Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Vesicare

Descriptions


Solifenacin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate. Solifenacin works on the muscles of the bladder to prevent them from causing incontinence.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of solifenacin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of solifenacin in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving solifenacin.

Pregnancy

Information about this solifenacin-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Ketoconazole
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Potassium
  • Sparfloxacin
  • Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Erythromycin
  • Escitalopram
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Lapatinib
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Sevoflurane
  • Siltuximab
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Telavancin
  • Terfenadine
  • Tetrabenazine
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Umeclidinium
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Ziprasidone

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bladder blockage (hard to urinate) or
  • Glaucoma, narrow-angle and controlled or
  • QT prolongation (a heart rhythm problem), history of or
  • Slow bowels or constipation—Use with caution. May make these conditions worse.
  • Glaucoma, narrow-angle and uncontrolled or
  • Stomach retention (food does not pass easily) or
  • Urinary retention (not passing urine)—Should not be used in patients with these conditions.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the tablet whole with water. Do not crush, break, or chew it. You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • To treat bladder problems:
      • Adults—At first, 5 milligrams (mg) as a single dose once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 10 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Solifenacin may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop taking this medicine and check with your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

This medicine may cause drowsiness, confusion, or blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may cause constipation. Call your doctor if you get severe stomach pain or become constipated for 3 or more days.

This medicine may cause dry mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  1. Bladder pain
  2. bloody or cloudy urine
  3. chills
  4. decrease in the frequency of urination
  5. decrease in urine volume
  6. difficult, burning, or painful urination
  7. difficulty in passing urine (dribbling)
  8. fever
  9. frequent urge to urinate
  10. painful urination
  11. swelling of the lower legs
  12. unusual tiredness or weakness

Incidence not known

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. chest pain or discomfort
  3. fainting
  4. irregular heartbeat recurrent
  5. irregular or slow heart rate
  6. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  7. rapid weight gain
  8. shortness of breath
  9. tingling of the hands or feet
  10. unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Acid or sour stomach
  2. belching
  3. body aches or pain
  4. congestion
  5. cough
  6. diarrhea
  7. discouragement
  8. feeling sad or empty
  9. general feeling of discomfort or illness
  10. headache
  11. heartburn
  12. hoarseness
  13. indigestion
  14. irritability
  15. joint pain
  16. lack of appetite
  17. loss of interest or pleasure
  18. lower back or side pain
  19. muscle aches and pains
  20. nervousness
  21. pounding in the ears
  22. runny nose
  23. shivering
  24. slow or fast heartbeat
  25. sore throat
  26. stomach discomfort, upset, or pain
  27. sweating
  28. tender, swollen glands in the neck
  29. tiredness
  30. trouble concentrating
  31. trouble with sleeping
  32. trouble with swallowing
  33. upper abdominal or stomach pain
  34. voice changes

Incidence not known

  1. Hives or welts
  2. itching
  3. redness of the skin
  4. skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.