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(fesoterodine fumarate) for Oral Administration
Toviaz contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-l-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-l-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C30H41NO7 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. Each Toviaz extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol.
What are the possible side effects of fesoterodine (Toviaz)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using fesoterodine and call your doctor at once if you have a serious side effect such as:
- chest pain, fast or uneven heart rate;
- swelling of your hands or feet;
- urinating less than usual or not at all; or
- painful or difficult urination.
Less serious side effects may include:
- dry mouth, dry eyes;
- blurred vision;
What are the precautions when taking fesoterodine fumarate extended-release tablets (Toviaz)?
Before taking fesoterodine, tell your doctor or pharmacist if you are allergic to it; or to tolterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric obstruction/retention).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (such as bladder outflow obstruction, enlarged prostate), slowed movement of stomach/intestines,...
Last reviewed on RxList: 8/13/2012
This monograph has been modified to include the generic and brand name in many instances.
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