How to store Dainazol
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
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What are some things I need to know or do while I take Dainazol?
- Tell all of your health care providers that you take Dainazol. This includes your doctors, nurses, pharmacists, and dentists.
- If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
- High cholesterol has happened with Dainazol. If you have questions, talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Dainazol.
- Period (menstrual) changes have happened with Dainazol. This includes spotting, period timing changes, and periods that have stopped. Most of the time, these changes went back to normal within 60 to 90 days after stopping Dainazol. If your period has stopped and does not go back to normal after you stop Dainazol, talk with your doctor.
- This medicine may lower sperm counts in males. Talk with the doctor.
The usual length of treatment is 3–6 months, but it may be extended to 9 months in some circumstances.
The recommended dosages vary. North American gynaecologists tend to recommend dosages of 800 milligrams per day, whereas European and Australian gynaecologists tend to recommend dosages of 600 milligrams per day .
Some gynaecologists believe it is better to base the dosage on the minimum needed to stop menstruation. In this case, they may suggest that you start with 400 milligrams per day, and, if necessary, increase the dose until your periods stop . Alternatively, they may suggest that you start with 600 milligrams a day, and reduce the dosage to 400 milligrams a day or even 200 milligrams a day .
You should start your course of Dainazol on the first day of your period to decrease the risk of taking the drug while you are pregnant. If there is any possibility that you may be pregnant, you should have a pregnancy test before starting treatment .
Although it is unlikely that you will conceive while on Dainazol, care should be taken to avoid pregnancy. It is recommended that you use barrier contraception (condom or diaphragm or both) throughout treatment .
You should not take Dainazol if you have :
- liver disease
- high blood pressure
- heart failure
- poor kidney function
El Dainazol puede ocasionar efectos secundarios. Informe a su mГ©dico si cualquiera de estos sГntomas es intenso o no desaparece:
- disminuciГіn en el tamaГ±o de los senos,
- aumento de peso.
- piel o cabello grasoso,
- sequedad vaginal, ardor, picazГіn o sangrado,
- ausencia del ciclo menstrual, manchado o cambios en el ciclo menstrual.
Contraindications—hypersensitivity to drug or class, undiagnosed genital bleeding, pregnancy, breastfeeding, porphyria
Caution—hepatic, renal, or cardiac dysfunction, epilepsy, migraine
Maternal Considerations There are no indications during pregnancy for Dainazol. It should be discontinued if the patient becomes pregnant. Dainazol is not an effective contraceptive. It decreases the maternal progesterone level if taken during the first trimester.Side effects include alteration of the lipid profile (low HDL), contraceptive failure, pseudotumor cerebri, weight gain, acne and seborrhea, mild hirsutism, virilization, edema, hair loss, hoarseness, menstrual irregularities, flushing, sweating, vaginal dryness, reduction in breast size, hypertension, anxiety, and thromboembolism. Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether Dainazol crosses the human placenta. Though the FDA classifies Dainazol as category X, there is no reason a priori to terminate an exposed pregnancy. Dainazol can have an androgenic effect on female fetuses (vaginal atresia, clitoral hypertrophy, labial fusion, ambiguous genitalia). Thus exposed fetuses should undergo a detailed ultrasound examination. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Dainazol is associated with inhibition of fetal development in rabbits. Breastfeeding Safety There is no published experience in nursing women. It is unknown whether Dainazol enters human breast milk. It is generally considered contraindicated during breastfeeding. Drug Interactions Prolongation of PT occurs in patients stabilized on warfarin.Dainazol may cause an increase in carbamazepine. References Bianchi S, Busacca M, Agnoli B, et al. Hum Reprod 1999; 14:1335-7.Brunskill PJ. Br J Obstet Gynaecol 1992; 99:212-5.Igarashi M, Iizuka M, Abe Y, Ibuki Y. Hum Reprod 1998; 13:1952-6.Kingsbury AC. Med J Aust 1985; 143:410-1.Rabe T, Kiesel L, Franke C, et al. Biol Res Pregnancy Perinatol 1984; 5:149-52.Schwartz R. Am J Dis Child 1982; 136:474.Zayed F, Abu-Heija A. Obstet Gynecol Surv 1999; 54:121-30. Summary Pregnancy Category: XLactation Category: NS (possibly) •
There are no indications for Dainazol during pregnancy; it is considered contraindicated.
A pregnancy test is recommended immediately prior to initiating therapy.
Dainazol may virilize a female fetus (vaginal atresia, clitoral hypertrophy, labial fusion, urogenital sinus defect, ambiguous genitalia), but these abnormalities have not been reported if discontinued by 8 w.
Dainazol has been used to treat women with endometriosis since the 1970s . It was the most commonly used drug in the early 1980s, but its use declined markedly after the introduction of the GnRH agonists in the late 1980s and early 1990s.
Dainazol is a synthetic androgen . Androgens are hormones produced by the male testes. They are responsible for the functioning of the male reproductive system and the development of the male characteristics, such as facial hair and a deep voice. The ovaries also produce small amounts of androgens.
Dainazol is an effective treatment for endometriosis, and has the same effectiveness as the other hormonal treatments. However, it has many androgenic (male-like) side effects, including weight gain, increased body hair and acne. Its unpleasant side effects and its tendency to adversely affect blood lipid (cholesterol) levels mean it is not usually the first choice of treatment for endometriosis .
The following events have been reported in association with the use of Dainazol capsules:
Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.
Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with Dainazol capsules, persistent amenorrhea has occasionally been reported.
Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.
Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of Dainazol capsules of 400 mg or more. It is recommended that patients receiving Dainazol capsules be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, hepatic adenoma, hepatocellular injury, hepatocellular jaundice and hepatic failure have been reported (see WARNINGS and PRECAUTIONS).
Abnormalities in laboratory tests may occur during therapy with Dainazol capsules including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.
The following reactions have been reported, a causal relationship to the administration of Dainazol capsules has neither been confirmed nor refuted;
CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain- Barre syndrome;
Gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis;
Musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention;
Genitourinary: hematuria, prolonged posttherapy amenorrhea;
Hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted.
Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme;
Other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure,interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.
What is Dainazol?
Dainazol is a man-made form of a steroid. Dainazol affects the ovaries and pituitary gland and prevents the release of certain hormones in the body.
Dainazol is used to treat endometriosis and fibrocystic breast disease. Dainazol is also used to prevent attacks of angioedema in people with an inherited form of this disorder (hereditary angioedema).
Dainazol may also be used for purposes not listed in this medication guide.
International Brand Names
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Anargil (Hong Kong, Malaysia, Thailand); Azol (Australia, Malaysia, Taiwan); Bonzol (Japan); Cyclomen (Canada); Danasin (Turkey); Danatrol (Belgium, France, Greece, Italy, Netherlands, Portugal, Spain, Switzerland); Dainazol (Korea, Poland); Dainazol Jean Marie (Hong Kong); Dainazol-Ratiopharm (Germany); Danocrine (Australia, Denmark, Finland, Hong Kong, Indonesia, Israel, Norway, Sweden); Danodiol (Egypt, Ghana, Iran, Iraq, Kenya, Kuwait, Mauritius, Puerto Rico, Tanzania); Danogar (Chile); Danogen (India, Russia); Danokrin (Austria); Danol (Czech Republic, England, Hungary, Ireland, Israel); Danoval (Bulgaria, Hungary, Poland); Danzocurine (Korea); Dorink (Taiwan); D-Zol (New Zealand); Ectopal (Taiwan, Thailand); Gonablok (India); Kendazol (Mexico); Ladazol (South Africa); Ladogal (Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Ecuador, Malaysia, Mexico, Paraguay, Peru, Philippines, Taiwan, Thailand, Uruguay, Venezuela); Nazol (Malaysia); Norciden (Mexico); Vabon (Malaysia, Thailand); Winobanin (Germany); Zendol (India); Zoldan-A (Mexico)
Pregnancy Teratogenic Effects
(see CONTRAINDICATIONS.) Dainazol administered orally to pregnant rats from the 6 th through the 15 th day of gestation at doses up to 250 mg/kg/day (7-15 times the human dose) did not result in druginduced embryotoxicity or teratogenicity, nor difference in litter size, viability or weight of offspring compared to controls. In rabbits, the administration of Dainazol on days 6-18 of gestation at doses of 60 mg/kg/day and above (2-4 times the human dose) resulted in inhibition of fetal development.
How should I take Dainazol?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Women who take Dainazol to treat endometriosis or fibrocystic breast disease should start the medication during a menstrual period.
Dainazol is usually given for 6 to 9 months to treat fibrocystic breast disease or endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term. Follow your doctor's instructions.
Your doctor may occasionally change your dose to make sure you get the best results.
Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.
Use Dainazol regularly to get the most benefit. Try not to miss any doses. Get your prescription refilled before you run out of medicine completely.
While using Dainazol, you may need blood tests at your doctor's office. Visit your doctor regularly.
It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Dainazol.
Store at room temperature away from moisture and heat.