INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FINPRO (tablets)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

FINPRO (tablets)

COMPOSITION:
Each film-coated tablet contains finasteride 5 mg
PHARMACOLOGICAL CLASSIFICATION
A21.12 Hormone inhibitors

PHARMACOLOGICAL ACTION
Finasteride is a synthetic 4-azasteriod compound. Finasteride is an inhibitor of Type II 5-alpha reductase, an intracellular enzyme that metabolises testosterone into the more potent androgen dihydrotestosterone (DHT). Finasteride has no affinity for the androgen receptor.
The development of the prostate gland and subsequent benign prostate hyperplasia (BHP) is dependent upon the conversion of testosterone to DHT within the prostate.
Finasteride reduces circulating and intraprostatic DHT. Within 24 hours after oral administration of finasteride there is a significant reduction in circulating DHT levels as a result of the inhibition of 5-alpha reductase.
Pharmacokinetics
Following an oral dose of 14C-finasteride in humans, the bioavailability is approximately 80% (relative to an intravenous reference dose) and is not affected by food.
Maximum finasteride plasma concentrations are reached about 2 hours after dosing and the absorption is complete after 6 to 8 hours. Protein binding is approximately 93%, plasma clearance about 165 mL/min and the volume of distribution, 76 litres.
Finasteride displays a mean plasma elimination half-life of approximately 6 hours (4 - 12 hours) in subjects 46 –60 years of age and approximately 8 hours in men 70 years of age and older.
Two metabolites of finasteride have been identified which possess only a small fraction of the 5-alpha reductase inhibitory activity of finasteride. 36% of the dose is excreted in the urine in the form of metabolites and 57% of the total dose is excreted in the faeces.

INDICATIONS
FINPRO is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
• Improve urinary flow and improve the symptoms associated with BPH by causing regression of the enlarged prostate
• Decrease the incidence of acute urinary retention
• Decrease the incidence of surgery including transurethral resection of the prostate (TURP) and prostatectomy

CONTRA-INDICATIONS
Hypersensitivity to any of the components of FINPRO
Pregnancy –(See “PRECAUTIONS”, “Use in Pregnancy and Lactating Mothers”and “Exposure to FINPRO–Risk to Male Foetus”below)
FINPRO is not indicated for use in women
FINPRO is not indicated for paediatric use

WARNINGS
FINPRO is contra-indicated for use in women when they are or may potentially be pregnant as it may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman. (see “Pregnancy and Exposure to FINPRO –Risk To Male Foetus” below).
It is not known whether FINPRO is excreted in breast milk.
Serum Prostate Specific Antigens (S-PSA) levels decrease in patients treated with FINPRO.

INTERACTIONS
No interactions of clinical importance have been identified.
FINPRO does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system.
Compounds tested in men included digoxin, propranolol, warfarin, glibenclamide and theophylline and no clinically meaningful interactions were found.
Other Concomitant Therapy
FINPRO has been used concomitantly with ACE-inhibitors, paracetamol, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), quinolones and benzodiazepines without evidence of clinically significant adverse interactions.

PREGNANCY AND LACTATION
Use in Pregnancy and Lactating Mothers
FINPRO is contra-indicated in pregnancy (see “CONTRA-INDICATIONS”).
Because of the ability of Type II 5-alpha reductase inhibitors to inhibit conversion of testosterone to dihydrotesterone these drugs, including FINPRO, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
Lactation
It is not known if FINPRO is excreted in human milk.
Exposure to FINPRO (by pregnant women) - Risk To Male Foetus
FINPRO tablets are film-coated and will prevent contamination with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
Pregnant women should not handle crushed or broken FINPRO tablets because of the possibility of absorption of FINPRO and the subsequent potential risk to male foetus (see “Use in Pregnancy”).
In addition, since FINPRO is present in semen, male patients should wear a condom or otherwise avoid exposure of female sexual partners at risk of becoming pregnant.

DOSAGE AND DIRECTIONS FOR USE
The recommended dosage is one FINPRO tablet daily with or without food.
Although early improvement in symptoms may be seen, a therapeutic trial of 6 –12 months may be necessary to assess whether a beneficial response has been achieved.
Dosage in Renal Insufficiency
Adjustments in dosage are not required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL /min) as there are no changes in the disposition of FINPRO as compared to healthy subjects.
Dosage in the Elderly
No adjustments in dosage are required even though the elimination of FINPRO is decreased in patients more than 70 years of age.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
SIDE EFFECTS
Reproductive system and breast disorders
Less frequent: Impotence,decreased libido, decreased volume of ejaculate, ejaculation disorder, gynaecomastia (breast tenderness and enlargement)
Incidence unknown: Testicular pain
Skin and subcutaneous tissue disorders
Less frequent: Skin rash
Other
Less frequent: Hypersensitivity reactions including pruritus, urticaria and swelling of the lips and face

SPECIAL PRECAUTIONS
General
The beneficial response of FINPRO may not be manifested immediately and thus patients with large residual urine volume and/or severely diminished urinary flow should be monitored carefully for obstructive uropathy.
Since serum markers of prostrate cancer may be reduced in patients taking FINPRO, such malignancies should be excluded before treatment of benign prostatic hyperplasia is initiated.
Effects on PSA and prostate cancer detection
No clinical benefit has been demonstrated in patients with prostate cancer treated with FINPRO.
Digital rectal examinations as well as other evaluations for prostate cancer are recommended prior to initiating therapy with FINPRO and periodically thereafter. Serum prostate-specific antigen (S-PSA) is also used for prostate cancer detection. Generally a baseline S-PSA greater than 10 ng/mL (Hybritech) prompts further evaluation and consideration of biopsy; for S-PSA levels between 4 and 10 ng/mL, further evaluation is advisable. The medical practitioner should be aware that the baseline S-PSA <4 ng/mL does not exclude prostate cancer.
FINPRO causes a decrease in S-PSA concentrations even in the presence of prostate cancer (see “Drug/Laboratory Test Interactions”). The reduction of levels in patients with BPH treated with FINPRO should be considered when evaluating S-PSA data and does not rule out concomitant prostate cancer.
Patients treated with FINPRO who have a sustained increase in S-PSA levels should be carefully evaluated.
Drug/Laboratory Test Interactions
Prostatic volume is correlated with a patient’s age whereas serum prostate serum antigen (S-PSA) concentration is correlated with a patient’s age and prostatic volume. When S-PSA laboratory determinations are evaluated, consideration should be given to the fact that S-PSA levels decrease in patients treated with FINPRO (see “PRECAUTIONS, Prostate Cancer”). S-PSA levels decrease rapidly within the first months of therapy, after which time, S-PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre-treatments value. This decrease is predictable over the entire range of S-PSA values, although it may vary in individual patients. Therefore, in typical patients treated with FINPRO for six months or more, S-PSA values should be doubled for comparison to normal ranges in untreated men. There is considerable overlap in S-PSA levels among men with and without prostate cancer. Therefore, in men with BPH, S-PSA values within the normal reference range, prostate cancer should not be ruled out regardless of FINPRO treatment. The ability of S-PSA to distinguish between BPH and cancer is not adversely affected by treatment with FINPRO.
Laboratory Test Findings
Consideration should be given to the fact that S-PSA levels are decreased in patients treated with FINPRO (see“PRECAUTIONS”) when S-PSA laboratory test determinations are evaluated.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
No specific treatment of over-dosage with FINPRO is recommended.
Treatment is symptomatic and supportive.

IDENTIFICATION
Blue coloured, oval shaped, biconvex film-coated tablets, debossed with ‘FIN’on one side and “5”on the other side.

PRESENTATION
FINPRO tablets are available in pack sizes of 28 tablets packed in PVC/aluminium blister strips.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light. Keep the blisters in the outer carton until required for use.
Women should not handle crushed or broken tablets of FINPRO when they are or may potentially be pregnant (see “CONTRA-INDICATIONS”, “Use in Pregnancy”and “Exposure to FINPRO - Risk to Male Fetus”).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
40/21.12/0567

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Dr. Reddy’s Laboratories (Pty) Ltd.
3rd Floor, TA Bank Building
160 Jan Smuts Avenue
Rosebank
2196 Johannesburg

DATE OF PUBLICATION OF THIS PACKAGE INSERT
July 2007

New addition to this site: January 2008
Source: Pharmaceutical Industry

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