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PROPECIA is a brand name for Finasteride, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PROPECIA® (finasteride tablets) is a Type II 5α-reductase inhibitor, indicated for: • the treatment of male pattern hair loss (androgenetic alopecia) in men who have mild to moderate scalp hair loss of the vertex and anterior mid-scalp. Clinical studies were conducted in men between 18 to 41 years of age. 1.1…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment The recommended dosage is one 1 mg tablet daily. PROPECIA may be taken with or without food. In general, daily use for three months or more is necessary before hair growth is increased and/or further hair loss is prevented.
Continued use is recommended to obtain maximum benefit. Withdrawal of treatment leads to reversibility of effect within 12 months. 15 mL/s [9 mL/min]) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
4 Administration PROPECIA is for oral administration. 5 Missed Dose If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual.
). Carcinogenesis and Mutagenesis Increased Risk of High-Grade Prostate Cancer with 5α-Reductase Inhibitors: Men aged 55 and over with a normal digital rectal examination and prostate specific antigen Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 1 mg docusate sodium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, methylhydroxypropylcellulose, microcrystalline cellulose, pregelatinized starch, red ferric oxide, sodium starch glycolate, talc, titanium dioxide, and yellow ferric oxide.
1%). (See 8 ADVERSE REACTIONS). 5% placebo). 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α- reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.
5 ng/mL at Month 12. Further, in clinical studies with PROSCAR® (finasteride, 5 mg) when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Other studies with PROSCAR showed it may also cause decreases in serum PSA in the presence of prostate cancer.
These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride. Any confirmed increase from the lowest PSA value while on PROPECIA may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor.
Non-compliance to therapy with PROPECIA may also affect PSA test results. Psychiatric There have been post-marketing reports of serious psychiatric symptoms in patients being treated with finasteride that sometimes continued after treatment discontinuation.
5 Post-Market Adverse Reactions). It is recommended that all patients be screened for suicidal ideation, self-harm, and depression and/or associated risk factors before treatment initiation. Clinical monitoring of all patients for signs and symptoms of psychiatric disorder should continue throughout treatment and after.
and 14 CLINICAL TRIALS). 2 Geriatrics (> 65 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use (see 14 CLINICAL TRIALS). 1 Pregnant Women, Exposure to Finasteride - Risk to Male Fetus); • Hypersensitivity to any component of this product.
PROPECIA is not indicated for use in women or children. 2 Recommended Dose and Dosage Adjustment The recommended dosage is one 1 mg tablet daily. PROPECIA may be taken with or without food. In general, daily use for three months or more is necessary before hair growth is increased and/or further hair loss is prevented.
Continued use is recommended to obtain maximum benefit. Withdrawal of treatment leads to reversibility of effect within 12 months. 15 mL/s [9 mL/min]) as pharmacokinetic studies did not indicate any change in the disposition of finasteride.
4 Administration PROPECIA is for oral administration. 5 Missed Dose If a tablet is missed at its usual time, an extra dose should not be taken. The next dose should be taken as usual. 5 OVERDOSAGE Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse reactions.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging PROPECIA 1 mg tablets are tan-colored, 8-sided, film-coated convex tablets with the code “P” logo on one side and PROPECIA on the other.
Available in blister packages of 28 tablets. 7 WARNINGS AND PRECAUTIONS General Caution should be used in the administration of PROPECIA in patients with liver function abnormalities, as finasteride is metabolized in the liver. Other causes of alopecia should be ruled out prior to prescribing PROPECIA.
1 Pregnant Women, Exposure to Finasteride - Risk to Male Fetus); • Hypersensitivity to any component of this product. PROPECIA is not indicated for use in women or children.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If these occur, treatment should be discontinued and patients advised to seek medical advice, as soon as possible. 1 Pregnant Women PROPECIA is not indicated for use in women. Women should not handle crushed or broken PROPECIA tablets when they are or may potentially be pregnant (see 2 CONTRAINDICATIONS).
Because of the ability of Type II 5α-reductase inhibitors such as finasteride to inhibit conversion of testosterone to dihydrotestosterone, PROPECIA may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
PROPECIA® (finasteride) Page 7 of 24 Exposure to Finasteride - Risk to Male Fetus:
Women should not handle crushed or broken tablets of PROPECIA when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
2 Breast-feeding It is not known whether PROPECIA is excreted in human milk. 3 Pediatrics (<18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use (see 14 CLINICAL TRIALS).
4 Geriatrics (> 65 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use (see 14 CLINICAL TRIALS).
Use in Postmenopausal Women:
Results of a one year placebo-controlled study, enrolling 137 healthy postmenopausal women with androgenetic alopecia (age range: 41-60 years), showed no benefit of treatment with PROPECIA 1 mg daily on scalp hair growth. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
PROPECIA® (finasteride) Page 8 of 24 Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 men and is generally well tolerated. In three 12-month, placebo-controlled, double-blind, multicenter studies of comparable design, the overall safety profiles of PROPECIA and placebo were similar.
Discontinuation of therapy due to any clinical adverse reactions occurred in […]
Efficacy and duration of treatment should be assessed periodically by the treating physician. Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported (see