Predisposing factors for coronary artery diseases: In women with predisposing factors for coronary artery disease (such as cigarette smoking, hypertension, hypercholesterolemia, obesity, diabetes and increasing age), the use of estrogen/progestogen combinations have been reported as an additional risk factor.
After the age of 35 years, estrogen/progestogen combinations should be considered only in exceptional circumstances and when the risk/benefit ratio has been carefully weighed by both the patient and the physician. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of this class of medication. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is more marked in women over 35 years of age. Women who use such medication should not smoke.
Estrogen/progestogen combinations may cause an increase in plasma lipoproteins and should be administered with caution to women known to have pre-existent hyperlipoproteinemia. Lipid profiles should be determined regularly in these patients.
The combination of obesity, hypertension and diabetes is particularly hazardous to women who are taking this class of medication. Should this triad of conditions develop, the patient should be placed on an alternate form of therapy.
Discontinue medication at the earliest manifestation of: Thromboembolic and cardiovascular disorders such as thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis.
The use of estrogen/progestogen-combination products should be avoided in conditions, which predispose to venous stasis and to vascular thrombosis, e.g., immobilization after accidents or confinement to bed during long-term illness. Under such conditions, other nonhormonal methods of treatment should be considered. For use when surgery is contemplated, see Precautions.
Visual defects, partial or complete.
Papilledema, or ophthalmic vascular lesions.
Severe headache of unknown etiology. Or worsening of pre-existing migraine headache.
Onset of jaundice or hepatitis.
Itching of the whole body.
Use in Pregnancy: Fetal abnormalities have been reported to occur in the offspring of women who have taken estrogen/progestogen combinations in early pregnancy. Rule out pregnancy as soon as it is suspected.
Use in Lactation: The use of estrogen/progestogen combinations during the period a mother is breast-feeding her infant may not be advisable. The hormonal components are excreted in breast milk and may reduce its quantity and quality. The long-term effects on the developing child are not known. This drug may cause fluid retention. Conditions such as epilepsy.