Delsia Special Precautions

Thromboembolic Disorders and Other Vascular Problems: Stop drospirenone 3 mg and ethinyl estradiol 0.03 mg combination if an arterial or venous thrombotic event occurs. Drospirenone-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. The risk of VTE has been reported to range from no increase to a three-fold increase. Before initiating use of drospirenone 3 mg and ethinyl estradiol 0.03 mg combination in a new COCs user or a woman who is switching from a contraceptive that does not contain drospirenone, consider the risks and benefits of a drospirenone-containing COCs in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs (see CONTRAINDICATIONS).
A number of reported studies have compared the risk of VTE for users of drospirenone 3 mg and ethinyl estradiol 0.03 mg combination to the risk for users of other COCs, including COCs containing levonorgestrel.
Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period. The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is reported to be highest during the first year of use. This increased risk, as compared to that in non-COCs users, is reported to be greatest during the first 6 months of COCs use. The greatest risk of VTE is reported to be present after initially starting a COCs or restarting (following a 4 week or greater pill-free interval) the same or a different COCs.
The risk of thromboembolic disease due to oral contraceptives gradually disappears after COCs use is discontinued.
If feasible, stop drospirenone 3 mg and ethinyl estradiol 0.03 mg combination at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start drospirenone 3 mg and ethinyl estradiol 0.03 mg combination no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
COCs have been reported to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.
Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Stop drospirenone 3 mg and ethinyl estradiol 0.03 mg combination if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately (see ADVERSE REACTIONS).
Hyperkalemia: Drospirenone 3 mg and ethinyl estradiol 0.03 mg combination contains 3 mg of the progestin drospirenone, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. Drospirenone 3 mg and ethinyl estradiol 0.03 mg combination is contraindicated in patients with conditions that predispose to hyperkalemia (that is, renal impairment, hepatic impairment, and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked during the first treatment cycle. Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs. Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin (see INTERACTIONS).
Carcinoma of the Breasts and Reproductive Organs: Women who currently have or have had breast cancer should not use drospirenone 3 mg and ethinyl estradiol 0.03 mg combination because breast cancer is a hormonally-sensitive tumor. There is substantial reported evidence that COCs do not increase the incidence of breast cancer. Although some past studies have reported that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
COCs are reported to be associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.
Liver Disease: Discontinue drospirenone 3 mg and ethinyl estradiol 0.03 mg combination if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COCs use until markers of liver function return to normal and COCs causation has been excluded.
Hepatic adenomas are reported to be associated with COCs use. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.
An increased risk of developing hepatocellular carcinoma has been reported in long-term (> 8 years) COCs users. However, the attributable risk of liver cancers in COCs users is reported to be less than one case per million users.
Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COCs-related cholestasis may have the condition recur with subsequent COCs use.
Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: During reported clinical studies with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue drospirenone 3 mg and ethinyl estradiol 0.03 mg combination prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (see CONTRAINDICATIONS). Drospirenone 3 mg and ethinyl estradiol 0.03 mg combination can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
High Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop drospirenone 3 mg and ethinyl estradiol 0.03 mg combination if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
Gallbladder Disease: A small increased relative risk of developing gallbladder disease has been reported among COCs users.
Carbohydrate and Lipid Metabolic Effects: Carefully monitor prediabetic and diabetic women who are taking drospirenone 3 mg and ethinyl estradiol 0.03 mg combination. COCs may decrease glucose tolerance in a dose-related fashion.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.
Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Headache: If a woman taking drospirenone 3 mg and ethinyl estradiol 0.03 mg combination develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue drospirenone 3 mg and ethinyl estradiol 0.03 mg combination if indicated.
An increase in frequency or severity of migraine during COCs use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COCs.
Bleeding Irregularities: Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COCs.
The percent of women who took drospirenone 3 mg and ethinyl estradiol 0.03 mg combination and experienced unscheduled bleeding has been reported to decrease over time from 12% at cycle 2 to 6% at cycle 13. <1% of the patients have been reported to discontinue due to bleeding complaints. These are described as metrorrhagia, vaginal hemorrhage, menorrhagia, abnormal withdrawal bleeding, and menometrorrhagia.
The average duration of scheduled bleeding episodes in the majority of subjects (86%-88%) was reported to be 4-7 days. Women who use drospirenone 3 mg and ethinyl estradiol 0.03 mg combination may experience absence of withdrawal bleeding, even if they are not pregnant. During cycles 2-13, 1-11% of women per cycle have been reported to experience no withdrawal bleeding. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.
If withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
Depression: Women with a history of depression should be carefully observed and drospirenone 3 mg and ethinyl estradiol 0.03 mg combination discontinued if depression recurs to a serious degree.
Interference with Laboratory Tests: The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs (see INTERACTIONS).
Drospirenone has been reported to cause an increase in plasma renin activity and plasma aldosterone induced by its mild anti-mineralocorticoid activity.
Monitoring: A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
Other Conditions: In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.
Excipients: DELSIA contains lactose. If patient has been told by the doctor that she has an intolerance to some sugars, contact the doctor before taking this medicinal product.
Use in Pregnancy: COCs Use Before or During Early Pregnancy: No increased risk of birth defects has been reported in women who have used oral contraceptives prior to pregnancy. No teratogenic effect has been reported when COCs are taken inadvertently during early pregnancy, particularly in so far as cardiac anomalies and limb-reduction defects are concerned.
The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy (see USE IN PREGNANCY & LACTATION).