Dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride are a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone DHT , a hormone necessary for normal development of male genitalia.

In animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. Therefore, dutasteride may cause fetal harm when administered to a pregnant woman. If dutasteride is used during pregnancy or if the patient becomes pregnant while taking dutasteride, the patient should be apprised of the potential hazard to the fetus.

Abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of the conversion of testosterone to DHT by 5 alpha-reductase inhibitors.

These results are similar to observations in male infants with genetic 5 alpha-reductase deficiency. Dutasteride is absorbed through the skin. To avoid potential fetal exposure, women who are pregnant or could become pregnant should not handle Dutasteride Capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water [see Warnings and Precautions 5. Dutasteride is secreted into semen.

This concentration is more than times less than concentrations producing abnormalities of male genitalia in animal studies.

In an embryo-fetal development study in female rats, oral administration of dutasteride at doses 10 times less than the maximum recommended human dose MRHD of 0. An increase in stillborn pups was observed at times the MRHD, and reduced fetal body weight was observed at doses of about 15 times the MRHD animal dose of 2. Increased incidences of skeletal variations considered to be delays in ossification associated with reduced body weight were observed at doses about 56 times the MRHD animal dose of Histological evaluation of the genital papilla of fetuses revealed evidence of feminization of the male fetus at all doses.

A second embryo-fetal study in rabbits at 0. In an oral pre- and post-natal development study in rats, dutasteride doses of 0. Unequivocal evidence of feminization of the genitalia i. Animal doses of 2. Effects on newborn startle response were noted at doses greater than or equal to In an embryo-fetal development study, pregnant rhesus monkeys were exposed intravenously to a dutasteride blood level comparable to the dutasteride concentration found in human semen.

The development of male external genitalia of monkey offspring was not adversely affected. Reduction of fetal adrenal weights, reduction in fetal prostate weights, and increases in fetal ovarian and testis weights were observed at the highest dose tested in monkeys. It is not known whether rabbits or rhesus monkeys produce any of the major human metabolites.

Estimates of exposure multiples comparing animal studies to the MRHD for dutasteride are based on clinical serum concentration at steady state. Nursing Mothers Dutasteride Capsules are contraindicated for use in women of childbearing potential, including nursing women.

It is not known whether dutasteride is excreted in human milk. Pediatric Use Dutasteride is contraindicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety or efficacy were observed between these subjects and younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology Renal Impairment No dose adjustment is necessary for Dutasteride Capsules in patients with renal impairment [see Clinical Pharmacology Hepatic Impairment The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied.

Because dutasteride is extensively metabolized, exposure could be higher in hepatically impaired patients. However, in a clinical trial where 60 subjects received 5 mg 10 times the therapeutic dose daily for 24 weeks, no additional adverse events were observed compared with those observed at the therapeutic dose of 0. Overdosage In volunteer trials, single doses of dutasteride up to 40 mg 80 times the therapeutic dose for 7 days have been administered without significant safety concerns.

In a clinical trial, daily doses of 5 mg 10 times the therapeutic dose were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.

There is no specific antidote for dutasteride. Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration. Dutasteride Capsules Description Dutasteride Capsules are a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT.

Each dutasteride capsule, administered orally, contains 0. The inactive excipients in the capsule shell are gelatin from certified BSE-free bovine sources , glycerin, titanium dioxide, ferric oxide yellow , and medium chain triglyceride. The red edible ink contains ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, red iron oxide, shellac glaze and simethicone.

DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.

Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it forms a stable enzyme complex. Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow.

Dutasteride does not bind to the human androgen receptor. Pharmacodynamics Effect on 5 Alpha-Dihydrotestosterone and Testosterone: The maximum effect of daily doses of dutasteride on the reduction of DHT is dose dependent and is observed within 1 to 2 weeks. After 1 and 2 weeks of daily dosing with dutasteride 0. In patients with BPH treated with dutasteride 0. Adult males with genetically inherited type 2 5 alpha-reductase deficiency also have decreased DHT levels. These 5 alpha-reductase-deficient males have a small prostate gland throughout life and do not develop BPH.

Except for the associated urogenital defects present at birth, no other clinical abnormalities related to 5 alpha-reductase deficiency have been observed in these individuals. Effects on Other Hormones: In healthy volunteers, 52 weeks of treatment with dutasteride 0.

Dissociation from this complex has been evaluated under in vitro and in vivo conditions and is extremely slow. Dutasteride does not bind to the human androgen receptor. Pharmacodynamics Effect On 5 Alpha-Dihydrotestosterone And Testosterone The maximum effect of daily doses of dutasteride on the reduction of DHT is dose dependent and is observed within 1 to 2 weeks.

After 1 and 2 weeks of daily dosing with dutasteride 0. In patients with BPH treated with dutasteride 0. Adult males with genetically inherited type 2 5 alpha-reductase deficiency also have decreased DHT levels. These 5 alpha-reductase deficient males have a small prostate gland throughout life and do not develop BPH. Except for the associated urogenital defects present at birth, no other clinical abnormalities related to 5 alpha-reductase-deficiency have been observed in these individuals.

Effects On Other Hormones In healthy volunteers, 52 weeks of treatment with dutasteride 0. Statistically significant, baseline-adjusted mean increases compared with placebo were observed for total testosterone at 8 weeks The median percentage changes from baseline within the dutasteride group were After stopping dutasteride for 24 weeks, the mean levels of testosterone and thyroidstimulating hormone had returned to baseline in the group of subjects with available data at the visit.

Other Effects Plasma lipid panel and bone mineral density were evaluated following 52 weeks of dutasteride 0. There was no change in bone mineral density as measured by dual energy x-ray absorptiometry compared with either placebo or baseline. In addition, the plasma lipid profile i. Pharmacokinetics Absorption Following administration of a single 0. This reduction is of no clinical significance.

Distribution Pharmacokinetic data following single and repeat oral doses show that dutasteride has a large volume of distribution to L. Dutasteride is highly bound to plasma albumin On average, at 12 months Metabolism And Elimination Dutasteride is extensively metabolized in humans. In addition, the hydroxydutasteride metabolite was formed by CYP3A4. The absolute stereochemistry of the hydroxyl additions in the 6 and 15 positions is not known. Dutasteride and its metabolites were excreted mainly in feces.

Your doctor will check if you have prostate cancer by doing a blood test for prostate-specific antigen PSA before and during your treatment with dutasteride to see if there are any changes. Dutasteride lowers PSA concentrations in your blood. If there is an increase in your PSA, your doctor may decide to do more tests to check if you have prostate cancer.

Not every pharmacy stocks this drug, so call ahead Insurance Many insurance companies will require a prior authorization before they approve the prescription and pay for dutasteride. Are there any alternatives? There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives. Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date.

However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional.

Dutasteride

However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. Effects on newborn startle response were noted at doses greater than or equal to The fertility effects were reversed by recovery week 6 at all doses, and sperm counts were normal 0.5 the end of a week recovery period. Unequivocal evidence of feminization of the genitalia i. This reduction is of no oral significance, dutasteride 0.5 mg oral tablets. In rats and dogs, repeated oral administration of dutasteride resulted in some animals showing signs of non-specific, dutasteride 0.5 mg oral tablets, reversible, centrally-mediated toxicity without associated histopathological tablets at exposures and fold the expected clinical exposure of parent drugrespectively, dutasteride 0.5 mg oral tablets. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2. Clinical monitoring Dutasteride may increase your risk for prostate cancer. Alpha-Adrenergic Antagonists In a single-sequence, crossover trial in healthy volunteers, dutasteride 0.5 mg oral tablets, the administration of tamsulosin or terazosin in combination with AVODART had no effect on the steadystate pharmacokinetics 0.5 oral dutasteride antagonist. Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5 alpha-reductase isoenzymes, with which it tablets a stable enzyme complex. Differences between the 2 groups were statistically significant from baseline at Dutasteride 3 in all 3 trials and were maintained through Month The mean prostate volume at trial entry was approximately 54 cc.

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