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Simpesse

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Overview

What is Simpesse?

Simpesse (levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) is an extended-cycle oral contraceptive consisting of 84 white tablets each containing 0.15 mg of levonorgestrel USP, a synthetic progestogen and 0.03 mg of ethinyl estradiol USP, and 7 light blue tablets containing 0.01 mg of ethinyl estradiol USP. The structural formulas for the active components are:

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-­17-hydroxy-, (17α)-, (-)-.

Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. : croscarmellose sodium, lactose monohydrate, magnesium stearate, methylene chloride, microcrystalline cellulose, and povidone. : colloidal silicon dioxide,  FD&C Blue No. 1, lactose monohydrate, povidone, pregelatinized starch (maize), stearic acid, and vitamin E. USP Dissolution Test is pending.



What does Simpesse look like?



What are the available doses of Simpesse?

Simpesse consists of 84 white tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 light blue tablets containing 0.01 mg ethinyl estradiol.

What should I talk to my health care provider before I take Simpesse?

How should I use Simpesse?

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

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 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.


What interacts with Simpesse?

Sorry No Records found


What are the warnings of Simpesse?

Sorry No Records found


What are the precautions of Simpesse?

Sorry No Records found


What are the side effects of Simpesse?

Sorry No records found


What should I look out for while using Simpesse?

Do not prescribe Simpesse to women who are known to have the following:

-        Smoke, if over age 35

-        Have deep vein thrombosis or pulmonary embolism, now or in the past

-        Have cerebrovascular disease

-        Have coronary artery disease

-        Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)

-        Have inherited or acquired hypercoagulopathies

-        Have uncontrolled hypertension

-        Have diabetes with vascular disease

-        Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35

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.

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What might happen if I take too much Simpesse?

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.


How should I store and handle Simpesse?

Store at FOR YOUR PROTECTION:Store at FOR YOUR PROTECTION:Product: 50436-3849NDC: 50436-3849-1 30 CAPSULE in a BOTTLENDC: 50436-3849-2 60 CAPSULE in a BOTTLEProduct: 50436-3849NDC: 50436-3849-1 30 CAPSULE in a BOTTLENDC: 50436-3849-2 60 CAPSULE in a BOTTLEProduct: 50436-3849NDC: 50436-3849-1 30 CAPSULE in a BOTTLENDC: 50436-3849-2 60 CAPSULE in a BOTTLE


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Clinical Information

Chemical Structure

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Clinical Pharmacology

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Non-Clinical Toxicology
Do not prescribe Simpesse to women who are known to have the following:

-        Smoke, if over age 35

-        Have deep vein thrombosis or pulmonary embolism, now or in the past

-        Have cerebrovascular disease

-        Have coronary artery disease

-        Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)

-        Have inherited or acquired hypercoagulopathies

-        Have uncontrolled hypertension

-        Have diabetes with vascular disease

-        Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35

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.

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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.

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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