The estrogen (ethinyl estradiol) intensifies the central and peripheric effects on ovulation, the viscosity of cervical mucus providing contraception. Antiandrogen attaches itself to androgenic receptors of androgen-dependent muscles (sebaceous glands, follicles, hair follicles) and reduces seborrhea, hirsutism and other. Because of its progestagens properties, depresses pituitary gonadotropin function and ovulation (contraceptive effect).

Thrombophlebitis, thromboembolic disorders, or a history of these conditions; cerebrovascular disorders; myocardial infarction or coronary artery disease; active liver disease or hepatic adenomas or carcinomas; history of cholestatic jaundice; known or suspected carcinoma of the breast; known or suspected estrogen-dependent neoplasia; undiagnosed abnormal vaginal bleeding; any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; when pregnancy is suspected or diagnosed; previous or existing liver tumors; severe diabetes with vascular changes; a history of sclerosis with deterioration during pregnancy.

Androgen-dependent diseases caused by an increased production of androgens (seborrhea, acne papulosa, acne pustulosa, papulonodular eruption, androgenic alopecia, hirsutism), hormonal contraception of women with signs of virilism.

The following drugs may reduce efficacy of Diane-35 and increase incidence of breakthrough bleeding: ampicillin, analgesics, antihistamines, antimigraine preparations, chloramphenicol, griseofulvin, isoniazid, neomycin, nitrofurantoin, penicillin V, phenylbutazone, sulfonamides and tetracycline, anticoagulants with estrogen/progestogen combinations, carbamazepine, phenobarbital, phenytoin, primidone and rifampin.

The patient is instructed to take 1 tablet daily (at the same time each day) for 21 consecutive days beginning on day 1 of her menstrual cycle. The tablets are then discontinued for 7 days (1 week). The patient begins her next and all subsequent 21-day course of tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets 7 days after discontinuation till the symptoms disappear and then 3 - 4 cycles more. It is recommended one more course if relapses appear. If the result is unsatisfactory after six-month treatment of seborrhea or acne and after 12 months of androgenic alopecia and hirsutism, it is recommended to increase a dose. If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours. If more than 12 hours have elapsed from the time of usual administration, the patient must shed the missed tablet and take remaining tablets at the usual time in order to avoid a premature withdrawal bleeding during this cycle.

There have been no reports of overdose with Diane-35. Treatment should be symptomatic, based on the knowledge of the pharmacological action of the constituents.

Nausea and vomiting, occasionally: gastrointestinal symptoms (such as abdominal cramps and bloating); breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; amenorrhea during and after treatment; temporary infertility; edema; chloasma or melasma which may persist; breast changes: tenderness, enlargement, and secretion; change in weight (increase or decrease); change in cervical erosion and secretion; endocervical hyperplasia; possible diminution in lactation when given immediately postpartum; cholestatic jaundice; migraine; increase in size of uterine leiomyomata; rash (allergic); mental depression; reduced tolerance to carbohydrates; premenstrual-like syndrome; intolerance to contact lenses; change in corneal curvature; cataracts; optic neuritis; retinal thrombosis; changes in libido; chorea; changes in appetite; cystitis-like syndrome; rhinitis; headache; nervousness; dizziness; hirsutism; loss of scalp hair; hemorrhagic eruption; vaginitis; porphyria; impaired renal function; auditory disturbances; hemolytic uremic syndrome and pancreatitis. Diane-35 was generally well tolerated.

Serious side effects reported with Diane-35 include deep venous thrombosis, venous thrombosis with pulmonary embolism, arterial emboli involving the extremities and the spleen, cerebral ischemic vascular accident, cerebral venous thrombosis, sinus thrombosis, retinal vein thrombosis, hypertensive crisis, migraine, pancreatitis, focal nodular hyperplasia of the liver, liver adenoma, primary bile duct carcinoma, hepatitis, liver dystrophy, cholangitis, pseudomembranous colitis, cholestasis, abdominal pain, epileptic seizures, cerebral tumor symptoms, acute brachiofacial paresis, acute hydrocephalus, manic syndrome, hyperpathia, ascites, diabetes mellitus, acute leukemia and breast cancer.

Predisposing factors for coronary artery diseases (such as cigarette smoking, hypertension, and hypercholesterolemia, obesity, diabetes and increasing age), the use of estrogen/progestogen combinations have been reported as an additional risk factor.