Duphaston tabs 10mg #28

Duphaston instruction for use

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Duphaston is a gestagenic drug.

Release form and composition

Dosage form - coated tablets: white, round biconvex with beveled edges and a dividing line on one side, on both sides of the risk there is an engraving "155" (20 pcs. In blisters, 1 blister in a cardboard box).
The active substance is dydrogesterone, in 1 tablet - 10 mg.
Auxiliary components: hypromellose, lactose monohydrate, corn starch, magnesium stearate, colloidal silicon dioxide.
Shell composition: white opadry Y-1-7000 (polyethylene glycol 400, hypromellose, titanium dioxide (E171)).

Pharmacodynamics

Dydrogesterone is a progestogen that is active when taken by mouth. In terms of its molecular structure, pharmacological and chemical properties, it is very close to natural progesterone.
Dydrogesterone does not have the side effects characteristic of most "androgenic" progestogens (synthetic progestogens), since it is not a testosterone derivative. It also lacks androgenic, estrogenic, thermogenic, glucocorticoid and anabolic activity.
Dydrogesterone is used in HRT (hormone replacement therapy) as a progestogenic component that helps maintain the beneficial effect of estrogens on the lipid composition of the blood. At the same time, dydrogesterone does not affect coagulation indices, which distinguishes it from estrogens, which, as a rule, have a negative effect on the blood coagulation system.
The drug does not adversely affect liver function and carbohydrate metabolism.
When taken orally, dydrogesterone selectively affects the lining of the uterus, thereby preventing an increased risk of malignant tumors and / or endometrial hyperplasia with an excess of estrogen.
Duphaston is indicated in all cases of endogenous progesterone deficiency. The drug has no contraceptive effect.
The therapeutic effect of drug treatment is achieved without disturbing menstrual function or suppressing ovulation. The drug makes conception possible and preserves the onset of pregnancy.

Pharmacokinetics

Dydrogesterone is rapidly absorbed from the gastrointestinal tract after oral administration. The maximum plasma concentration is reached after 2 hours. Dydrogesterone is 97% bound to plasma proteins.
Metabolized in the liver. Metabolism is carried out by hydroxylation of ketone groups of the 20th carbon atom, methyl groups of the 21st carbon atom and methyl groups of the 16-α carbon atom (in a small amount).
From 56 to 79% is excreted in the urine. After a day, about 85% of the drug is excreted, and after 72 hours, the process of excretion of Duphaston practically ends.
With limited renal function, there was no delay or enhancement of the action of dydrogesterone. The metabolites of the drug are found in urine mainly in the form of glucuronic acid conjugates. Dydrogesterone is not detected in the urine unchanged.

Indications for use

The use of Duphaston is indicated for women with progesterone deficiency. The characteristic symptoms of progesterone deficiency are:
    Infertility due to luteal insufficiency;
    Endometriosis;
    Miscarriage, threatening or habitual (against the background of progesterone deficiency);
    Secondary amenorrhea (in combination therapy with estrogens);
    Dysfunctional uterine bleeding;
    Premenstrual syndrome;
    Irregular menstruation, dysmenorrhea.
In addition, the drug is used in the form of hormone replacement therapy to neutralize the proliferative effect of estrogens on the endometrium in patients with disorders caused by surgical or natural menopause with an intact uterus.

Contraindications

    Lactase deficiency, galactose and glucose intolerance, malabsorption syndrome;
    Breastfeeding period;
    Hypersensitivity to the components of the drug.
If the patient has a history of pruritus during a previous pregnancy, Duphaston should be used with caution.

Instructions for use of Duphaston: method and dosage

The tablets are taken orally.
A single dose of the drug is 10 mg, the frequency of administration and the period of treatment depend on the clinical indications:
    Endometriosis: 2-3 times a day continuously or from the 5th to the 25th day of the menstrual cycle;
    Infertility due to luteal insufficiency: once a day from the 14th to the 25th day of the cycle, continuous therapy lasts at least 6 subsequent cycles. During the first months of pregnancy, Duphaston continues to be taken according to the scheme recommended for a routine abortion;
    Threatening abortion: once - 40 mg, then 10 mg is taken every 8 hours until the condition stabilizes;
    Habitual miscarriage: 2 times a day until the 20th week of pregnancy, then the dose should be gradually reduced;
    Premenstrual syndrome: 2 times a day from the 11th to the 25th day of the cycle;
    Dysmenorrhea: 2 times a day from the 5th to the 25th day of the cycle;
    Irregular menstruation: 2 times a day from the 11th to the 25th day of the cycle;
    Amenorrhea: in combination with estrogens (they are prescribed once a day from the 1st to the 25th day of the cycle) Duphaston is taken 10 mg 2 times a day from the 11th to the 25th day of the cycle;
    Dysfunctional uterine bleeding: 2 times a day, the course of therapy is 5-7 days;
    Prevention of dysfunctional uterine bleeding: 2 times a day from the 11th to the 25th day of the cycle;
    Hormone replacement therapy: with continuous administration of estrogens, the drug is prescribed 10 mg once a day for 14 days (with a menstrual cycle of 28 days), and with a cyclic scheme of estrogen therapy - during the last 12-14 days of estrogen use. In case of an inadequate response to progestogen therapy, confirmed by ultrasound or biopsy, it is recommended to increase the daily dose to 20 mg.

Side effects

    On the part of the hepatobiliary system: rarely - minor functional disorders of the liver, accompanied by malaise, weakness, sometimes pain in the abdomen or jaundice;
    From the side of the hematopoietic system: in isolated cases - hemolytic anemia;
    From the nervous system: headache, migraine;
    From the immune system: very rarely - hypersensitivity reactions;
    On the part of the skin and subcutaneous tissue: allergic reactions, in the form of itching, rash, urticaria; very rarely - Quincke's edema;
    On the part of the reproductive system: rarely - increased sensitivity of the mammary glands, breakthrough uterine bleeding, which can be prevented by increasing the dose;
    Others: very rarely - peripheral edema.

Overdose

To date, no cases of overdose of Duphaston have been registered. In case of accidental intake of the drug in doses significantly exceeding therapeutic doses, it is recommended to perform gastric lavage.
In case of an overdose, treatment is symptomatic; there is no antidote for dydrogesterone.

Special instructions

In the event of breakthrough bleeding, it is necessary to increase the dose of the drug.
With hormone replacement therapy and other cases of combined administration of Duphaston with estrogen drugs, it is necessary to take into account the contraindications and recommendations associated with their use.
It is recommended to start carrying out hormone replacement therapy only after collecting a complete history; during treatment, individual tolerance should be periodically monitored. The patient should be informed about what symptoms of changes in the mammary glands should be reported to the doctor. Mammography and other tests are performed in accordance with generally accepted screening for patients.
An accurate assessment of the benefits and risks of hormone replacement therapy can be determined over time.
In the event of breakthrough uterine bleeding during or after a course of therapy, an endometrial biopsy should be performed to exclude malignant neoplasms.
If the patient's history has indications of the presence of a progesterone-dependent tumor (for example, meningioma), as well as in case of its progression during previous hormone therapy or during pregnancy, Duphaston should be used after a thorough examination.
The drug does not affect the ability to drive vehicles and mechanisms.

The use of Duphaston during pregnancy and lactation

According to the instructions, Duphaston is used during pregnancy according to indications.
Since dydrogesterone can be excreted in breast milk, it is recommended to stop breastfeeding if drug treatment is necessary.

Childhood use

The drug is not used in pediatric practice.
The drug can be prescribed to girls in adolescence with menstrual irregularities (the appropriateness of the use of dydrogesterone and the dosage is determined by the doctor).

With impaired renal function

Dydrogesterone is prescribed with caution to patients with impaired renal function.

For violations of liver function

In severe liver diseases, the use of the drug is contraindicated. For mild and moderate liver dysfunctions, Duphaston is used with caution.

Drug interactions

Simultaneous use with rifampicin, phenobarbital and other inducers of microsomal liver enzymes can accelerate the metabolic processes of dydrogesterone and reduce the effectiveness of the drug.
Clinically significant cases of incompatibility of Duphaston with other drugs have not been established.

Terms and conditions of storage

Store in its original packaging in a dry place at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 5 years.

Reviews about Duphaston

According to reviews, Duphaston increases the likelihood of conception (with the correct diagnosis and adherence to the treatment regimen), significantly alleviates the symptoms that appear during menopause, and is effective for endometriosis, ovarian cysts and polycystic ovaries.
After the course of treatment, the menstrual cycle stabilizes in most patients. There is also evidence of the effectiveness of the drug in uterine fibroids.
Among the adverse reactions described by women who took Duphaston, the most common were nausea, abdominal pain, loose stools, general weakness and weight gain. However, despite the unwanted side effects, positive reviews of the drug are more common.

Terms of sell

You can buy Duphaston without a prescription.