Flutamide Information
Flutamide (Flutamide)
Flutamide (Flutamide) Description
Flutamide (Flutamide) Capsules USP contain Flutamide (Flutamide) , an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, α,α,α-Trifluoro-2-methyl-4’-nitro--propionotoluidide and has the following structural formula:
CHFNO M.W. 276.21
Flutamide (Flutamide) is a buff to yellow powder. Each capsule, for oral administration, contains 125 mg Flutamide (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.
Flutamide (Flutamide) Indications And Usage
Flutamide (Flutamide) capsules are indicated for use in combination with LHRH agonists for the management of locally confined Stage B-C and Stage D metastatic carcinoma of the prostate.
Flutamide (Flutamide) Contraindications
Flutamide (Flutamide) capsules are contraindicated in patients who are hypersensitive to Flutamide (Flutamide) or any component of this preparation.
Flutamide (Flutamide) capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).
Flutamide (Flutamide) Precautions
In a 1-year dietary study in male rats, interstitial cell adenomas of the testes were present in 49% to 75% of all treated rats (daily oral doses of 10, 30, and 50 mg/kg/day were administered). These produce plasma C values that are 1, 2 to 3, and 4 fold, respectively, those associated with therapeutic doses in humans. In male rats similarly dosed for 1 year, tumors were still present after 1 year of a drug-free period, but the incidences were 43% to 47%. In a 2 year carcinogenicity study in male rats, daily administration of Flutamide (Flutamide) at these same doses produced testicular interstitial cell adenomas in 91% to 95% of all treated rats as opposed to 11% of untreated control rats. Mammary adenomas, adenocarcinomas, and fibroadenomas were increased in treated male rats at exposure levels that were 1 to 4 fold those observed during therapeutic dosing in humans. There are likewise reports of malignant breast neoplasms in men treated with Flutamide (Flutamide) capsules (see section).
Flutamide (Flutamide) did not demonstrate DNA modifying activity in the Ames Salmonella/Microsome Mutagenesis Assay. Dominant lethal tests in rats were negative.
Reduced sperm counts were observed during a 6 week study of Flutamide (Flutamide) monotherapy in normal human volunteers.
Flutamide (Flutamide) did not affect estrous cycles or interfere with the mating behavior of male and female rats when the drug was administered at 25 and 75 mg/kg/day prior to mating. Males treated with 150 mg/kg/day (30 times the minimum effective antiandrogenic dose) failed to mate; mating behavior returned to normal after dosing was stopped. Conception rates were decreased in all dosing groups. Suppression of spermatogenesis was observed in rats dosed for 52 weeks at approximately 3, 8, or 17 times the human dose and in dogs dosed for 78 weeks at 1.4, 2.3, and 3.7 times the human dose.
Flutamide (Flutamide) Adverse Reactions
Treatment with Flutamide (Flutamide) capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing Flutamide (Flutamide) capsules + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below.
Additional adverse event data was collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study. Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%).
The following adverse experiences were reported during a multicenter clinical trial comparing Flutamide (Flutamide) capsules + LHRH agonist versus placebo + LHRH agonist.
The most frequently reported (greater than 5%) adverse experiences during treatment with Flutamide (Flutamide) capsules in combination with an LHRH agonist are listed in the table below. For comparison, adverse experiences seen with an LHRH agonist and placebo are also listed in the following table.
As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone.
The only notable difference was the higher incidence of diarrhea in the Flutamide (Flutamide) + LHRH agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH agonist (4%), which was severe in less than 1%.
In addition, the following adverse reactions were reported during treatment with Flutamide (Flutamide) + LHRH agonist.
Flutamide (Flutamide) Overdosage
In animal studies with Flutamide (Flutamide) alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia.
Clinical trials have been conducted with Flutamide (Flutamide) in doses up to 1500 mg per day for periods up to 36 weeks with no serious adverse effects reported. Those adverse reactions reported included gynecomastia, breast tenderness, and some increases in SGOT. The single dose of Flutamide (Flutamide) ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established.
Flutamide (Flutamide) is highly protein bound and is not cleared by hemodialysis. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
Flutamide (Flutamide) Dosage And Administration
The recommended dosage is 2 capsules 3 times a day at 8-hour intervals for a total daily dose of 750 mg.
Flutamide (Flutamide) How Supplied
Flutamide (Flutamide) Capsules USP, 125 mg are available as light brown opaque oblong hard gelatin capsules, spin printed with
and “4960” in black ink containing 125 mg Flutamide (Flutamide) packaged in bottles of 180 and 500 capsules.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured In India By:
Goa, India
Manufactured For:
Sellersville, PA 18960
Rev. A 1/2011
Flutamide (Flutamide) Important Patient Information For Flutamide Capsules Usp
Read this information carefully each time your prescription is refilled because there may be new information available. This summary does not tell you everything you need to know about Flutamide (Flutamide) therapy. Your doctor is the best source of information about your treatment. Ask your doctor about questions you have.
Flutamide (Flutamide) , in combination with other therapies, is a treatment option for men with some types of prostate cancer.
Prostate cancer results from the abnormal growth of prostate cells. Medical scientists do not know exactly what causes the abnormal cells, but age, environment and genetics are important factors. Male hormones ("androgens") cause the cancer to grow. The cancer growth can be slowed down by blocking the effect of androgens.
The Flutamide (Flutamide) product is used together with an injection called "LHRH agonist," as a combined treatment called "total androgen blockade." The goal of this treatment is to reduce androgen levels and to block the effect of androgen on the tumor. The LHRH agonist reduces androgen levels. Flutamide (Flutamide) therapy blocks the effect of androgen on the tumor.
You should not take Flutamide (Flutamide) if you have liver problems or if you are allergic to it. Flutamide (Flutamide) is for use only in men; therefore women should not take Flutamide (Flutamide) .
Some men taking the Flutamide (Flutamide) product had liver injury and needed to be hospitalized. In rare cases, men died because of liver failure while they were taking Flutamide (Flutamide) . In about half of these cases, the liver failure occurred in the first 3 months that they were taking Flutamide (Flutamide) .
Because the Flutamide (Flutamide) product may cause liver failure, . These tests help identify whether you are having liver problems. A recommended schedule for these blood tests is:
In addition, you should call your doctor right away if you have any of the following signs or symptoms:
Take your Flutamide (Flutamide) capsules as your doctor has prescribed. The usual dosing is 2 capsules every 8 hours.
Your doctor will determine whether Flutamide (Flutamide) therapy is right for you based on many different factors. These include how large your tumor is, how far it has spread and your physical condition. In addition to Flutamide (Flutamide) , you may be getting other treatments, including regular injections of LH-RH agonist or radiation therapy. Do not stop or interrupt any treatment without consulting your healthcare professional.
If you miss a dose of Flutamide (Flutamide) capsules, simply continue therapy with your next scheduled dose. Do not try to make up for it by taking extra capsules.
If you are taking any other medicines, especially warfarin (a blood-thinning drug), tell your doctor before beginning Flutamide (Flutamide) therapy.
In a medical study, when Flutamide (Flutamide) was taken together with an LHRH agonist, the most common side effects were hot flashes, loss of sex drive (libido) and impotence. In addition, some men had diarrhea, nausea or vomiting, and breast enlargement.
In another medical study, when the Flutamide (Flutamide) product was taken together with goserelin acetate (an LHRH agonist) and radiation therapy, the side effects of Flutamide (Flutamide) were about the same as when radiation therapy was given alone. These included hot flashes, diarrhea, nausea and skin rash.
If you experience moderate diarrhea due to Flutamide (Flutamide) capsules, the following advice may help:
If your diarrhea continues or it becomes severe, contact your doctor right away.
Your doctor may perform other regular tests (such as the PSA blood test) to ensure that your body is responding to treatment. Ask your doctor if you have any questions about how your Flutamide (Flutamide) therapy is being monitored.
Please ask your doctor about any questions concerning prostate cancer or Flutamide (Flutamide) therapy, or you can also ask for a more detailed leaflet that is written for healthcare professionals.
Manufactured In India By:
Goa, India
Manufactured For:
Sellersville, PA 18960
Rev. A 1/2011
Flutamide (Flutamide) Principal Display Panel
NDC 0172-4960-58
Flutamide (Flutamide)
Capsules USP
125 mg
PHARMACIST: PLEASE DISPENSE WITH ATTACHED
PATIENT INFORMATION LEAFLET
Rx only
180 CAPSULES
TEVA
