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PROPECIA (FINASTERIDE): PRESCRIBING INFORMATION
Propecia (Finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5-alpha-reductase, an intracellular enzyme that converts the androgen testosterone into 5-alpha-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide,N-(1,1-dimethylethyl)-3-oxo-,(5-alpha,17-beta)-. The empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55.
Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.
Propecia tablets for oral administration are film-coated tablets that contain 1 mg of finasteride and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, hydroxypropyl methylcellulose, sodium starch glycolate, hydroxypropyl cellulose LF, magnesium stearate, titanium dioxide, talc, yellow ferric oxide, docusate sodium, and red ferric oxide.
Propecia clinical pharmacology
Propecia clinical studies
INDICATIONS AND USAGE
Finasteride (Propecia) is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area.
Efficacy in bitemporal recession has not been established.
Propecia (Finasteride) 1 mg tablets are not indicated in women.
Propecia (Finasteride) is not indicated in children.
Propecia (Finasteride) tablets are contraindicated in the following:
Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5-alpha-reductase inhibitors to inhibit the conversion of testosterone to DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. In female rats, low doses of Propecia administered during pregnancy have produced abnormalities of the external genitalia in male offspring.
Hypersensitivity to any component of this medication.
USE IN SPECIAL POPULATIONS
Propecia use in special populations
Propecia adverse reactions
DOSAGE AND ADMINISTRATION
The recommended dosage is 1 mg orally once a day.
Propecia (Finasteride) may be administered with or without meals.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
In clinical studies, single doses of Finasteride (Propecia) up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.
Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m2 (400 mg/kg) and 5900 mg/m2 (1000 mg/kg), respectively.
Propecia (Finasteride) tablets, 1 mg, are tan, octagonal, film-coated convex tablets with "stylized P" logo on one side and "PROPECIA" on the other. They are supplied as follows:
unit of use bottles of 30 (with desiccant)
ProPak - unit of use bottles of 90 (with desiccant).
Storage and Handling
Store Propecia (Finasteride) tablets at room temperature, 15-30°C (59-86°F). Keep container closed and protect from moisture.
Women should not handle crushed or broken Finasteride (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. Propecia (Finasteride) tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
Manufactured and distributed by Merck pharmaceutical company and its divisions.
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