Brand
name: Danazol (Oral Route)
Drug Information provided by: Micromedex
Description
Danazol may be used for a number of different medical problems. These
include treatment of:
* Pain and/or infertility due to endometriosis;
* A tendency for females to develop cysts in the breasts (fibrocystic breast
disease); or
* Hereditary angioedema, which causes swelling of the face, arms, legs, throat,
windpipe, bowels, or sexual organs.
Danazol may also be used for other conditions as determined by your
doctor.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use,
experience may show that it is also useful for other medical problems.
Although these uses may not be included in product labeling, danazol
is used in certain patients with the following medical conditions:
* Gynecomastia (excess breast development in males)
* Menorrhagia (excessively long menstrual periods)
* Precocious puberty in females (premature sexual development)
This product is available in the following dosage forms: Before Using
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 this medicine, the following should be considered:
Allergies : Tell your doctor if you have ever had any unusual or allergic
reaction to this medicine or any other medicines. Also tell your health
care
professional if you have any other types of allergies, such as to foods,
dyes, preservatives, or animals. For non-prescription products, read
the label or package ingredients carefully.
Pediatric : Danazol may cause male-like changes in female children
and cause premature sexual development in male children. It may also
slow or stop growth
in any child.
Geriatric : Many medicines have not been studied specifically in older
people. Therefore, it may not be known whether they work exactly the
same way
they do in younger adults. Although there is no specific information
comparing use of danazol in the elderly with use in other age groups,
danazol has effects similar to androgens (male hormones). Androgens
used in older males may increase the risk of developing prostate enlargement
or cancer.
Pregnancy :
Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive
evidence of fetal abnormalities. This drug should not be used in women who
are or may become pregnant because the risk clearly outweighs any possible
benefit.
Breastfeeding : There are no adequate studies in women for determining
infant risk when using this medication during breastfeeding. Weigh
the potential
benefits against the potential risks before taking this medication
while breastfeeding.
Drug Interactions :Using this medicine with any of the following medicines
is not recommended. Your doctor may decide not to treat you with this
medication or change
some of the other medicines you take.
* Bupropion
Other Interactions
Certain medicines should not be used at or around the time of eating
food or eating certain types of food since interactions may occur.
Using alcohol or tobacco with certain medicines may also cause interactions
to occur. Discuss with your healthcare professional the use of your
medicine with food, alcohol, or tobacco.
Proper Use
In order for danazol to help you, it must be taken regularly for the
full time of treatment as ordered by your doctor.The dose of this medicine
will be different for different patients. Follow your doctor's orders
or the directions on the label. The following
information includes only the average doses of this medicine. If your
dose is different, do not change it unless your doctor tells you to
do so.
The amount of medicine that you take depends on the strength of the
medicine. Also, the number of doses you take each day, the time allowed
between doses, and the length of time you take the medicine depend
on the medical problem for which you are using the medicine.
* For capsules dosage form:
o Adults and teenagers:
+ For treatment of endometriosis: 100 to 400 milligrams (mg) two times a day
for at least three to six months, and possibly for nine months.
+ For treatment of fibrocystic breast disease: 50 to 200 mg two times a day
for six months or until signs of the disease go away, whichever comes first.
+ For prevention of attacks of hereditary angioedema: 200 mg two or three times
a day. The dose may be lowered, depending upon your condition.
o Children: Dose must be determined by your doctor.
Missed Dose : If you miss a dose of this medicine, take it as soon
as possible. However, if it is almost time for your next dose, skip
the missed dose
and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away
from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions : Your doctor should check your progress at regular visits
to make sure that this medicine does not cause unwanted effects.
Contact your doctor if you are a female and have a larger clitoris
(sexual organ), deepening of your voice, or unnatural hair growth after
taking danazol. Your doctor may advise you to stop taking the medicine
so these effects do not get worse.
For patients with diabetes:
* This medicine may affect blood glucose (sugar) levels. If you notice
a change in the results of your blood or urine glucose test or if you
have any questions about this, check with your doctor.
Danazol may cause your skin to be more sensitive to sunlight than
it is normally. Exposure to sunlight, even for brief periods of time,
may cause a skin rash, itching, redness, or other discoloration of
the skin, or a severe sunburn. When you begin taking this medicine:
* Stay out of direct sunlight, especially between the hours of 10:00
a.m. and 3:00 p.m., if possible.
* Wear protective clothing, including a hat. Also, wear sunglasses.
* Apply a sun block product that has a skin protection factor (SPF) of a least
15. Some patients may require a product with a higher SPF number, especially
if they have a fair complexion. If you have questions about this, check with
your health care professional.
* Apply a sun block lipstick that has an SPF of at least 15 to protect your
lips.
* Do not use a sunlamp or tanning bed or booth.
If you have a severe reaction from the sun, check with your doctor.
If you are taking danazol for endometriosis or fibrocystic breast
disease:
* During the time you are taking danazol, your menstrual period may
not be regular or you may not have a menstrual period at all. This
is to be expected when you are taking this medicine. If regular menstruation
does not begin within 60 to 90 days after you stop taking this medicine,
check with your doctor.
* During the time you are taking danazol, you should use birth control methods
that do not contain hormones. If you have any questions about this, check with
your health care professional.
* If you suspect that you may have become pregnant, stop taking this medicine
and check with your doctor. Continued use of danazol during pregnancy may cause
male-like changes in female babies.
Side Effects : Along with its needed effects, a medicine may cause
some unwanted effects. Although not all of these side effects may
occur,
if they
do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following
side effects occur: For both females and malesLess common.
* Acne
* Dark-colored urine * Increased oiliness of hair or skin * Muscle
cramps or spasms * Swelling of feet or lower legs * Unusual tiredness
or weakness
* Weight gain (rapid).* Enlarged clitoris * Hoarseness or deepening of voice
* Unnatural hair growth
Some side effects may occur that usually do not need medical attention.
These side effects may go away during treatment as your body adjusts
to the medicine. Also, your health care professional may be able to
tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side
effects continue or are bothersome or if you have any questions about
them:
For both females and malesLess common
* Flushing or redness of skin * Mood or mental changes * Nervousness.*
Increased sensitivity of skin to sunlight.For females only
Less common
* Burning, dryness, or itching of vagina
* Vaginal bleeding
