Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith description, Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith side effects, Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith price, Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith substance

Fluoxymesterone, an androgenic hormone, is similar to the male hormone testosterone.

Fluoxymesterone, an androgenic hormone, is similar to the male hormone testosterone. It is prescribed for males when this hormone is absent or low or to treat delayed onset of puberty in males.Fluoxymesterone is an oral steroid which was introduced on the market by Upjohn Company in 1957. Its fluoxymesterone substance is a precursor of methyltestosterone which, through changes in the chemical structure, was made much more androgenic than testosterone. The anabolic component of Fluoxymesterone is only slightly pronounced. Based on its characteristics Fluoxymesterone is used mainly when the athlete is more interested in a strength buildup rather than in a muscle gain. Powerlifters and weightlifters who must stay within a certain weight class often use Fluoxymesterone because they are primarily interested in a strength gain without adding body weight. In bodybuilding this drug is almost exclusively taken during preparation for a competition. Since the substance is strongly androgenic while at the same time aromatizing very poorly, Fluoxymesterone helps the athlete obtain an elevated androgen level while keeping the estrogen concentration low. With a lower body fat content Fluoxymesterone gives the bodybuilder a distinctive muscle hardness and sharpness. Although the muscle diameter does not increase, it appears more massive since the muscle density is improved. The generally observed dose is normally 20-40 mg/day. Bodybuilders are usually satisfied with 20-30 mg/day while powerlifters often take 40 mg/day or more. The daily dosage is usually split into two equal amounts and taken mornings and evenings with plenty of fluids. Since the tablets are 17-alpha alkylated, they can be taken during meals without any loss in effect.

Fluoxymesterone

Use and dosage of Fluoxymesterone

Fluoxymesterone is an oral steroid which was introduced on the market by Upjohn Company in 1957. Fluoxymesterone substance is precursor of methyltestosterone. Through its changes in the chemical structure, was made much more androgenic than testosterone. The anabolic component is only slightly pronounced. Based on its characteristics Fluoxymesterone is used mainly when the athlete is more interested in a strength build up rather than in a muscle gain. Powerlifters and weightlifters who must stay within a certain weight class often use this drug because they are primarily interested in a strength gain without adding body weight. In bodybuilding Fluoxymesterone is almost exclusively taken during preparation for a competition. Since its substance is strongly androgenic while at the same time aromatizing very poorly, this substance helps the athlete obtain an elevated androgen level while keeping the estrogen concentration low. With a low body fat content Fluoxymesterone gives the bodybuilder a distinctive muscle hardness and sharpness. Although the muscle diameter does not increase, it appears more massive since the muscle density is improved. The fact that daily dose of up to 20 mg does not cause water and salt retention makes it even more desirable. During a diet, it helps the athlete get through difficult, intense training while increasing the aggressiveness of many users. This is another reason why Fluoxymesterone (fluoxymesterone) is so popular among powerlifters, weightlifters, football players, and, in particular, boxers. The generally observed dose is normally 20-40 mg/day. Bodybuilders are usually satisfied with 20-30 mg/day while powerlifters often take 40 mg/day or more. The daily dosage of Fluoxymesterone (fluoxymesterone) is usually split into two equal amounts and taken mornings and evenings with plenty of fluids. Since the tablets are l7-alpha alkylated, they can be taken during meals without any loss in effect. Those who are tired of taking Dianabol (methandrostenolone) tablets will find fluoxymesterone an interesting alternative. In the meantime we know several bodybuilders who have combined this steroid with injectable, mostly anabolic, steroid preparations such as Anadur, Deca-Durabolin, Primobolan Depot, or Equipoise. The quick strength gain induced by Fluoxymesterone can usually be turned into solid, high-quality muscle tissue by taking the above steroids. This is an especially welcome change for athletes who easily retain water and have to fight against swollen breast glands. Many will be surprised at what progress can be achieved by a simple combination of 30 mg/day and 700 mg Equipoise every two days over a four week period.
Fluoxymesterone side effects

Besides Anadrol (oxymetholone) and Methyltestostcrone it is the oral steroid with the most side effects. Those who would like to try Fluoxymesterone should limit the intake to 4- 6 weeks and take no more than 20-30 mg daily. Fluoxymesterone puts extremely high stress on the liver and is thus potentially liver damaging. Other frequently-observed side effects are increased production of the sebaceous gland (which goes hand in hand with acne), nasal bleeding, headaches, gastrointestinal pain, and reduced production of the body's own hormones. Men who tries this steroid become easily irritable and aggressive. Gynecomastia and high blood pressure caused by edemas do not occur with Fluoxymesterone. Do not be surprised, however, when on its package insert you read the words "gynecomastia" and "edemas." This standard warning, due to legal provisions, is included in all strong androgenic steroids. Women should avoid this drug since it can cause substantial and in part irreversible virilization symptoms. Fluoxymesterone is rarely found on the American black market, sometimes the Italian, Greek, or French version of Upjohn shows up. The Italian and French types are all indented with the UPJOHN imprint on the back.

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Alternative Description Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith:

GENERIC NAME: FLUOXYMESTERONE - ORAL (floo-OX-i-MES-ter-one)

FLUOXYMESTERONE USES: This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Fluoxymesterone is similar to the natural testosterone produced by your body. It belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally.Fluoxymesterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty.

fluoxymesterone - oral

HOW TO USE: Take this medication by mouth with or without food, usually 1 to 4 times a day, as directed by your doctor.Dosage is based on your medical condition, testosterone blood levels, and response to treatment.Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.Do not suddenly stop using fluoxymesterone if you have been using it regularly for an extended time or if it has been used in high doses. In such cases, your body will no longer make its own testosterone, and withdrawal reactions (such as tiredness, weakness, depression) may occur. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Abnormal drug-seeking behavior is possible with this medication, and it is frequently misused for its muscle-enhancing effects. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Doing so may increase serious side effects (such as increased risk for heart disease, stroke, liver disease, ruptured tendons/ligaments, improper bone development in adolescents). Properly stop the medication when so directed. Tell your doctor if your condition does not improve or worsens.

Side Effects Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith: Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring.If you are male, tell your doctor immediately if any of these unlikely but serious side effects occur: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.If you are female, tell your doctor immediately if any of these unlikely but serious side effects occur: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.This medication can cause your body to hold on to extra body water (edema). This can increase your risk of heart failure. Tell your doctor immediately if any of these unlikely but serious signs of water retention or heart failure occur: decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breath while lying down.Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects.

PRECAUTIONS: Before taking fluoxymesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer in men, prostate cancer.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, chest pain, heart attack), liver problems, kidney problems, other types of cancer, certain mineral imbalance (high calcium blood level), high cholesterol, high blood pressure, enlarged prostate, breathing problems (such as sleep apnea, chronic obstructive pulmonary disease-COPD), diabetes.If you have diabetes, this product may decrease your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of low blood sugar, such as increased hunger, dizziness, or unusual sweating. Your anti-diabetic medication or diet may need to be adjusted.This drug may affect your cholesterol and may increase your risk of heart or blood vessel problems (coronary artery disease). Your doctor will monitor your cholesterol level closely.Tell your doctor if you become bed-ridden (unable to walk) for a prolonged time while using this medication. Your doctor may monitor your blood calcium level to prevent problems.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Caution is advised when using this drug in older adults because they may be at greater risk for prostate/liver problems and swelling of arms/legs.Caution is advised when using this drug in children because bone growth may be affected, causing shorter adult height. Your child's doctor will monitor growth and bone development during treatment.This medication must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that women using this medication use 2 effective forms of birth control (such as condoms and birth control pills) while taking this medication. Consult your doctor.It is not known whether this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (such as warfarin).Corticosteroids (such as hydrocortisone, prednisone) may increase the risk of edema and heart failure.This medication may interfere with certain laboratory tests (including thyroid function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately.

NOTES: Do not share or sell this medication to others. It is against the law.Laboratory and/or medical tests (such as blood testosterone levels, red blood cell counts, liver function tests, blood cholesterol levels, PSA test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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Alternative Description Fluoxymesterone® Tablets 10mg USP - (Generic Fluoxymesterone) by Upsher-Smith:

fluoxymesterone

Generic Name: fluoxymesterone (floo OX i MES te rone)
Brand Name: Androxy, Halotestin

What is fluoxymesterone?

Fluoxymesterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

Fluoxymesterone is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or other hormonal imbalances.

Fluoxymesterone is also used in women to treat breast cancer that has spread to other parts of the body. Fluoxymesterone treats only the symptoms of metastatic breast cancer but does not treat the cancer itself.

Fluoxymesterone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fluoxymesterone?

This medicine can cause birth defects. Do not use fluoxymesterone if you are pregnant.

You should not use fluoxymesterone if you have prostate cancer or male breast cancer.

Fluoxymesterone will not enhance athletic performance and should not be used for that purpose or shared with another person.

What should I discuss with my healthcare provider before taking fluoxymesterone?

You should not use fluoxymesterone if you are allergic to it, or if you have:

• prostate cancer;
• male breast cancer; or
• if you are pregnant.

Fluoxymesterone will not enhance athletic performance and should not be used for that purpose or shared with another person.

To make sure fluoxymesterone is safe for you, tell your doctor if you have:

• benign prostatic hypertrophy (BPH);
• breast cancer;
• delayed puberty (unless you are taking fluoxymesterone to treat it);
• liver or kidney disease;
• diabetes;
• any debilitating condition; or
• heart disease, coronary artery disease (hardened arteries), congestive heart failure, or a history of heart attack.

This medication can harm an unborn baby or cause birth defects. Do not use fluoxymesterone if you are pregnant. Use effective birth control to avoid pregnancy during your treatment with fluoxymesterone. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether fluoxymesterone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking fluoxymesterone.

Fluoxymesterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.

How should I take fluoxymesterone?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

While using fluoxymesterone, you may need frequent blood tests.

Store at room temperature away from moisture, heat, and light.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking fluoxymesterone?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Fluoxymesterone will not enhance athletic performance and should not be used for that purpose or shared with another person.

Fluoxymesterone side effects

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

Stop using fluoxymesterone and call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• increased or ongoing erection of the penis;
• nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless; or
• upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving fluoxymesterone may develop male characteristics, which could be irreversible if testosterone treatment is continued. Stop taking this medication and call your doctor at once if you notice any of these signs of excess testosterone:

• changes in menstrual periods;
• male-pattern hair growth (such as on the chin or chest);
• hoarse voice; or
• enlarged clitoris.

Common side effects (in men or women) may include:

• acne, changes in skin color;
• increased hair growth;
• male pattern baldness;
• increased or decreased interest in sex;
• breast swelling;
• headache, anxiety, depression; or
• numbness, burning, pain, or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

 

Fluoxymesterone dosing information

Usual Adult Dose for Hypogonadism -- Male:

5 to 20 mg orally once a day or divided into 3 or 4 doses. It is usually preferable to begin treatment with full therapeutic doses which should later be adjusted to individual requirements.

Usual Adult Dose for Breast Cancer:

10 to 40 mg orally per day divided into 3 or 4 doses. The duration of therapy is at least one month for a satisfactory response, and 2 to 3 months for an objective response. Females with disseminated breast carcinoma should have frequent determination of the urine and serum calcium levels during the course of therapy. Female patients should also be observed for signs of virilization which is usual following androgen use at high doses. They may be instructed to report any hoarseness, acne, changes in menstrual periods or increase in facial hair. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made that some virilization will be tolerated during the treatment for malignant disease.

Usual Adult Dose for Postmenopausal Symptoms:

1 to 2 mg orally 2 times a day for 3 to 6 weeks. Fluoxymesterone is generally administered in combination with ethinyl estradiol.

Usual Pediatric Dose for Delayed Puberty -- Male:

2.5 to 20 mg orally per day or in 3 to 4 divided doses for up to 4 to 6 months. Dosage should be carefully titrated utilizing a low dosage.

What other drugs will affect fluoxymesterone?

Other drugs may interact with fluoxymesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Fluoxymesterone Side Effects

Not all side effects for fluoxymesterone may be reported. You should always consult a doctor or healthcare professional for medical advice.

For the Consumer

Applies to fluoxymesterone: oral tablets

Side effects include:

Males: Gynecomastia, frequent or persistent penile erections.

Females: Amenorrhea, other menstrual irregularities, inhibition of gonadotropin secretion, virilization (e.g., deepening of the voice, clitoral enlargement).

For Healthcare Professionals

Applies to fluoxymesterone: compounding powder, oral tablet

Dermatologic

Dermatologic side effects have included hirsutism, seborrhea, and acne. While alopecia usually presents as male pattern baldness, patchy alopecia has also been reported in some female patients.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Hepatic

Hepatic side effects have included cholestatic jaundice, alterations in liver function tests, and rarely hepatocellular neoplasms and peliosis hepatitis. Patients should be instructed to report any changes in skin color, abdominal pain lasting more than a few days, white bowel movements, dark urine, or yellowing of the eyes.

Hematologic

Hematologic side effects have included suppression of clotting factors II, V, VII, and X, polycythemia and bleeding in patients on concomitant anticoagulant therapy .

Nervous system

Nervous system side effects have included increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Hypersensitivity

Hypersensitivity side effects have included skin manifestations and anaphylactoid reactions.

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium. Patients should be instructed to report edema.

Genitourinary

Genitourinary side effects in male patients have included gynecomastia, and excessive frequency and duration of penile erections. Oligospermia has been reported at higher dosages. Male patients should be instructed to report too frequent or persistent erections of the penis. Patients with benign prostatic hypertrophy may develop acute urethral obstruction.

Genitourinary side effects in female patients have included amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens can cause virilization of external genitalia of the female fetus. Female patients should be instructed to report any hoarseness, acne, changes in menstrual periods or increase in facial hair.

Endocrine

Endocrine side effects have included increases in serum cholesterol. Large doses of exogenous androgens may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).

References

1. "Product Information. Halotestin (fluoxymesterone)." Pharmacia and Upjohn, Kalamazoo, MI.

2. "Multum Information Services, Inc. Expert Review Panel"

Fluoxymesterone Dosage

Usual Adult Dose for Hypogonadism - Male

5 to 20 mg orally once a day or divided into 3 or 4 doses. It is usually preferable to begin treatment with full therapeutic doses which should later be adjusted to individual requirements.

Usual Adult Dose for Breast Cancer

10 to 40 mg orally per day divided into 3 or 4 doses. The duration of therapy is at least one month for a satisfactory response, and 2 to 3 months for an objective response. Females with disseminated breast carcinoma should have frequent determination of the urine and serum calcium levels during the course of therapy. Female patients should also be observed for signs of virilization which is usual following androgen use at high doses. They may be instructed to report any hoarseness, acne, changes in menstrual periods or increase in facial hair. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made that some virilization will be tolerated during the treatment for malignant disease.

Usual Adult Dose for Postmenopausal Symptoms

1 to 2 mg orally 2 times a day for 3 to 6 weeks. Fluoxymesterone is generally administered in combination with ethinyl estradiol.

Usual Pediatric Dose for Delayed Puberty - Male

2.5 to 20 mg orally per day or in 3 to 4 divided doses for up to 4 to 6 months. Dosage should be carefully titrated utilizing a low dosage.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosage may depend on specific malignancy and whether other cytotoxic agents are coadministered. Reference to specific protocols is recommended.

Precautions

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Patients should be instructed to report too frequent or persistent erections of the penis. Priapism is indicative of excessive doses and the need to temporarily discontinue fluoxymesterone therapy. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized. Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, and ankle swelling. Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically. Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically with long-term administration. Fluoxymesterone is contraindicated in males with carcinoma of the breast.

Dialysis

Data not available

Other Comments

Exogenous androgen therapy can accelerate bone maturation without producing compensatory gain in linear growth. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. The effects on bone maturation should be monitored by assessing the bone age of the wrist and hand every 6 months.

Fluoxymesterone

Pronunciation: flew-ox-ee-MESS-teh-rone
Class: Androgen

Trade Names

Fluoxymesterone
- Tablets 10 mg

Pharmacology

Promotes growth and development of male reproductive organs, maintains secondary sex characteristics, increases protein anabolism, and decreases protein catabolism.

Indications and Usage

Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone; delayed puberty (men); palliation of androgen-responsive recurrent mammary cancer in women who are more than 1 yr but less than 5 yr postmenopausal (women).

Contraindications

Men with carcinoma of the breast; men with known or suspected carcinoma of the prostate gland; women known or suspected to be pregnant; patients with serious cardiac, hepatic, or renal disease; hypersensitivity to any component of the product.

Dosage and Administration

Delayed Puberty (Men)
Adults

PO Titrate dose utilizing a low dose, appropriate skeletal monitoring, and by limiting the duration of therapy to 4 to 6 mo.

Inoperable Carcinoma of the Breast (Women)
Adults

PO 10 to 40 mg/day, in divided doses, for palliative therapy.

Male Hypogonadism
Adults

PO 5 to 20 mg/day for complete replacement.

General Advice

• Administer without regard to meals. Administer with food if GI upset occurs.

Storage/Stability

Store tablets at controlled room temperature (68° to 77°F).

Drug Interactions

Insulin

Blood glucose levels may be reduced by fluoxymesterone, decreasing insulin requirements.

Oral anticoagulants (eg, warfarin)

Effects of oral anticoagulant may be increased. Dosage reduction may be required.

Laboratory Test Interactions

Thyroxine-binding globulin levels may be decreased; however, thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.

Adverse Reactions

CNS

Increased or decreased libido; headache; anxiety; depression; generalized paresthesia.

Dermatologic

Hirsutism; male pattern baldness; seborrhea; acne.

GI

Nausea.

Genitourinary

Amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, virilization including deepening of voice, clitoral enlargement (women); gynecomastia, excessive frequency and duration of penile erection, oligospermia (men).

Hematologic

Suppression of clotting factors II, V, VII, and X; polycythemia.

Hepatic

Cholestatic jaundice; altered LFTs; hepatocellular neoplasms, peliosis hepatitis.

Metabolic

Sodium, chloride, water, potassium, calcium, and inorganic phosphate retention.

Miscellaneous

Allergic hypersensitivity (including skin manifestations and anaphylactoid reactions).

Precautions

Monitor

Determine liver enzymes, lipid profile, and hemoglobin and hematocrit levels before starting and periodically during treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

Pregnancy

Category X . Ensure that X-ray examinations of bone age are made every 6 mo during treatment of prepubertal male.

Lactation

Undetermined.

Children

Use with caution and only by specialists aware of the adverse effects on bone maturation.

Elderly

Elderly men may be at increased risk of developing prostatic hypertrophy or carcinoma.

Athletic performance

Abuse of this agent to enhance athletic performance has potential risk of serious adverse reactions.

Breast cancer and immobilized patients

May cause hypercalcemia.

Delayed puberty

Because bone maturation without compensatory linear growth can occur, use with caution in males with delayed puberty.

Edema

Use with caution in patients with conditions that might be affected by fluid retention (eg, renal, hepatic, or cardiac disease).

Gynecomastia

May occur and persist in patients being treated for hypogonadism.

Hepatic effects

Cholestatic hepatitis and jaundice may occur. Prolonged use of high doses may result in hepatic adenomas, hepatocellular carcinoma, and peliosis hepatitis.

Oligospermia and reduced ejaculatory volume

May occur after prolonged use or excessive dosage.

Priapism

May be indicative of excessive dosage.

Urethral obstruction

May develop in patients with benign prostatic hypertrophy.

Virilization

May occur in women using high-dose androgens.

Patient Information

• Instruct patient, family, or caregiver to take (give) exactly as prescribed and to not change the dose or discontinue therapy unless advised by health care provider.
• Advise patient, family, or caregiver that each dose may be taken without regard to meals but to take with food if stomach upset occurs.
• Instruct patient, family, or caregiver that if a dose is missed to skip that dose and not to double the next dose.
• Advise patient that medication does not enhance athletic performance and not to use for this purpose because of potential serious adverse health risks.
• Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
• Instruct patient, family, or caregiver to discontinue therapy and immediately contact health care provider if any of the following occur: persistent nausea or vomiting, yellowing of skin or eyes, swelling of feet or ankles.
• Instruct men to report too frequent or persistent erections to health care provider.
• Instruct women to report hoarseness, acne, changes in menstrual periods, or increase in facial hair to health care provider.
• Caution women of childbearing potential to avoid becoming pregnant while being treated.

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