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TAJ PHARMA INDIA / Product / Dupatox™ (Dydrogesterone 10 mg) Tablets
Dupatox Dydrogesterone Taj Pharma
Dupatox Dydrogesterone 10 mg TabletsDupatox Dydrogesterone Taj Pharma Ltd.Dupatox Dydrogesterone Taj Pharmaindex

Dupatox™ (Dydrogesterone 10 mg) Tablets

Generic Name

Dydrogesterone 10 mg


Brand Name

Dupatox™


Dosage Form

Tablets


Strength and Dosage

10 mg


Therapeutic Category

Endometriosis ,Menstrual disorders


Patient Information Leaflet

Summary of Product Characteristics pdfIcon

Product Description


Active Ingredients:
1 tablet contains dydrogesterone (9beta,10alpha-pregna-4,6-diene-3,20-dione) 10 mg.
COMPOSITION
1 tablet contains dydrogesterone 10 mg.

PHARMACOLOGICAL CLASSIFICATION
A. 21.8.2 Progesterones without estrogens


PHARMACOLOGICAL ACTION

Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus.
At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.
Furthermore, Dupatox Dydrogesterone 10 mg Tablets is non-androgenic, non-estrogenic, non-corticoid, non-anabolic and is not excreted as pregnanediol.


INDICATIONS

Irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency.
Combined with an estrogenic substance, Dupatox Dydrogesterone 10 mg Tablets can be applied in secondary amenorrhoea, dysfunctional uterine bleeding and post-menopausal complaints where endogenous progesterone deficiency is implicated.


CONTRA INDICATIONS

Dupatox Dydrogesterone 10 mg Tablets should not be given to patients with undiagnosed vaginal bleeding nor to those with a history of thromboembolic disorders.


DOSAGE AND DIRECTIONS FOR USE

In general
The dosage schemes below are meant as general recommendations. For optimal therapeutic effect, the dosages are to be adapted to the nature and severity of the disorder.
In irregular cycles due to endogenous progesterone deficiency
Dupatox Dydrogesterone 5 to 10 mg is recommended especially in irregular cycles due to shortened luteal phase (ie pre-menopause). Treatment should be repeated for several cycles.
In secondary amenorrhoea
Administration of Dupatox Dydrogesterone in combination with an estrogen is usually recommended as in these conditions endogenous progesterone deficiency is nearly always accompanied by estrogen deficiency. 0,05 mg ethinylestradiol is administered each day from the 1st to the 25th day of the cycle, and 5 mg Dupatox Dydrogesterone is added twice daily from the 11th to the 25th day. Five days after the subsequent withdrawal bleeding, the same is repeated to imitate a natural cycle.
In dysfunctional uterine bleeding
The symptomatic treatment is aimed at stopping the bleeding and including a subsequent withdrawal bleeding.

To stop bleeding:
Dupatox Dydrogesterone 10 mg together with 0,10 mg ethinylestradiol twice daily for 5 to 7 days.

To prevent heavy bleedings:
Dupatox Dydrogesterone 5 mg twice daily from day 11 to day 25 of the cycle, if necessary, combined with an estrogen during the first half of the cycle.

In post-menopausal complaints
If for the symptomatic treatment of post-menopausal complaints estrogens are used (hormone replacement therapy – HRT), Dupatox Dydrogesterone 10 mg is used to counteract the effects of unopposed estrogens on the endometrium. A subsequent withdrawal bleeding is induced.

If on continuous estrogen therapy:
Dupatox Dydrogesterone 10 mg twice daily during the first 12 to 14 days of each calendar month.

If on cyclic estrogen therapy:
Dupatox Dydrogesterone 10 mg twice daily during the last 12 to 14 days of the treatment.


SIDE EFFECTS AND SPECIAL PRECAUTIONS

Side effects of Dupatox Dydrogesterone may include gastro-intestinal disturbances, allergic skin rashes or urticaria, changes in libido, acne, fluid retention, mass gain, mental depression and breast changes, which may include discomfort or gynaecomastia. Alterations in liver function tests have been reported and less frequently jaundice.
In a small percentage of the treated cases, breakthrough bleeding may occur, which can be prevented by increasing the dosage. During the clinical application of Dupatox Dydrogesterone, no virilising side effects were observed.
Dupatox Dydrogesterone should be used with caution in patients with cardiovascular, renal or hepatic impairment, diabetes mellitus, asthma, epilepsy and migraine. It should be used with care in persons with a history of mental depression.


KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See “Side effects and special precautions”. Treatment is symptomatic and supportive.


IDENTIFICATION

Round, flat, white tablets with bevelled edges, one side with an inscription “S”, the other side with “155”on either side of the break mark.


PRESENTATION

Available in packs of 30 tablets.


STORAGE INSTRUCTIONS

Store in a dry, dark place at temperatures not exceeding 25°C. Keep out of reach of children.

Medicines can interact with complementary preparations and vitamins.Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.
The instructions on how you should keep your medicine are on the pharmacy label. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

Specific information on how to look after Dydrogesterone/Estradiol can be found in the Patient Information Leaflet that comes with this medicine or on the medicine label. Alternatively, you can request information about how to look after your medicine from your doctor or pharmacist.

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.


“Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir ,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

Dupatox™ (Dydrogesterone 10 mg) Tablets – TAJ PHARMA INDIA |Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus.

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