Monday, August 31, 2009

Duphaston Tablet

Duphaston
dydrogesterone
20 tablets

Solvay
Pharmaceuticals


COMPOSITION
Each tablet contains; dydrogesterone 10 mg

MODE OF ACTION
Dydrogesterone is an orally-active pcogestogen which produces a complete secretory endometrium in an oestrogen-primed uterus thereby providing protection for estrogen induced increased risk for endometrium hyperplasia and / or carcinogenesis. It is indicated of endogenous progesterone deficiency.
Dydrogesterone has no estrogenic, no androgenic, no thermogenic, no anabolic, and no corticoid activity.

INDICATIONS
  • Infertility due to luteal insufficiency.
  • Threatened abortion which is related to luteal deficiency.
  • Habitual abortion associated with proven progesterone deficiency.
  • Amenorrhoea (secondary)
  • Function uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
  • Endometriosis
  • Dysmenorrnoea (primary) unrelated to an obvious physical cause such as uterine polyps, pelvic inflammatory disease or uterine leiomyomata. Adjunct to oestrogen replacement therapy.

POSOLOGY
Dosage in infertility due to tuteal insufficiency
10 mg dydrogesterone twice daily from the 11th to the 25th day of the cycle. The treatment is to be continued for at least 6 successive cycles, it is advised to continue this treatment during the first few months of a possible pregnancy, at dosages as are recommended for habitual abortion.

Dosage in threatened abortion which is related to luteal deficiency
Intial dose: 40 mg Duphaston at once, followed by 10 mg every 8 hours until symptom cease. Increase the dose by 10 mg every 8 hours when the symptoms recur or do not disappear during treatment. After the symptoms have disappeared, the effective dose should be maintained for 1 week and reduced gradually if the symptom is not recur.

Dosage in habitual abortion associated with proven progesterone deficiency
Treatment should be started as soon as possible, preferably, before conception. 10 mg dydrogesterone twice daily is to be given from the 11th to the 25th day of the cycle with continuous administration after conception. The treatment must be continued at any rate until the 20th week of pregnancy, then the dose can be reduced gradually.

Dosage in amenorrhoea (secondary)
  • An oestrogen once daily from day 1 to 25 of the cycle, and Duphaston 10 mg twice daily from day 11 to 25.
  • In oligomenorrhoea (functional amenorrhoea): 10 mg daily for five days will induce withdrawal bleeding in most patients.
Dosage in abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology [functional bleeding), such as submucous fibroids or uterine cancer
  • To arrest functional bleeding: 10 to 20 mg (1 to 2 tablets) one or two times a day for five to ten days.
  • To prevent further heavy bleeding: 10 to 20 mg (1 to 2 tablets) one or two times a day from the 11th to 25th day of the menstrual cycle and repeated cyclically as needed.
Dosage in endometriosis
10 mg twice daily starting with the 5" day of the menstrual cycle and ending on the 25th day. An alternative regimen is continuous administration.

Dosage In dysmenormoea (primary)
Unrelated to an obvious physical cause such as uterine polyps, pelvic inflammatory disease or uterine leiomyomi.
10 mg twice daily starting with the 5th day of the menstrual cycle and ending on the 25th day.

Adjunct to oestrogen replacement therapy
10 mg daily for 10 to 12 days per month is adequate for most patients.
20 mg daily for 10 to 12 days per month should be used only in the event unacceptable withdrawal bleeding.

OVERDOSAGE
Overdosage may cause nausea and withdrawal bleeding may occur in females. In case of overdoses or accidental ingestion, children should be observed closely although no medication is required. Gastric lavage or syrup of ipecacuanha may be given if deemed necessary. Therapy with Duphaston tablets must be adapted to the specific indications and therapeutic response of the individual patient, all dosage schedules assume the interval between menses to be 28 days.

PRECAUTIONS AND WARNING
Breakthrough bleeding may occur in a few patients. This can, however, be prevented by increasing the dosage. As a general rule, HRT should not be prescribed without a yearly generally physical examination, including a gynaecology examination. A mammogram on regular intervals Is generally advised. Breakthrough bleedings or abnormal findings at the gynaecological examination may be an indication for endometrial assessment.

Although not reported with the use of dydrogesterone, progestogens have been associated with the occurrence of several serious conditions including thromboembolism, stroke, myocardial infarction, hepatic adenoma, gall bladder disease, and hypertension, which have occurred in patients using oral contraceptives containing oestrogens and progestogens. The doctor should therefore be aware of these disorders and the drug should be discontinued immediately they occur or are suspected.

It is known that progestogens may cause some degree of fluid retention. Though this has never been reported for dydrogesterone, patients with epilepsy, migraine, asthma and cardiac or renal dysfunctions should be carefully observed while on therapy as fluid retention may be a factor.
Patients with history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
Any possible influence of prolonged dydrogesterone therapy on pituitary, ovarian, adrenal, hepatic or uterine function awaits further study.
Masculinisation has been observed In patients receiving certain progestogens.
Dydrogesterone is a progestogen, but to date female masculinisation has not been observed with this agent.
The use of progestational agents during the first four months of pregnancy is not recommended.
Detectable amounts of progestogens have been identified in the milk of mothers receiving them. The effect of this on the breastfed infant has not been determined.
Therefore Duphaston are not recommended for women who are breast feeding.

SIDE EFFECTS
  • Breakthrough bleeding may occur. This can, however, be prevented by increasing the dosage.
  • Nausea, breast tenderness, headache, bloated feeling, transient dizziness and skin reaction have occasionally been reported.
  • Menstrual changes, oedema, weight change are common.
  • Other adverse reactions that have been occasionally reported include hair abnormalities, vision changes, depression, confusion, abdominal pain, hepatitis, shortness of breath and slurred speech.
  • Although not reported with the use of dydrogesterone, an increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives containing oestrogens and progestogens: thrombophlebitis, pulmonary embolism, coronary thrombosis, cerebral thrombosis, cerebral haemorrhage, hypertension, gall bladder disease, liver tumors, congenital anomalies.
  • There is evidence of and association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: mesenteric thrombosis, neuro-ocular lesions e.g. retinal thrombosis and optic neuritis.

CONTRAINDICATIONS
Undiagnosed abnormal vaginal bleeding.
Thrombophlebitis or thromboembolic disorders. Cerebrovascular or coronary artery disease, or a past history of these conditions. Missed abortion. Known or suspected carcinoma of the breast. Known or suspected carcinoma of genital organs. Hepatic disease or dysfunction, a history of cholestatic jaundice or pruritus of pregnancy and in Dubin - Johnson syndrome and Rotor syndrome. History of herpes of pregnancy.
Sicklecell anaemia. Benign or malignant liver tumours which developed during the use of oral contraceptives.

STORAGE
Store below 30°C.

PACKING
Boxes of 20 tablets (1 blister of 20 tablets) Reg. No. DKI0681600617A1

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER


Manufactured by:
Solvay Pharmaceuticals B.V., Weesp, The Netherlands

Imported by:
PT. Solvay Pharma Indonesia, Jakarta, Indonesia

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