Puyol 200mg Davipharm medicine for endometriosis (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Danazol

Ingredient

Composition information	Content
Danazol	200mg

Uses

indications

Puyol 200 mg drugs are indicated in the following cases:

Treatment reduces symptoms for endometriosis and/or reduces the peanuts. Danazol can be combined with surgical treatment or hormonal treatment alone in humans who do not respond to other treatment or intolerance or contraindication to hormone treatment. Due to uterine dysfunction.

Danazol directly inhibits the pituitary - ovaries should prevent the pituitary and hypothalamus gonadotropin.

Synthetic inhibitors of sex steroids and attached to sex steroid receptors in the cytoplasm of the target tissue, leading to anti -estrogen effects, assimilated and weak androgen effects.

Medicines have weak metabolic and androgen properties but do not have the effect of estrogen and progestogen. Androgen activity is related to the dose.

In addition, Danazol also reduces many concentrations of IgG, IGM, IgA as well as phospholipids and IgG autoimmune antibodies in endocarditis patients with autoimmune antibodies.

Danazol does not inhibit the pituitary gland release corticotropine and adrenal glands release cortisol.

Some studies show that in women, Danazol inhibits the excretion of FSH and LH between cycles and reduces the concentration of estradiol, progesterone in plasma. However, in some other studies, there is no change in or changing very little plasma concentrations in FSH, LH, Estradiol, Progesterone and ProLactin after using Danazol.

In men treatment with Danazol shows a decrease in FSH, LH, testosteron and dihydroepiandosteron levels.

In the treatment of endometriosis, danazol inhibits the ovaries to create steroids, thus causing normal and peanut endometrial atrophy.

Non -ovary and followed by amenorrhea appears when treatment is about 6 - 8 weeks.

Danazol also reduces the abnormal rate of breast tissue development.

Patients with genetic angize treated with Danazol showed that the concentration of esterase inhibitor C1 in the serum increased 4.5 times and the C4 complement increased by 15 times compared to before treatment.

In patients who lack factor VIII (Hemophilia A) and lack of IX (Hemophilia B), Danazol increases the concentration of factor VIII and IX factor. In addition, Danazol also increases the concentration of alpha-antitrypsin in patients with a shortage of this factor.

Patients with plateletal hemorrhage treated with Danazol treated significantly reducing antibodies of platelet resistant IgG, especially in patients who have failed with spleen cut and other treatments (such as colchicin, coconut alcaloid, corticosteroid).

pharmacokinetic

absorption

Danazol is well absorbed by oral. In healthy women, when taking Danazol doses 400 mg 2 times/ day, for 2 consecutive days, the highest concentration achieved in plasma is about 140 - 460 nanogam/ ml, on average, about 260 nanogam/ ml, 2 hours after the last dose. Biomedical research shows that the concentration of plasma Danazols does not increase linear compared to oral dose. When doubling the dose, plasma Danazol concentration increased by 35 - 40%. Taking medicine with a fatty meal (about 30 g of fat) can increase bioavailability and CMAX is 3-4 times higher than when you are hungry. However, when taking the medicine with the meal, the time to reach CMAX is about 30 minutes slow.

Metabolism

Danazol is metabolized mainly in the liver. The main metabolites found in urine are 2-hydroxymethylihihyliesterone and Ethisteron. These metabolites do not have the anti -resistant to Gonadotropin. Donazol's activity increases slightly when used simultaneously with active inhibitors of drug metabolic enzymes. No isolated metabolites of Danazol have the same pituitary inhibition activity as Danazol.

Allocation and elimination

Information about distribution and elimination of Danazol is still very limited.

Metabolic substances are excreted in urine and feces. Danazol's waste sale time is about 3-6 hours after taking a single dose, but increases to 26 hours if the dose is repeated. Danazol and metabolites can undergo liver -intestinal cycle.

Before taking Puyol 200mg Davipharm medicine for endometriosis (3 blisters x 10 tablets)

How to use

Puyol 200mg drug used orally. Do not take medicine with a fatty meal. In women, they need to start treatment from the first day of the menstrual cycle, or when the test results have confirmed that the patient is not pregnant. Women of reproductive age should use non -hormone contraception during treatment. The effectiveness varies depending on the patient, so it is necessary to adjust the dose depending on the patient to achieve the lowest doses effectively.

Dosage

Endometriosis is mild: Danazol 100 - 200 mg/time, 2 times/day continuously for 3-6 months, in case of necessity can be treated up to 9 months. Treatment until menstrual bleeding.

Endometriosis is average and heavy: Danazol 400 mg/time, 2 times/day for 3-6 months, in case of necessity can be treated up to 9 months. The dose can be adjusted gradually depending on the response and tolerance of the patient.

Pre -endometrial treatment: 400 - 800 mg/day divided into 4 times, within 3-6 weeks.

benign fibroids: Danazol 50 - 200mg/time, 2 times/day, change the dose depending on the response, continuous treatment within 3-6 months.

Big breasts in men: Danazol 200 mg/day, use continuously if after 2 months do not meet the dose increasing up to 400 mg/day divided into 4 times. The male and male adult teenager initially dose 400 mg/day, divided into 4 times. Maximum dose of 800 mg/day. The treatment time is usually 6 months.

Genetic angioedema: Danazol 200 mg/time, 2-3 times/day depending on the response of the patient. When achieved appropriate, gradually reduce the dose up to 50% or lower for 1-3 months. If there is an exacerbation, the daily dose increases to 200 mg/day. During the dose adjustment period, the patient must be monitored closely.

Treatment of menstrual dysfunction due to functional disorders: daily dose of 200 mg/day in a short time. After 3 months, check the treatment.

Elderly: Do not recommend use.

Children: Do not recommend taking children's drugs.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? In the event of an overdose, it is necessary to consider reducing the absorption of drugs by activated carbon, continue to monitor patients in the room when any late reaction occurs.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Puyol 200 mg, you may experience unwanted effects (ADR).

Blood

Increase the number of red blood cells and platelets. Secondary growth of red blood cells or polycythemia, recovery. Acidic hypernagics, leukopenia, and thrombocytopenia have also been recorded.

Endocrine

Androgen effects: Acne, weight gain, increased cravings, skin or greasy hair, hair, hair loss, voice changes may include hoarseness, sore throat or deep or instability voice. Nervous, emotional changes erratically, dry vagina, itching, burning or bleeding, reducing breast size. Bleeding and ovulation in cycles may return to normal within 60 - 90 days after stopping the drug, but maybe some cases ADR does not lose after stopping the drug, prolonged amenorrhea is sometimes reported. Reduce sperm.

Metabolism and nutrition

Insulin resistance may increase in patients with diabetes, hypoglycemia symptoms in patients without diabetes have also been reported due to plasma glucagon glucagon, mitigating glucose tolerance.

Temporary transformation of lipoprotein, manifested by increasing LDL-C, HDL-C decrease, affecting all other ingredients, reducing AI and AII apolipoprotein, often occurring when treated with Danazol in women.

Clinical significance of these changes has not been established. Aminolevulinic acid (ALA) Synthetase (ALA), reducing globulin attached to the thyroid, T4, along with increased T3 absorption but no thyroid stimulating hormones or free thyroxin index can also occur during treatment.

Mental

Emotions are easy to change, anxiety, depression, stress and change of libido.

Neurology

Dizziness, headache, dizziness, hyperplanded intracranial pressure (fake brain) shows with headaches, vomiting or nausea, field disorders.

Danazol may worsen epilepsy and onset this condition in patients at risk. Keeping water can explain to a few wrist tubular syndrome reports. Danazol can also cause migraine. Guillain-Barré syndrome.

Eyes

Visuality disorders such as blurred vision, difficulty focusing, difficulty wearing contact lenses and refractive disorders need to adjust. Heart hypertension, chest drum, tachycardia. Clogging events include vertical sinus thrombosis, cerebrovascular thrombosis as well as arterial thrombosis. Myocardial infarction. Blood vessels flush, worsen hypertension.

respiratory - chest - mediastinum

Pleural pain, interstitial pneumonia. Digesting nausea, epigastric pain. Liver - bile increased serum transminase, rare jaundice of cholestasis, benign liver cell glands and pancreatitis. Hematuria and malignant liver tumor have been reported when used for prolonged use.

Skin and subcutaneous tissue

rash, may be a rash or bleeding, hemorrhage, urticaria and may be accompanied by face edema, fever. Very rarely reacts to light. Inflammation of pink button, changing skin pigmentation, flaking dermatitis and diverse roses have also been reported. The chromosome is fixed.

muscle - bone and connective tissue

Cramps or muscle spasms, may be serious, pain or swelling, stiffness, back pain. Creatin phosphokinase may also increase. Muscle tremor, local muscle vibration, limb pain, joint pain and joint swelling.

kidney - urinary - genital

There have been rare reports of bleeding when used for prolonged patients with genetic angioedema.

The whole body and place of use

tired.

Instructions on how to handle ADR

Danazol causes ends of hormones, these ADRs are often lost after stopping the drug, however, there are some cases of non -recovery androgen effects. Therefore, it is necessary to monitor the signs of maleization.

Danazol may cause liver failure, so periodically monitoring liver and transaminase function in patients treated with Danazol.

In addition, it is possible to experience local hemorrhage in the liver, benign liver tumors, liver cancer, these ADRs often do not show symptoms until there are complications that can be life -threatening as bleeding in the abdomen. Therefore, in the case of prolonged treatment must monitor early detection of these risks ...

The risk of fake tumor can occur when treated with Danazol is shown with headache, vomiting, nausea, visual disorders, need to look at the bottom of the eye, if there is an edema of the eye, the medication must stop and immediately move to the neurotransmitter for treatment.

If during treatment with danazol in patients with breast fibroids, the tumor is large, it is necessary to check to eliminate breast cancer.

The drug can cause other unwanted effects. It is necessary to closely monitor and recommend the patient to notify the doctor with unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Puyol 200 mg drugs in the following cases:

Patients with hypersensitivity to Danazol or any ingredient of the drug.

Pregnant women, nursing women, patients with abnormal vaginal bleeding have not been identified.

Patients with liver failure, kidney failure, heart failure, patphyrin patient.

is or having a history of active thrombosis or tolerance.

u depends on androgen.

Caution when using

Precautions when taking drugs for patients with kidney or liver disease, hypertension or other cardiovascular diseases and any condition may be worse due to water retention as well as patients with diabetes, red blood cells, epilepsy, patients with a history of thrombosis and patients who have a significant Androgen reaction or persistent genital therapy.

adjustment of simultaneous treatment, especially in patients with hypertension, diabetes or epilepsy when starting or stopping using Danazol as well as during treatment.

Be cautious when taking medication for patients with lipoprotein disorders. Danazol may cause high density lipoprotein disorders (low density lipoprotein, low density lipoprotein), thus taking into account the risk of coronary artery pathology when indicating Danazol treatment and considering benefits - risks.

Be cautious when taking medication for migraine patients.

Be cautious when using Danazol in patients who have been diagnosed with malignant disease or suspicion.

It is necessary to eliminate hormonal carcinoma before appointment of danazol or danazol treatment that the nodes in the breast are still or bigger. When there are signs of maleization, it is necessary to stop treating with danazol.

While androgen effects are often recovered, continuing to use Danazol when there are signs of menstrualization that can cause non -recovery androgen effects.

It is necessary to stop treating with danazol if there is any clinical significance that occurs, especially when there is evidence of a thorn, headache, visual disorders or other signs or symptoms of increased intracranial pressure, jaundice or other manifestations of liver, thrombosis or thrombosis. In addition to clinical monitoring on all patients, appropriate subclinical monitoring should be considered, which may include periodic liver function assessment and hematological status.

When prolonged treatment (> 6 months) or repeated treatments, it is recommended for 6 -month liver ultrasound for patients. When used for a long time, Danazol can poison liver cells, may appear benign or malignant liver cells, but may not show symptoms until complications or exacerbations. The risk of life -threatening due to abdominal bleeding.

start treatment with Danazol during the menstrual cycle. It is advisable to use the non -hormone contraception to be effective.

Lowest dose is effective.

When treated with Danazol, it is necessary to test periodically every 3-4 months on the volume, characteristics of semen, quantity and ability to motivate sperm, especially in young people.

Need to carefully monitor the erection of Danazol's influence on male sex hormones, this effect may not be reduced after stopping the drug. For women, the drug can inhibit ovulation and reduce libido.

Danazol may increase the risk of ovarian cancer in patients with endometriosis. Patients treated with Danazol may appear symptoms of brain tumors, need to be checked regularly, stop the drug immediately if symptoms and transfer to a neurologist for treatment. Denazol treatment should also be cautious in people who have had endocrine - metabolic diseases such as parathyroid failure, people with low calcium levels in the blood.

The ability to drive and operate machinery

Danazol has a significant impact on the ability to drive and operate machinery. However, it is necessary to be cautious.

Pregnancy

Danazol may be harmful to the fetus. The effect of male sex hormones for the fetus causes disorders such as hypertrophy of clitoris, large lips and folds, causing female genitals shaped like scrotum, extraordinary genitals, vaginal development abnormalities that may be available to the fetus if the mother uses Danazol during pregnancy. Also Danazol can cause miscarriage.

Women who are of reproductive age when appointed Danazole need advice on using contraceptives that do not use hormones and warn the risk of harmful to the fetus if pregnant during treatment. If the patient accidentally takes Danazol during pregnancy or pregnancy during the treatment with Danazol, it is necessary to stop the drug and let the mother know about the risk of harmful to the fetus.

Breastfeeding period

because Danazol is in breast milk and has the risk of serious adverse adverse reactions for breastfed babies, so it is necessary to consider or use medication or stop breastfeeding depending on the level of the mother's use of Danazol.

Drug interaction

Diabetes treatment: avoid coordination because Danazol can cause insulin resistance causing diabetes. If it is necessary to coordinate to notify patients and check blood glucose. Adjust the dose of diabetes treatment during and after treatment of Danazol.

Anti -seizure drugs: Danazol can affect carbamazepine plasma concentrations and can both respond to patients with this drug and with phenytoin. The same interaction can occur with phenobarbital.

Oral anticoagulant: Danazol can increase the effect of warfarin.

Anti -hypertension drugs: Due to the ability to cause water, Danazol may fight against the effect of anti -hypertension drugs.

Cyclosporin and Tacrolimus: Danazol can increase the plasma concentrations of cyclosporin and tacrolimus, leading to increased toxicity on the body of these drugs.

Steroids: Although specific cases have not been described, there is a possibility of interactions between Danazol and sexual steroid therapy.

Migraine treatment: Danazol can cause migraine and may reduce the effect of the drug to treat this condition.

ethyl alcohol: Integrated drugs shown by nausea and shortness of breath have been reported.

Alpha Calcidol: Danazol can increase blood calcium response in patients with primary hypothyroidism, need to reduce the dose of this drug.

interact with subclinical tests: Danazol may affect testosterone quantitative tests or plasma proteins.

Statin: The risk of muscle and muscle disease still increases when using simultaneously Danazol with statins metabolized by CYP3A4 such as simvastatin, Atorvastatin and Lovastatin.

Medicinal interaction - Food: Slow food achieves cmax in serum, fat foods increase the concentration of drugs in serum.

Storage

In a dry place, avoid light, the temperature does not exceed 30 ° C.

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