Finasteride Teva pills coated 5mg N30
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Active ingredients
Finasteride
Release form
Coated pills
Composition
Finasteride 5 mg, Excipients: lactose monohydrate (200 mesh) 108.0 mg, pregelatinized starch 5.0 mg, sodium lauryl sulfate 0.5 mg, sodium carboxymethyl starch (type A) 10.0 mg, povidone-KZO 2.0 mg , microcrystalline cellulose 18.5 mg, magnesium stearate 1.0 mg, film coating Opadry blue 03G20795 (hypromellose bsR (E464) 2.50 mg, titanium dioxide (E171) 0.7944 mg, macrogol-6000 0.40 mg, macrogol-400 0.25 mg, indigo carmine lacquer aluminum (E132) 0.0556 mg
Pharmacological effect
Finasteride is a 4-azasteroid compound that selectively and competitively inhibits 5α-reductase. This nicotinamide adenine dinucleotide phosphate (NADP) -dependent enzyme converts testosterone to dihydrotestosterone. The drug specifically inhibits isoenzyme 5α-reductase type 2, which leads to a significant decrease in dihydrotestosterone levels in the prostate gland (> 90%) and in the circulatory system (from 60% to 80%). Finasteride increases the level of testosterone in the prostate gland (approximately 85%) in patients with BPH, this does not affect the growth and morphology of the prostate gland. The drug has no pronounced affinity for androgen receptors. Finasteride significantly reduces plasma PSA levels by 41% - 71% in patients with symptoms of BPH. However, the drug does not affect the ratio of unbound and total PSA levels. The size of the prostate gland decreases under the influence of finasteride due to atrophy and apoptosis. The histological changes caused by the drug effect were observed 6 months after the start of treatment. The glandular elements of the prostate tissue are most sensitive to finasteride. The drug reduces the detrusor tone in patients with urinary retention caused by BPH.
Pharmacokinetics
Finasteride is well absorbed in the gastrointestinal tract, food slows down the rate of absorption, but does not affect the amount of absorption. The average bioavailability of finasteride is 63% (within 34 - 71%), based on the ratio of the area under the curve to the intravenous control dose. The maximum concentration of finasteride in plasma is 37 ng / ml (27–49%) and is reached within 1–2 hours after administration. The drug accumulates in the body with repeated multiple injections.The establishment of an equilibrium concentration occurs after 17 days, the exact time is not known. Approximately 90% of finasteride circulates in a state associated with plasma proteins. The volume of distribution of finasteride is high (76 l in a stable condition); the drug penetrates the blood-brain barrier and a small amount is found in the semen. The drug can be absorbed through the skin upon contact with crushed pills. Finasteride is metabolized primarily by the liver to form inactive metabolites. Plasma clearance of finasteride 165 ml / min (70 -279ml / min) and a half-life of 6 hours. About 39% (32 - 46%) of the dose taken is excreted in the urine as metabolites and 57 (51 - 64%) through the intestine. The pharmacokinetics of the drug as a whole do not change with an increase in the duration of renal failure. Pharmacokinetics of the drug in conditions of liver failure has not been studied.
Indications
Finasteride-Teva is indicated for benign prostatic hyperplasia (to reduce the size of the prostate gland, increase the maximum rate of outflow of urine and reduce the symptoms associated with hyperplasia, reduce the risk of acute urinary retention and the associated probability of surgical intervention.
Contraindications
Hypersensitivity to finasteride and other components of the drug, prostate cancer, urinary tract obstruction, children's age. With caution - a violation of liver function.
Use during pregnancy and lactation
Women of childbearing age and pregnant women should avoid contact with the drug, because it has teratogenic properties (the ability to suppress the conversion of testosterone to dihydrotestosterone can cause a violation of the development of the genital organs in the male fetus), penetrates into the seminal fluid.
Dosage and administration
Finasteride-Teva is taken orally, regardless of food intake, 1 tablet (5 mg) per day for 6-7 months.
Side effects
On the part of the nervous system: infrequently - drowsiness. On the part of the genital organs and the mammary gland: very often - impotence, often - decreased libido, ejaculation disorders, decreased ejaculate volume, an increase and tenderness of the mammary glands; infrequently - pain in the testicles; very rarely - the secretion of secretion from the mammary glands, the formation of nodules in the mammary glands.In most patients, these phenomena were transient in nature. Allergic reactions: often - skin rash; rarely - pruritus, urticaria, angioedema of the lips and face. On the laboratory side: rarely - a decrease in PSA concentration.
Overdose
Patients received finasteride in a single dose of up to 400 mg and in multiple doses of up to 80 mg / day for 3 months, with no undesirable effects observed. There are no recommendations for the specific treatment of overdose with finasteride.
Interaction with other drugs
Not detected clinically significant interactions with other finasteride preparatami.Pri finasteride combined use with propranolol, digoxin, glibenclamide, warfarin, theophylline, angiotensin converting enzyme inhibitors, acetaminophen, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers, nitrates, diuretics, blockers of H2-histamine receptors, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs, quinolones and benzo Odiazepines are not detected clinically significant manifestations of drug interactions.
special instructions
Before treatment, it is necessary to exclude diseases that can simulate benign prostatic hyperplasia, such as infectious prostatitis, prostate cancer, urethral stricture, bladder hypotension, and a number of changes in the urinary system arising from certain diseases of the nervous system. Since the use of finasteride has a decrease in prostate-specific antigen (by 41% and 48%, respectively, by 6 and 12 months from the start of therapy), periodically during the therapy process, patients should be examined to exclude prostate cancer. Women of childbearing age and pregnant women should avoid contact with the crushed pills of the drug Finasteride, because the ability of the drug to suppress the conversion of testosterone to dihydrotestosterone can cause a violation of the development of the genital organs in the male fetus. Finasteride pills are film-coated and during normal handling, if they are not ground into powder or their integrity is broken, contact with the active substance is excluded.