VIORELE (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) provides an oral contraceptive regimen .It is used to prevent pregnancy.
It may be given to you for other reasons. Talk with the doctor.
Use Viorele (ethinyl estradiol and desogestrel) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
Follow how to use as you have been told by the doctor or read the package insert.
Take Viorele (ethinyl estradiol and desogestrel) at the same time of day.
Take with or without food. Take with food if it causes an upset stomach.
If you also take colesevelam, take it at least 4 hours before or after you take Viorele (ethinyl estradiol and desogestrel).
Do not skip doses, even if you do not have sex very often.
If you throw up or have diarrhea, Viorele (ethinyl estradiol and desogestrel) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
Thrombophlebitis and venous thrombosis with or without embolism
Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives:
The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
Gastrointestinal symptoms (such as abdominal cramps and bloating)
Change in menstrual flow
Temporary infertility after discontinuation of treatment
Melasma which may persist
Breast changes: tenderness, enlargement, secretion
Change in weight (increase or decrease)
Change in cervical erosion and secretion
Diminution in lactation when given immediately postpartum
Reduced tolerance to carbohydrates
Change in corneal curvature (steepening)
Intolerance to contact lenses
The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
Changes in appetite
Loss of scalp hair
Impaired renal function
Hemolytic uremic syndrome
Changes in libido
Store at 20° to 25°C (68° to 77°F).
Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and possibly with griseofulvin, ampicillin, and tetracyclines (72).
Combination OCs have been shown to significantly decrease plasma concentrations of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.
Interactions With Laboratory Tests
Certain endocrine and liver function tests and blood components may be affected by oral contraceptives:
Increased prothrombin and factors VII, VIII, IX and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
Other binding proteins may be elevated in serum.
Sex hormone-binding globulins are increased and result in elevated levels of total circulating sex steroids; however, free or biologically active levels either decrease or remain unchanged.
High-density lipoprotein cholesterol (HDL-C) and triglycerides may be increased, while low-density lipoprotein cholesterol (LDL-C) and total cholesterol (Total-C) may be decreased or unchanged.
Glucose tolerance may be decreased.
Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.