Pronor (Finasteride): For Benign Prostatic Hyperplasia (BPH)

Pronor contains Finasteride, a competitive inhibitor of the 5$\alpha$-reductase enzyme. It is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in adult males. It belongs to the therapeutic class of BPH/Urinary retention/Urinary incontinence.

How Pronor Works (Pharmacology)

Finasteride works by:

• Inhibiting 5$\alpha$-Reductase Enzyme: It is a competitive inhibitor selective for the 5$\alpha$-reductase type 2 enzyme. This enzyme is responsible for converting testosterone to dihydrotestosterone (DHT) within the prostate gland.
• Reducing DHT Levels: By inhibiting 5$\alpha$-reductase, Finasteride significantly reduces the levels of DHT in the prostate. DHT is the more potent androgen responsible for the development and enlargement of the prostate gland (BPH).
• No Androgen Receptor Affinity: Finasteride has no affinity for androgen receptors, meaning its action is specifically on the enzyme that produces DHT, not on the androgen receptors themselves.
• Regression of Enlarged Prostate: The reduction in DHT leads to the regression (shrinking) of the enlarged prostate gland.
• Improved Urinary Flow and Symptoms: This regression helps to improve urinary flow and alleviate the symptoms associated with BPH, such as urinary hesitancy, frequency, and nocturia.

Key Indications & Benefits

Pronor is indicated for the treatment and control of benign prostatic hyperplasia (BPH) to:

• Cause regression of the enlarged prostate.
• Improve urinary flow.
• Improve the symptoms associated with BPH.

Dosage & Administration

• The recommended dosage is one 5 mg tablet daily.
• Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued.
• Always consult a registered physician for medication use.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking Pronor.

Contraindications:

• Hypersensitivity to any component of this medication.
• Women and pediatric patients (Finasteride use is contraindicated in these populations).

Side Effects:

Pronor is generally well tolerated. In clinical studies, the following adverse experiences (possibly drug-related) were reported in approximately 1% of patients treated for 12 months with 5 mg Pronor daily:

• Impotence (3.7%)
• Decreased libido (3.3%)
• Decreased volume of ejaculate (2.8%)

Pregnancy & Lactation:

• Pregnancy:Finasteride is contraindicated in women who are or may become pregnant. This is because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus (teratogenicity, specifically affecting male sexual differentiation).
  • Exposure to male fetus risk: Crushed or broken Finasteride Tablets should not be handled by women who are or may become pregnant.
  • Small amounts of finasteride have been recovered from the semen of patients receiving 5 mg/day. It is not known whether a male fetus may be adversely affected if his mother is exposed to the semen of a treated patient. Therefore, if the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g., by use of a condom) or discontinue Finasteride.
• Lactation: Finasteride is not indicated for use in women. It is unknown whether finasteride is excreted in human milk.

Precautions & Warnings:

• General: Since the beneficial response may not be immediate, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.
• Prostate Cancer:
  • Digital rectal examination (DRE) and other evaluations for prostate cancer should be performed on patients with BPH prior to initiating therapy with Pronor and periodically thereafter.
  • Pronor causes a decrease in serum concentration of prostate-specific antigen (PSA), a marker of prostatic cancer. Therefore, a reduction in PSA levels in patients treated with Pronor does not rule out concomitant prostate cancer.
  • No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Pronor.

Drug Interactions:

• No clinically important drug interactions have been identified.
• Pronor does not appear to significantly affect the cytochrome P450 linked drug metabolizing enzyme system.
• Compounds tested in man include Propranolol, Digoxin, Glibenclamide, Warfarin, Theophylline, and antipyrine with no significant interactions.

Use in Special Populations

• Renal Insufficiency: Dosage adjustments are not necessary in patients with renal insufficiency as pharmacokinetic studies did not indicate any change in the disposition of Pronor.
• Hepatic Insufficiency: There are no data available in patients with hepatic insufficiency.
• Elderly: No dosage adjustment is required in elderly patients.
• Pediatric Patients: Contraindicated.

Overdose Effects

• Overdose information is not detailed, but generally, Finasteride has a wide therapeutic window.
• Treatment for overdose would likely be symptomatic and supportive.

Storage Conditions

Store at a cool and dry place (below 30°C). Protect from light and moisture. Keep all medicines out of the reach of children.