Levonorgestrel and ethinyl estradiol and ethinyl estradiol

What is Levonorgestrel and ethinyl estradiol and ethinyl estradiol?

• Levonorgestrel and ethinyl estradiol and ethinyl estradiol (LoSeasonique) is an estrogen/progestin COC is used by women to prevent pregnancy.

Levonorgestrel

Ethinylestradiol

What are the uses of this medicine?

• Levonorgestrel and ethinyl estradiol and ethinyl estradiol (LoSeasonique) is a birth control pill.
• It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.

How does this medicine work?

• Combination OCs 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Ever had breast cancer or any cancer that is sensitive to female hormones
• Liver disease, including liver tumors
• Ever had blood clots in your arms, legs, or lungs
• Ever had a stroke
• Ever had a heart attack
• Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• An inherited problem with your blood that makes it clot more than normal
• High blood pressure that medicine can't control
• Diabetes with kidney, eye, or blood vessel damage
• Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
• Smoke and are over 35 years old
• Are pregnant

What drug interactions can this medicine cause?

Tell your health care provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate

• Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy.

Is this medicine FDA approved?

• Initial U.S. Approval: 1982

How should this medicine be used?

Recommended dosage:

• The dosage of LoSeasonique is one orange tablet containing levonorgestrel and ethinyl estradiol daily for 84 consecutive days, followed by one yellow ethinyl estradiol tablet for 7 days.
• To achieve maximum contraceptive effectiveness, LoSeasonique must be taken exactly as directed and at intervals not exceeding 24 hours.
• Take one tablet daily by mouth at the same time every day for 91 days.

Administration:

• Take one pill at the same time every day until you have taken the last pill in the tablet dispenser.
• Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).
• Do not skip pills even if you do not have sex very often.
• When you finish a tablet dispenser
• After taking the last yellow pill, start taking the first orange pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started.
• If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking LoSeasonique.
• Instruct the patient to begin taking LoSeasonique on the first Sunday after the onset of menstruation.
• If menstruation begins on a Sunday, the first orange tablet is taken that day.
• One orange tablet should be taken daily for 84 consecutive days, followed by one yellow tablet for 7 consecutive days.
• A non-hormonal back-up method of contraception (such as condoms or spermicide) should be used until an orange tablet has been taken daily for 7 consecutive days.
• A scheduled period should occur during the 7 days that the yellow tablets are taken.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 84 orange tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol.

This medicine is available in fallowing brand namesː

• LoSeasonique

What side effects can this medication cause?

The most common side effects of this medicine include:

• Spotting or bleeding between menstrual periods
• Nausea
• Breast tenderness
• Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

• Acne
• Less sexual desire
• Bloating or fluid retention
• Blotchy darkening of the skin, especially on the face
• High blood sugar, especially in women who already have diabetes
• High fat levels in the blood.
• Depression, especially if you have had depression in the past. Call your health care provider immediately if you have any thoughts of harming yourself.
• Problems tolerating contact lenses
• Weight changes

What special precautions should I follow?

• 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. Stop LoSeasonique if a thrombotic event occurs. Stop LoSeasonique at least 4 weeks before and through 2 weeks after major surgery. Start LoSeasonique no earlier than 4 weeks after delivery, in women who are not breastfeeding.
• Discontinue LoSeasonique if jaundice occurs. Steroid hormones may be poorly metabolized in patients with impaired liver function.
• 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. Do not prescribe LoSeasonique for women with uncontrolled hypertension or hypertension with vascular disease.
• COCs may decrease glucose tolerance in a dose-related fashion. Monitor prediabetic and diabetic women taking LoSeasonique. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias.
• If a woman taking COCs develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue COCs if indicated.
• Unscheduled (breakthrough) bleeding and spotting sometimes occur in patients on COCs, especially during the first 3 months of use. Evaluate irregular bleeding or amenorrhea.
• Women who currently have or have had breast cancer should not use COCs because breast cancer may be hormonally sensitive.
• 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.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• withdrawal bleeding in females and nausea

Treatment of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy.
• The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy.

Can this medicine be used in children?

• Safety and efficacy of LoSeasonique have been established in women of reproductive age.
• Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older.
• Use of this product before menarche is not indicated.

What are the active and inactive ingredients in this medicine?

Part 1:

Active ingredient:

• LEVONORGESTREL
• ETHINYL ESTRADIOL

Inactive ingredients:

• INACTIVE INGREDIENTS
• Ingredient Name Strength
• STARCH, CORN
• FD&C YELLOW NO. 6
• HYPROMELLOSES
• LACTOSE
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• TITANIUM DIOXIDE
• TRIACETIN

Part 2:

Active ingredient:

• ETHINYL ESTRADIOL

Inactive ingredients:

• ANHYDROUS LACTOSE
• D&C YELLOW NO. 10
• FD&C YELLOW NO. 6
• HYPROMELLOSES
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLACRILIN POTASSIUM
• POLYETHYLENE GLYCOL
• POLYSORBATE 80
• TITANIUM DIOXIDE

Who manufactures and distributes this medicine?

• TEVA WOMEN’S HEALTH, INC.
• Subsidiary of TEVA PHARMACEUTICALS USA, INC.
• Sellersville, PA

What should I know about storage and disposal of this medication?

• Store at 20 to 25°C (68 to77°F).

• Dailymed label info on Levonorgestrel and ethinyl estradiol and ethinyl estradiol
• FDA Levonorgestrel and ethinyl estradiol and ethinyl estradiol

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