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Dupatox Dydrogesterone 10 mg Tablets
 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
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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.
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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.
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To stop bleeding:
Dupatox Dydrogesterone 10 mg together with 0,10 mg
ethinylestradiol twice daily for 5 to 7 days. |
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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.
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If on continuous estrogen therapy:
Dupatox Dydrogesterone 10 mg twice daily during the first 12
to 14 days of each calendar month. |
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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.
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