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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, sodium starch glycolate, hydroxypropyl methylcellulose, hydroxypropyl cellulose LF, titanium dioxide, magnesium stearate, talc, docusate sodium, yellow ferric oxide, and red ferric oxide. The recommended dosage is 1 mg orally once a day and may be administered with or without meals.
In general, daily administration for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated from time to time. Withdrawal of treatment would lead to reversal of effect within 12 months. No drug interactions of clinical importance have been ruled out. Finasteride does not prove to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include propranolol,antipyrine, digoxin, theophylline, and warfarin and no clinically meaningful interactions were found. PROPECIA is contraindicated in pregnancy because the ability of the Type II5-reductase inhibitors to inhibit the conversion of testosterone to DHT and it may cause abnormalities on the external genitalia of the male fetus of a pregnant woman who receives finasteride. If the patient got pregnant, she should be informed on the potential risk to the male fetus. This drug is also contraindicated to patients having hypersensitivity reaction to this kind of medications.
Finasteride is a competitive and particular inhibitor of Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Two distinct isozymes are found in rats, mice, monkeys, and humans, Type I and II. In humans, Type I 5a-reductase is particulary found in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5a-reductase is r for approximately one-third of circulating DHT. The Type II 5a-reductase isozyme is normally found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.