Finasteride 5mg Tablets
It is used to treat the signs of an enlarged prostate. It may take a few months to see the full effect.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Benign Prostatic Hyperplasia (BPH) Agent
Pharmacologic Class
5-alpha Reductase Inhibitor
Pregnancy Category
Category X
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Finasteride 5mg is a medication used to treat benign prostatic hyperplasia (BPH), also known as an enlarged prostate. It works by shrinking the prostate gland, which can help improve urine flow and reduce symptoms like frequent urination or difficulty urinating. It does this by blocking a hormone in the body that causes the prostate to grow.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
To keep your medication effective, store the tablets in their original container at room temperature. Make sure to keep the cap tightly closed and protect the medication from light.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
To keep your medication effective, store the tablets in their original container at room temperature. Make sure to keep the cap tightly closed and protect the medication from light.
What to Do If You Miss a Dose
If you miss a dose, skip it and take your next dose at the usual time. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once a day, with or without food.
- Do not crush or break tablets, as the active ingredient can be absorbed through the skin and may be harmful to pregnant women or women of childbearing potential.
- It may take 6 months or more to see the full benefits of the medication.
- Continue regular check-ups with your doctor, including prostate exams and PSA tests, as recommended.
- Report any new or worsening symptoms, especially breast changes or mood changes, to your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
Benign Prostatic Hyperplasia (BPH):
5 mg orally once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Not indicated for pediatric use)
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No dosage adjustment necessary; Finasteride is not dialyzable.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended, but use with caution.
Moderate:
No specific dosage adjustment recommended, but use with caution.
Severe:
No specific dosage adjustment recommended, but use with caution. Data are limited.
Pharmacology
Mechanism of Action
Finasteride is a synthetic 4-azasteroid compound that is a specific inhibitor of steroid 5-alpha-reductase, an intracellular enzyme that converts testosterone to the more potent androgen dihydrotestosterone (DHT). DHT is primarily responsible for the development and enlargement of the prostate gland. By inhibiting 5-alpha-reductase type II, finasteride significantly lowers circulating and intraprostatic DHT levels, leading to regression of prostatic hyperplasia, improvement in urinary flow, and reduction in BPH symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 63-65%
Tmax:
1-2 hours
FoodEffect:
Absorption rate is slightly decreased by food, but the extent of absorption is not affected.
Distribution:
Vd:
Approximately 76 L
ProteinBinding:
Approximately 90%
CnssPenetration:
Limited (detectable in CSF, but at very low concentrations)
Elimination:
HalfLife:
Approximately 5-6 hours (range 3-16 hours, can be prolonged in elderly)
Clearance:
Approximately 165 mL/min
ExcretionRoute:
Approximately 57% in feces and 39% in urine as metabolites. Less than 1% excreted as unchanged drug in urine.
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
Clinical improvement in BPH symptoms may take 6 months or more.
PeakEffect:
Maximum reduction in prostate volume and improvement in urinary flow typically observed after 6-12 months of treatment.
DurationOfAction:
Effects persist as long as treatment is continued. DHT levels return to baseline within approximately 14 days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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
A lump in the breast, breast pain or soreness, or nipple discharge
Enlarged breasts
Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Feeling tired or weak
Decreased interest in sex
Ejaculation problems
Difficulty getting or maintaining an erection (these effects may persist even after stopping the medication)
Reporting Side Effects
If you have questions or concerns about side effects, consult your doctor. 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 immediate medical attention:
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
A lump in the breast, breast pain or soreness, or nipple discharge
Enlarged breasts
Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Feeling tired or weak
Decreased interest in sex
Ejaculation problems
Difficulty getting or maintaining an erection (these effects may persist even after stopping the medication)
Reporting Side Effects
If you have questions or concerns about side effects, consult your doctor. 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:
- Breast lumps, pain, or nipple discharge (may indicate male breast cancer)
- Depressed mood, thoughts of self-harm
- Severe allergic reactions (e.g., rash, itching, swelling of face/lips/tongue/throat, difficulty breathing)
- Persistent sexual side effects (e.g., decreased libido, erectile dysfunction, ejaculation problems) after stopping the drug (Post-Finasteride Syndrome - PFS, though not universally recognized as a distinct syndrome, these symptoms are reported by some patients)
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 symptoms you experienced as a result of the allergy.
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in pregnant or breastfeeding women, so it is crucial to discuss this with your doctor.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor determine whether it is safe for you to take this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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 symptoms you experienced as a result of the allergy.
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in pregnant or breastfeeding women, so it is crucial to discuss this with your doctor.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This information will help your doctor determine whether it is safe for you to take this medication.
* Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
This medication may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.
There is an increased risk of developing a severe form of prostate cancer associated with the use of medications like this one, as observed in clinical trials where these drugs were used to reduce the risk of prostate cancer. Discuss this risk with your doctor.
Although rare, male breast cancer has been reported in some individuals taking this medication. Consult your doctor to understand this potential risk.
This medication may affect sperm quality, which could impact fertility. If you are concerned about fathering a child, discuss this with your doctor.
If you are pregnant, avoid handling crushed or broken tablets, as they may pose a risk. If you accidentally come into contact with a crushed or broken tablet, immediately wash the affected area with soap and water.
Regular monitoring is crucial while taking this medication. Schedule a rectal exam to check your prostate gland and undergo blood tests, including a Prostate-Specific Antigen (PSA) test, as directed by your doctor. Discuss the results and any concerns with your healthcare provider.
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
This medication may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.
There is an increased risk of developing a severe form of prostate cancer associated with the use of medications like this one, as observed in clinical trials where these drugs were used to reduce the risk of prostate cancer. Discuss this risk with your doctor.
Although rare, male breast cancer has been reported in some individuals taking this medication. Consult your doctor to understand this potential risk.
This medication may affect sperm quality, which could impact fertility. If you are concerned about fathering a child, discuss this with your doctor.
If you are pregnant, avoid handling crushed or broken tablets, as they may pose a risk. If you accidentally come into contact with a crushed or broken tablet, immediately wash the affected area with soap and water.
Regular monitoring is crucial while taking this medication. Schedule a rectal exam to check your prostate gland and undergo blood tests, including a Prostate-Specific Antigen (PSA) test, as directed by your doctor. Discuss the results and any concerns with your healthcare provider.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials with single doses up to 400 mg and multiple doses up to 80 mg/day for 3 months.
What to Do:
In case of suspected overdose, contact a poison control center or emergency room immediately. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Prostate-Specific Antigen (PSA)
Rationale: To establish a baseline value before treatment. Finasteride lowers PSA levels by approximately 50% in men with BPH, even in the presence of prostate cancer. This reduction should be considered when evaluating PSA values.
Timing: Prior to initiating therapy
Digital Rectal Exam (DRE)
Rationale: To assess prostate size and consistency, and rule out prostate cancer.
Timing: Prior to initiating therapy
Urinary symptoms assessment (e.g., AUA Symptom Score)
Rationale: To quantify baseline symptom severity.
Timing: Prior to initiating therapy
Routine Monitoring
Prostate-Specific Antigen (PSA)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Interpretation should account for the ~50% reduction caused by finasteride. A sustained increase in PSA while on finasteride should prompt evaluation for prostate cancer.
Action Threshold: Any sustained increase from the nadir PSA level, or a PSA value that would be concerning if doubled (to account for finasteride's effect), should be investigated.
Digital Rectal Exam (DRE)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Normal prostate consistency and size for age.
Action Threshold: Any new nodule, induration, or asymmetry should be investigated.
Urinary symptoms assessment
Frequency: Periodically (e.g., every 6-12 months)
Target: Improvement or stabilization of symptoms.
Action Threshold: Worsening symptoms may indicate treatment failure or progression of BPH/other conditions.
Symptom Monitoring
- Changes in urinary flow (e.g., weaker stream, increased frequency, nocturia)
- Breast tenderness or enlargement (gynecomastia)
- Decreased libido
- Erectile dysfunction
- Ejaculation disorder
- Depressed mood or depression
- Allergic reactions (e.g., rash, itching, hives, swelling of lips/face)
Special Patient Groups
Pregnancy
Contraindicated in women who are or may potentially be pregnant. Finasteride can cause abnormalities of the external genitalia of a male fetus if administered to pregnant women. Exposure to crushed or broken tablets should be avoided by pregnant women.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity (external genital abnormalities) in male fetuses.
Second Trimester:
Risk of teratogenicity in male fetuses.
Third Trimester:
Risk of teratogenicity in male fetuses.
Lactation
Not indicated for use in women. It is not known whether finasteride is excreted in human milk. Due to the potential for adverse effects on a nursing infant, particularly a male infant, if a woman were to be exposed, caution is advised.
Infant Risk:
Low (Not indicated for women, but theoretical risk to male infant if exposed via breast milk).
Pediatric Use
Not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No dosage adjustment is necessary in elderly patients. While the elimination half-life may be slightly prolonged in men over 70 years of age, this does not warrant a dosage reduction.
Clinical Information
Clinical Pearls
- Finasteride 5mg is specifically for BPH; Finasteride 1mg is for androgenetic alopecia (male pattern hair loss). Do not confuse the dosages.
- Patients should be informed that finasteride can lower PSA levels, which may mask the detection of prostate cancer. Any sustained increase in PSA while on finasteride should be carefully evaluated.
- While rare, there is an increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors, including finasteride, observed in some studies (e.g., PCPT study).
- Sexual side effects (decreased libido, erectile dysfunction, ejaculation disorder) are common and should be discussed with patients. Some patients report persistent sexual side effects even after discontinuing the drug (Post-Finasteride Syndrome), though this is a controversial area.
- Pregnant women or women of childbearing potential should not handle crushed or broken finasteride tablets due to the risk of absorption and potential harm to a male fetus.
Alternative Therapies
- Alpha-blockers (e.g., Tamsulosin, Alfuzosin, Doxazosin, Silodosin)
- Other 5-alpha reductase inhibitors (e.g., Dutasteride)
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., Tadalafil for BPH symptoms)
- Surgical interventions (e.g., TURP, laser prostatectomy)
- Minimally invasive procedures (e.g., UroLift, Rezum)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.