Composition:
Cyproterone acetate, Ethinyloestradiol.
Description and Pharmacology:
Diane-35 ED
is a progestogen-/oestrogen combination for the treatment of signs of
andro-genisation in the woman. At the same time, it is a reliable contraceptive
for women who suffer primarily from these signs or in whom acne and similar
conditions occur or deteriorate under the use of other ovulation inhibitors.
Indications:
For the treatment of signs of andro-genisation in women such as severe acne
(involving inflammation or nodularity or risk of scarring) where prolonged oral
antibiotics or local treatment alone has not been successful, or idiopathic
hirsutism of mild to moderate degree. Diane-35 ED will also provide effective
oral contraception in this patient group.
If the hirsutism has only recently appeared or has lately
intensified to a considerable extent the cause (androgen-/producing tumour or
an adrenal enzyme defect) must be clarified by differential diagnosis.
Conta-indications:
applicable to all combined oral contraceptives.
1. Thrombophlebitis, existing or previous thromboembolic
disorders in arteries or veins and states which predispose to such diseases
(e.g. disturbances of the clotting system with a tendency towards thrombosis,
certain heart diseases).
2. A past history of deep-vein thrombophlebitis.
3. Cerebrovascular or coronary artery disease.
4. Known or suspected or previous carcinoma of the breast.
5. Known or suspected or previous oestrogen-/dependent
neoplasia.
6. Undiagnosed abnormal vaginal bleeding, known or suspected
carcinoma of genital organs.
7. Known or suspected pregnancy.
8. Hepatic dysfunction, a history of cholestatic jaundice or
pruritus of pregnancy, Dubin-Johnson or Rotor syndromes.
9. Previous or existing liver tumours.
10. A history of otosclerosis with deterioration during
pregnancy.
11. A history of herpes of pregnancy.
12. Sickle-cell anaemia.
13. Abnormal lipid metabolism.
14. Severe diabetes with vascular changes.
15. Lactation.
Warnings and Precaution:
Please read the original package insert for details!
Adverse Reaction:
applicable to all combined oral contraceptives
An increased incidence of the following serious conditions
has been associated with the use of oral contraceptives (see Warnings) -
thrombo-phlebitis, pulmonary embolism, coronary thrombosis, cerebral thrombosis
and haemorrhage, hypertension, gall bladder disease, congenital anomalies.
Please read the original package insert for more information!
Dosage and Administration:
Therapy should not be initiated unless pregnancy has been excluded.
The first tablet is taken on the first day of a menstrual
period, from the red section of the calendar pack marked with the appropriate
day of the week.
A tablet is then taken daily until the pack is empty.
A new pack is commenced on the very next day, again
selecting the appropriate tablet from the red section.
A bleeding usually occurs whilst tablets are being taken
from the red section of the calendar pack.
The tablet should be swallowed whole, with a little water.
The time of day at which the tablet is taken in immaterial, but once a time has
been chosen, the patient should keep to it every day; for example, after
breakfast or at bed-time.
Pack:
Composition:
Box of 63 tablets with cyproterone acetate 2000mcg and
ethinyloestradiol 35mcg.
LINK:
http://www.asia.diane35.com