Name: Generic Propecia
Brand: Finasteride
SKU: 2109
Availability: InStock
Rating: 4.21 (237 reviews)

Use

Therapeutic indications

Propecia is indicated in men aged 18 to 41 for undeveloped stages of androgenetic alopecia. Propecia stabilizes the process of androgenetic alopecia. Efficacy in receding bitemporal chasms and at an advanced stage of hair loss has not been established.

Dosage and method of administration

Dose

1 tablet (1 mg) daily with or without meals.

There is no evidence that an increase in dosage increases the effectiveness of the product.

The effectiveness and duration of treatment should be regularly evaluated by the attending physician. Three to six months of treatment once a day are usually necessary before you can see overt stabilization of hair loss. Its continuous use is recommended to maintain the therapeutic benefit. If treatment is stopped, the beneficial effects begin to diminish in the sixth month and disappear after 9 to 12 months.

Administration form

Broken or crushed Propecia tablets should not be handled by women who are pregnant or who may be pregnant due to the possibility of absorption of finasteride and therefore the potential risk to a male fetus (see section Pregnancy and lactation). ) Propecia tablets are film-coated, which prevents contact with the active ingredient during normal handling, provided the tablets are not broken or crushed.

Patients with kidney failure.

No dosage adjustment is necessary in patients with renal impairment.

Prescription and delivery conditions

List I.

Duration and special precautions for conservation

Shelf life: 3 years.

Special storage precautions: This medicine does not require any special storage precautions.

Preclinical safety data

Mutagenicity / carcinogenicity

Genotoxicity and carcinogenicity studies have shown no risk to humans.

Effects on reproduction and fertility.

The effects on embryonic and fetal development have been studied in rats, rabbits, and rhesus monkeys.

In rats treated with doses of 5 to 5,000 times the recommended human dose, the appearance of hypospadias has been observed in male fetuses and has been dose dependent. In rhesus monkeys, treatment with oral doses of 2 mg / kg / day also resulted in external genital defects. Intravenous doses of up to 800 ng / day in rhesus monkeys have had no effect on the male fetus. This equates to at least 750 times the highest estimated exposure of pregnant women to the finasteride contained in the sperm of couples treated with 1 mg / day (see Pharmacokinetic Properties section). In the rabbit study, fetuses were not exposed to finasteride during the critical period of genital development.

Neither ejaculation volume, sperm count, nor fertility were affected in rabbits after treatment with 80 mg / kg / day, a dose that in other studies has led to a marked decrease in weight of the sexual appendages. In rats treated for 6 and 12 weeks with 80 mg / kg / day (approximately 500 times the clinical exposure), no effect on fertility was observed. After 24 to 30 weeks of treatment, some reductions in fertility and a marked reduction in the weight of the prostate and seminal vesicles have been observed. All changes were reversible within 6 weeks. The reduction in fertility has been shown to be caused by altered seminal plug formation, an effect that does not affect humans. The development of newborns and their reproductive capacity at the age of sexual maturity were not influenced.

After insemination in female sperm rats of the epididymis from rats treated for 36 weeks at 80 mg / kg / day, no effect was observed on various fertility parameters.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

Contraindicated in women (see sections Pregnancy and lactation "Fertility, pregnancy and lactation" and Pharmacodynamic properties "Pharmacodynamic properties").

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

Pregnancy and lactation

Pregnancy

Propecia is contraindicated in women due to the risk during pregnancy. Due to the ability of finasteride to inhibit the conversion of testosterone to dihydrotestosterone (DHT), Propecia can cause abnormalities in the external genitalia of a male fetus, if administered to a pregnant woman (see section Instructions for use, handling and disposal).

Breastfeeding

The passage of finasteride into breast milk is unknown.

Fertility

There are no long-term data on fertility in humans, and no specific studies have been conducted in hypofertile men. Men who want to procreate were initially excluded from clinical studies. Although no significant negative effects on fertility have been observed in animal studies, cases of infertility and / or poor semen quality have been reported on the market spontaneously. In some of these cases, the patients had other risk factors that could have contributed to infertility. When treatment was stopped, normalization or improvement in sperm quality was observed.

Warnings and precautions for use

Pediatric population

Propecia should not be used in children. There are no data demonstrating the efficacy or safety of finasteride in children younger than 18 years.

Effects on prostate specific antigen (PSA)

In clinical studies with Propecia in men aged 18 to 41 years, the mean value of prostate specific antigen (PSA) decreased from 0.7 ng / ml before treatment to 0.5 ng / ml after 12 months of treatment. It is necessary to double the PSA level before considering the result of this test in men taking Propecia.

Effects on fertility.

See section Pregnancy and lactation "Fertility, pregnancy and lactation".

Liver failure

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

Breast cancer

Post-marketing cases of breast cancer have been observed in men treated with 1 mg finasteride. Physicians should direct their patients to report any changes in breast tissue immediately, such as size, pain, gynecomastia, or 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 1 mg. Patients should be monitored for psychiatric symptoms and, if symptoms develop, treatment with finasteride should be discontinued and patients should be advised to seek medical advice.

Lactose intolerance

Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption should not take this medicine.

ANSM alert of 10/26/2017:

Depression (and suicidal ideation) has been observed with finasteride.

Any change in mood should lead to discontinuation and monitoring of treatment.

Interaction with other medicinal products and other forms of interaction

Finasteride is metabolized mainly by the cytochrome P450 3A4 system without altering it. Although the risk of finasteride changing the pharmacokinetics of other drugs is considered low, cytochrome P450 3A4 inhibitors and inducers are likely to affect the plasma level of finasteride. However, according to established safety margins, an increase due to the concomitant use of such inhibitors is unlikely to have clinical consequences.

Interaction studies have only been performed in adults.

Caution

Undesirable effects

Side effects reported during clinical and / or post-marketing studies are listed in the table below.

The frequency of these effects is defined as follows:

Very common (≥ 1/10); Frequent (≥ 1/100, minus 1/10); Uncommon (≥ 1/1000, minus 1/100); Rare (≥ 1 / 10,000, minus 1 / 1,000); 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 cannot be determined as it results from cases of spontaneous pharmacovigilance.

Immune system disorders.

Frequency not known: hypersensitivity reactions such as rash, itching, hives and angioedema (including inflammation of the lips, tongue, throat and face).

Psychiatric disorders

Uncommon *: decreased libido

Uncommon: depression †

Heart conditions

Frequency not known: palpitations

Hepatobiliary disorders.

Frequency not known: increase in liver enzymes.

Reproductive system and breast disorders.

Uncommon *: erectile dysfunction, ejaculation disorder (including reduced ejaculation volume)

Frequency not known: tension and enlargement of the breasts, testicular pain, infertility **

* Incidences given as a difference compared to placebo during 12-month clinical studies.

† This adverse reaction was identified during post-marketing surveillance, but the incidence in phase III randomized controlled clinical trials (protocols 087, 089, and 092) was no different between finasteride and placebo.

** See Warnings and Precautions for Use.

Furthermore, since its commercialization, the following side effects have been reported: persistence of sexual dysfunction (decreased libido, erection and ejaculation disorders) after stopping treatment with finasteride, breast cancer in men (see section 4.4) .

Adverse sexual effects were more frequent in men treated with finasteride than in those who received placebo, with frequencies of 3.8% vs. 2.1% respectively during the first 12 months. The incidence of these effects decreased to 0.6% in men treated with finasteride over the next four years. About 1% of men (in each group) discontinued treatment in the first 12 months due to treatment-related sexual adverse events. This incidence subsequently decreased.