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fesoterodine fumarate

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Overview

What is fesoterodine fumarate?

Fesoterodine fumarate extended-release tablet contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist.

Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The molecular formula is CHNO and its molecular weight is 527.66. The structural formula is:

The asterisk (*) indicates the chiral carbon.

Fesoterodine fumarate is a white to off-white powder which is freely soluble in water and methanol.

Each fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and xanthan gum. Additionally each 4 mg tablets contain iron oxide yellow.



What does fesoterodine fumarate look like?



What are the available doses of fesoterodine fumarate?

What should I talk to my health care provider before I take fesoterodine fumarate?

How should I use fesoterodine fumarate?

Fesoterodine fumarate extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ()

Patients with severe renal impairment (CL < 30 mL/min) ()

Patients taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin. ()


What interacts with fesoterodine fumarate?

Sorry No Records found


What are the warnings of fesoterodine fumarate?

Sorry No Records found


What are the precautions of fesoterodine fumarate?

Sorry No Records found


What are the side effects of fesoterodine fumarate?

Sorry No records found


What should I look out for while using fesoterodine fumarate?

Fesoterodine fumarate extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Fesoterodine fumarate is also contraindicated in patients with known hypersensitivity to the drug or its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. ()


What might happen if I take too much fesoterodine fumarate?

Overdosage with fesoterodine fumarate can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.


How should I store and handle fesoterodine fumarate?

Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Fesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 4 mg are light yellow, beveled edge, oval shape, film-coated tablets debossed with "479" on one side and plain on the other side and are supplied as follows:  NDC 68382-479-06 in bottle of 30 tablets NDC 68382-479-16 in bottle of 90 tablets NDC 68382-479-77 in cartons of 100 (10 x 10) unit-dose tabletsFesoterodine Fumarate Extended-release Tablets, 8 mg are white to off-white, beveled edge, oval shape, film-coated tablets debossed with "480" on one side and plain on the other side are supplied as follows: NDC 68382-480-06 in bottle of 30 tablets NDC 68382-480-16 in bottle of 90 tablets NDC 68382-480-77 in cartons of 100 (10 x 10) unit-dose tablets


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine and is also one of the active moieties of tolterodine tartrate tablets and tolterodine tartrate extended-release capsules.

Muscarinic receptors play a role in contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

Non-Clinical Toxicology
Fesoterodine fumarate extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Fesoterodine fumarate is also contraindicated in patients with known hypersensitivity to the drug or its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. ()

Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine. In some cases angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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