Solifenacin

What is solifenacin used for?

Solifenacin is a prescription medicine that is used to treat an overactive bladder.

Description

Solifenacin succinate tablets (Solifenacin succinate) are muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo [2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C23H26N2O2•C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:

Solifenacin succinate is white to pale yellowish-white crystal or crystalline powder. It is freely soluble in water, methanol and chloroform. Each Solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each Solifenacin succinate tablet also contains the following inert ingredients: Colloidal Silicon dioxide (Aerosil 200) NF, Corn Starch NF (Maize Starch B-Pharma Grade),HPMC 2910/Hypromellose USP, Hydroxy Propyl Methyl Cellulose USP (Methocel E5 Premium LV), Iron Oxide Red NF (for 10 mg Solifenacin succinate tablet), Iron Oxide Yellow NF (for 5 mg Solifenacin succinate tablet), Lactose Monohydrate NF – Pharmatose 200 M (Milled), Lactose Monohydrate NF (Super Tab 11SD), Macrogol/PEG NF, Magnesium Stearate NF (Ligamed MF-2-V), Talc USP and Titanium Dioxide USP.

Mechanism of Action

Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion.

Before taking solifenacin, tell your doctor:

• If you are allergic to solifenacin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Glaucoma, liver disease, slow clearing of the stomach, or trouble passing urine.
• If you are breast-feeding. Do not breast-feed while you take solifenacin.

This is not a list of all drugs or health problems that interact with solifenacin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take solifenacin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take solifenacin?

• Tell all of your health care providers that you take solifenacin. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how solifenacin affects you.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• A very bad reaction called angioedema has happened with solifenacin. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.
• If you are 65 or older, use solifenacin with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using solifenacin while you are pregnant.

How is solifenacin best taken?

Use solifenacin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole with a drink of water.
• Keep taking solifenacin as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of solifenacin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Very bad belly pain.
• Not sweating during activities or in warm temperatures.
• Trouble passing urine.

What are some other side effects of solifenacin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Blurred eyesight.
• Dry eyes.
• Constipation.
• Dry mouth.
• Feeling sleepy.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out solifenacin?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

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