Pronor Tablet

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

• To cause regression of the enlarged prostate
• To improve urinary flow
• To improve the symptoms associated with BPH.

Finasteride, a competitive inhibitor of the 5α reductase enzyme which is used in the treatment of benign prostatic hyperplasia. It is selective for 5α reductase type 2 enzyme and has no affinity for androgen receptors. The development of the prostate gland and subsequent BPH is dependent upon conversion of testosterone to dihydrotestosterone (DHT) within the prostate. Finasteride belongs to a new class of specific inhibitors of 5α reductase, an intracellular enzyme, which metabolises testosterone into the more potent androgen, DHT. Finasteride has no affinity for the androgen receptor.

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.

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

Hypersensitivity to any component of this medication. Finasteride use is also contraindicated in women and paediatric patient

Pronor is well tolerated. In clinical studies, the following adverse experiences have been reported as possibly drug related in 1% of patients treated for 12 months with 5 mg Pronor daily: impotence (3.7%), decreased libido (3.3%), and decreased volume of ejaculate (2.8%).

Finasteride is contraindicated in women who are or may become pregnant. Finasteride is not indicated for use in women. It is not known whether finasteride is excreted in human milk.

Exposure to finasteride-risk to male fetus: Crushed or broken Finasteride Tablets should not be handled by women who are or may become pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Similarly, small amounts of finasteride have been recovered from the semen in subjects receiving Finasteride 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 patient being treated with finasteride. Therefore, when the patients 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

General: Since the beneficial response to Pronor may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy.

Prostate cancer: Digital rectal examination, as well as, 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 markers of prostatic cancer such as prostate specific antigen (PSA); therefore, reduction of serum levels of these markers in patients with BPH 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.

Renal insufficiency: Dosage adjustments are not necessary in patients with renal insufficiency since 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.

BPH/ Urinary retention/ Urinary incontinence

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