Indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as  certain inherited thrombophilias, hypertension, hyperlipidemias, obesity, and diabetes.

A two-to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed.

An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes.

There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.

Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms of estrogen cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance.

Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception.

Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

Desogen is contraindicated in patients with:

• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebral vascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Severe hypertension
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast (or personal history of breast cancer)
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
• Hepatic tumors (benign or malignant) or active liver disease
• Known or suspected pregnancy
• Heavy smoking (≥15 cigarettes per day) and over age 35
• Receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

Contraceptive effectiveness may be reduced when hormonal contraceptives are coadministered with some antibiotics, anticonvulsants, and other drugs that increase metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include barbiturates, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate and griseofulvin.

Herbal products containing St. John’s wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids.

Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine, and clofibric acid, have been noted when these drugs were administered with oral contraceptives.

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

GoToSource

• Use in patients before menarche and use in patients over 65 years of age. GoToSource

• Preventing bone loss related to hypoestrogenism in hypothalamic oligo-amenorrheic subjects. GoToSource 

• Acne. GoToSource

• Primary dysmenorrhea. GoToSource

• Premenstrual dysphoric disorder. GoToSource

• Endometriosis pain. GoToSource

• Migraines with aura. GoToSource

• Polycystic ovary syndrome. GoToSource

• Hirsutism. GoToSource

Venous and arterial thrombotic and thromboembolic events (deep vein leg thrombosis, pulmonary embolism, femoral vein thrombosis, portal thrombosis and caval or renal thrombosis). GoToSource

Myocardial infarction and stroke. GoToSource

Gallbladder disease. GoToSource

Breast cancer. GoToSource

Increased glucose levels. GoToSource 

Membranous dysmenorrhea with chronic fatigue syndrome. GoToSource

Lawsuits filed for blood clots, strokes and heart attacks.