OXYBUTYNIN CHLORIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

NuCare Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

OXYBUTYNIN CHLORIDE

Samenstelling:

OXYBUTYNIN CHLORIDE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

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 20 NDC 68071-1875-2 bottles of 30 NDC 68071-1875-3 bottles of 60 NDC 68071-1875-6 bottles of 90 NDC 68071-1875-9 bottles of 120 NDC 68071-1875-1 bottles of 270 NDC 68071-1875-7 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

OXYBUTYNIN CHLORIDE- OXYBUTYNIN CHLORIDE TABLET
NUCARE PHARMACEUTICALS, 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
22
31
3
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