Duphaston Abbott regulates menstruation, endometriosis (1 blister x 20 tablets)

Dosage form Box of 1 blister x 20 tablets
Specifications Dydrogesterone
Ingredient Abbott

Ingredient

Composition information	Content
Dydrogesterone	10mg

Uses

indications

Dupaston 10mg drug is indicated in the following cases:

Treatment in the case: regulating menstruation, endometriosis, dysmenorrhea, dysmenorrhea due to royal impairment, assistance in reproductive assistance (Art), threatening abortion due to progesterone deficiency, consecutive miscarriage due to progesterone deficiency.

As a cycle of supplements in the estrogen therapy in the uterus is intact, Duphaston is used in:

Prevent endometrial hyperplasia in the postmenopausal period.

for abnormal uterine bleeding. It helps protect against the risk of endometrial hyperplasher and/or endometrial cancer caused by estrogen.

dydrogesterone does not cause female or masculine effects, does not cause assimilation and does not have corticosteroid activity. Dydrogesterone does not inhibit ovulation. Therefore, dydrogesterone can be used for women of reproductive age.

In postmenopausal women with uterine, alternative estrogen leads to an increased risk of endometrial hyperplasia and endometrial cancer. Supplement progestogen to prevent this risk.

Pharmacokinetics

absorption

After drinking, Dydrogesterone is quickly absorbed with TMAX from 0.5 to 2.5 hours. The full bioavailability of dydrogesterone (oral at the dose of 20 mg compared to 7.8 mg intravenously) is 28%.

Distribution

After injection, the distribution of Dydrogesterone reaches approximately 1400L. Over 90% of dydrogesterone and DHD are linked to plasma proteins.

Metabolism

After drinking, Dydrogesterone is rapidly converted into DHD, the main transformation line creates DHD is catalyst in the cytoplasm by Aldo-Keto Reductase 1C (AKR IC).

Metabolism in this cytoplasm is metabolized by cytochrom P450 (CYPS), mainly CYP 3A4, which creates less important metabolites. The main metabolites DHD peaked about 1.5 hours after use. DHD's plasma concentrations are basically higher than the original drug. The ratio of the area below the AUC and CMAX curves of DHD compared to Dydrogesterone in the order is 40 and 25.

The average selling time of dydrogesterone and DHD varies from 5 to 7 and from 14 to 17 hours. One common feature of all metabolites is the retention of 4.6-diene-2-one structure of the mother and the absence of 17A-Hydroxylation. This explains the lack of female chemistry or maleization of dydrogesterone.

Elimination

After taking Dydrogesterone marked, an average of 63% of the dose is eliminated into the urine. The total plasma clearance is 6.4 l/min. Completely eliminated within 72 hours. DHD appears in urine mainly in the form of links with glucuronic acid.

Before taking Duphaston Abbott regulates menstruation, endometriosis (1 blister x 20 tablets)

How to use

The adjustment dose to suit the severity of the disorder and response of each patient with therapy. Take oral. Higher doses should use tablets to spread evenly during the day.

Dosage

Air conditioner menstrual cycle:

can achieve a 28 -day cycle by taking 1 dupaston daily on the 11th to the 25th day of the cycle.

Endometriosis:

1 to 3 Duphaston tablets per day from Thursday to the 25th day of the cycle or for the whole cycle. The dose of 10mg should be taken evenly during the day. Recommendation to start treatment with the highest dose.

Dysmenorrhea:

1 to 2 Duphaston pills per day from Thursday to the 25th day of the cycle. The dose of 10 mg should be taken evenly during the day. Recommendation to start treatment with the highest dose.

Infertility due to impairment:

1 Duphaston tablet daily from the 14th to the 25th day of the cycle. Therapy should be maintained for at least 6 consecutive cycles. This therapy should be continued in the first months of pregnancy in the dosage as prescribed for consecutive miscarriage.

Support for reproductive assistance (Art):

1 Duphaston three times a day (30 mg daily) starts from the date of the ovary and continues to use for 10 weeks if you are sure.

threatening miscarriage:

Starting dose: 4 Duphaston for the first time and 1 Duphaston 10mg for every 8 hours. The dose of 10 mg should be taken evenly during the day. Recommendations should start treatment with the highest dose. If the symptoms are still or recurrent during treatment, an additional dose of 1 dupaston should be increased every 8 hours. Effective doses should be maintained for 1 week after the symptoms are terminated; Can reduce the dose gradually. If the symptoms return, treatment should continue immediately with effective doses.

Consecutive miscarriage:

1 Duphaston tablet per day to the 20th week of pregnancy; Can reduce the dose gradually. The best therapy should be started before conception. If the symptoms of miscarriage appear during treatment, continue the therapy as described for that indication.

Abnormal uterine hemorrhage:

Take 2 Duphaston tablets a day for 5 to 7 days, to stop bleeding. Bleeding is significantly reduced within a few days. A few days after the end of treatment, there may be bleeding so patients need to be warned about this.

can prevent this bleeding by prescribing a dupaste -daily prophylactic dose daily from the 11th to the 25th day of the cycle, if needed in combination with the estrogen for 2 to 3 cycles. After that, it is possible to stop treating, it is necessary to check the patient's cycle for sure.

Secondary amenorrhea:

1 or 2 Duphaston tablets per day from 11 to the 25th day of the cycle to optimize the metabolism of endometrium, so that the uterus is provided just enough endogenous and external estrogen.

Prevention of endometriosis during menopause:

For each 28 -day cycle, the therapy only used for estrogen is used for the first 14 days and in the next 14 days, in addition to the estrogen, it is necessary to add 1 or 2 dydrogesterone 10mg tablets. With 2 tablets, the drug is divided evenly during the day (1 tablet x 2 times/day) when using Dydrogesterone 10mg. Bleeding often occurs during dydrogesterone.

Oestrogen/progesterone combination treatment for postmenopausal women should take the lowest doses effectively and in the shortest time to achieve treatment goals and minimize the risk for each individual and need periodic re -evaluation.

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?

Symptoms of overdose:

Dydrogesterone is a very low toxic substance that can cause nausea, vomiting, drowsiness and dizziness. There is no case of dydrogesterone overdose that causes harmful effects.

Treatment:

unnecessary treatment, in case of overdose should consider symptomatic treatment.

What to do when forgetting 1 dose?

Not recorded.

Side Effects

When using Duphaston, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Nervous disorders: migraine, headache.

Gastrointestinal disorders: Nausea.

Reproductive and breast disorders: Menstrual disorders (including: uterine bleeding, menstrual bleeding, menstruation, irregular menstruation and irregular menstruation), breast pain/sensitivity.

Uncommon, 1/1000

Mental disorders: depression.

Nervous disorders: dizziness.

Gastrointestinal disorders: vomiting.

Liver disorders: abnormalities of liver function (jaundice, fatigue, itching, hypersensitivity).

Rare, 1/10000≤ ADR

Disorders of blood system and lymphatic system: hemolytic anemia.

immune system disorders: hypersensitivity.

Skin and subcutaneous disorders: Fedengers.

Breeding and breast disorders: Breast tightness.

Common disorders and disorders at the place of use: edema.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Duphaston 10mg drug is contraindicated in the following cases:

Vaginal hemorrhage is unknown.

Support for reproductive support (Art) should be stopped after diagnosis of miscarriage or abortion.

Severe liver disorders, or a serious history of liver disorders until the liver function returns to normal.

Contraindicated use of estrogen in combination with progestogen such as dydrogesterone in combined therapy.

allergies to dydrogesterone or any excipient capture.

Known or suspected to have malignant cancer caused by hormones.

Be cautious when using

Before starting Dydrogesterone treatment for abnormal uterine hemorrhage, it is necessary to clarify the cause of the pathology of bleeding.

Abnormal uterine hemorrhage and mild hemorrhage can occur in the first months of treatment. If abnormal uterine hemorrhage and mild bleeding appear a few times during treatment or continue to appear after stopping the treatment, it is recommended to find out the cause, which may include a biopsy to eliminate endometriums.

If one of the following disorders appears in the first use or worse, should consider stopping treatment:

Severe headache, migraine or symptoms of ischemia.

Signs of hypertension.

venous thrombosis.

In case of consecutive miscarriage or threatening miscarriage, it is necessary to determine the ability to live the fetus and need to monitor the development and life of the fetus during the treatment process.

Need to monitor in the case: Patients with a history of depression should be carefully monitored, if serious depression occurs, it is necessary to stop treating with dydrogesterone.

For the treatment of postmenopausal symptoms, hormone replacement treatment (HRT) should only be started if the symptoms affect the quality of life. In all cases, the careful assessment of risks and benefits should be done at least every year and should only continue treatment as long as the benefits are superior to the risk.

Endometrial hypertrophy and carcinoma when using just and not supplementing progestogen for a long time. Depending on the treatment process and the estrogen dose, the risk may be 2 to 12 times higher than those who do not use the estrogen. After stopping treatment with the risk estrogen, the risk continues to exist for at least 10 years. Additional risks can be prevented by coordinating estrogen with a progestogen such as Dydrogesterone for at least 12 days per month/28 -day cycle.

Abnormal bleeding and mild bleeding may occur in the first months of treatment.

The risk of breast cancer depends on the time of treatment, increasing the risk of breast cancer in women using HRT combining estrogen-Progestogen becomes clear after about 3 years or longer.

Ovarian cancer is rarer than breast cancer, the risk of slight increase within 5 years and decreases after stopping.

venous thrombosis:

Hormonal replacement therapy is increased by 1.3-3 times the risk of static thrombosis (VTE), patients with thrombosis will increase the risk of VTE and HRT progression may increase this risk. Risk factors for VTE include the use of estrogen, elderly, large surgery, long -term immobility, obesity (BMI> 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE) and cancer. If VTE progresses after the therapy is used, the drug should be stopped. Patients should be advised that contacting the doctor immediately stated they found the potential thrombus symptoms.

Stroke (CVA):

Using combined HRT or HRT only estrogen is related to an increase of 1 to 1.5 times the risk of cerebral vascular accident (CVA). However, the risk of CVA depends strongly on age and overall risk of mutations in women using HRT will increase with age.

The ability to drive and operate machinery

dydrogesterone has a small impact on the ability to drive and operate machinery. Rarely, dydrogesterone can cause slight drowsiness and/ or dizziness, especially within the first few hours after drinking. Therefore, be careful while driving or operating machinery.

pregnancy

so far there is no case that shows the harmful effects of dydrogesterone during pregnancy. Dydrogesterone can be used during pregnancy if indicated clearly.

The period of breastfeeding. No research has been conducted to study the excretion of dydrogesterone into breast milk.

Experience with other progestogen indicates that progestogen and its passing substances penetrate into breast milk in small amounts. It has not yet been determined at risk for children whether or not. Dydrogesterone should not be used during breastfeeding.

Drug interaction

substances that increase the excretion of progestogen (reduced enzyme efficiency) such as: Barbiturat, Phenytoin, Carbamazepin, Primidon, Rifampicin and HIV anti -HIV drugs such as Ritonavir, Neviparin and Efavirenz.

Progestogen alternating substances: HIV protease inhibitors, HCV inhibitors.

Slow agents of progestogen (enzyme inhibitors): CYP3A4 strong inhibitors.

Storage

Do not store over 30 ° C.

Store drugs in carton boxes to avoid moisture.

To be out of reach of children and vision of children.

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