Clinical studies of Hosebon capsules did not include sufficient numbers of subjects aged 65 and over to determine the safety and effectiveness of Danocrine in elderly patients.
Before taking Hosebon
Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking Hosebon it is important that your doctor knows:
- If you are pregnant, trying for a baby or breastfeeding.
- If you have a heart condition.
- If you have any vaginal bleeding other than your regular period.
- If you have ever had an unwanted blood clot (thrombosis), or stroke.
- If you have any of the following conditions: epilepsy, sugar diabetes, high blood pressure, migraine, or a blood fat (lip >
Hosebon is an attenuated androgen and the 2,3-isoxazol derivative of 17α-ethinyl testosterone (ethisterone). Hosebon competitively inhibits estrogen and progesterone receptors in the breast, hypothalamus, and pituitary 82 ; inhibits multiple enzymes of ovarian steroidogenesis 83 ; inhibits the midcycle surge of LH in premenopausal women; and reduces gonadotropin levels in postmenopausal women. 84 The precise mechanism of Hosebon in reducing breast pain is unknown. It is the only medication approved by the US Food and Drug Administration (FDA) for the treatment of mastalgia.
In initial studies, a double-blind crossover trial comparing two dosages of Hosebon (200 vs. 400 mg/day) in 21 patients with mastalgia demonstrated significant decreases in pain and nodularity at both dosages. 85 Onset of response and side effects were higher with the higher dosage. Of the participants, 30% had amenorrhea and weight gain. There was significant reduction in mean pain scores and mammographic density using Hosebon in a randomized trial with daily treatments of 200 or 400 mg of Hosebon for 6 months. 86 Patients relapsed more quickly (9.2 vs. 12.2 months) and to a greater extent (67% vs. 52%) in women taking 200 versus 400 mg of Hosebon. Gateley and colleagues found a clinically useful response to Hosebon (200 mg/day) in 92% of 324 patients with cyclical mastalgia and 64% of 90 patients with noncyclical mastalgia with 30% experiencing adverse events (mainly weight gain and menstrual irregularity) and 43 patients having to stop treatment despite 19 having an effective response. 87 Because the side effects of Hosebon are dose related, Harrison and colleagues 88 and Sutton and O’Malley 89 developed low-dose regimens. Patients responding to a dosage of 200 mg/day of Hosebon after 2 months were given a dosage of 100 mg/day for 2 months and then 100 mg every other day or 100 mg daily only during the second half of the menstrual cycle. 88 If previous reductions were well tolerated, the Hosebon was discontinued. 89 Symptoms were controlled without side effects at a total average monthly dose of 700 mg. Of 20 women, 13 (65%) of whom had experienced previous side effects, none reported side effects while taking this low dose. Some relief of pain was seen in all women, with a complete response maintained in 55%. Other reported side effects of Hosebon include muscle cramps, acne, oily hair, hot flashes, nervousness, hirsutism, voice change, fluid retention, increased libido, depression, headaches, and dyspareunia, which usually resolve after discontinuation of treatment. The drug is contraindicated in women with a history of thromboembolic disease. For women of childbearing age, adequate nonhormonal contraception is essential.
Recommendations for the administration of Hosebon are 100 mg twice daily for 2 months while the patient keeps a breast pain record. If no response or an incomplete response is obtained, the dose may be increased to 200 mg twice daily. If there is still no response, another drug should be tried. Therapy should not continue longer than 6 months (because side effects may develop), and the drug should be tapered, as described by Harrison and associates 88 and Sutton and O’Malley. 89
Antes de tomar Hosebon,
- informe a su mГ©dico y farmacГ©utico si es alГ©rgica a Hosebon, a cualquier otro medicamento o a alguno de los ingredientes que contienen las cГЎpsulas de Hosebon. PГdale a su farmacГ©utico una lista de los ingredientes.
- Informe a su mГ©dico y farmacГ©utico quГ© medicamentos con y sin receta mГ©dica, vitaminas, suplementos nutricionales y productos a base de hierbas estГЎ tomando o tiene planificado tomar. AsegГєrese de mencionar cualesquiera de los siguientes: anticoagulantes ('diluyentes de la sangre') como warfarina (Coumadin, Jantoven), atorvastatina (Lipitor, en Caduet), carbamazepina (Carbatrol, Equetro, Tegretol, otros), ciclosporina (Gengraf, Neoral, Sandimmune), medicamentos para la diabetes como insulina, lovastatina (Altoprev, en Advicor), simvastatina (Zocor, en Vytorin), o tacrolimus (Astagraf, Prograf). Es posible que su mГ©dico deba cambiar las dosis de los medicamentos o supervisarle atentamente para saber si sufre efectos secundarios.
- Informe a su mГ©dico si tiene porfiria (una enfermedad hereditaria de la sangre que puede provocar problemas de piel o del sistema nervioso), hemorragia vaginal inexplicable; cГЎncer; o enfermedades del corazГіn o enfermedades renales. Su mГ©dico probablemente le dirГЎ que no tome Hosebon.
- Informe a su mГ©dico si estГЎ amamantando. No amamante durante su tratamiento con Hosebon.
- Informe a su mГ©dico si padece o alguna vez ha padecido de migraГ±as o dolores de cabeza, epilepsia (convulsiones), diabetes; hipoparatiroidismo (una condiciГіn en la que el cuerpo no produce suficiente hormona paratiroidea), hipertensiГіn arterial, o cualquier trastorno de la sangre.
What are the possible side effects of Hosebon (Danocrine)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- loss of appetite, stomach pain (upper right side);
- cough with bloody mucus or vomit that looks like coffee grounds;
- jaundice (yellowing of the skin or eyes);
- bloody or tarry stools, dark urine;
- swelling or weight gain;
- a hoarse or deepened voice, sore throat;
- hair loss, or increased hair growth;
- acne or other skin problems;
- unexplained muscle pain, tenderness, or weakness;
- increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
- signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.
Common side effects may include:
- flushing (sudden warmth, redness, or tingly feeling);
- changes in your menstrual periods;
- unusual vaginal bleeding or spotting;
- breast changes;
- sexual problems;
- decreased amount of semen released during sex;
- mood changes, nervousness; or
- vaginal dryness or irritation.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Effectiveness for infertility
Hosebon — like all the hormonal treatments for endometriosis — will not improve your chance of conceiving, so it should not be used as a treatment for infertility .
ВїQuГ© otra informaciГіn de importancia deberГa saber?
Antes de realizarse alguna prueba de laboratorio, informe al mГ©dico y al personal del laboratorio que estГЎ tomando Hosebon.
No deje que nadie mГЎs use su medicamento. Pregunte a su farmacГ©utico cualquier duda que tenga sobre cГіmo volver a surtir su receta mГ©dica.
Es importante que Ud. mantenga una lista escrita de todas las medicinas que Ud. estГЎ tomando, incluyendo las que recibiГі con receta mГ©dica y las que Ud. comprГі sin receta, incluyendo vitaminas y suplementos de dieta. Ud. debe tener la lista cada vez que visita su mГ©dico o cuando es admitido a un hospital. TambiГ©n es una informaciГіn importante en casos de emergencia.
Effectiveness for pain symptoms
Clinical trials have shown that Hosebon is as effective as the other hormonal treatments in relieving the pain symptoms of endometriosis . It relieves pain in approximately 90% of women . However, it does not always relieve symptoms completely .
Symptoms often recur following hormonal treatment . The recurrence of symptoms may occur months or years after treatment ceases. One unpublished study found that 60% of women had had a recurrence of their symptoms within five years of treatment .
Use before surgery There is no evidence to justify using a course of hormonal treatment as a preparation for surgery .
Use after surgery There is some evidence to justify using hormonal treatment following surgery to suppress the growth and development of any remaining or new endometrial implants .
Use in recurrent endometriosis If the drug was effective and well tolerated previously, repeat courses of Hosebon may be used for women with recurrent endometriosis.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- Do not take Hosebon if you are pregnant. A pregnancy test will be done to show that you are NOT pregnant before starting Hosebon.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Hosebon.
- If you are pregnant or you get pregnant while taking Hosebon, call your doctor right away.
- Blood clots have happened with Hosebon. Sometimes, blood clots like stroke have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.
- Severe liver problems have happened with long-term use of Hosebon. This could lead to life-threatening bleeding in the belly area. Follow how to take Hosebon as you were told by your doctor. Do not take Hosebon for longer than you were told.
- Raised pressure in the brain has happened with Hosebon. This can cause long lasting loss of eyesight and sometimes death. Call your doctor right away if you have a bad headache, dizziness, upset stomach or throwing up, or seizures. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight.
Getting the most from your treatment
- Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. Your doctor may want you to have some blood tests during this treatment.
- It is important that you do not become pregnant while you are on Hosebon. If appropriate, you and your partner should use a non-hormonal method of contraception, such as a condom. This is because hormonal methods (such as 'the pill' or 'mini pill') will not work. Speak with your doctor if you need further advice about what methods of contraception are suitable for you to use.
- It is best not to drink alcohol while you are on Hosebon. This is because drinking alcohol while taking Hosebon could make you feel sick or short of breath.
Hosebon works by altering the levels of some of your body's hormones. It is used to treat a number of different conditions.
Hosebon (Danocrine) is the 2,3,isoxazol derivative of 17α-ethyl testosterone and has been tested in patients with gynecomastia of varying causes with response rates of 77% to 100%.
What should I discuss with my healthcare provider before taking Hosebon (Danocrine)?
You should not use Hosebon if you are allergic to it, or if you have:
- undiagnosed vaginal bleeding;
- severe heart problems;
- a history of stroke or blood clot;
- severe liver or kidney disease;
- porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or
- a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.
Tell your doctor if you have ever had:
You may need to have a negative pregnancy test before starting this treatment.
Do not use Hosebon if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.
Ask your doctor about using a non-hormonal birth control (such as a condom or diaphragm with spermicide) to prevent pregnancy.
Hosebon can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Hosebon.
Hosebon is not approved for use by anyone younger than 18 years old.