Alopec, 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. Alopec belongs to a new class of specific inhibitors of 5α reductase, an intracellular enzyme, which metabolises testosterone into the more potent androgen, DHT. Alopec has no affinity for the androgen receptor.
Alopec is used 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.
Alopec is also used to associated treatment for these conditions: Androgenetic Alopecia, Benign Prostatic Hyperplasia (BPH), Idiopathic Hirsutism, Symptomatic Benign Prostatic Hyperplasia
|Other Names||Finasterida, Finasteride, Finasteridum|
Approximately 90% of circulating finasteride is bound to plasma proteins.
|Therapeutic Class||BPH/ Urinary retention/ Urinary incontinence|
|Manufacturer||Square Pharmaceuticals Ltd|
|Last Updated:||June 23, 2021 at 11:20 am|
Table Of contents
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.
Alopec 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 Alopec daily: impotence (3.7%), decreased libido (3.3%), and decreased volume of ejaculate (2.8%).
General: Since the beneficial response to Alopec 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 Alopec and periodically thereafter. Alopec 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 Alopec does not rule out concomitant prostate cancer. No clinical benefit has yet been demonstrated in patients with prostate cancer treated with Alopec.
No clinically important drug interactions have been identified. Alopec 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.
- Take with or without food. The absorption is unaffected by food.
Volume of Distribution
The volume of distribution is 76 L at steady state, ranging from 44 to 96 L. Alopec has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF. It is not known whether finasteride is excreted in human milk.
In healthy young subjects receiving finasteride, the mean elimination half-life in plasma was 6 hours ranging from 3 to 16 hours. In elderly patients over the age of 70 years, the half-life is prolonged to 8 hours.
In healthy young subjects (n=15), the mean plasma clearance of finasteride was 165 mL/min with the range between 70 and 279 mL/min.
Pregnancy & Breastfeeding use
Alopec is contra-indicated in women who are or may become pregnant. Alopec 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 Alopec 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 Alopec 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 Alopec.
Hypersensitivity to any component of this medication. Alopec use is also contraindicated in women and paediatric patient
Renal insufficiency: Dosage adjustments are not necessary in patients with renal insufficiency since pharmacokinetic studies did not indicate any change in the disposition of Alopec.
Hepatic insufficiency: There are no data available in patients with hepatic insufficiency.
Elderly: No dosage adjustment is required in elderly patients.
Store at 20-25° C. Protect from light.