Flavoxate 100mg Tablets
It is used to treat signs of urinary problems.
Drug Class
Urinary Antispasmodic
Pharmacologic Class
Direct Acting Urinary Tract Smooth Muscle Relaxant
Pregnancy Category
Category B
FDA Approved
Feb 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Flavoxate is a medication used to relieve symptoms like painful urination, frequent urination, and urgency that can occur with certain bladder or urinary tract conditions. It works by relaxing the muscles in your bladder and urinary tract.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Ensure that all medications are stored in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Ensure that all medications are stored in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid driving or operating machinery until you know how this medication affects you, as it may cause dizziness or blurred vision.
- Avoid alcohol, as it may increase drowsiness.
- Stay hydrated unless otherwise advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg to 200 mg three or four times a day
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
symptomaticrelief:
Administer 100 mg to 200 mg three or four times a day as needed for symptomatic relief.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age.
Adolescent:
Not recommended for children under 12 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
Use with caution; consider lower doses or extended intervals due to potential accumulation of metabolites.
Dialysis:
Not well studied; use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
Use with caution; consider lower doses due to extensive hepatic metabolism.
Confidence:
Medium
Pharmacology
Mechanism of Action
Flavoxate exerts a direct spasmolytic action on the smooth muscle of the urinary tract. It also possesses local anesthetic and anticholinergic properties. Its primary action is to relax the smooth muscles of the bladder and urinary tract, thereby reducing symptoms such as dysuria, urgency, nocturia, suprapubic pain, and frequency associated with various urological disorders.
Pharmacokinetics
Absorption:
Bioavailability:
Not available
Tmax:
Approximately 1-2 hours (for parent drug); 4-5 hours (for active metabolite)
FoodEffect:
Not significantly affected by food.
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.5-3.5 hours (parent drug); 4-5 hours (MFCA)
Clearance:
Not available
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
Less than 1% of parent drug is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes
PeakEffect:
Approximately 2-4 hours
DurationOfAction:
Approximately 6 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Fast or abnormal heartbeat
Feeling confused
Changes in eyesight, eye pain, or severe eye irritation
Pain when passing urine
Fever, chills, or sore throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy or sleepy
Headache
Feeling nervous and excitable
Blurred eyesight
Dry mouth
Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Fast or abnormal heartbeat
Feeling confused
Changes in eyesight, eye pain, or severe eye irritation
Pain when passing urine
Fever, chills, or sore throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy or sleepy
Headache
Feeling nervous and excitable
Blurred eyesight
Dry mouth
Upset stomach or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or drowsiness
- Severe blurred vision or eye pain
- Difficulty urinating (worsening urinary retention)
- Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Bleeding from the stomach or bowel
+ Blockage of the urinary tract
+ Bowel obstruction
+ Poor bowel muscle tone
+ Thinning of the gastrointestinal (GI) tract
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Bleeding from the stomach or bowel
+ Blockage of the urinary tract
+ Bowel obstruction
+ Poor bowel muscle tone
+ Thinning of the gastrointestinal (GI) tract
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid operating a vehicle or performing any tasks that require alertness and clear vision until you understand how this medication affects you.
Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your health and the health of your baby.
To ensure your safety, avoid operating a vehicle or performing any tasks that require alertness and clear vision until you understand how this medication affects you.
Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Severe anticholinergic effects (e.g., severe dry mouth, blurred vision, dilated pupils, rapid heart rate, fever, flushed skin, confusion, hallucinations, urinary retention, decreased bowel sounds)
- CNS depression (e.g., profound drowsiness, coma)
- Respiratory depression
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Physostigmine may be used to reverse severe anticholinergic effects, but only under strict medical supervision.
Drug Interactions
Moderate Interactions
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines): May potentiate anticholinergic side effects such as dry mouth, blurred vision, constipation, and urinary retention.
- Drugs that cause drowsiness (e.g., opioids, benzodiazepines, alcohol): May enhance CNS depressant effects.
Monitoring
Baseline Monitoring
Urinary symptoms (e.g., frequency, urgency, dysuria, nocturia, suprapubic pain)
Rationale: To establish baseline severity and assess treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Symptom relief (e.g., reduction in urgency, frequency, pain)
Frequency: Daily/Weekly, as per patient report
Target: Significant reduction in bothersome symptoms
Action Threshold: Lack of improvement or worsening of symptoms after a reasonable trial period (e.g., 1-2 weeks) may indicate need for re-evaluation or alternative therapy.
Adverse effects (e.g., dry mouth, blurred vision, nausea, dizziness, headache, drowsiness)
Frequency: Regularly, especially during initial therapy and dose adjustments
Target: Absence or mild, tolerable side effects
Action Threshold: Persistent or severe adverse effects warrant dose reduction or discontinuation.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Nausea
- Vomiting
- Dizziness
- Headache
- Drowsiness
- Nervousness
- Vertigo
- Urinary retention (rare)
Special Patient Groups
Pregnancy
Flavoxate is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies; human data limited.
Second Trimester:
No specific increased risk identified in animal studies; human data limited.
Third Trimester:
No specific increased risk identified in animal studies; human data limited.
Lactation
It is not known whether flavoxate or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate is administered to a nursing woman. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Unknown; potential for anticholinergic effects in the infant.
Pediatric Use
Safety and effectiveness in children under 12 years of age have not been established. Use is not recommended in this age group.
Geriatric Use
Use with caution in elderly patients, as they may be more susceptible to anticholinergic side effects (e.g., dry mouth, constipation, blurred vision, cognitive impairment, urinary retention). Consider starting with lower doses and titrating slowly.
Clinical Information
Clinical Pearls
- Flavoxate is primarily used for symptomatic relief of bladder irritation and spasms, not for treating underlying infections. An infection should be ruled out or treated concurrently.
- Patients should be advised that relief of symptoms may not be immediate and may take a few days.
- Due to its anticholinergic properties, it should be used with caution in patients with glaucoma (especially angle-closure), pyloric or duodenal obstruction, or obstructive uropathies (e.g., prostatic hypertrophy) where urinary retention could be exacerbated.
- Patients should be warned about potential for drowsiness or blurred vision and advised to avoid activities requiring mental alertness until effects are known.
Alternative Therapies
- Oxybutynin (anticholinergic)
- Tolterodine (anticholinergic)
- Solifenacin (anticholinergic)
- Darifenacin (anticholinergic)
- Fesoterodine (anticholinergic)
- Trospium (anticholinergic)
- Mirabegron (beta-3 adrenergic agonist)
- Vibegron (beta-3 adrenergic agonist)
Cost & Coverage
Average Cost:
$15 - $40 per 30 tablets (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.