It should be emphasized that finasteride is not indicated for use in women, and is classified by the U. Women who choose to take finasteride for hirsutism related to PCOS should be informed of the potential risks associated with this treatment and take precautions to prevent an unplanned pregnancy. E-mail: david. Drug information provided by Lexi-Comp. Accessed April 19,
Submission of a letter will Average penis size inches construed as granting the Anf permission to publish the letter in any of its publications in any form. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia. Cahill bristol. Tell your healthcare provider if you have any side effect that bothers you or that does not Propecia and pregnant women away. This is called her background risk. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses. In addition, information wmoen collected regarding sexual function pregmant on a self-administered questionnaire and non-scalp body hair growth. In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type Propecia and pregnant women isozyme. New Engl J Med Give today.
Tentacle adventure. Indications and Usage Propecia
However I just wanted to let individuals know that two Propecia and pregnant women dermatologist have said that if you take this you need to use a higher dosage Health Professionals Fact Sheets F. Your doctor prescribed you a drug known to cause birth defects in women? I took finasteride for a few years and recently decided to just quit. I adn done all that I can so far. Here's everything you need to know about prefnant, Propecia and pregnant women, and after surgery for BPH. The product monograph is very alarming: it sounds as if even handling the medication could cause harm, especially to a male fetus. Author information Copyright and License information Disclaimer. If you have or have had prostate cancer, this drug can make it worse. If the gonads become testes, they Propwcia to produce androgens, primarily testosterone, by about eight weeks after conception. I take 2. Cerner Multum, Inc. Learn the connection between caffeine and Teen fuge, and find tips for kicking your coffee addiction. N Engl J Med.
The product monograph is very alarming: it sounds as if even handling the medication could cause harm, especially to a male fetus.
- Propecia is used for the treatment of male pattern hair loss on the vertex and the anterior mid-scalp area.
- Finasteride is also known as: Propecia , Proscar.
- Adam Cloe.
- Finasteride oral tablet is available as the brand-name drugs Proscar and Propecia.
Drug information provided by: IBM Micromedex. It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Blood tests may be needed to check for unwanted effects. Women and children should not use this medicine. Women who are pregnant or may become pregnant should not handle crushed or broken tablets.
Finasteride can be absorbed through the skin and cause birth defects in male babies. This medicine may cause changes to the breast tissue. Tell your doctor if you have any lumps, pain, tenderness, or an enlargement of the breasts while using this medicine. This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer.
Tell your doctor if you have concerns about this risk. Make sure you tell all of your doctors that you are using this medicine. This medicine may cause a decrease in the amount of semen you ejaculate during sex. This will not affect your sperm count or your ability to have children. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Mayo Clinic does not endorse companies or products. Advertising revenue supports our not-for-profit mission.
Make an appointment. Visit now. Explore now. Choose a degree. Get updates. Give today. Drugs and Supplements Finasteride Oral Route. Products and services. Free E-newsletter Subscribe to Housecall Our general interest e-newsletter keeps you up to date on a wide variety of health topics.
Sign up now. Precautions Drug information provided by: IBM Micromedex It is very important that your doctor check your progress at regular visits. Mayo Clinic Marketplace Check out these best-sellers and special offers on books and newsletters from Mayo Clinic.
Although both can lead to pain and difficulty…. I also am older so the propecia is not an issue with childbirth. Absorption through the skin while handling tablets is extremely unlikely to cause fetal exposure or harm. Laborde, E. Can natural remedies help relieve symptoms from an enlarged prostate? In general, a mild allergy to finasteride will result in a rash which may be itchy or cause hives.
Propecia and pregnant women. Is Finasteride Harmful to a Foetus (an Unborn Child)?
Visit your doctor regularly. Store Propecia at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Do not take two doses at one time. Seek emergency medical attention or call the Poison Help line at An overdose of Propecia is not expected to produce life-threatening symptoms. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
The sexual side effects of Propecia decreased libido, trouble having an erection, ejaculation problems may continue after you stop taking this medication. Talk to your doctor if you have concerns about these side effects.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. There may be other drugs that can interact with Propecia. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Other brands: Proscar. Propecia reviews. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to Drugs. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We comply with the HONcode standard for trustworthy health information - verify here. Skip to Content. Drug Status Rx. Availability Prescription only.
Drug Class. Related Drugs. Propecia Images. The product monograph is very alarming: it sounds as if even handling the medication could cause harm, especially to a male fetus. Should a man stop taking finasteride if his partner is planning pregnancy or is pregnant? What is the risk to the fetus if its mother accidentally handles crushed or broken tablets? Taking 1 mg of finasteride daily did not have any clinically significant effect on men's semen.
Absorption through the skin while handling tablets is extremely unlikely to cause fetal exposure or harm. There is no reason to discontinue the drug.
Motherisk is currently following up women who are pregnant or planning pregnancy and whose partners are taking finasteride. National Center for Biotechnology Information , U. Journal List Can Fam Physician v. Can Fam Physician. Pole and G. Author information Copyright and License information Disclaimer. Hospital for Sick Children, Toronto, Ont. Copyright notice. Int J Dermatol.
Finasteride (Oral Route) Precautions - Mayo Clinic
Generic Name: finasteride Dosage Form: tablet, film coated. Medically reviewed by Drugs. Last updated on May 1, Withdrawal of treatment leads to reversal of effect within 12 months. Propecia is not indicated for use in women.
Women should not handle crushed or broken Propecia tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. In clinical studies with Propecia finasteride, 1 mg in men years of age, the mean value of serum prostate specific antigen PSA decreased from 0. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride.
Propecia is not indicated for use in pediatric patients [see Use in Specific Populations 8. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In three controlled clinical trials for Propecia of month duration, 1. Integrated analysis of clinical adverse experiences showed that during treatment with Propecia, 36 3. In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.
Two other studies showed that finasteride at 5 times the dosage of Propecia 5 mg daily produced significant median decreases of approximately 0. In the clinical studies with Propecia, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.
In years of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder. New reports of drug-related sexual adverse experiences decreased with duration of therapy.
The relationship between long-term use of finasteride and male breast neoplasia is currently unknown. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score prostate cancer was higher in men treated with finasteride 1.
The clinical significance of these findings with respect to use of Propecia by men is unknown. The following adverse reactions have been identified during post approval use of Propecia.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:.
Hypersensitivity Reaction : hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema including swelling of the lips, tongue, throat, and face ;. No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome Plinked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.
Propecia is contraindicated for use in women who are or may become pregnant. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Women who are pregnant or may become pregnant should not handle crushed or broken Propecia tablets because of possible exposure of a male fetus.
In an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis gestation days 6 to Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia.
At oral maternal doses approximately 0. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0. No abnormalities were observed in female offspring exposed to any dose of finasteride in utero. No effects on fertility were seen in female offspring under these conditions. However, this study may not have included the critical period for finasteride effects on development of male external genitalia in the rabbit.
No other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose. Clinical efficacy studies with Propecia did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for Propecia [see Clinical Pharmacology However the efficacy of Propecia in the elderly has not been established.
Caution should be exercised in the administration of Propecia in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver [see Clinical Pharmacology No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology Propecia finasteride tablets contain finasteride as the active ingredient.
The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is Its structural formula is:. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.
Propecia finasteride tablets are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, yellow ferric oxide, and red ferric oxide.
Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II. In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type II isozyme. In men with male pattern hair loss androgenetic alopecia , the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp.
Administration of finasteride decreases scalp and serum DHT concentrations in these men. The relative contributions of these reductions to the treatment effect of finasteride have not been defined.
By this mechanism, finasteride appears to interrupt a key factor in the development of androgenetic alopecia in those patients genetically predisposed. Finasteride has no affinity for the androgen receptor and has no androgenic, antiandrogenic, estrogenic, antiestrogenic, or progestational effects.
In studies with finasteride, no clinically meaningful changes in luteinizing hormone LH , follicle-stimulating hormone FSH or prolactin were detected. In healthy volunteers, treatment with finasteride did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.
Finasteride had no effect on circulating levels of cortisol, thyroid-stimulating hormone, or thyroxine, nor did it affect the plasma lipid profile e. Bioavailability of finasteride was not affected by food.
There is a slow accumulation phase for finasteride after multiple dosing. The mean finasteride level was 0. Finasteride is extensively metabolized in the liver, primarily via the cytochrome P 3A4 enzyme subfamily. Mean terminal half-life in plasma was 4. No dosage adjustment is necessary in patients with renal impairment. In patients with chronic renal impairment, with creatinine clearances ranging from 9.
Urinary excretion of metabolites was decreased in patients with renal impairment. This decrease was associated with an increase in fecal excretion of metabolites. The effect of hepatic impairment on finasteride pharmacokinetics has not been studied. Caution should be used in the administration of Propecia in patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.
A positive correlation between the proliferative changes in the Leydig cells and an increase in serum LH levels 2- to 3-fold above control has been demonstrated in both rodent species treated with high doses of finasteride. In an in vitro chromosome aberration assay, using Chinese hamster ovary cells, there was a slight increase in chromosome aberrations. All these effects were reversible within 6 weeks of discontinuation of treatment.
No drug-related effect on testes or on mating performance has been seen in rats or rabbits. This decrease in fertility in finasteride-treated rats is secondary to its effect on accessory sex organs prostate and seminal vesicles resulting in failure to form a seminal plug. The seminal plug is essential for normal fertility in rats but is not relevant in man. There were three double-blind, randomized, placebo-controlled studies of month duration.
The two primary endpoints were hair count and patient self-assessment; the two secondary endpoints were investigator assessment and ratings of photographs. In addition, information was collected regarding sexual function based on a self-administered questionnaire and non-scalp body hair growth.
The three studies were conducted in men with mild to moderate, but not complete, hair loss. Of the men who completed the first 12 months of the two vertex baldness trials, elected to continue in double-blind, placebo-controlled, month extension studies. There were men receiving Propecia for both the initial study and first extension periods up to 2 years of treatment and 60 men receiving placebo for the same periods. The extension studies were continued for 3 additional years, with men on Propecia and 23 on placebo entering the fifth year of the study.
In order to evaluate the effect of discontinuation of therapy, there were 65 men who received Propecia for the initial 12 months followed by placebo in the first month extension period. Some of these men continued in additional extension studies and were switched back to treatment with Propecia, with 32 men entering the fifth year of the study.
Lastly, there were men who received placebo for the initial 12 months followed by Propecia in the first month extension period. Some of these men continued in additional extension studies receiving Propecia, with men entering the fifth year of the study see Figure 1 below. Hair counts were assessed by photographic enlargements of a representative area of active hair loss.
In these two studies in men with vertex baldness, significant increases in hair count were demonstrated at 6 and 12 months in men treated with Propecia, while significant hair loss from baseline was demonstrated in those treated with placebo.
In men treated with Propecia, the maximum improvement in hair count compared to baseline was achieved during the first 2 years. Although the initial improvement was followed by a slow decline, hair count was maintained above baseline throughout the 5 years of the studies. This increase in hair count was less 56 hairs above original baseline than the increase 91 hairs above original baseline observed after 1 year of treatment in men initially randomized to Propecia. Although the increase in hair count, relative to when therapy was initiated, was comparable between these two groups, a higher absolute hair count was achieved in patients who were started on treatment with Propecia in the initial study.
Patient self-assessment was obtained at each clinic visit from a self-administered questionnaire, which included questions on their perception of hair growth, hair loss, and appearance. This self-assessment demonstrated an increase in amount of hair, a decrease in hair loss, and improvement in appearance in men treated with Propecia.
Investigator assessment was based on a 7-point scale evaluating increases or decreases in scalp hair at each patient visit.