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Last Updated : 8/26/2018

General Information on Segesterone Acetate and Ethinyl Estradiol

Generic Name : Segesterone Acetate and Ethinyl Estradiol

Pronunciation : se-JES-ter-one & ETH-in-il-es-tra-DYE-ole

Latest prescription information about Segesterone Acetate and Ethinyl Estradiol. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
Therapeutic Classification : Contraceptives

Trade Names/Brand Names of Segesterone Acetate and Ethinyl Estradiol

Annovera

Why is Segesterone Acetate and Ethinyl Estradiol Prescribed? (Indications)

Segesterone acetate and ethinyl estradiol vaginal system is a hormone-releasing system used to prevent pregnancy in females of reproductive potential for about one year which covers approximately thirteen 28-day menstrual cycles.

It is a progestin/estrogen combined hormonal contraceptive (CHC), a flexible donut-shaped vaginal ring which is reusable, and non-biodegradable. It is easy to wash and stored when not in use.

Segesterone acetate and ethinyl estradiol vaginal system works by preventing or suppressing ovulation by blocking specific enzyme secretion, thereby inhibiting the development of ovarian follicles. 

When should Segesterone Acetate and Ethinyl Estradiol not to be taken? (Contraindications)

Segesterone acetate and ethinyl estradiol vaginal system should not be used in females of reproductive potential with-

• Allergic to segesterone acetate and ethinyl estradiol vaginal system
• History of breast cancer or hormone (estrogen/progestin) sensitive cancer
• Liver disease (Cirrhosis, hepatitis, liver tumors)
• High risk of blood clot formation
• Undiagnosed abnormal bleeding in the uterus
• Body mass index above 29 kg/m2
• Hepatitis C and taking medications such as ombitasvir, paritaprevir, and ritonavir
• Diabetes
• Uncontrolled hypertension
• A migraine headache
• Breastfeeding
• Cigarette smoking
• Age above 35 years old

What is the dosage of Segesterone Acetate and Ethinyl Estradiol?

• Each segesterone acetate (SA) and ethinyl estradiol (EE) flexible vaginal system releases approximately 0.15 mg of segesterone acetate and 0.013 mg of ethinyl estradiol in a day.

• This vaginal ring is about 56 mm in overall diameter and 8.4 mm in cross-sectional diameter and contains two channels, one of which releases SA and the other core releases SA and EE.

How should Segesterone Acetate and Ethinyl Estradiol be taken?

• One flexible vaginal system should be placed into the vagina and remain there continuously for three weeks (i.e., 21 days) following which it should be removed for one week (i.e., 7 days).

• The vaginal system should be washed with mild soap and warm water. It can be patted dry with a clean towel while keeping outside for one week when the bleeding occurs.

• The vaginal ring should be pressed before insertion and must be placed into the vagina by choosing a comfortable insertion position while standing, squatting, or lying down.

• It should be placed entirely into the vagina behind the pelvic bone. The time and the date of insertion should be noted down so that women can remove the vaginal system after three weeks to have a contraceptive-free interval for one week.

• The vaginal system can be easily removed by hooking the index finger into the ring and gently pulling it out.

• If the contraceptive system is not placed into the vagina for more than a week, women should be advised to use an additional contraceptive.

• In case of an accidental expulsion or sudden removal, the vaginal system should be replaced into the vagina within 2 hours, and no backup contraception is required.

• If it is kept out for more than 2 hours, consideration of additional contraceptive is needed. Similarly, if the vaginal system is kept out for more than seven days there will be an increase in pregnancy risk and additional contraception is required. This deviation can also affect the day of the next schedule of inserting the vaginal system.

• The vaginal system should be removed if it is placed into the vagina for more than 21 days and can be reinserted during the next 21 day cycle to follow a 21/7 schedule.

• Females while switching from other contraceptive measures to segesterone acetate and ethinyl estradiol vaginal system should consider the following dosing schedule-

From Progestin-only pills (POP): Use the vaginal system at the time while taking next POP pill
From Progestin injection: Use at the time when the next injection is scheduled.
From Implants: Use the vaginal system at the time of implant.
From Progestin Intrauterine system (IUS): Use the system at the time of IUS removal.
In all the above-switched cases of other hormonal contraceptives, women should follow additional barrier methods during sexual intercourse at least for the first seven days of using the vaginal system.

• A pregnancy test should be carried out if there is no bleeding during the last seven days of the cycle when the vaginal system is removed. Stop using again if pregnancy is confirmed and get a doctor’s opinion accordingly.

• Using additional barrier methods during sexual intercourse is required at least for the first seven days if the menstrual cycles are irregular.

What are the warnings and precautions for Segesterone Acetate and Ethinyl Estradiol?

Monitor patients for the symptoms and signs of the following illness and use of the hormonal contraceptive system should be discontinued if the side effects are severe.

• An occurrence of blood clots
• High blood pressure
• Obesity
• High levels of cholesterol (fats) in the blood
• Depression
• Cervical cancer

Toxic shock syndrome (TSS), a life-threatening complication caused by certain bacterial infections which include symptoms such as fever, low blood pressure, rashes, and skin peeling.

Consult an eye specialist if any symptoms and signs of vision disturbances occur in women who use the vaginal system. Discontinue use if there is any unexplained loss of vision, or reports of other eye disorders.

Stop using segesterone acetate and ethinyl estradiol vaginal system at least four weeks before or 2 weeks after any major surgery to avoid the risk of thromboembolic events where the blood clots move from one place to another.

Menstrual disorders such as an absence of menstruation or bleeding irregularities can occur while using segesterone acetate and ethinyl estradiol vaginal system. The pregnancy status must be ruled out in case of missed periods.

The use of segesterone acetate and ethinyl estradiol vaginal system should be discontinued if a continuous or frequent episode of a severe headache occurs.

Tan or dark skin color may occur in females who use the vaginal system, mainly in those with a history of chloasma or melasma. They must be advised to avoid exposure to the sun and ultraviolet radiation.

Vaginal irritation or ulceration can occur in women who use the vaginal system and in such cases it should be removed based on a doctor’s approval.

The vaginal system should be started four weeks after childbirth, five days after a first-trimester abortion or 4 weeks after a second-trimester miscarriage to avoid the risk of thromboembolism (obstruction of a blood vessel by a blood clot that has moved from the site of circulation).

Women who wish to switch from other combined hormonal contraceptives to segesterone acetate and ethinyl estradiol vaginal system can start using the vaginal system on any day but should use within seven hormone-free days. In this case, no backup contraception is required.

What are the side effects of Segesterone Acetate and Ethinyl Estradiol?

•  Common: A migraine headache, nausea, vomiting, stomach pain, diarrhea, blood clots, painful menstruation, vaginal discharge, pain and tenderness in the breast, itching of the genital area

•  Others: Fungal infections, allergic reactions, spontaneous abortions, psychiatric events such as depression, urinary tract infections

What are the other precautions for Segesterone Acetate and Ethinyl Estradiol?

• Women should be aware that the segesterone acetate and ethinyl estradiol vaginal system will not protect against HIV infections and other sexually transmitted infections. So, extreme caution is necessary in such cases.

• Smoking cigarettes and using the vaginal system in women above 35 years of age can result in serious side effects. This risk increases with the number of cigarettes smoked every day and the increase in age.

• Using combined hormonal contraceptives that contain estrogen hormone in need for emergency contraception while using the segesterone acetate and ethinyl estradiol vaginal system is not recommended.

What are the Drug Interactions of Segesterone Acetate and Ethinyl Estradiol?

Drugs that decrease the effect of segesterone acetate and ethinyl estradiol vaginal system should be avoided.

• Phenytoin
• Carbamazepine
• Rifampin
• Topiramate
• Rufinamide
• Antiviral drugs (e.g., Amprenavir, Ritonavir, Lopinavir)
• St.John’s Wort

Drugs that increase the effect of segesterone acetate and ethinyl estradiol vaginal system may result in toxicity.

• Antifungal drugs (e.g., Itraconazole, Voriconazole)
• Grapefruit juice

The effect of the following drugs is reduced if it is taken along with the vaginal system and should not be taken together.

• Acetaminophen
• Morphine
• Temazepam

The dose of the following drugs should be increased as their effects are significantly reduced by the segesterone acetate and ethinyl estradiol vaginal system.

• Thyroid hormones
• Corticosteroids
• Lamotrigine

What are the storage conditions for Segesterone Acetate and Ethinyl Estradiol?

• Store the vaginal system at room temperature below 25° C.

• Protect the vaginal system from direct sunlight.

• Do not refrigerate the vaginal system in a freezer and also avoid keeping in excessive heat.

Last Updated : 8/26/2018
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