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

What is Fluoxymesterone

Fluoxymesterone is used for treating a deficiency of the male hormone testosterone when the body does not make enough. It is also used to stimulate puberty in males with delayed puberty.Treating advanced breast cancer in women who are 1 to 5 years past menopause.

Fluoxymesterone is an androgen.It works by stimulating normal growth and development of the male sex organs and maintaining normal secondary sex characteristics.It is unknown exactly how Fluoxymesterone works to treat breast cancer.

Before taking Fluoxymesterone

Some medical conditions may interact with Fluoxymesterone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have prostate problems, high blood calcium levels, or heart, liver, or kidney disease

Some MEDICINES MAY INTERACT with Fluoxymesterone . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluoxymesterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Taking Fluoxymesterone

Use Fluoxymesterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluoxymesterone may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Fluoxymesterone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluoxymesterone .

Fluoxymesternoe Side Effects

ll medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in sexual desire; absence of menstrual flow; acne; breast swelling or tenderness; deepening of voice; growth of facial hair; headache; irregular menstrual flow; mood changes; painful, prolonged erection; swelling of the clitoris.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ankle swelling; change in skin color; nausea; vomiting; weight gain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider.

Effects with other drugs

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Before using Fluoxymesterone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For androgens, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to androgens. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Androgens are not recommended during pregnancy. When given to pregnant women, the medicine has caused male features to develop in female babies.

Breast-feeding—Use is not recommended in nursing mothers, since androgens may pass into the breast milk and may cause unwanted effects in the nursing baby, such as premature (too early) sexual development in males and development of male features in female babies.

Children—Androgens may cause children to stop growing. In addition, androgens may make male children develop too fast sexually and may cause male-like changes in female children.

Older adults—When older male patients are treated with androgens, they may have an increased risk of enlarged prostate (a male gland) or their existing prostate cancer may get worse. For these reasons, a prostate examination and a blood test to check for prostate cancer is often done before androgens are prescribed for men over 50 years of age. These examinations may be repeated during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking androgens, it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Anti-infectives by mouth or by injection (medicines for infection) or
• Antithyroid agents (medicines for overactive thyroid) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicines for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Oral contraceptives (birth control pills) containing estrogen or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Valproic acid (e.g., Depakene)—Use of these medicines with androgens may increase the chance of liver problems. Your doctor may want you to have extra blood tests that check your liver while you are taking any of these medicines with an androgen

• Anticoagulants (blood thinners)—Androgens can increase the effect of these medicines and possibly cause excessive bleeding

Other medical problems—The presence of other medical problems may affect the use of androgens. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer (in males) or
• Prostate cancer—Androgens can cause growth of these tumors

• Breast cancer (in females)—Androgens may cause high calcium levels in the blood to become worse

• Diabetes mellitus (sugar diabetes)—Androgens can increase or decrease blood sugar levels. Careful monitoring of blood glucose should be done

• Edema (swelling of face, hands, feet, or lower legs) or
• Kidney disease or
• Liver disease—These conditions can be worsened by the fluid retention (keeping too much water in the body) that can be caused by androgens. Also, liver disease can prevent the body from removing the medicine from the bloodstream as fast as it normally would. This could increase the chance of side effects occurring

• Enlarged prostate—Androgens can cause further enlargement of the prostate

• Heart or blood vessel disease—Androgens can make these conditions worse because androgens may increase blood cholesterol levels. Also, androgens can cause fluid retention (keeping too much water in the body), which also can worsen heart or blood vessel disease

Proper Use

Take this medicine only as directed. Do not take more of it and do not take it more often than your doctor ordered . Doing so may increase the chance of side effects.

There are two types of testosterone skin patches. The matrix-type is applied to skin of the scrotum. The reservoir-type is never applied to the skin of the scrotum. It is applied to other parts of the body. Be sure you know which type you are using so that you will apply it properly. These skin patches come with patient directions. Read them carefully before using the patch.

For patients taking fluoxymesterone or methyltestosterone :

• Take this medicine with food to lessen possible stomach upset, unless otherwise directed by your doctor.

Precautions

Women should be observed for signs of virilization which is usual following androgen use at high doses. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. 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.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.