DRUGS & SUPPLEMENTS

Flutaplex

advertisement
How long you have been taking the medicine?

Flutaplex uses



Flutaplex Capsules, USP

Rx only

Revised: July 2014

195814-2

Rx only

WARNINGS:

Hepatic Injury:

There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Flutaplex. Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy and death related to acute hepatic failure. The hepatic injury was reversible after discontinuation of therapy in some patients. Approximately half of the reported cases occurred within the initial 3 months of treatment with Flutaplex.

Serum transaminase levels should be measured prior to starting treatment with Flutaplex. Flutaplex is not recommended in patients whose ALT values exceed twice the upper limit of normal. Serum transaminase levels should then be measured monthly for the first 4 months of therapy, and periodically thereafter. Liver function tests also should be obtained at the first signs and symptoms suggestive of liver dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, “flu-like” symptoms, hyperbilirubinuria, jaundice or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, Flutaplex should be immediately discontinued with close follow-up of liver function tests until resolution.

DESCRIPTION:

Flutaplex Capsules contain Flutaplex, an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, 2-methyl-N-[4-nitro-3-(tri­fluoro­methyl)phenyl] propanamide. The compound is a buff to Yellow powder and has the following structural formula:

Each capsule, for oral administration, contains 125 mg Flutaplex and has the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and sodium lauryl sulfate.

The ingredients in the capsule shell are black iron oxide, gelatin, red iron oxide, yellow iron oxide, and titanium dioxide.

The ingredients in the imprinting ink are D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol, and synthetic black iron oxide.

Flutaplex chemical structure C11H11F3N2O3 Molecular Weight: 276.2

advertisement

CLINICAL

Pharmacology:

General:

In animal studies, Flutaplex demonstrates potent antiandrogenic effects. It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both. Prostatic carcinoma is known to be androgen-sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen, e.g., castration. Elevations of plasma testosterone and estradiol levels have been noted following Flutaplex administration.

Pharmacokinetics:

Absorption: Analysis of plasma, urine, and feces following a single oral 200 mg dose of tritium-labeled Flutaplex to human volunteers showed that the drug is rapidly and completely absorbed. Following a single 250 mg oral dose to normal adult volunteers, the biologically active alpha-hydroxylated metabolite reaches maximum plasma concentrations in about 2 hours, indicating that it is rapidly formed from Flutaplex. Food has no effect on the bioavailability of Flutaplex.

Distribution: In male rats administered an oral 5 mg/kg dose of 14C-flutamide neither Flutaplex nor any of its metabolites is preferentially accumulated in any tissue except the prostate. Total drug levels were highest 6 hours after drug administration in all tissues. Levels declined at roughly similar rates to low levels at 18 hours. The major metabolite was present at higher concentrations than Flutaplex in all tissues studied. Following a single 250 mg oral dose to normal adult volunteers, low plasma concentrations of Flutaplex were detected. The plasma half-life for the alpha-hydroxylated metabolite of Flutaplex is approximately 6 hours. Flutaplex, in vivo, at steady-state plasma concentrations of 24 to 78 ng/mL, is 94% to 96% bound to plasma proteins. The active metabolite of Flutaplex, in vivo, at steady-state plasma concentrations of 1556 to 2284 ng/mL, is 92% to 94% bound to plasma proteins.

Metabolism: The composition of plasma radioactivity, following a single 200 mg oral dose of tritium-labeled Flutaplex to normal adult volunteers, showed that Flutaplex is rapidly and extensively metabolized, with Flutaplex comprising only 2.5% of plasma radioactivity 1 hour after administration. At least six metabolites have been identified in plasma. The major plasma metabolite is a biologically active alpha-hydroxylated derivative which accounts for 23% of the plasma tritium 1 hour after drug administration. The major urinary metabolite is 2-amino-5-nitro-4-phenol.

Excretion: Flutaplex and its metabolites are excreted mainly in the urine with only 4.2% of a single dose excreted in the feces over 72 hours.

Single Dose Steady State
Flutamide Hydroxyflutamide Flutamide Hydroxyflutamide
Cmax (ng/mL) 25.2 ± 34.2 894 ± 406 113 ± 213 1629 ± 586
Elimination half-life (hr) - 8.1 ± 1.3 7.8 9.6 ± 2.5
Tmax (hr) 1.9 ± 0.7 2.7 ± 1.0 1.3 ± 0.7 1.9 ± 0.6
Cmin (ng/mL) - - - 679 ± 316

Special Populations:

Geriatric: Following multiple oral dosing of 250 mg t.i.d. in normal geriatric volunteers, Flutaplex and its active metabolite approached steady-state plasma levels (based on pharmacokinetic simulations) after the fourth Flutaplex dose. The half-life of the active metabolite in geriatric volunteers after a single Flutaplex dose is about 8 hours and at steady state in 9.6 hours.

Race: There are no known alterations in Flutaplex absorption, distribution, metabolism, or excretion due to race.

Renal Impairment: Following a single 250 mg dose of Flutaplex administered to subjects with chronic renal insufficiency, there appeared to be no correlation between creatinine clearance and either Cmaxor AUC of Flutaplex. Renal impairment did not have an effect on the Cmax or AUC of the biologically active alpha-hydroxylated metabolite of Flutaplex. In subjects with creatinine clearance of <29 mL/min, the half-life of the active metabolite was slightly prolonged. Flutaplex and its active metabolite were not well

dialyzed. Dose adjustment in patients with chronic renal insufficiency is not warranted.

Hepatic Impairment: No information on the pharmacokinetics of Flutaplex in hepatic impairment is available (see BOXED WARNING , Hepatic Injury ).

Women, Pediatrics: Flutaplex has not been studied in women or pediatric subjects.

Drug-Drug Interactions: Interactions between Flutaplex capsules and LHRH-agonists have not occurred. Increases in prothrombin time have been noted in patients receiving warfarin therapy (see PRECAUTIONS ).

Clinical Studies:

Flutaplex has been demonstrated to interfere with testosterone at the cellular level. This can complement medical castration achieved with LHRH-agonists which suppresses testicular androgen production by inhibiting luteinizing hormone secretion.

The effects of combination therapy have been evaluated in two studies. One study evaluated the effects of Flutaplex and an LHRH-agonist as neoadjuvant therapy to radiation in stage B2-C prostatic carcin­o­ma and the other study evaluated Flutaplex and an LHRH-agonist as the sole therapy in stage D2 prostatic carcinoma.

Stage B 2 -C Prostatic Carcinoma: The effects of hormonal treatment combined with radiation was studied in 466 patients (231 Flutaplex capsules + goserelin acetate implant + radiation, 235 radiation alone) with bulky primary tumors confined to the prostate (stage B2) or extending beyond the capsule (stage C), with or without pelvic node involvement.

In this multicentered, controlled trial, administration of Flutaplex capsules (250 mg t.i.d.) and goserelin acetate (3.6 mg depot) prior to and during radiation was associated with a significantly lower rate of local failure compared to radiation alone (16% vs. 33% at 4 years, P<0.001). The combination therapy also resulted in a trend toward reduction in the incidence of distant metastases (27% vs. 36% at 4 years, P =0.058). Median disease-free survival was significantly increased in patients who received complete hormonal therapy combined with radiation as compared to those patients who received radiation alone (4.4 vs. 2.6 years, P<0.001). Inclusion of normal PSA level as a criterion for disease-free survival also resulted in significantly increased median disease-free survival in patients receiving the combination therapy (2.7 vs. 1.5 years, P<0.001).

Stage D 2 Prostatic Carcinoma: To study the effects of combination therapy in metastatic disease, 617 patients (311 leuprolide + Flutaplex, 306 leuprolide + placebo) with previously untreated advanced prostatic carcinoma were enrolled in a large multicentered, controlled clinical trial.

Three and one-half years after the study was initiated, median survival had been reached. The median actuarial survival time was 34.9 months for patients treated with leuprolide and Flutaplex versus 27.9 months for patients treated with leuprolide alone. This 7-month increment represents a 25% improvement in overall survival time with the Flutaplex therapy. Analysis of progression-free survival showed a 2.6-month improvement in patients who received leuprolide plus Flutaplex, a 19% increment over leuprolide and placebo.

advertisement

INDICATIONS AND USAGE:

Flutaplex capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate.

Stage B 2 -C Prostatic Carcinoma:

Treatment with Flutaplex capsules and the goserelin acetate implant should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.

Stage D 2 Metastatic Carcinoma:

To achieve benefit from treatment, Flutaplex capsules should be initiated with the LHRH-agonist and continued until progression.

CONTRAINDICATIONS:

Flutaplex capsules are contraindicated in patients who are hypersensitive to Flutaplex or any component of this preparation.

Flutaplex capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).

WARNINGS:

Hepatic Injury: See BOXED WARNING .

Use in Women:

Flutaplex capsules are for use only in men. This product has no indication for women, and should not be used in this population, particularly for non-serious or non-life-threatening conditions.

Fetal Toxicity:

Flutaplex may cause fetal harm when administered to a pregnant woman.

Aniline Toxicity:

One metabolite of Flutaplex is 4-nitro-3-fluoromethylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia and cholestatic jaundice have been observed in both animals and humans after Flutaplex administration. In patients susceptible to aniline toxicity (e.g., persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease and smokers), monitoring of methemoglobin levels should be considered.

advertisement

PRECAUTIONS:

General:

In clinical trials, gynecomastia occurred in 9% of patients receiving Flutaplex together with medical castration.

Information for Patients:

Patients should be informed that Flutaplex capsules and the drug used for medical castration should be administered concomitantly, and that they should not interrupt their dosing or stop taking these medications without consulting their physician.

Laboratory Tests:

Regular assessment of serum Prostate Specific Antigen may be helpful in monitoring the patient's response. If PSA levels rise significantly and consistently during Flutaplex therapy the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment period free of antiandrogen while continuing the LHRH analogue may be considered.

Drug Interactions:

Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Flutaplex was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Flutaplex capsules are administered concomitantly with warfarin.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

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. These produced plasma Cmax 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 Flutaplex 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 Flutaplex capsules (see ADVERSE REACTIONS section).

Flutaplex 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 Flutaplex monotherapy in normal human volunteers.

Flutaplex 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.

Animal Toxicology:

Serious cardiac lesions were observed in 2/10 beagle dogs receiving 25 mg/kg/day for 78 weeks and 3/16 receiving 40 mg/kg/day for 2-4 years. These lesions, indicative of chronic injury and repair processes, included chronic myxomatous degeneration, intra-atrial fibrosis, myocardial acid­ophilic degeneration, vasculitis and perivasculitis. The doses at which these lesions occurred were associated with 2-hydroxyflutamide levels that were 1-to 12-fold greater than those observed in humans at therapeutic levels.

Pregnancy: Pregnancy Category D:

There was decreased 24-hour survival in the offspring of pregnant rats treated with Flutaplex at doses of 30, 100 or 200 mg/kg/day (approximately 3, 9 and 19 times the human dose). A slight increase in minor variations in the development of the sternebrae and vertebrae was seen in fetuses of rats treated with two higher doses. Feminization of the male rats also occurred at the two higher dose levels. There was a decreased survival rate in the offspring of rabbits receiving the highest dose (15 mg/kg/day, equal 1.4 times the human dose).

advertisement

ADVERSE REACTIONS:

Stage B 2 -C Prostatic Carcinoma:

Treatment with Flutaplex 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 Flutaplex + goserelin acetate implant + radiation versus radiation alone. The most frequently reported adverse experiences are listed below.

Additional adverse event data were 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%).


Adverse Events During Acute

Radiation Therapy

(within first 90 days of radiation therapy)

(n = 231) (n = 235)

Goserelin Acetate Implant +

Flutaplex +

Radiation

% All



Radiation

Only

% All

Rectum/Large Bowel 80 76
Bladder 58 60
Skin 37 37
Adverse Events During Late Radiation Phase

(after 90 days of radiation therapy)

(n = 231) (n = 235)


Goserelin Acetate Implant +

Flutaplex +

Radiation

% All



Radiation

Only

% All

Diarrhea 36 40
Cystitis 16 16
Rectal Bleeding 14 20
Proctitis 8 8
Hematuria 7 12

Stage D 2 Metastatic Carcinoma:

The following adverse experiences were reported during a multicenter clinical trial comparing Flutaplex + LHRH agonist versus placebo + LHRH agonist.

The most frequently reported (greater than 5%) adverse experiences during treatment with Flutaplex 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.

(n=294)

Flutaplex + LHRH agonist

% All


(n=285)

Placebo + LHRH agonist

% All

Hot Flashes 61 57
Loss of Libido 36 31
Impotence 33 29
Diarrhea 12 4
Nausea/Vomiting 11 10
Gynecomastia 9 11
Other 7 9
Other GI 6 4

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 Flutaplex + 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 Flutaplex + LHRH agonist.

Cardiovascular System: hypertension in 1% of patients.

Central Nervous System: CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients.

Gastrointestinal System: anorexia 4%, and other GI disorders occurred in 6% of patients.

Hematopoietic System: anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients.

Liver and Biliary System: hepatitis and jaundice in less than 1% of patients.

Skin: irritation at the injection site and rash occurred in 3% of patients.

Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients. In addition, the following spontaneous adverse experiences have been reported during the marketing of Flutaplex: hemolytic anemia, macrocytic anemia, methemoglobinemia, sulfhemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis), and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the Flutaplex and/or its metabolites. Also reported were cholestatic jaundice, hepatic enceph­alopathy, and hepatic necrosis. The hepatic conditions were often reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of Flutaplex.

Malignant breast neoplasms have occurred rarely in male patients being treated with Flutaplex.

Abnormal Laboratory Test Values: Laboratory abnormalities including elevated SGOT, SGPT, bilirubin values, SGGT, BUN, and serum creatinine have been reported.

OVERDOSAGE:

In animal studies with Flutaplex alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia.

Clinical trials have been conducted with Flutaplex 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 Flutaplex ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established.

Flutaplex 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.

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.

HOW SUPPLIED:

Flutaplex Capsules, USP are available as:

125 mg: Brown opaque cap and white opaque body filled with yellow powder.

Imprinted in black ink with “WPI 2227”.

Available in bottles of:

180 NDC-0591-2466-18

Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP/NF.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Manufactured by:

Actavis Laboratories FL, Inc.

Fort Lauderdale, FL 33314 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised: July 2014

195814-2

Flutaplex (FLEW-tuh-mide)

Capsules, USP

Important Patient Information

Rx only

Important information for patients taking Flutaplex capsules:

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 Flutaplex therapy. Your doctor is the best source of information about your treatment. Ask your doctor about questions you have.

What is Flutaplex therapy?

Flutaplex, 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 Flutaplex 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. Flutaplex therapy blocks the effect of androgen on the tumor.

Who should not take the Flutaplex product?

You should not take Flutaplex if you have liver problems or if you are allergic to it. Flutaplex capsules are for use only in men, therefore women should not take Flutaplex capsules.

Are there important risks I should know about Flutaplex therapy?

Some men taking the Flutaplex product had liver injury and needed to be hospitalized. In rare cases, men died because of liver failure while they were taking Flutaplex. In about half of these cases, the liver failure occurred in the first 3 months that they were taking Flutaplex.

Because the Flutaplex product may cause liver failure, it is very important that you have all blood tests recommended by your doctor. These tests help identify whether you are having liver problems.

A recommended schedule for these blood tests is:

  • before starting Flutaplex treatment.
  • every month for the first 4 months of therapy.
  • periodically after the first 4 months.

In addition, you should call your doctor right away if you have any of the following signs or symptoms:

  • loss of appetite.
  • nausea and vomiting.
  • stomach or abdominal pain.
  • fatigue (feeling extremely tired).
  • flu-like symptoms (muscle aches, soreness).
  • brown urine.
  • jaundice (yellowing of the skin or whites of the eyes).

These may be signs of liver failure.

How should I take Flutaplex capsules?

Take your Flutaplex capsules as your doctor has prescribed. The usual dosing is 2 capsules every 8 hours.

Your doctor will determine whether Flutaplex 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 Flutaplex, you may be getting other treatments, including regular injections of LHRH agonist or radiation therapy.

Do not stop or interrupt any treatment without consulting your healthcare professional.

If you miss a dose of Flutaplex capsules, simply continue therapy with your next scheduled dose. Do not try to make up for it by taking extra capsules.

Can I take other medicines?

If you are taking any other medicines, especially warfarin (a blood-thinning drug), tell your doctor before beginning Flutaplex therapy.

What are the other possible side effects of taking Flutaplex capsules?

In a medical study, when Flutaplex 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 Flutaplex product was taken together with goserelin acetate (an LHRH agonist) and radiation therapy, the side effects of Flutaplex therapy were about the same as when radiation therapy was given alone. These included hot flashes, diarrhea, nausea and skin rash.

What can I do if I get diarrhea?

If you experience moderate diarrhea due to Flutaplex capsules, the following advice may help:

  • drink plenty of fluids.
  • reduce your intake of dairy products (for example, milk, cheese, yogurt).
  • increase your intake of whole grains, fruits, and vegetables.
  • stop laxative use.
  • take nonprescription antidiarrheal medicines.

If your diarrhea continues or it becomes severe, contact your doctor right away.

Are there any other lab tests my doctor will be performing?

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 Flutaplex therapy is being monitored.

Please ask your doctor about any questions concerning prostate cancer or Flutaplex therapy, or you can also ask for a more detailed leaflet that is written for healthcare professionals.

Manufactured by:

Actavis Laboratories FL, Inc.

Fort Lauderdale, FL 33314 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised: July 2014 195814-2

Flutaplex pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Flutaplex available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Flutaplex destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Flutaplex Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Flutaplex pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


advertisement

References

  1. Dailymed."FLUTAMIDE CAPSULE [ACTAVIS PHARMA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FLUTAMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "flutamide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Flutaplex?

Depending on the reaction of the Flutaplex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Flutaplex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Flutaplex addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sDrugs.com conducted a study on Flutaplex, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Flutaplex consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 10 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2018 "sDrugs.com". All Rights Reserved