TOLTERODINE TARTRATE- tolterodine tartrate tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Camber Pharmaceuticals, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

Tolterodine Tartrate Tablets 1 mg are pale yellow, round, biconvex, film-coated tablets debossed with ‘'J'’ on one side and ‘'157’' on the other side. They are supplied as follows: Bottle of 60 tablets                                                                                   NDC 31722-805-60 Bottle of 500 tablets                                                                                 NDC 31722-805-05 Blister card of 10 unit dose tablets (ALU-ALU)                                        NDC 31722-805-31 Blister pack of 100 (10x10) unit dose tablets (ALU-ALU)                        NDC 31722-805-01 Blister card of 10 unit dose tablets (PVC-PVDC)                                     NDC 31722-805-32 Blister pack of 100 (10x10) unit dose tablets (PVC-PVDC)                     NDC 31722-805-02 Tolterodine Tartrate Tablets 2 mg are white, round, biconvex, film-coated tablets debossed with ‘'J’' on one side and ‘'158'’ on the other side. They are supplied as follows: Bottle of 60 tablets                                                                                  NDC 31722-806-60 Bottle of 500 tablets                                                                                NDC 31722-806-05 Blister card of 10 unit dose tablets (ALU-ALU)                                       NDC 31722-806-31 Blister pack of 100 (10x10) unit dose tablets (ALU-ALU)                       NDC 31722-806-01 Blister card of 10 unit dose tablets (PVC-PVDC)                                    NDC 31722-806-32 Blister pack of 100 (10x10) unit dose tablets (PVC-PVDC)                    NDC 31722-806-02 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Annora Pharma Pvt. Ltd. Sangareddy - 502313, Telangana, India. Revised: 05/2021

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Camber Pharmaceuticals, Inc.
----------
Revised: 8/2021
Document Id: c9a8a649-3330-59a0-e053-2995a90ad3c3
34391-3
Set id: f67fce7c-69d3-42ae-8c1d-2e26fd4d7415
Version: 1
Effective Time: 20210816
Camber Pharmaceuticals, Inc.

Характеристики продукта

TOLTERODINE TARTRATE - TOLTERODINE TARTRATE TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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TOLTERODINE TARTRATE TABLETS
DESCRIPTION
Tolterodine tartrate tablets contain tolterodine tartrate. The active
moiety, tolterodine, is
a muscarinic receptor antagonist. The chemical name of tolterodine
tartrate is 2-[(1R)-3-
[Bis (1-methylethyl) amino]-1-phenylpropyl] - 4- Methyl phenol
tartrate. The empirical
formula of tolterodine tartrate is C
H
NO.C
H
O
, and its molecular weight is
475.57. The structural formula of tolterodine tartrate is represented
below:
Tolterodine tartrate USP is a white or almost white crystalline
powder. The pKa value is
9.87. Sparingly soluble in water, slightly soluble in anhydrous
ethanol, practically
insoluble in heptane.
Tolterodine tartrate tablets for oral administration contain 1 or 2 mg
of tolterodine
tartrate USP. The inactive ingredients are colloidal silicon dioxide,
dibasic calcium
phosphate dihydrate, hypromellose, magnesium stearate,
microcrystalline cellulose,
purified stearic acid, sodium starch glycolate and titanium dioxide.
Additionally 1 mg
tablet contains iron oxide yellow and iron oxide red.
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
22
31
4
6
6
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