INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DUPHASTON 10 mg TABLETS

Solvay
Pharmaceuticals

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DUPHASTON 10 mg TABLETS

COMPOSITION
1 tablet contains dydrogesterone (9beta,10alpha-pregna-4,6-diene-3,20-dione) 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, Duphaston 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, Duphaston can be applied in secondary amenorrhoea, dysfunctional uterine bleeding and post-menopausal complaints where endogenous progesterone deficiency is implicated.

CONTRA-INDICATIONS
Duphaston 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
Duphaston 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 Duphaston 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 Duphaston 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: Duphaston 10 mg together with 0,10 mg ethinylestradiol twice daily for 5 to 7 days.
-	To prevent heavy bleedings: Duphaston 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), Duphaston 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: Duphaston 10 mg twice daily during the first 12 to 14 days of each calendar month.
-	If on cyclic estrogen therapy: Duphaston 10 mg twice daily during the last 12 to 14 days of the treatment.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects of Duphaston 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 Duphaston, no virilising side effects were observed.
Duphaston 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.

REGISTRATION NUMBER
S/21.8.2/165

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/09072/07)
106 Sixteenth Road
Randjespark
Midrand 1685
P O Box 5278
Halfway House 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 January 1993

Solvay Pharmaceuticals BV Weesp The Netherlands
Applicant:
SCHERING (PTY) LTD
(Reg No: 1964/09072/07)

Updated on this site: December 2000
Current: April 2005
Source: Community Pharmacy
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