Simpesse

SIMPESSE- levonorgestrel and ethinyl estradiol and ethinyl estradiol
Aurobindo Pharma Limited

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications (4) .]

1 INDICATIONS AND USAGE

Simpesse® (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

Take one tablet by mouth at the same time every day. The dosage of Simpesse is one white tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one light blue ethinyl estradiol tablet for 7 days. To achieve maximum contraceptive effectiveness, Simpesse must be taken exactly as directed and at intervals not exceeding 24 hours.
Instruct the patient to begin taking Simpesse on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first white tablet is taken that day. One white tablet should be taken daily for 84 consecutive days, followed by one light blue tablet for 7 consecutive days. A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until a white tablet has been taken daily for 7 consecutive days. A scheduled period should occur during the 7 days that the light blue tablets are taken.
Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of Simpesse, following the same schedule: 84 days taking a white tablet followed by 7 days taking a light blue tablet. If the patient does not immediately start her next pill pack, she should protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken a white tablet daily for 7 consecutive days.
If unscheduled spotting or bleeding occurs, instruct the patient to continue on the same regimen. If the bleeding is persistent or prolonged, advise the patient to consult her healthcare provider.
For patient instructions regarding missed pills, see FDA-Approved Patient Labeling.

For postpartum women who are not breastfeeding, start Simpesse no earlier than four to six weeks postpartum due to increased risk of thromboembolism. If the patient starts on Simpesse postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken a white tablet for 7 consecutive days.

3 DOSAGE FORMS AND STRENGTHS

Simpesse tablets (levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) are available in Extended-Cycle Wallets, each containing a 13-week supply of tablets: 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 light blue tablets each containing 0.01 mg of ethinyl estradiol. The white tablets are round, biconvex, beveled-edge, debossed with “S” on one side and “27” on other side. The light blue tablets are mottled, round, biconvex, beveled-edge, debossed with “S” on one side and “45” on other side.

4 CONTRAINDICATIONS

Simpesse is contraindicated in females who are known to have or develop the following conditions:

  • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:

— Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)].

— Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)].

— Have cerebrovascular disease [see Warnings and Precautions (5.1)]

— Have coronary artery disease [see Warnings and Precautions (5.1)].

— Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)].

— Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)].

— Have uncontrolled hypertension [see Warnings and Precautions (5.5)].

— Have diabetes with vascular disease [see Warnings and Precautions (5.7)].

— Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8)].

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic and Other Vascular Events

Stop Simpesse if an arterial or deep venous thrombotic event occurs. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The excess risk is highest during the first year of use of a COC. 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. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
Use of Simpesse provides women with more hormonal exposure on a yearly basis than conventional monthly oral contraceptives containing the same strength synthetic estrogens and progestins (an additional 9 and 13 weeks of exposure to progestin and estrogen, respectively, per year).
If feasible, stop Simpesse at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Simpesse no earlier than 4 to 6 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.
COCs have been shown 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), and 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 Simpesse if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

5.2 Malignant Neoplasms

Breast Cancer

Simpesse is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4)].

Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use [see Postmarketing Experience (6.2)].

Cervical Cancer

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings are due to differences in sexual behavior and other factors.

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