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dupatox tablets- dydrogesterone
 
dupatox tablets- dydrogesterone
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dupatox tablets- dydrogesterone

     
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Dydrogesterone 10 mg Tablets

(Dupatox Leaflet)      

Dupatox ® Tablets
Dydrogesterone 10 mg Tablets

FOR INDIAN MARKET:
Dydrogesterone Tablets IP
Each uncoated tablet contains: Dydrogesterone IP 10 mg
Excipients ......................Q.S.

FOR EXPORT MARKET:
Dydrogesterone Tablets BP / USP
Each uncoated tablet contains: Dydrogesterone BP / USP 10 mg
Excipients ......................Q.S.

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

Dydrogesterone 10 mg Tablets dydrogesterone (9beta,10alpha-pregna-4,6-diene-3,20-dione) 10 mg
 

Dupatox Dydrogesterone 10 mg Tablets

DUPATOX TABLETS 10MG CONTAIN DYDROGESTERONE, A SYNTHETIC PROGESTERONE, USED TO TREAT A VARIETY OF CONDITIONS RESULTING FROM A LACK OF ENDOGENOUS (NATURALLY PRODUCED) PROGESTERONE, INCLUDING MENSTRUAL DISORDERS AND ENDOMETRIOSIS, AND FOR HORMONE REPLACEMENT THERAPY (HRT) AND TRANSGENDER HORMONE THERAPY.

Dupatox tablets 10mg are used to Treat Several Conditions That Are The Result Of A Lack Of Progesterone Including Menstrual Disorders Like, Secondary Amenorrhoea (Menstrual Periods That Have Stopped, Are Absent Or Irregular), dysmenorrhoea or painful periods, premenstrual syndrome and abnormal uterine bleeding, which occurs during the menstrual cycle instead of at the end. Dupatox tablets 10mg are also used to treat endometriosis (growth of endometrial tissue outside the uterus causing pain and bleeding), infertility and spontaneous abortion (miscarriage); and are to counteract the stimulating effect of oestrogen on the endometrium, therefore reducing the risk of endometrial cancer, which can develop in response to oestrogen in women taking hormone replacement therapy (HRT) for menopausal symptoms. Adding a progestogen with an oestrogen is thought to help the feminisation process for male to female transsexuals and Dupatox 10 is used as a component of transgender hormone therapy, to help stimulate breast development and reduce the production of testosterone.

Treating endometriosis with Dupatox
Dupatox tablets 10mg contain dydrogesterone, a synthetic derivative of the female sex hormone progesterone, which means that its chemical structure closely resembles that of naturally produced progesterone and it therefore works in a similar way. During a normal menstrual cycle, progesterone (produced by the ovaries) acts on the endometrium and causes it to stop growing and start secreting hormones and other proteins needed to maintain a pregnancy, if conception occurs. If not, levels of oestrogen and progesterone fall and the endometrium is shed (menstruation). Endometriosis is the growth of endometrial tissue outside the uterus which behaves in the same way as uterine endometrium, including its response to progesterone. Dupatox 10 acts on the endometrium in all its locations to stop it growing, which alleviates symptoms of endometriosis including pain and bleeding.

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.

Dupatox Dydrogesterone Manufacturer

Dupatox Dydrogesterone Tablets

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.

Dupatox Dydrogesterone Taj Pharma Ltd.

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.

How should Dupatox be stored?
You should keep your Dupatox tablets 10mg in the blister pack until use.
Store in a cool dry place below 30°C.


Dydrogesterone is an orally active progestogen

dupatox tablets- dydrogesterone

 
     
For more information, please see Full Prescribing Information.

dupatox tablets- dydrogesterone


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)

 




Dydrogesterone 10 mg Tablets

 

 

              
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TREATING MENSTRUAL PROBLEMS WITH DUPATOX
DUPATOX TABLETS 10MG CONTAIN DYDROGESTERONE, A SYNTHETIC DERIVATIVE OF THE FEMALE SEX HORMONE PROGESTERONE, WHICH MEANS THAT ITS CHEMICAL STRUCTURE CLOSELY RESEMBLES THAT OF NATURALLY PRODUCED PROGESTERONE AND IT THEREFORE WORKS IN A SIMILAR WAY. A NORMAL MENSTRUAL CYCLE IS DEPENDENT ON THE INTERACTION OF SEVERAL HORMONES, INCLUDING OESTROGEN AND PROGESTERONE PRODUCED BY THE OVARIES AS WELL OTHER REGULATING HORMONES PRODUCED BY THE PITUITARY GLAND. IF ANY OF THESE HORMONES ARE NOT PRODUCED IN THE CORRECT AMOUNTS THIS CAN DISRUPT THE CYCLE AND CAUSE PROBLEMS LIKE AMENORRHOEA (MENSTRUAL PERIODS THAT HAVE STOPPED, ARE ABSENT OR IRREGULAR) AND ABNORMAL UTERINE BLEEDING DURING THE MENSTRUAL CYCLE INSTEAD OF AT THE END. DUPATOX 10 CAN RE-ESTABLISH A REGULAR MENSTRUAL CYCLE BY HELPING TO RESTORE NATURAL HORMONE LEVELS.
DUPATOX FOR HORMONE REPLACEMENT THERAPY (HRT)
DUPATOX TABLETS 10MG CONTAIN DYDROGESTERONE,
A SYNTHETIC DERIVATIVE OF THE FEMALE SEX HORMONE PROGESTERONE, WHICH MEANS THAT ITS CHEMICAL STRUCTURE CLOSELY RESEMBLES THAT OF NATURALLY PRODUCED PROGESTERONE AND IT THEREFORE WORKS IN A SIMILAR WAY. TAKING OESTROGEN FOR HORMONE REPLACEMENT THERAPY (HRT) HELPS REDUCE SYMPTOMS OF MENOPAUSE CAUSED BY OESTROGEN DEFICIENCY, INCLUDING, HOT FLUSHES, NIGHT SWEATS, SLEEPLESSNESS, VAGINAL DRYNESS, HEADACHES, MOOD SWINGS, LACK OF CONCENTRATION AND LOSS OF ENERGY. OESTROGEN ALSO HAS SEVERAL OTHER BENEFICIAL ACTIONS IN VARIOUS METABOLIC PROCESSES INCLUDING BONE TURNOVER AND LIPID (FAT) METABOLISM, BUT ITS EFFECT OF THICKENING THE ENDOMETRIUM (UTERINE LINING), IN THE ABSENCE OF PROGESTERONE, WHICH INHIBITS ENDOMETRIAL GROWTH, CAN LEAD TO ENDOMETRIAL (UTERINE) CANCER IN SOME MENOPAUSAL WOMEN TAKING OESTROGEN ONLY HRT. DUPATOX 10 COUNTERACTS THE STIMULATING EFFECT OF OESTROGEN ON THE ENDOMETRIUM, REDUCING THE RISK OF ENDOMETRIAL CANCER, WHICH CAN DEVELOP IN RESPONSE TO AN OESTROGEN, IN WOMEN TAKING HRT FOR MENOPAUSAL SYMPTOMS.

DUPATOX FOR TRANSGENDER TREATMENT
DUPATOX TABLETS 10MG CONTAIN DYDROGESTERONE, A SYNTHETIC DERIVATIVE OF THE FEMALE SEX HORMONE PROGESTERONE, WHICH MEANS THAT ITS CHEMICAL STRUCTURE CLOSELY RESEMBLES THAT OF NATURALLY PRODUCED PROGESTERONE AND IT THEREFORE WORKS IN A SIMILAR WAY. ADDING A PROGESTOGEN WITH AN OESTROGEN IS THOUGHT TO HELP THE FEMINISATION PROCESS FOR MALE TO FEMALE TRANSSEXUALS AND DUPATOX 10MG TABLETS ARE USED AS A COMPONENT OF TRANSGENDER HORMONE THERAPY, TO HELP STIMULATE THE DEVELOPMENT OF FEMALE SEXUAL CHARACTERISTICS, SUCH AS BREAST DEVELOPMENT, AND REDUCE THE PRODUCTION OF TESTOSTERONE.

DUPATOX FOR FEMINISING HORMONE THERAPY
DUPATOX TABLETS 10MG ARE USED AS A PROGESTOGEN COMPONENT OF TRANSGENDER HORMONE THERAPY ALONG WITH THE FEMINISING HORMONE OESTROGEN, TO HELP STIMULATE THE DEVELOPMENT OF FEMALE SEXUAL CHARACTERISTICS, SUCH AS BREAST DEVELOPMENT, AND REDUCE THE PRODUCTION OF TESTOSTERONE.

WHAT ARE THE SIDE EFFECTS OF DUPATOX?
THE MOST FREQUENTLY REPORTED SIDE EFFECTS WHEN TAKING DUPATOX TABLETS 10MG, INCLUDE: NAUSEA, BLOATING, BREAST PAIN, IRREGULAR BLEEDING, DIZZINESS, WEIGHT GAIN, SKIN RASH AND ITCH.

WHEN SHOULD DUPATOX NOT BE USED?
YOU SHOULD NOT USE DUPATOX TABLETS 10MG IF YOU:
• ARE ALLERGIC TO DYDROGESTERONE OR ANY OTHER INGREDIENT IN DUPATOX 10
• ARE PREGNANT OR PLANNING TO BECOME PREGNANT, WITHOUT DISCUSSION WITH YOUR DOCTOR
• HAVE A PAST OR FAMILY HISTORY OF CARCINOMA OF THE BREAST, ENDOMETRIAL CARCINOMA OR LIVER DISEASE
• A HISTORY OF THROMBOSIS (BLOOD CLOTS) OR STROKE
• ABNORMAL GENITAL BLEEDING OF UNKNOWN CAUSE
HOW SHOULD DUPATOX BE TAKEN?
YOU SHOULD TAKE DUPATOX TABLETS 10MG, WITH A GLASS OF WATER, WITH OR WITHOUT FOOD, ONCE OR TWICE DAILY. THE DOSE OF DUPATOX 10 YOU TAKE, HOW OFTEN YOUR TAKE IT AND FOR HOW LONG DEPENDS ON WHAT YOU ARE BEING TREATED FOR. YOU SHOULD CONTINUE TO TAKE YOUR TABLETS FOR AS LONG AS YOUR DOCTOR RECOMMENDS, WHICH MAY BE FOR 5 DAYS, OR TAKEN CONTINUALLY FOR SEVERAL DAYS A MONTH AND REPEATED EACH MENSTRUAL CYCLE FOR SEVERAL MONTHS, AS NEEDED; OR TAKEN CONTINUOUSLY.

HOW LONG SHOULD YOU TAKE DUPATOX?
YOU SHOULD CONTINUE TO TAKE YOUR DUPATOX TABLETS 10MG FOR AS LONG AS YOUR DOCTOR RECOMMENDS, WHICH MAY BE FOR 5 DAYS, OR TAKEN CONTINUALLY FOR SEVERAL DAYS A MONTH AND REPEATED EACH MENSTRUAL CYCLE FOR SEVERAL MONTHS, AS NEEDED; OR TAKEN CONTINUOUSLY.

MISSED DOSE OF DUPATOX
IF YOU MISS A DOSE OF DUPATOX DUPATOX TABLETS 10MG TAKE IT AS SOON AS YOU REMEMBER, UNLESS IT IS TIME TO TAKE THE NEXT DOSE, THEN SKIP THE MISSED DOSE. DO NOT TAKE A DOUBLE DOSE.
 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 


 

 

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Dupatox® Tablets - Dydrogesterone 10 mg TabletsDydrogesterone 10 mg Tablets - Dydrogesterone 10 mg Tablets

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