posted April 05, 2000 12:23 PM            

FDA Approved Uses

Used to treat primary or secondary hypogonadism.

Used to induce puberty in males with familial delayed puberty.

Used to help treat metastatic breast cancer in women who have been postmenopausal for 1 to 5 years, who have hormone receptor positive tumors and who have responded to hormone therapy in the past.

Contraindications

Any of the following may be reason to choose a different drug. Inform your doctor before starting therapy.

Allergic to fluoxymesterone

Males with cancer of the breast or prostate gland

Serious heart, liver or kidney diseaseer.

Dosage and Administration

Dosages may require modification to adjust for individual sensitivities and associated medical conditions.

Adults Under 60
For treatment of hormone deficiency:
5 mg taken 1 to 4 times daily. The dose should be adjusted as needed.

For treatment of female breast cancer:
10 to 40 mg taken daily in divided doses.
Take tablets with food.

Adults 60 and Over
Reduced dosage may be necessary. Consult your physician.

Infants and Children
For treatment of delayed puberty in males:
2.5 to 10 mg taken daily. The dose should be adjusted to the lowest dose needed and used for 4 to 6 months.

Maximum Dosage Recommendations
Do not exceed the recommended doses, unless deemed necessary by your doctor.

Usual Duration of Use
The length of therapy varies depending on the condition being treated.

If You Miss a Dose
Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage

Keep all medications out of the reach of children

Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

DRUG INTERACTIONS
Check the drugs and vitamins you take for possible interactions.

You may experience the following side effects with the use of this drug:

Common Symptoms

Effects in women
Menstrual changes
Virilism (masculinization of features, with such symptoms as acne, decreased breast size, deepening of the voice, male pattern baldness, unnatural hair growth)

Effects in males
Breast soreness
Breast enlargement
Priapism (persistent and painful erection)
Urinary tract infection

Less Common to Rare Symptoms
Swelling of the lower legs and feet
Nausea or vomiting
Diarrhea
Stomach pain
Headache
Acne
Change in sexual desire
Insomnia
Dizziness
Flushing
Liver damage
Leukopenia (low levels of white blood cells in the blood)
Benign prostatic hypertrophy (difficulty urinating) in men

Life-threatening Symptoms
Leukopenia
Severe allergic reaction

Possible Overdose Symptoms
None reported

What to Do in Case of Overdose

In the event of a suspected overdose, dial 911 for emergency help or call your poison control center.

Precautions

This drug may accelerate bone maturation without the accompanying linear growth in children.
This drug may cause testicular atrophy.
This medication may affect blood glucose levels. If you are a diabetic, monitor your blood glucose levels closely while using this medication.
Since this drug can cause an increase in blood calcium levels, periodic blood tests should be conducted. Consult your physician.

Adults Over 60
Use with caution in this age group, as older patients are more likely to experience the drug's adverse reactions, especially urinary retention. This drug may worsen your existing heart problems and hypertension.

Pregnancy Risk Category: X

Pregnancy Warnings
This drug causes fetal harm and is contraindicated in pregnant women. Do not use if you are pregnant or plan to become pregnant.

Nursing Mothers
Because of the risk of potential harm to the newborn, avoid using this drug while breastfeeding. If therapy is necessary, avoid breastfeeding while on this drug.

Prolonged Use
Prolonged use can cause kidney stone formation, reduction in sperm count and volume of semen, and unnatural hair growth and deepening of the voice in females. Avoid unless directed by your physician.

Discontinuing Therapy
No problems are expected. Consult your physician about discontinuing.

Operating a Vehicle or Heavy Machinery
No problems are expected.

Sun Exposure
No problems are expected.

------------------
The Cuban

posted April 05, 2000 11:20 PM            

------------------
The Cuban

posted April 05, 2000 11:56 PM            

------------------
SEMPER FI
Chestys Homeworld