Finasteride 1mg Tablets

Manufacturer CAMBER PHARMACEUTICALS Active Ingredient Finasteride 1 mg Tablets(fi NAS teer ide) Pronunciation fi NAS teer ide
It is used to help hair growth in male pattern baldness. It may take 3 months to see the full effect.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Agent for androgenetic alopecia
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Pharmacologic Class
5-alpha reductase inhibitor
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Pregnancy Category
Category X
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FDA Approved
Dec 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Finasteride 1mg is a medication used to treat male pattern hair loss (androgenetic alopecia). It works by blocking a hormone in your body that causes hair follicles to shrink, helping to slow down hair loss and promote new hair growth. It needs to be taken daily for several months to see results, and continued use is necessary to maintain the benefits.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, and at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.

Storing and Disposing of Your Medication

Store the tablets in their original container at room temperature, keeping the cap tightly closed. Protect the medication from light to preserve its effectiveness.

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 once or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the medication consistently at the same time each day.
  • Do not crush or break tablets, especially if a pregnant woman might handle them.
  • Understand that results take time (3-6 months) and are not guaranteed for everyone.
  • Be aware that hair loss will likely resume if treatment is stopped.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 mg orally once daily
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

androgeneticAlopecia: 1 mg orally once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; not dialyzable

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution
Moderate: No specific adjustment recommended, use with caution
Severe: No specific adjustment recommended, use with caution

Pharmacology

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Mechanism of Action

Finasteride is a competitive and specific inhibitor of Type II 5-alpha reductase, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT). DHT is the primary androgen responsible for the development of androgenetic alopecia in genetically predisposed men. By inhibiting this enzyme, finasteride significantly lowers serum and scalp DHT levels, thereby reducing the miniaturization of hair follicles and promoting hair growth.
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Pharmacokinetics

Absorption:

Bioavailability: 63-80%
Tmax: 1-2 hours
FoodEffect: Food does not affect bioavailability

Distribution:

Vd: 76 L
ProteinBinding: Approximately 90%
CnssPenetration: Limited

Elimination:

HalfLife: 5-6 hours (range 3-16 hours)
Clearance: Not available
ExcretionRoute: Approximately 57% in feces, 39% in urine
Unchanged: Negligible
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Pharmacodynamics

OnsetOfAction: DHT suppression within 24 hours; clinical hair growth effects typically observed after 3 months of daily use
PeakEffect: Maximum hair growth benefits typically seen after 12 months of continuous treatment
DurationOfAction: Effects are maintained as long as treatment continues; reversal of effects occurs within 12 months of discontinuation

Safety & Warnings

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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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:

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 do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

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

These are not all the possible side effects that may occur. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
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Seek Immediate Medical Attention If You Experience:

  • Decreased libido (sex drive)
  • Erectile dysfunction (difficulty getting or keeping an erection)
  • Ejaculation disorder (e.g., decreased ejaculate volume)
  • Breast tenderness or enlargement (gynecomastia)
  • Depression, including suicidal thoughts
  • Allergic reactions (rash, itching, hives, swelling of the lips and face)
  • Testicular pain
  • Changes in breast tissue (lumps, pain, nipple discharge) - report immediately as these could be signs of male breast cancer (rare).
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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. Be sure to describe the symptoms you experienced.
If you are pregnant, plan to become pregnant, or are breastfeeding. This medication is not approved for use in these situations, so it is crucial to discuss this with your doctor.
Potential interactions with other medications or health conditions. To ensure safe use, tell your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have.
Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm it is safe to do so in conjunction with this medication.
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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.

Clinical trials have shown that men taking medications like this one to reduce the risk of prostate cancer were more likely to develop a severe form of prostate cancer compared to those not taking these medications. Discuss this risk with your doctor.

Although rare, male breast cancer has been associated with this medication. Consult your doctor to understand this potential risk.

This drug may also 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 to your unborn baby. If you accidentally come into contact with a crushed or broken tablet, immediately wash the affected area with soap and water.
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Overdose Information

Overdose Symptoms:

  • No specific symptoms of overdose have been reported in clinical studies with single doses up to 400 mg and multiple doses up to 80 mg/day for 3 months.

What to Do:

In the event of suspected overdose, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment should be symptomatic and supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Prostate-Specific Antigen (PSA)

Rationale: Finasteride decreases PSA levels by approximately 50% in men with benign prostatic hyperplasia (BPH) and androgenetic alopecia. This reduction should be considered when interpreting PSA values for prostate cancer screening. A new baseline PSA should be established after 6-12 months of treatment.

Timing: Prior to initiation of therapy (if age-appropriate for prostate cancer screening)

Liver Function Tests (LFTs)

Rationale: Although rare, hepatic impairment has been reported. Consider baseline if pre-existing liver disease.

Timing: Prior to initiation of therapy (if clinically indicated)

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Routine Monitoring

Hair Growth Assessment

Frequency: Every 3-6 months initially, then annually

Target: Improved hair count, thickness, and reduced hair loss

Action Threshold: Lack of improvement after 12 months may warrant re-evaluation of treatment or consideration of alternative therapies.

Prostate-Specific Antigen (PSA)

Frequency: As per standard prostate cancer screening guidelines, with adjustment for finasteride effect

Target: Interpretation requires doubling the observed PSA value for comparison with normal ranges in untreated men.

Action Threshold: Any sustained increase in PSA while on finasteride should be carefully evaluated, including consideration of non-compliance to therapy.

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Symptom Monitoring

  • Sexual dysfunction (decreased libido, erectile dysfunction, ejaculation disorder)
  • Breast tenderness and/or enlargement (gynecomastia)
  • Depression and/or anxiety
  • Allergic reactions (rash, itching, hives, swelling of the lips and face)
  • Testicular pain

Special Patient Groups

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Pregnancy

Finasteride is contraindicated in women who are or may potentially be pregnant due to the risk of abnormalities of the external genitalia of a male fetus. Pregnant women should not handle crushed or broken finasteride tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.

Trimester-Specific Risks:

First Trimester: High risk of external genital abnormalities in male fetus.
Second Trimester: Risk of external genital abnormalities in male fetus.
Third Trimester: Risk of external genital abnormalities in male fetus.
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Lactation

Finasteride is not indicated for use in women. It is unknown whether finasteride is excreted in human milk. Due to the potential for adverse effects on a nursing infant, it is not recommended for use in lactating women.

Infant Risk: Unknown; potential for adverse effects on male infant development.
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Pediatric Use

Finasteride 1mg is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.

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Geriatric Use

No dosage adjustment is necessary in elderly patients. However, the effect of finasteride on PSA levels should be considered when interpreting PSA results in older men undergoing prostate cancer screening.

Clinical Information

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Clinical Pearls

  • Finasteride 1mg is specifically for male pattern hair loss; it is not indicated for hair loss in women or children.
  • Consistent daily use is crucial for efficacy; skipping doses or stopping treatment will lead to reversal of benefits.
  • Patients should be counseled on the potential for sexual side effects (decreased libido, erectile dysfunction, ejaculatory disorders) and mood changes (depression, anxiety).
  • The effect on PSA levels must be communicated to patients and their healthcare providers for accurate prostate cancer screening interpretation.
  • Rare cases of male breast cancer have been reported; patients should be advised to report any breast lumps, pain, or nipple discharge immediately.
  • Results are gradual; patients should be encouraged to be patient and continue treatment for at least 12 months before assessing full efficacy.
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Alternative Therapies

  • Topical minoxidil (e.g., Rogaine)
  • Hair transplantation surgery
  • Low-level laser therapy (LLLT)
  • Platelet-rich plasma (PRP) therapy
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generic)
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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 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.