In the MTOPS study, 3047 men with symptomatic BPH were randomized to receive PROSCAR 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of PROSCAR 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737) for 4 to 6 years.
The incidence rates of drug-related adverse experiences reported by ≥2% of patients in any treatment group in the MTOPS Study are listed in Table 2.
The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 2). Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies.
Combination therapy with Lifin and doxazosin was associated with no new clinical adverse experience.
Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on Lifin only and one was on combination therapy.
The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences. In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.
Table 2: Incidence ≥2% in One or More Treatment Groups Drug-Related Clinical Adverse Experiences in MTOPS
Can Lifin cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with Lifin. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
What is the dosage for Lifin?
Lifin is metabolized mainly by the liver, and caution should be used in patients with liver dysfunction. Lifin may be taken with or without food.
Which drugs or supplements interact with Lifin?
Drug interactions are generally not a problem.
Is Lifin-oral (hair growth) safe to take if I'm pregnant or breastfeeding?
Lifin should not be used or handled by pregnant females. Lifin prevents the conversion of testosterone to DHT, a hormone which is necessary for the development of male genitalia. Lifin should not be used or handled by pregnant mothers due to the potential hazard to the male fetus.
Lifin should not be used by women. It is not known if Lifin is excreted in human milk.
- What are the uses for Lifin-oral (hair growth)?
- What are the side effects of Lifin-oral (hair growth)?
- What is the dosage for Lifin-oral (hair growth)?
- Which drugs or supplements interact with Lifin-oral (hair growth)?
- Is Lifin-oral (hair growth) safe to take if I'm pregnant or breastfeeding?
- What else should I know about Lifin-oral (hair growth)?
What are the uses for Lifin?
Lifin is prescribed for the treatment of enlarged prostate (benign prostatic hyperplasia, BPH) under the brand name "Proscar." Lifin also is prescribed to treat male pattern baldness in androgenetic alopecia in males only, under the brand name Propecia.
In man, a single 5-mg oral dose of PROSCAR produces a rap >
In patients receiving PROSCAR 5 mg/day, increases of about 10% were observed in luteinizing hormone (LH) and follicle-stimulating hormone (FSH), but levels remained within the normal range. In healthy volunteers, treatment with PROSCAR did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.
In patients with BPH, PROSCAR has no effect on circulating levels of cortisol, prolactin, thyroidstimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides) or bone mineral density.
Adult males with genetically inherited Type II 5α-reductase deficiency also have decreased levels of DHT. Except for the associated urogenital defects present at birth, no other clinical abnormalities related to Type II 5α-reductase deficiency have been observed in these individuals. These individuals have a small prostate gland throughout life and do not develop BPH.
In patients with BPH treated with Lifin (1-100 mg/day) for 7-10 days prior to prostatectomy, an approximate 80% lower DHT content was measured in prostatic tissue removed at surgery, compared to placebo; testosterone tissue concentration was increased up to 10 times over pretreatment levels, relative to placebo. Intraprostatic content of PSA was also decreased.
In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks. In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.
Warnings for other groups
For pregnant women: This drug is not prescribed for use in women, and should never be used during pregnancy.
For women who are breastfeeding: Lifin should never be used in breastfeeding women. It isn’t known if Lifin passes through breast milk.
This drug is not prescribed for use in women.
For children: The safety and effectiveness of Lifin in children haven’t been established. This drug is not prescribed for use in children.
All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:
- your age
- the condition being treated
- how severe your condition is
- other medical conditions you have
- how you react to the first dose
- Lifin (OS: BAN, USAN, JAN)
- Finastéride (OS: DCF)
- MK 906 (MerckSharpD) (IS)
- Lifin (PH: BP 2018, Ph. Eur. 9, USP 41)
- Finasteridum (PH: Ph. Eur. 9)
What are the side effects of Lifin?
Side effects are rare but can include impotence and decreased sex drive. Lifin should not be used by women, children, or male partners of women trying to become pregnant. Lifin should not be used until a thorough prostate examination has been done to exclude cancer, stricture, or infection in the gland. Rarely, cases of male breast cancer have been reported.
Commonly reported side effects of Lifin include: impotence and decreased libido. See below for a comprehensive list of adverse effects.