Duphaston Tablet (Dydrogesterone) 10MG Uses, Dosage, Side Effects

October 5, 2025By pharmacyonlinehere

Duphaston Tablet 10MG Uses Dosage Details

Duphaston Tablet (Dydrogesterone) is an orally very effective and active progestogen medicine. Which produces a complete secretory endometrium in an oestrogen primed uterus thereby. Which provide protection for oestrogen induced increased risk for endometrium hyperplasia And carcinogenesis. Meanwhile, dydrogesterone has no oestrogenic or any androgenic, nor thermogenic, and no anabolic or not any corticoid activity.

Dydrogesterone Duphaston 10MG Tablets

Duphaston Tablet Composition

10 mg tablets contains : Dydrogesterone U. S. P. 10 mg.

Excipient(s) with known effect : 111.1 mg lactose monohydrate

Duphaston Tablet Indication

Hormone Replacement Therapy

Duphaston Tablets Used To counteract the effects of oestrogen on the endometrium in-hormone replacement therapy for women with disorders because of the natural and surgical induced menopause with an intact uterus.

Progesterone deficiencies

Treatment of dysmenorrhoea
Treatment of endometriosis
For the treatment of secondary amenorrhoea
Treatment of irregular cycles
Treatment of dysfunctional uterine bleeding
For the treatment of pre-menstrual syndrome
Treatment of threatened and habitual miscarriage, associated with proven progesterone deficiency
Treatment of infertility due to luteal insufficiency
Luteal support for the part of an Assisted Reproductive Technology (ART) treatment.

Duphaston (Dydrogesterone) Tablet Dosage And Administration

Dosages, treatment schedule and duration of treatment may adapted to the severity of the dysfunction and the clinical response.

Dysmenorrhose:

Duphaston 10MG, or 20 mg during pregnancy first trimester per day from day 5 to day 25 of the menstrual cycle.

Endometriosis:

10MG to 30 mg per day during pregnancy first trimester from day 5 to day 25 of the cycle or continuously.

Dysfunctional Uterine Bleeding:

When treatment is started to arrest a bleeding episode Duphaston 20MG to 30 mg (dydrogesterone) per day is to be given for up to 10 days. For continuous treatment 10 MG to Duphaston 20 mg per day should be given during pregnancy second trimester (the second half of the menstrual cycle). The starting day and the number of treatment days will depend on the individual cycle length.

Withdrawal bleeding occurs if the endometrium has adequately primed with either endogenous or estrogen.

Secondary Amenorrhoea:

10MG or 20 mg per day to be given daily for 14 days (during pregnancy second trimester). On the other hand, the second half of the theoretical menstrual cycle to produce an optimum secretory transformation of an endometrium in the patients.

Pre-Menstrual Syndrome;

10 mg twice daily starting with the second half of the treatment menstrual cycle until the first day of the next cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Irregular Cycles:

10mg or 20 mg per day starting with the second half of the menstrual cycle until next cycle. The starting day and the number of treatment days will depend on the individual cycle length.

Threatened Miscarriage:

An initial dosage of up to 40 mg may be given following by 20mg or 30 mg per day until symptoms remit.

Habitual Miscarriage:

10 mg (dydrongesterone) twice daily until the twelfth week of pregnancy (during pregnancy first trimester).

Infertility Due To Luteal Insufficiency:

10mg or 20 mg daily starting with the (during pregnancy second trimester) second half of the menstrual cycle until the first day of the next cycle. Treatment should be maintained for at least three consecutive cycles.

Luteal Support A Part Of Assisted Reproductive Technology (ART) Treatment

10 mg tab three times a day (30 mg daily ) starting at the day of oocyte retrieval and continuing for 10 week if pregnancy is confirmed.

Hormone Replacement Therapy:

Continuous Sequential Therapy :

An estrogen dosed continuously and one tab of 10 mg is added for the last 14 day of every 28 day cycle, in a sequential manner.

Cyclic Therapy:

When an estrogen dosed cyclically with a treatment free interval, usually 21 days on and 7 days off. Meanwhile, One capsule of 10 mg added for the last 12 to 14 days of estrogen therapy. However, There is no releated use of dydrogesterone before menarche. The safety and efficacy of this medication in adolescents aged 12-18 years has not been established.

Contraindications Of The Medicine

Hypersensitivity to the active ingredients and substance or to any of the excipients.
Known or suspected progestogen dependent neoplasms e.g. meningioma.
Undiagnosed vaginal bleeding.
Treatment for luteal support as part of an Assisted Reproductive Technology (ART) treatment should discontinued upon diagnosis of miscarriage.
If used to prevent endometrial hyperplasia (in women using estrogens). Contraindications for use of oestrogens in combination with progestagens such as this medication

Warnings And Special Precautios Details

Before initiating dydrogesterone treatment for abnormal bleeding the etiology for the bleeding should be clarified. Furthermore, It may also cause Break through bleeding and spotting may occur during the initial first months of treatment. If break through bleeding or spotting appears after some time on therapy, the reason should be investigated. Which may include endometrial biopsy to exclude endometrial malignancy.

Conditions Which Need Supervision

If any of the following conditions are present, have occurred previously, and have been aggravated during pregnancy or previous hormone treatment. The patients should be closely supervised. It should be taken into account that these condition.

Prophyria
Depression
Abnormal liver function values caused by acute or chronic liver disease.

Other Conditions

Patients with rare hereditary problem of galactose intolerance, lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.

For the treatment of postmenopausal symptoms, HRT should only initiated for symptoms that adversely affect quality of life. In all cases a careful appraisal of the risks and benefits should undertaken at least annually and HRT should only continued as long as the benefit out weighs the risk.

Medical Examination/ Following-Up

Before initiation or reinstituting HRT a complete personal and family medical history should taken. Physical including pelvic and examination should be guided by this and by the check ups are recommended of a frequency and nature adapted to the original women. Women should be advised what changes in their feeding place should reported to their doctor or nurse. Investigations including appropriate imaging tools e.g. mammography, should carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Endometrial Hyperplasia

Long term use of oestrogens without additions of progestagens increases the change of endometrial hyperplasia and endometrial carcinoma in women with a uterus. This risk may largely prevented by combining the oestreogen therapy for at least 12 days per cycle with a progestagen such as this product

Feeding Place Cancer

The overall evidence suggests an increase risk of Feeding Place cancer in women taking combined estrogen. And possibly also estrogen only HRT, that dependent on the duration of taking HRT, combination estrogen progestogen therapy: The randomized placebo controlled trial, women health initiative study (WHI). And epidemiological studies consistence in finding an increased risk of cancer in women taking combined estrogen- progestogen for HRT that becomes apparent after about of use 3 years.

The excess risk become apparent within a few years of use but returns to baseline within a few (at most five ) years after stopping treatment. HRT, especially estrogen- progestogen combined treatment, increases the density of mammougraphic images which may adversely affect the detection of cancer.

Ovarian Cancer

Ovarian cancer is much rarer than cancer. Epidemioloogical evidence from a large meta analysis suggests a slightly increased risk in women taking oestrogen only or combined oestreogen progestogen HRT, which become apparent with in 5 years of use and diminishes over time after stopping. Some other studies including the WHI trial suggest that use of combined HRT may associated a similar, or slightly smaller, risk.

Coronary Artery Disease (CAD)

No evidence from randomized controlled of protection against myocardial infarction in with out existing CAD who received combined estrogen-progestogen or estrogen- only HRT.

Combined estrogen-progestogen therapy: The relative risk of CAD during use i=of combined estrogenprogestogen HRT is slightly increased. As the basolute risk of CAD is strongly dependent of age, the umber of extra cases of CAD due to estrogen-progestogen use is very low in healthy women close to menopause, but will risk with more advanced age.

Carebrovascular Accident (CVA)

Combined estrogen progestongen and estrogen only therapy associated with an up to 1.5 fold increase in risk of ischemic stroke. The relative risk dose not change with age or time since menopause. However, as the baseline risk of stroke mainly based on the age, meanwhile, the overall risk of stroke in women who use HRT will increase with age.

Excipients:

This medicinal product contains lactose monohydrate.

Patients with rare hereditary problem of galactose intolerance, the lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.

Drug Interactions Information

In vitro data show that the major metabolic pathway generation the main pharmacologically active metabolits 20a diahydrodydrogeserone(DHD ) catalyzed by aldo keto rductase 1C(AKR 1 C) in human cytosol. Next to the cytosolic metabolism there are metabolic transformatins by cytochome P450 iso-enzymes , nearly exclusively via CYP3A4, resulting in several minor metebolic. The main active metabolitedha DHD is substrate for metabolic tranformation by CYP3A$. Therefore,the metabloism of dydrogesterone and DHD may increased by concomitant use of substance known to induce CYP enzymes such as anticonvulsants (e.g. phenobarbital,phenytoin, carbamazepine) anti-infectives (e.g. rifampicin, phenytoin,efavirenz) and herbal preparations containing e.g. st john’s wort (Hypericum perforatum), valerian root, sage, or gingko biloba. Ritonavir and elfinavir, although know as strong cytochrome enzyme inhibitors, by ci=ontrast exhibit enzyme-inducing properties when used concomitantly with steroid hormoned.

Clinically an increased metabolism of the medicine may lead to a decreased effect. Invitro studies have shown that this medication and DHD do not inhit or induce syp drug metabolizing enzymes at clinically relevant concentrations.

Duphaston Uses During Pregnancy

Estimated that more than 10 million prognancie have exposed to dydrogesterone. So far no indications of a harmful effect shown of this medication during pregnancy.

Some progestogens have reported in this liter of dydrogesterone (Duphaston) use during pregnancy. And some progestogens reported in the literature to be associated with an increased risk of hypospadias. However due to confounding factors during pregnancy, have not shown any increase in risk. Noother epiemiological data hitherto available.

Effects in non-clinical embryo-fetal and post -natal development students in line with the pharmacological profile. Untoward effects occurred considerably, Indicating little relevance to clinical use.

Use During Baby feeding

No data exist on excretion of this medication in mother’s milk. Experience with other progestogens indicates that progestogens and the metabolites pass to mother’s milk in small quantities. Whether a risk to the child not known.Therefore, it should not used during the lactation period.

Fertility

Furthermore, There is no authentic evidence available that can prove it decreases fertility at therapeutic dose.

Effects On Ability To Drive And Use Machines

Dydrogesterone has minor influence on the ability to drive and use machines. Infrequently, it may cause mild somnolence and/or dizziness, especially within the first few hours after intake. Therefore, can should taken when driving or using machines.

Duphaston Side Effects

Like all medicines Duphaston Side Effects also noticed. If you notice any side effects not mentioned here, please inform your doctor or pharmacist. The most commonly reported adverse drug reaction of patients treated with dydrogesterone in clinical trials of indications without estrogen treatment are: migraines/headache, nausea, menstrual disorders and pain/tenderness. The following undesirable effects have observed during clinical trials using this medication (n=3483). In indications without estrogen treatment and from spontaneous reporting:

Side Effects Of Duphaston 10MG Tablets

Lotus I study for luteal support as part of an assisted reproductive technology treatment: The most frequently reported events were: Vaginal hemorrhage, nausea, procedural pain, headache, abdominal, and biochemical pregnancy.

The only related treatment emergent adverse event (TEAE) reported in 2% of subjects in either treatment group vaginal hemorrhage.

Side Effects In Adolescent Population

Based on spontaneous reports and limited clinical trial data. The side effects profile in adolescents expected similar to that seen in adults.

Undesirable Effects That Are Associated With An Estrogen-Progestogen Treatment:

cancer, endometrial hyperplasia, endometrial carcinoma, ovarian cancer
Venous thromboembolism
Myocardial infarction, coronary artery disease, ischemic stroke

Overdosage Symptoms & Treatment

Limited data are available about the Duphaston Medicine overdose use in humans. Dydrogesterone well tolerated after oral dosing. No reports of ill effects from overdose recorded. If a large overdose discovered within two or three hours and treatment seems desirable, gastric lavage recommended. No specific antidotes and treatment should symptomatic.

Medicine Storage Instructions

Store Duphaston medicine below 25 C temperature. Store the medicine in a dry place and protect from moisture and sunlight. Always keep all the medicine out of the reach of the children.

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Duphaston (Dydrogesterone) 10 MG Tablets Price (Rs. 828 PKR) & $ 5 USD In USA

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