Overview
DESCRIPTION 21 white active tablets each containing 0.1 mg of levonorgestrel USP, (17α)-(-)-13-ethyl-17-hydroxy-18,19, dinorpregna-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-diol. The inactive ingredients present are cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and...
Mechanism of Action
CLINICAL PHARMACOLOGY Mode of Action Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Pharmacokinetics Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol tablets in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first-pass metabolism.
Indications
- INDICATIONS AND USAGE Levonorgestrel and Ethinyl Estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Common Doses
- Refer to label
Dosage
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, levonorgestrel and ethinyl estradiol tablets must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of levonorgestrel and ethinyl estradiol tablets is one white tablet daily for 21 consecutive days, followed by one orange inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that levonorgestrel and ethinyl estradiol tablets be taken at the same time each day.
Contraindications
- CONTRAINDICATIONS Combination oral contraceptives should not be used in women with any of the following conditions: Thrombophlebitis or thromboembolic disorders A history of deep-vein thrombophlebitis or thromboembolic disorders Cerebrovascular or coronary artery disease (current or past history) Valvular heart disease with thrombogenic complications Thrombogenic rhythm disorders Hereditary or acquired thrombophilias Major surgery with prolonged immobilization Diabetes with vascular involvement Headaches with focal neurological symptoms Uncontrolled hypertension Current diagnosis of, or...
Side Effects
- ADVERSE REACTIONS An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives: Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.