, 5 mg, are round, light blue, scored tablets debossed "4853" and "V" on one side separated by a horizontal score and plain on the reverse side. The tablets are supplied as follows:

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
OXYBUTYNIN CHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Each scored oxybutynin chloride tablet contains 5 mg of oxybutynin
chloride. Chemically, oxybutynin
chloride is d,l (racemic) 4-diethylamino-2-butynyl
phenylcyclohexylglycolate hydrochloride. The
empirical 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 393.95. It is readily soluble
in water and acids, but relatively insoluble in alkalis.
Oxybutynin Chloride Tablets are for oral administration.
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.
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 oral administration of oxybutynin chloride, oxybutynin is
rapidly absorbed achieving C
within an hour, following which plasma concentration decreases with an
effective half-life of
approximately 2 to 3 hours. The a