Flutasin capsules

Flutasin

  • Active Ingredient: Flutamide
  • 250 mg
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What is Flutasin?

The active ingredient of Flutasin brand is flutamide. Flutamide is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones). C11H11F3N2O3 M.W. 276.21 Flutamide is a buff to yellow powder. Each capsule, for oral administration, contains 125 mg Flutamide and has the following inactive ingredients: black iron oxide, corn starch, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, red iron oxide, sodium lauryl sulfate, titanium dioxide and yellow iron oxide.

Used for

Flutasin is used to treat diseases such as: Hirsutism, Prostate Cancer.

Side Effect

Possible side effects of Flutasin include: blistering, peeling, or loosening of the skin; general tiredness and weakness; continuing stomach pain; joint or muscle pain; pale skin; Decreased interest in sexual intercourse.

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Michael Stewart, Reviewed by Sid Dajani | Last edited 22 May 2019 | Certified by The Information Standard

Treatment with Flutasin will be started by a specialist doctor.

The usual dose is one tablet three times daily.

Remember to keep your regular appointments with your doctor and clinic so that your progress can be monitored.

Mechanism of Action

Flutasin is a nonsteroidal antiandrogen that competitively binds androgen receptors throughout the body. This inhibits cell growth in prostate cancer by inhibiting testosterone’s stimulatory effects. The drug has a half-life of 6 hours, meaning dosing will have to occur a minimum of 3 times a day to maintain adequate serum levels. The liver metabolizes Flutasin mainly via the CYP3A4 and other cytochrome enzymes such as CYP1A2. Flutasin is primarily excreted in the urine, with less than 5% being excreted in the feces.

Administration

Flutasin is taken as a 250 mg oral capsule given every 8 hours.

For stage B2-C prostatic carcinoma, it is advised that patients take Flutasin in combination with a gonadotropin-releasing hormone analog that is started eight weeks before the initiation of radiation therapy and continued throughout the course of radiation treatment.

For stage D2 metastatic carcinoma of the prostate, it is advised that the patient take Flutasin in combination with a gonadotropin-releasing hormone analog.

Flutam >

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Flutasin can cause serious liver problems. Call your doctor at once if you have:

  • nausea, upper stomach pain, loss of appetite;
  • itching, tired feeling, flu-like symptoms;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • breast swelling or tenderness;
  • hot flashes;
  • vomiting, diarrhea; or
  • impotence, loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Flutam >About Flutasin
  • Before taking Flutasin
  • How to take Flutasin
  • Getting the most from your treatment
  • Can Flutasin cause problems?
  • How to store Flutasin
  • Important information about all medicines
  • Anti-androgens

    Flutasin , a synthetic anti-androgen used in the treatment of prostate cancer, has led to asymptomatic elevations of serum transaminases and clinically significant injury that mainly manifests as biochemically hepatocellular. There have been multiple examples of severe hepatic necrosis with fulminant liver failure. 1041–1043 Explants have shown massive necrosis, and biopsies severe acute hepatitis, with or without mild cholestasis. There appears be to an increased risk of Flutasin liver injury in patients with underlying chronic viral hepatitis. 1044

    Cyproterone, another anti-androgen used for prostate cancer, has been implicated in several cases of severe, sometimes fatal hepatocellular damage, 1045–1047 and biochemical evidence of injury in up to 25% of patients. Biopsies have shown acute cholestatic hepatitis, with submassive necrosis at autopsy. HCC has developed during cyproterone therapy in noncirrhotic livers, but the link remains controversial. 1048

    Rare cases of acute liver failure have been reported with both bicalutamide 1049 and nilutamide. 1050

    Indications

    Flutasin is indicated for the adult population only in the treatment of stage B2-C and stage D2 metastatic carcinoma of the prostate.

    There has been some off-label use for the treatment of hair loss, hirsutism, polycystic ovarian syndrome, and acne. Flutasin has been shown to have fewer side effects in women but continues to have hepatotoxic effects in this population.

    In the treatment of acne and seborrhea in women, low-dose Flutasin has shown to effectively decrease acne after 6 months of treatment with peak benefit at 1 year of use. Other agents have been used in the past for their antiandrogenic effects, such as spironolactone, but Flutasin has shown to be the superior antiandrogenic treatment of acne in women, with up to 90% resolution of acne as compared to 40% with spironolactone.

    Flutasin has been effective in treating female pattern hair loss. Flutasin can be taken alone or in conjunction with oral birth control in the treatment of hair loss, and this regiment has proven to be superior to cyproterone acetate and finasteride.

    In the treatment of hirsutism, Flutasin has been shown to have equal or greater effectiveness at treating symptomatology although it has a risk of hepatic injury compared to other agents such as finasteride, cyproterone acetate, and spironolactone.

    First discovered in 1967, it was originally made for use as an antibiotic. It was developed by the Schering Plough Corporation of Germany and later was discovered to have antiandrogenic properties. Clinical trials began in 1971, and the drug was finally released to the public in 1983 in Germany. In 1989, Flutasin was approved by the United States Food and Drug Administration. Flutasin was the first nonsteroidal antiandrogen drug on the market. Other nonsteroidal antiandrogen pharmaceuticals that have been released are nilutamide, which was introduced in 1989, and bicalutamide, which was introduced in 1995.


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