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Androcur

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Cyproterone Acetate Tablets (Cyproterone Acetate) Instructions

Common Name: Cyproterone Acetate
Trade Name: Androcur
Full Names: Cyproterone Acetate Tablets, Cyproterone, Cyproterone Acetate, Androcur


Indications:
Reduced libido in males; inoperable prostate cancer; signs of severe virilization in females: such as very severe hirsutism, androgen-dependent severe alopecia, eventually leading to baldness (severe androgenic alopecia), often accompanied by severe acne and/or seborrhea.


Usage and dosage:
General treatment starts with 1 tablet bid, and can be increased to 2 tablets bid if necessary, or even 2 tablets tid in the short term. The medicine should be swallowed with a small amount of liquid after meals. When satisfactory results are achieved, the lowest possible dose should be used to maintain the effect. Usually, half a tablet twice a day is enough. When establishing a maintenance dose or stopping medication, the dose should not be reduced suddenly but gradually. The daily dose should be reduced by 1 tablet or preferably half a tablet every few weeks. In order to stabilize the therapeutic effect, the use of this drug must be prolonged for a period of time, and if possible, psychotherapy methods must be used at the same time. u2003
Inoperable prostate cancer:
To eliminate the effect of adrenocortical androgens after orchiectomy: 2 tablets each time, 1-2 times a day (i.e. 100-200 mg). Without orchiectomy: 2 tablets each time, 2-3 times a day (i.e. 200-300 mg). Treatment dosage should not be changed or interrupted after symptoms change or decrease.
When treating with gonadotropin-releasing hormone agonist (LH-Rha), in order to reduce the initial increase in male sex hormones: start with this medicine alone, 2 tablets each time, 2 times a day (i.e. 200 mg) for 5-7 days, followed by 2 tablets each time, 2 times a day (200 mg in total), and use it at the same time with one LH-Rha for a total of 3-4 weeks. To eliminate the effect of adrenocortical androgens during LH-Rha treatment: For continuous anti-androgen therapy, take 2 tablets of this drug each time, 1-2 times a day (i.e. 100-200 mg). u2003

Signs of severe virilization in women:
For example, very severe hirsutism, androgen-dependent severe alopecia, eventually leading to baldness (severe androgenic alopecia), often accompanied by severe acne and/or seborrhea. Treatment for women of childbearing age should start on the first day of the menstrual cycle (i.e. the first day of bleeding). Only women with amenorrhea can start drug treatment immediately. In this case, day 1 of treatment is considered day 1 of the cycle and routine observation is followed as recommended below. On the 1st to 10th day of the menstrual cycle, 2 tablets of this medicine should be swallowed with water every day after meals. In addition, these women also take preparations containing estrogen and progesterone, such as 1 oral contraceptive pill every day from the 1st to 21st day of the menstrual cycle, to provide necessary contraceptive protection and stabilize the menstrual cycle. Women receiving cyclic combination therapy should take their medications at a fixed time each day. If the fixed taking time exceeds 12 hours, the contraceptive effect of this cycle may be reduced, but this medicine and oral contraceptives should still be taken according to the instructions to avoid early bleeding in this cycle. Missed pills can be ignored, but a non-hormonal contraceptive method (except for safety periods and temperature measurement) should be used for the remainder of the cycle. After 21 days of taking the drug, there is an observation period of 7 days of stopping the drug. During this period, withdrawal bleeding will occur. Exactly 4 weeks after the start of the first course of treatment, that is, on the same day of the week, the next cycle of combination therapy will be started regardless of whether the bleeding stops. If bleeding does not occur during drug withdrawal, necessary diagnostic tests should be performed. After clinical symptoms improve, the daily dose of this drug can be reduced to one or half a tablet during the first 10 days of combined therapy. Oral contraceptives alone may be sufficient. This drug can be used alone in postmenopausal patients or in patients who have had a hysterectomy. Depending on the severity of symptoms, the average dose of this drug should be 1 to 1/2 tablets once daily for 21 days, followed by 7 days off medication.


Adverse reactions:
Breast tenderness, pain, secretion; headache; migraine; change in libido; depression; intolerance to contact lenses; nausea; vomiting; changes in vaginal secretions; various skin diseases; fluid retention; weight changes; allergic reactions; abnormal liver function; elevated serum triglycerides.


Taboos:
1. Compound preparations containing estrogen and progesterone cannot be used in any of the following situations. If any of the following conditions occurs for the first time while using these preparations, the medication must be discontinued immediately.
2. Thrombosis (venous or arterial) or a history of thrombosis (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident).
3. There are prodromal symptoms of thrombosis or related medical history (such as transient ischemic attack, angina pectoris).
4. Diabetes involving blood vessels.
5. The presence of severe or multiple risk factors for venous or arterial thrombosis is also a contraindication.
6. Exist or have had severe liver disease, as long as the liver function values ​​have not returned to normal.
7. There is or has been a history of liver tumors (benign or malignant).
8. Malignant tumors affected by sex steroid hormones are known or suspected to exist in the reproductive organs or breasts.
9. Undiagnosed vaginal bleeding.
10. Known or suspected pregnancy.
11. Breastfeeding.
12. Are allergic to any component of compound cyproterone acetate tablets.
13. Compound cyproterone acetate tablets cannot be used on men.


Precautions:
Pregnancy, breastfeeding, liver disease, history of jaundice or persistent pruritus during pregnancy, history of herpes during pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumors (not due to metastatic prostate cancer), wasting disease (except inoperable prostate cancer), severe chronic depression, previous or existing thromboembolic conditions, severe diabetes with vascular changes, sickle cell anemia.
Patients with prostate cancer who have a history of thromboembolism, sickle cell anemia, or severe diabetes with vascular changes must carefully weigh the pros and cons in each case before using this drug.
Patients whose occupations require a high degree of concentration (such as drivers, machine operators) should be used with caution. This drug can cause fatigue and loss of energy, and may also affect the ability to concentrate.
The libido-lowering effect of this drug can be weakened by the anti-inhibitory effect of alcohol.
This drug should not be given before the end of puberty, since its adverse effects on physical growth, as well as on the endocrine function axis that is not yet stable, cannot be ruled out.
During treatment, liver function, adrenocortical function and red blood cell count should be checked regularly. Use with caution in patients with diabetes, as oral antidiabetic drug or insulin requirements may vary.
As with other sex steroid hormones, benign and malignant hepatic changes have been reported in individual cases.
In very rare cases, liver tumors may cause life-threatening intra-abdominal bleeding. Therefore, when abnormal upper abdominal discomfort occurs and does not disappear on its own in a short period of time, appropriate diagnosis and treatment should be carried out.
Before treatment begins, a thorough physical and gynecological examination (including breast and cervical cytology smears) should be performed.
Women of childbearing age must rule out pregnancy.
If during combination therapy, a small amount of irregular bleeding occurs within 3 weeks of taking the medicine, the medicine should not be stopped. However, if bleeding is excessive, necessary examinations should be performed.


Storage:
Sealed and stored


Mechanism of action:
This drug is an anti-androgen inhibitor, which can inhibit the effects of male sex hormones (androgens). Androgens can also be produced in small amounts by female organs, and also have certain progesterone and anti-gonadotropin effects. For men, treatment with this drug can reduce sexual desire and sexual function, and suppress gonadal function. These changes are reversible after stopping treatment. This drug protects androgen-dependent target organs, such as the prostate, from the effects of androgens derived from the gonads and/or the adrenal cortex. In women, this drug can reduce hirsutism, androgen-dependent alopecia and increased sebaceous gland function. During treatment, ovarian function is suppressed.


Safety and efficacy:
Cyproterone acetate tablets have significant effects. Cyproterone acetate tablets are a powerful anti-androgen drug with an effective rate of 100% in treating acne. It can significantly reduce seborrhea. It is reported that the seborrhea rate was reduced by 85.5% in the third month of treatment and by 96.2% in the sixth month. Cyproterone acetate tablets can be used as the first-line drug for female acne patients who require contraception. Cyproterone acetate tablets can also achieve satisfactory results in treating stubborn acne in patients with ovarian cysts. It is also effective for female hirsutism and female androgenic alopecia.