females Animal data No adverse developmental outcomes were observed in animal reproduction studies with oral solifenacin succinate to pregnant mice during organogenesis at a 10 mg/day dose (1.2x the maximum recommended human dose [MRHD]) Administration of doses ≥3.6x the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring Lactation No information available Solifenacin is present in mouse milk When a drug is present in animal milk, it is likely to be present in human milkPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Competitive muscarinic-receptor antagonist Absorption Peak plasma concentration Tablets: 32.3 ng/mL (5-mg dose); 62.9 ng/mL (10-mg dose) Solution: 2.5-29 ng/mL Peak plasma time Tablets: 3 hr (5-mg dose); 8 hr (10-mg dose) Solution: 2-6 hr Bioavailability Tablets or solution: ~90% Distribution Protein bound: 98% Metabolism Extensively metabolized by the liver, primarily CYP3A4 Metabolites: 4R-hydroxy solifenacin (active); N-glucuronide, N-oxide, and 4R-hydroxyN-oxide of solifenacin (inactive) Elimination Excretion: Urine (69%), feces (23%) Half-life Adults: 45-68 hr Children and adolescents: ~26 hr Oral Administration Tablets May take with or without food Administer with water and swallow whole Oral suspension Shake bottle well before administration of each dose Take once daily, followed by liquid (eg, water or milk) after each dose Missed dose Missed dose <12 hr: Take as soon as possible Missed dose >12 hr: Skip dose and wait for next scheduled dose Storage Tablets Store at 25ºC (68-77ºF) with excursions permitted to 15-30ºC (59-86ºF) Oral suspension Store at 20-25ºC (68-77ºF) with excursions permitted to 15-30ºC (59-86ºF) Store in original bottle to protect from degradation; discard any unused product 28 days after opening the original bottle Dispense in a tight, light-resistant container BRAND FORM. UNIT PRICE PILL IMAGE Vesicare oral- 10 mg tabletVesicare oral- 5 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletsolifenacin oral- 10 mg tabletsolifenacin oral- 5 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationsolifenacin oral SOLIFENACIN - ORAL (SOE-li-FEN-a-sin) COMMON BRAND NAME(S): Vesicare, Vesicare LS USES: Solifenacin is used to treat an overactive bladder. By relaxing the muscles in the bladder, solifenacin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics. HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using solifenacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once a day. Take it with a full glass of liquid. Swallow the tablet whole because the powder in the tablet has a bitter taste.If you are using the liquid form of this medication, shake the bottle well before taking each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. After taking your dose, drink a glass of water or milk. Avoid taking the liquid form with food or other drinks, as this may cause a bitter taste.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Children's dose is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: Dry mouth, constipation, drowsiness, stomach upset, blurred vision, dry eyes, headache, or unusual tiredness/weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, constipation for 3 or more days, difficulty urinating, signs of kidney infection (such as burning/painful/frequent urination, fever, pink/bloody urine), mental/mood changes (such as confusion, hallucinations).Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking solifenacin, tell your doctor or pharmacist if you are allergic to it; 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (urinary retention), other bladder problems (such as blockage), stomach/intestinal blockage (gastric retention), personal or family history of glaucoma (angle-closure type), liver disease, bowel disease (such as ulcerative colitis), slowed movement of stomach/intestines, constipation, kidney disease, enlarged prostate, a certain muscle/nerve disease (myasthenia gravis).This drug may make you drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: pramlintide, potassium tablets/capsules.Other medications can affect the removal of solifenacin from your body, which may affect how solifenacin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole), mifepristone, among others. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include fast/irregular heartbeat, agitation. NOTES: Do not share this medication with others. MISSED DOSE: If you miss a dose, take it as soon as you remember if it is within 12 hours on the same day. If it is more than 12 hours when you remember, skip the missed dose. Take your next dose at the regular time on the next day. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Store the liquid form in the original bottle with the cap tightly closed. Discard any remaining medication 28 days after first opening the bottle.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised January 2022. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC