Proscar online in Australia

What is Proscar used for?

· Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).

· Reduced risk of acute urinary retention (URE) and surgery in patients with moderate to severe symptoms of BPH.

For information on treatment effects and populations studied in clinical trials, see the Pharmacodynamic Properties section.

Conditions for which this medicine may be prescribed

• Benign prostatic hyperplasia

Proscar drug administration and dosage method

Dose

The daily dose is one 5 mg tablet.

Even if rapid improvement can be seen in a few weeks, treatment of at least six months may be necessary to achieve maximum benefit.

Possible side effects of the drug Proscar

• Hypersensitivity reaction
• Angioedema
• Swollen lips
• Swollen tongue
• Swollen throat
• Swelling of the face
• Decreased libido
• Anxiety
• Depression
• Palpitation
• Increased liver enzymes.
• Skin itching
• Hives
• Acne
• Impotence
• Ejaculation disorder
• Gynecomastia
• Breast tenderness
• Abnormal sexual function
• Erectile dysfunction
• Testicular pain
• Male sterility
• Sperm abnormality
• Reduced ejaculation
• Male breast cancer
• Asthenia
• Hypotension
• Orthostatic hypotension
• Dizziness
• Drowsiness
• Prostate cancer
• Change of humor
• Depressed mood
• Suicidal idea

Show more The most common side effects are impotence and decreased libido. These side effects appear very quickly after the start of treatment and disappear during the continuation of treatment in most patients.

Side effects reported with Chibro-Proscar and / or finasteride used in lower doses during clinical trials and / or since marketing are listed in the table below.

The frequency of side effects is determined as follows:

Very common (≥ 1/10), Common (≥ 1/100 to minus 1/10), Uncommon (≥1 / 1000 to minus 1/100), Rare (≥1 / 10,000 to minus 1/1000), Very rare (less than 1 / 10,000), frequency not known (cannot be estimated from the available data).

The frequency of adverse reactions reported since marketing has not been established as it is based on spontaneous reports.

In addition, cases of breast cancer have been reported in men in clinical trials and after the product has been placed on the market (see section 4.4).

MTOPS Study (Prostate Symptom Medical Therapy)

The MTOPS study compared finasteride at the dose of 5 mg / day (n = 768), doxazosin at the dose of 4 or 8 mg per day (n = 756), the combination of finasteride at the dose of 5 mg / day and doxazosin. at a dose of 4 or 8 mg / day (n = 786) and placebo (n = 737). In this study, the safety and tolerance profile of drugs taken in combination was generally comparable to the profile of each drug taken separately. The frequency of ejaculation disorders in patients receiving the combination was comparable to the sum of the frequencies observed for this adverse effect with each of the two drugs administered as monotherapy.

EA: finasteride side effect: 5 mg / day; Doxazosin: 4 to 8 mg / day

* excluding orthostatic hypotension.

Other long-term data

In a 7-year, placebo-controlled study of 18,882 healthy men, 9,060 of whom had aspiration prostate biopsy data available for analysis, prostate cancer was detected in 803 men (18). , 4%) treated with Chibro-Proscar and 1,147 men (24.4%) who received a placebo. In the Chibro-Proscar group, 280 men (6.4%) had prostate cancer detected by aspiration biopsy, scoring 7-10 on the Gleason scale compared to 237 men (5.1%) in the placebo group. Further analysis suggests that the increase in the prevalence of high-grade prostate cancer observed in the Chibro-Proscar group may be explained by detection bias due to the effect of Chibro-Proscar on prostate volume. Of all the prostate cancers diagnosed in this study, about 98% were classified as intracapsular (clinical stage T1 or T2) at the time of diagnosis. The clinical importance of a score of 7 to 10 on the Gleason scale is unknown.

Laboratory analysis results.

When performing PSA tests in the laboratory, it should be noted that PSA levels are lower in patients treated with Chibro-Proscar (see section 4.4). Special warnings and precautions for use).

Contraindications: when not to use this medicine?

• Hypersensitivity to finasteride
• Woman
• Lack of male contraception
• Galactose intolerance
• Glucose malabsorption syndrome
• Galactose malabsorption syndrome
• Lactase deficiency

Chibro-Proscar is not indicated for women or children.

Chibro-Proscar is contraindicated in the following cases:

Hypersensitivity to the active substance or to any of the excipients included in the Composition section.

· Pregnancy: in women who are pregnant or likely to be pregnant (see section Fertility, pregnancy and lactation Pregnancy and lactation, Exposure to finasteride and risk to the male fetus).

Presentation of this medicine

5, 14, 28, 84, 90 tablets in blister (PVC / PE / PVDC / Aluminum).

5, 14 tablets in blister (aluminum / aluminum).

28 tablets in heat-sealed blisters (aluminum / aluminum).

Not all presentations can be marketed.

Appearance and shape

Compressed film.

Proscar: its other forms

• Proscar 5 mg film-coated tablet, box of 28

Composition of the drug Proscar

There is no data to suggest that Chibro-Proscar affects the ability to drive or use machines.

Warnings and precautions for use

• Reserved for adult men
• Significant residual volume after urination
• PSA monitoring
• PSA increase
• Breast mass
• Chest pain
• Gynecomastia
• Human mammary secretions
• Man whose partner is pregnant or is likely pregnant
• Psychiatric disorder
• Liver failure

Show more General

To avoid obstructive complications, it is important that patients with a large residual volume after urination and / or a very low urine flow are carefully monitored. The possibility of a surgical operation should be considered.

Effects on PSA (prostate specific antigen) levels and detection of prostate cancer

To date, treatment with Chibro-Proscar has shown no clinical benefit in patients with prostate cancer. In controlled clinical studies, PSA assays and prostate biopsies have been performed periodically in patients with BPH and elevated serum PSA levels. In these studies, Chibro-Proscar did not appear to affect the detection rate of prostate cancer. The overall incidence of prostate cancer in the groups of patients treated with Chibro-Proscar was not significantly different from that of the groups receiving placebo.

Before starting Chibro-Proscar treatment, and periodically thereafter, a digital rectal exam is recommended, as well as additional prostate cancer screenings. Serum PSA levels are also used to detect prostate cancer. In general, a baseline PSA value greater than 10 ng / ml (Hybritech test) encourages further examination and consideration of a biopsy; For PSA levels between 4 and 10 ng / ml, further evaluation is recommended. PSA values in men with and without prostate cancer are similar. Therefore, a PSA level within normal reference limits does not exclude prostate cancer in a patient with BPH, whether or not they have been treated with Chibro-Proscar. A baseline PSA level of less than 4 ng / ml does not exclude prostate cancer.

Chibro-Proscar causes an approximately 50% decrease in serum PSA levels in patients with BPH, even in the presence of prostate cancer. This reduction in PSA levels in patients with BPH treated with Chibro-Proscar should be taken into account when evaluating PSA values and does not exclude concomitant prostate cancer. This decrease is predictable regardless of PSA level, although it may vary from one individual to another. The analysis of the PSA levels measured in more than 3,000 patients in the framework of the PLESS study (Long-term efficacy and safety study PROSCAR), carried out in double blind versus placebo and with a duration of 4 years, confirmed that, in patients treated with Chibro-Proscar for 6 months or more, the PSA level must be doubled in order to be interpreted compared to the normal values observed in untreated patients. Thanks to this adjustment, the PSA dose maintains its sensitivity, specificity and reliability as a detection method for prostate cancer.

Any sustained increase in PSA levels in patients treated with finasteride should be carefully evaluated, taking into account the possibility of non-compliance with Chibro-Proscar treatment.

Chibro-Proscar does not significantly decrease the percentage of free PSA (free PSA / total PSA ratio), which remains constant even when treated with Chibro-Proscar. No adjustment is necessary when using the percentage of free PSA for the detection of prostate cancer.

Pharmacological interactions with laboratory tests.

Effect on PSA levels

The PSA level is related to the age of the patient and the volume of the prostate, and the volume of the prostate is related to the age of the patient. When interpreting the PSA level values, it should be remembered that this level decreases in patients treated with Chibro-Proscar.

In most patients, a rapid decrease in PSA levels was observed during the first months of treatment, and then stabilized around a new baseline. The new base value obtained after treatment is equivalent to approximately 50% of the initial value measured before treatment. Therefore, in typical patients treated with Chibro-Proscar for 6 months or more, the PSA level must be multiplied by 2 in order to be interpreted compared to the reference values observed in untreated men. For a clinical interpretation, see Warnings and Precautions for Use Special Warnings and Precautions for Use, Effects on PSA Levels, and Prostate Cancer Screening.

Male Breast Cancer

Breast cancer has been reported in clinical studies and post-marketing experience in men treated with a 5 mg dose of finasteride. Doctors should inform their patients that they should be warned immediately in the event of an enlarged breast, pain, gynecomastia, or a nipple discharge.

Mood swings and depression

Changes in mood, including depression, depression, and, less frequently, suicidal thoughts, have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and, if these appear, patients should be advised to seek medical advice.

Pediatric use

Chibro-Proscar is not indicated in children.

Safety and effectiveness in children have not been established.

Lactose

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency, or malabsorption of glucose or galactose (rare inherited diseases).

Liver failure

The effect of liver failure on the pharmacokinetics of finasteride has not been studied.

Mechanism of action: how does it work?

Pharmacotherapeutic group: ALPHA-5-TESTOSTERONE REDUCTASE INHIBITORS, ATC code: G04CB01.

Finasteride is a specific inhibitor of the intracellular enzyme 5 alpha-reductase, which metabolizes testosterone (T) to dihydrotestosterone (DHT), a biological control of the activity of this enzyme.

The development of the prostate gland, and thus benign prostatic hyperplasia, has been shown to be influenced by DHT resulting from the transformation of T to DHT in the prostate through 5 alpha -reductase activity.

People with congenital 5 alpha reductase deficiency have very low DHT, a small prostate, and do not develop benign prostatic hyperplasia.

Finasteride reduces circulating and intraprostatic DHT. The significant reduction in circulating DHT appears within 24 hours of taking finasteride orally.

Finasteride has no affinity for androgen receptors.

A significant difference in activity was observed compared to placebo during clinical studies:

· At 3 months for decreased prostate volume,

At 4 months at peak urine flow,

· At 7 months in symptomatic scores.

For large prostates, the therapeutic response may be more important.

A randomized, double-blind study (PLESS) compared finasteride with placebo in 3,040 patients with a large prostate and moderate to severe symptoms of benign prostatic hyperplasia.

Patients were randomized to receive either finasteride 5 mg / day (1,524 patients) or placebo (1,516 patients) for 4 years.

The treatment with finasteride allowed to obtain:

· A reduction in the number of patients with acute urinary retention or recourse to prostate surgery: 100 (6.6%) with finasteride versus 199 (13.2%) with placebo.

Finasteride and placebo:

· The number of patients with acute retention was respectively 42 (2.8%) in the finasteride group and 99 (6.6%) in the placebo group,

· The number of patients undergoing prostate surgery was 69 (4.6%) in the finasteride group and 152 (10.1%) in the placebo group, respectively.

Therefore, the treatment of 100 patients for 4 years allowed to avoid approximately 4 episodes of acute urine retention and 6 resources for surgical intervention.

In terms of tolerance, we observed under finasteride, compared to placebo, an increase of 8.9% in the percentage of patients with effects: impotence, decreased libido, ejaculation disorders and the appearance of gynecomastia.

The multi-center, double-blind, randomized, placebo-controlled study with a median duration of 5 years, the US study MTOPS (Medical Therapy of Prostatic Symptoms), was conducted in 3,047 men with symptomatic BPH who received finasteride 5 mg / day (n = 768), either doxazosin 4 or 8 mg / day (n = 756), or the combination of finasteride 5 mg / day and doxazosin 4 or 8 mg / day (n = 786), or a placebo (n = 737) .

The main end point of the study was the time between randomization and clinical progression of BPH, defined by the first appearance of one of the following criteria: ≥ 4 point increase in the baseline value of symptom score (measured on the symptom scale) validated by the American Urological Association), acute urine retention, BPH-related kidney failure (creatinine elevation), recurrent or severe urinary tract infections, or incontinence.

Compared to placebo, treatment with finasteride, doxazosin, or combination resulted in a significant reduction in the risk of clinical progression of BPH by 34% (p = 0.0018) and 39% (p = 0.0002), respectively. ) and 67% (p minus 0.0001), corresponding to 128 cases (17.4%) with placebo, 89 (11.6%) with finasteride, 85 (11.2%) with doxazosin and 49 (6.2%) with the association. Most of the events (274 out of 351) that contributed to the progression of BPH are related to an increase of ≥4 points in the symptom score; the risk of increasing the symptom score decreased by 30% (p = 0.0156), 46% (p = 0.0001) and 64% (p minus 0.0001), respectively in finasteride, doxazosin and association versus placebo.

The incidence of clinical progression of BPH was approximately 5% lower with the combination than with finasteride (95% CI = [2.6%; 8.2%]; p minus 0.001) or doxazosin used alone (95% CI = [2.2%; 7.8 %]; p minus 0.001).

41 of the 351 events that contributed to the progression of BPH were acute urinary retention, 18 cases (2.4%) with placebo, 6 (0.8%) with finasteride, 13 (1.7%) in doxazosin, and 4 (0.5%) with the combination; the risk of developing acute urine retention was reduced by 67% (p = 0.0114), 31% (p = 0.2963) and 79% (p = 0.0013), respectively, in the finasteride and doxazosin groups and with the combination versus placebo.

Only the finasteride and finasteride / doxazosin groups were significantly different from placebo.

The risk of invasive treatment for BPH (secondary endpoint) was reduced by 64% (p = 0.0004), 3% (p = 0.8686) and 67% (p = 0.0001) respectively in the groups. of finasteride, doxazosin and combination compared to placebo, which corresponds to 40 cases (5.4%) with placebo, 15 (2%) with finasteride, 41 (5.4%) with doxazosin and 14 (1.8%) with the association. Only the finasteride and finasteride / doxazosin groups were significantly different from placebo.

In this study, the safety and tolerance profile of drugs taken in combination was generally comparable to the profiles of each of the drugs taken separately. However, the undesirable effects linked to the following two classes of organs: "nervous system" and "urogenital system", were observed more frequently when the two drugs were combined (see section Undesirable Effects).

Interactions: do not take this medicine with ..

No clinical drug interactions have been identified.

Finasteride is metabolized primarily through cytochrome P450 3A4, but does not appear to have a significant effect on it.

Although the risk of finasteride affecting the kinetics of other drugs is low, cytochrome P450 3A4 inhibitors and inducers are likely to affect plasma concentrations of finasteride. However, given the established safety margins, any increase due to the concomitant use of such inhibitors is unlikely to have clinical consequences.

Drugs studied in humans included propranolol, digoxin, glibenclamide, warfarin, theophylline, and phenazone and no clinically significant interactions were observed.

Incompatibilities

Aimlessly.

How to react in case of overdose?

Patients have been treated with single doses of finasteride up to 400 mg and with repeated doses of up to 80 mg daily for three months with no side effects.

No specific treatment is recommended in case of overdose with Chibro-Proscar.

Proscar: pregnancy, lactation and fertility

Pregnancy

Finasteride has no therapeutic indication in women.

Finasteride is contraindicated in pregnant women or may be pregnant due to its endocrine effects resulting in abnormalities of the external genitalia in the male fetus.

Therefore, it is essential for a pregnant woman or likely to be pregnant, to avoid contact with broken finasteride tablets. Chibro-Proscar tablets are film-coated, which prevents contact with the active ingredient during normal handling, provided the tablets are not broken or crushed.

Small amounts of finasteride have been found in the semen of subjects receiving 5 mg of finasteride per day. There is no data to conclude that a male fetus is affected if its mother is exposed to the semen of a patient treated with finasteride. When the patient's partner is pregnant or likely to be pregnant, condoms are recommended to minimize the partner's exposure to sperm.

Breastfeeding

The passage of finasteride into breast milk is unknown.

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