Contraception and Treatment of Severe Acne and Idiopathic Hirsutism with Diane-35

What is Hirsutism?

Hirsutism in women causes a male pattern of body hair, sometimes excessive, particularly in locations where women normally do not develop terminal hair during puberty (chest, abdomen, back and face). Hirsutism can be caused by either an increased level of androgens, the male hormones, or an oversensitivity of hair follicles to androgens. Another common cause of hirsutism is polycystic ovarian syndrome (PCOS).
The top symptom of hirsutism is hair growth on the abdomen, breasts, and upper lip (male-pattern hair growth in women). If hirsutism is caused by high levels of male hormones, symptoms can also include Irregular menstrual periods, Acne, Loss of feminine body shape and Signs of masculinity such as deepening voice, male pattern baldness, enlarged clitoris and enlarged shoulder muscles.
A common pharmacological treatment is Cyproterone acetate, a progestin that also has strong antiandrogenic action. In addition to single form, it is also available in some formulations of combined oral contraceptives like Diane-35 .

Diane-35 Tablets – Product Information

Diane-35 tablets manufactured by Bayer Schering Pharma is used as a oral contraceptive as well for the the treatment of signs of androgenisation 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 (excess hair on the face, chest, abdomen or legs), of mild to moderate degree.
The most important factors that cause the contraceptive effect of Diane-35 are the inhibition of ovulation and the changes in the cervical secretion.
Treatment with Diane-35 for 3 to 4 months leads to the healing of existing acne efflorescences. The excessive greasiness of the hair and skin generally disappears earlier. The loss of hair which frequently accompanies seborrhoea likewise diminishes. In women experiencing mild forms of hirsutism and in particular, slightly increased facial hair, results do not, however become apparent until after several months of use.

Diane-35 Tablets - Contraindications

Diane-35 is contraindicated in patients with

• Hypersensitivity to the active ingredients cyproterone acetate and/or ethinyl estradiol or to any of the other components of the medicine.
• Personal or family history of confirmed, idiopathic venous thromboembolism (VTE)(where a family history refers to VTE in a sibling or parent at a relatively early age).
• Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
• Sickle-cell anaemia
• Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).
• Presence of severe or multiple risk factor(s) for venous or arterial thrombosis
• History of migraine with focal neurological symptoms.
• Diabetes mellitus with vascular involvement.
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.Severe hepatic disease as long as liver function values have not returned to normal.Jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome
• History of deterioration of otosclerosis during pregnanacy.
• Presence or history of liver tumors (benign or malignant).
• Known or suspected sex steroid influenced malignancies (e.g. of the genital organs or the breasts).
• Undiagnosed vaginal bleeding.
• Known or suspected pregnancy.
• Lactation.
• Disorders of lipid metabolism
• History of herpes gestationis

Diane-35 Tablets - Dosage

The recommended adult Oral dosage of Diane-35 Tablets is one tablet is to be taken daily. The tablets must be taken at about the same time every day, with some liquid as needed. Tablet taking should be continuous. One tablet of Diane-35 is to be taken daily for 21 consecutive days. Withdrawal bleeding should usually occur on day 2 to 3 after the last tablet is taken. Each subsequent pack is started after a 7 day tablet free interval.
How to start Diane-35 Tablets:
Tablet taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Starting on day 2 -5 of the menstrual cycle is permitted, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking. When you have taken all 21 tablets in this pack, wait 7 days and then start a new pack of Diane-35. During the 7 days that you are not taking any tablets, you should have your period, usually 2-4 days after you have taken your last tablet.
The first tablet in every subsequent pack will always be taken on the same day of the week that you first began taking Diane-35 tablets regardless of whether your bleeding has already ceased (which it usually has) or is still continuing.

Diane-35 Tablets - Missed Dose Instructions

The management of missed tablets can be guided by the following two basic rules: Tablet-taking must never be discontinued for more than 7 days; and 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian axis.
If the user is less than 12 hours late in taking a tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
Week 1: The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tabs at the same time. She then continues to take tablets at her usual time. In addition, a barrier method eg, a condom, should be used for the next 7 days.
Week 2: The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tabs at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the 1st missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case or if she missed more than one tablet, the woman should be advised to use extra precautions for 7 days.
Week 3: The risk of reduced reliability is imminent because of the forthcoming tablet-free interval. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following 2 options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet, the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the first of these 2 options and to use extra precautions for the next 7 days as well.
The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take tablets at her usual time. The next pack must be started as soon as the current pack is finished i.e., no gap should be left between packs. The user is unlikely to have a withdrawal bleed until the end of the second pack, but she may experience spotting or breakthrough bleeding on tablet-taking days.

Side Effects of Diane-35 Tablets

The most common side effects (1% or more) reported in patients treated with Diane-35 Tablets are nausea, abdominal pain, weight increased, headache,depressed mood, mood altered, breast pain, breast tenderness. The uncommon side effects (Occuring in 1 per thousand or more and less than 1 in 100) are vomiting, diarrhea, fluid retention, migrane, libido decreased, breast hypertrophy, Rash, and urticaria. The rare side effects include contact lens intolerance, hypersensitivity, weight decreased, libido increased, vaginal discharge, breast discharge, Erythema nodosum and erythema multiforme.

Diane-35 - More Details

For more details please watch the presentation below:

Diane-35 for Contraception and Treatment of Severe Acne and Idiopathic Hirsutism