TOLTERODINE TARTRATE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

TOLTERODINE TARTRATE (UNII: 5T619TQR3R) (TOLTERODINE - UNII:WHE7A56U7K)

Verfügbar ab:

Proficient Rx LP

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Tolterodine tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tablets, are metabolized to 5-hydroxymethyl tolterodine.

Produktbesonderheiten:

Tolterodine Tartrate Tablets, 1 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed with “93” on one side and “0010” on the other side containing 1 mg tolterodine tartrate, packaged in bottles of 30 (NDC 71205-319-30), 60 (NDC 71205-319-60) and 90 (NDC 71205-319-90) tablets. PHARMACIST: Dispense in a tight 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. Manufactured In India By: Cipla Ltd. Goa, India Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. D 4/2015

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TOLTERODINE TARTRATE- TOLTERODINE TARTRATE TABLET, FILM COATED
PROFICIENT RX LP
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TOLTERODINE TARTRATE TABLETS
DESCRIPTION
This product contains tolterodine tartrate. The active moiety,
tolterodine, is a muscarinic receptor
antagonist. The chemical name of tolterodine tartrate is
(R)-2-[3-[bis(1-methylethyl)-amino]1-
phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate
(1:1) (salt). It has the following
structural formula:
C
H NO M.W. 475.6
Tolterodine tartrate is a white, crystalline powder. The pKa value is
9.87 and the solubility in water is
12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and
practically insoluble in toluene. The
partition coefficient (Log D) between n-octanol and water is 1.83 at
pH 7.3.
Each tolterodine tartrate tablet, for oral administration, contains 1
mg or 2 mg of tolterodine tartrate. In
addition, each tablet contains the following inactive ingredients:
corn starch, croscarmellose sodium,
hypromellose, lactose monohydrate, microcrystalline cellulose,
polyethylene glycol, sodium stearyl
fumarate, and titanium dioxide.
CLINICAL PHARMACOLOGY
Tolterodine is a competitive muscarinic receptor antagonist. Both
urinary bladder contraction and
salivation are mediated via cholinergic muscarinic receptors.
After oral administration, tolterodine is metabolized in the liver,
resulting in the formation of the 5-
hydroxymethyl derivative, a major pharmacologically active metabolite.
The 5-hydroxymethyl
metabolite, which exhibits an antimuscarinic activity similar to that
of tolterodine, contributes
significantly to the therapeutic effect. Both tolterodine and the
5-hydroxymethyl metabolite exhibit a
high specificity for muscarinic receptors, since both show negligible
activity or affinity for other
neurotransmitter receptors and other potential cellular targets, such
as calcium channels.
Tolterodine has a pronounced effect on bladder function. Effects on
urodynamic parameters before and
1 and 5 hours after a single 6.4 mg dose of tolterodine
immediate-release w