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PROSCAR (FINASTERIDE): PRESCRIBING INFORMATION
Proscar (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.
Proscar (Finasteride) tablets for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: microcrystalline cellulose, hydrous lactose, pregelatinized starch, hydroxypropyl cellulose LF, sodium starch glycolate, hydroxypropyl methylcellulose, magnesium stearate, titanium dioxide, talc, FD & C Blue 2 aluminum lake, docusate sodium, yellow iron oxide.
INDICATIONS AND USAGE
Finasteride (Proscar) is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
Reduce the risk of acute urinary retention
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Combination with Alpha-Blocker
Proscar tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed >= 4 point increase in American Urological Association (AUA) symptom score).
Limitations of Use
Finasteride (Proscar) 5 mg tablets are not approved for the prevention of prostate cancer.
DOSAGE AND ADMINISTRATION
Proscar (Finasteride) may be administered with or without meals.
The recommended dose of Finasteride (Proscar) tablets is one tablet (5 mg) taken once a day.
Combination with Alpha-Blocker
The recommended dose of Finasteride (Proscar) is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin.
DOSAGE FORMS AND STRENGTHS
5 mg blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and PROSCAR on the other.
Proscar (Finasteride) 5 mg tablets are contraindicated in the following:
Hypersensitivity to any component of this medication.
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 5-alpha-dihydrotestosterone (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 finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.
WARNINGS AND PRECAUTIONS
Proscar warnings and precautions
Proscar adverse reactions
Cytochrome P450-Linked Drug Metabolizing Enzyme System
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in man have included digoxin, antipyrine, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.
Other Concomitant Therapy
Although specific interaction studies were not performed, Proscar (Finasteride) was concomitantly used in clinical studies with acetylsalicylic acid, acetaminophen, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, anti-convulsants, analgesics, beta-adrenergic blocking agents, calcium channel blockers, diuretics, cardiac nitrates, HMG-CoA reductase inhibitors, benzodiazepines, nonsteroidal anti-inflammatory drugs (NSAIDs), H2-antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.
USE IN SPECIFIC POPULATIONS
Proscar use in specific populations
Proscar clinical pharmacology
Proscar nonclinical toxicology
Proscar clinical studies
Patients have received single doses of Proscar (Finasteride) up to 400 mg and multiple doses of Proscar (Finasteride) tablets up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with Proscar 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.
HOW SUPPLIED / STORAGE AND HANDLING
Proscar (Finasteride) 5 mg tablets are blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and "PROSCAR" on the other.
Storage and Handling
Store at room temperatures below 30°C (86°F). Protect from light and keep container tightly closed.
Women should not handle crushed or broken Proscar 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.
Manufactured and distributed by Merck pharmaceutical company and its divisions.
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