Tolterodine Tartrate

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Overview

What is Tolterodine Tartrate?

Tolterodine tartrate extended-release capsules contain 2 mg or 4 mg of tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (+)-()-2-[I-[2-(Diisopropylamino)ethyl]benzyl]--cresol L-tartrate (1:1) (salt). The molecular formula of tolterodine tartrate is CHNO. Its structure is:

Tolterodine tartrate, USP is a white to off-white colored solid with a molecular weight of 475.6. The pK 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 capsule contains 2 mg or 4 mg of tolterodine tartrate with the following inactive ingredients: ethylcellulose, FD&C Blue No. 2, gelatin, hypromellose, sodium lauryl sulfate, sugar spheres, talc and titanium dioxide. The 2 mg capsules also contain yellow iron oxide.

The imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol and shellac.

What does Tolterodine Tartrate look like?

What are the available doses of Tolterodine Tartrate?

Tolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.

What should I talk to my health care provider before I take Tolterodine Tartrate?

How should I use Tolterodine Tartrate?

Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency .

The recommended dose of tolterodine tartrate extended-release capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for tolterodine tartrate extended-release capsules 2 mg .

What interacts with Tolterodine Tartrate?

Sorry No Records found

What are the warnings of Tolterodine Tartrate?

Sorry No Records found

What are the precautions of Tolterodine Tartrate?

Sorry No Records found

What are the side effects of Tolterodine Tartrate?

Sorry No records found

What should I look out for while using Tolterodine Tartrate?

Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine

, (

), (

)]

.

What might happen if I take too much Tolterodine Tartrate?

Overdosage with tolterodine tartrate extended-release capsules can potentially result in severe central anticholinergic effects and should be treated accordingly.

ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. In clinical trials of normal volunteers and patients, QT interval prolongation was observed with tolterodine immediate-release at doses up to 8 mg (4 mg bid) and higher doses were not evaluated .

A 27-month-old child who ingested 5 to 7 tolterodine immediate-release 2 mg tablets was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered.

How should I store and handle Tolterodine Tartrate?

Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Tolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsulesTolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.The 2 mg capsule is a green opaque cap and green opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-825-30 bottles of 30 capsulesNDC 60429-825-90 bottles of 90 capsulesNDC 60429-825-05 bottles of 500 capsulesThe 4 mg capsule is a powder blue opaque cap and powder blue opaque body, hard-shell gelatin capsule filled with white to off-white beads. The capsule is axially printed with over in black ink on both the cap and body. They are available as follows:NDC 60429-826-30 bottles of 30 capsulesNDC 60429-826-90 bottles of 90 capsulesNDC 60429-826-05 bottles of 500 capsules

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Tolterodine acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors. 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 5-hydroxymethyl tolterodine (5-HMT), the major pharmacologically active metabolite. 5-HMT, which exhibits an antimuscarinic activity similar to that of tolterodine, contributes significantly to the therapeutic effect. Both tolterodine and 5-HMT 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.

Non-Clinical Toxicology

Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine

, (

), (

)]

.

Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate extended-release capsules. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, tolterodine tartrate extended-release capsules should be discontinued and appropriate therapy promptly provided.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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