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RINGZA is a brand name for Ethinyl Estradiol (also known as Ethinylestradiol), supplied as a ring (slow-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RINGZA (segesterone acetate and ethinyl estradiol vaginal system) is indicated for use by women of reproductive potential to prevent pregnancy. RINGZA has not been adequately studied in women with a Body Mass Index (BMI) > 29.0 kg/m2. 1.1 Pediatrics Pediatrics (< 18 years of age): No efficacy and safety data in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Pregnant Women: RINGZA should not be used in women who are pregnant. 0 kg/m2 because this subpopulation was excluded from the RINGZA clinical trials after venous thrombotic events (VTEs) were reported.
See 7 WARNINGS AND PRECAUTIONS:
General and 8 ADVERSE REACTIONS. 4 DRUG-DRUG INTERACTIONS. • Discontinue medication: Please see 7 WARNINGS AND PRECAUTIONS: General. 2 Recommended Dose and Dosage Adjustment RINGZA (segesterone acetate and ethinyl estradiol vaginal system) is a user-controlled, reversible, slow- release ring that can be reused for up to 1 year.
First insertion must be prior to expiration date. 4 Administration: How to Start RINGZA). One RINGZA should be inserted in the vagina by the women herself. RINGZA is to remain in the vagina continuously for 21 days (3 complete weeks).
It is removed for a 1-week dose-free interval, and during this time a withdrawal bleed usually occurs. RINGZA 3-weeks in and 1-week out represents a cycle of use. One RINGZA slow-release ring is effective for up to 13 cycles (1 year).
The safety and efficacy of RINGZA has not been established in women under 18 years of age. The use of RINGZA before menarche is not indicated. RINGZA has not been studied in postmenopausal women and is not indicated in this population (see 1 INDICATIONS).
4 Administration With clean hands, the user can choose an insertion position that is comfortable, such as lying down, squatting, or standing (Figure 1). The sides of the slow-release ring are pressed together for insertion into the vagina (Figure 2).
Figure 1 – Positions for RINGZA insertion Figure 2 – Holding RINGZA and pressing the sides together When properly inserted, the slow-release ring should be entirely in the vagina and behind the pelvic bone (Figure 3). The day and time of insertion should be noted so that the slow-release ring can be removed 3 weeks later, on the same day and at about the same time.
Figure 3 – Inserting RINGZA RINGZA can be removed by hooking an index finger into the slow-release ring inside the vagina and gently pulling the slow-release ring (Figure 4). The removed slow-release ring should be cleaned with unscented mild soap and warm water, patted dry with a clean cloth towel or paper towel, and placed in its case during the 1-week dose-free interval.
4 DRUG-DRUG INTERACTIONS. • Discontinue medication: Please see 7 WARNINGS AND PRECAUTIONS: General. 2 Recommended Dose and Dosage Adjustment RINGZA (segesterone acetate and ethinyl estradiol vaginal system) is a user-controlled, reversible, slow- release ring that can be reused for up to 1 year.
First insertion must be prior to expiration date. 4 Administration: How to Start RINGZA). One RINGZA should be inserted in the vagina by the women herself. RINGZA is to remain in the vagina continuously for 21 days (3 complete weeks).
It is removed for a 1-week dose-free interval, and during this time a withdrawal bleed usually occurs. RINGZA 3-weeks in and 1-week out represents a cycle of use. One RINGZA slow-release ring is effective for up to 13 cycles (1 year).
The safety and efficacy of RINGZA has not been established in women under 18 years of age. The use of RINGZA before menarche is not indicated. RINGZA has not been studied in postmenopausal women and is not indicated in this population (see 1 INDICATIONS).
4 Administration With clean hands, the user can choose an insertion position that is comfortable, such as lying down, squatting, or standing (Figure 1). The sides of the slow-release ring are pressed together for insertion into the vagina (Figure 2).
Figure 1 – Positions for RINGZA insertion Figure 2 – Holding RINGZA and pressing the sides together When properly inserted, the slow-release ring should be entirely in the vagina and behind the pelvic bone (Figure 3). The day and time of insertion should be noted so that the slow-release ring can be removed 3 weeks later, on the same day and at about the same time.
Figure 3 – Inserting RINGZA RINGZA can be removed by hooking an index finger into the slow-release ring inside the vagina and gently pulling the slow-release ring (Figure 4). The removed slow-release ring should be cleaned with unscented mild soap and warm water, patted dry with a clean cloth towel or paper towel, and placed in its case during the 1-week dose-free interval.
4 DRUG-DRUG INTERACTIONS. RINGZA (segesterone acetate and ethinyl estradiol vaginal system) Page 5 of 51 Unclassified / Non classifié • hypersensitivity to RINGZA or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.
This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs should not be used by women who are over 35 years of age and smoke.
See 7 WARNINGS AND PRECAUTIONS:
Cardiovascular. • RINGZA does not protect against sexually transmitted diseases (STDs) including HIV/AIDS. For protection against STDs, it is advisable to use latex or polyurethane condoms in combination with RINGZA. 1 Dosing Considerations • Pregnant Women: RINGZA should not be used in women who are pregnant.
0 kg/m2 because this subpopulation was excluded from the RINGZA clinical trials after venous thrombotic events (VTEs) were reported.
See 7 WARNINGS AND PRECAUTIONS:
General and
RINGZA is contraindicated in women with: • a high risk of arterial or venous thrombotic diseases such as women who are known to: o smoke, if over age 35 (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ethinyl Estradiol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
At the end of the dose-free interval, the slow-release ring should be cleaned prior to being placed back in the vagina for another 21 continuous days (3 complete weeks). Bleach or cleaning products other than unscented mild soap should not be used.
RINGZA (segesterone acetate and ethinyl estradiol vaginal system) Page 7 of 51 Unclassified / Non classifié Figure 4 – Removing RINGZA How to Start RINGZA IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of RINGZA.
No Hormonal Contraceptive Use in the Preceding Cycle and after Copper Intrauterine Device (IUD) Removal: The woman should insert RINGZA between days 2 and 5 of her regular menstrual bleeding; no back-up contraception is needed. If menstrual cycles are irregular or if the start is more than 5 days from the last menstrual bleeding, the woman should use an additional barrier method, such as a male condom or spermicide, for the first 7 days of RINGZA use.
Switching from a CHC:
A woman who has been using her CHC method consistently and correctly, and if it is reasonably certain that she is not pregnant, may switch from her previous CHC to RINGZA on any day of the CHC cycle (Day 1-28), without the need for back-up contraception, but no more than 7 hormone-free days should occur before starting RINGZA.
Switching from a Progestin-Only Method [Progestin-only pills (POP), Progestin Injection, Progestin Implant, Progestin Intrauterine System (IUS)]: If a woman has no contraindications to the use of ethinyl estradiol (EE), she may elect to switch from a progestin-only method to RINGZA.
If switching from progestin-only pills, she should begin RINGZA at the time she would have taken her next POP pill. If switching from an injection, she should begin RINGZA at the time of her next scheduled injection. If switching from an implant or an IUS, she should begin RINGZA at the time of implant or IUS removal.
In all of these cases, an additional barrier method should be used, such as a male condom or spermicide, for the first 7 days of RINGZA use.
Use after Abortion or Miscarriage:
If a woman has no contraindications to the use of EE, RINGZA may be initiated for contraception within the first 5 days following a complete first trimester abortion or miscarriage without additional back-up contraception. If more than 5 days have elapsed from the first trimester abortion or miscarriage, then follow the instructions for “No Hormonal Contraceptive Use in the Preceding Cycle” and a barrier method should be used from the time of the first trimester abortion or miscarriage to the initiation of RINGZA.
RINGZA should not be started earlier than 4 weeks after a second trimester abortion or miscarriage due to the increased risk of thromboembolism.
See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS:
Cardiovascular. RINGZA (segesterone acetate and ethinyl estradiol vaginal system) Page 8 of 51 Unclassified / Non classifié Following Childbirth: RINGZA should not be started sooner than 4 weeks postpartum and only in women who choose not to breastfeed.
Prior to 4 weeks postpartum there is an increased risk of thromboembolism.
See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS:
Cardiovascular. The initiation of RINGZA 4 weeks or more postpartum should be accompanied by an additional method of contraception, such as male condoms or spermicide, for […]
At the end of the dose-free interval, the slow-release ring should be cleaned prior to being placed back in the vagina for another 21 continuous days (3 complete weeks). Bleach or cleaning products other than unscented mild soap should not be used.
RINGZA (segesterone acetate and ethinyl estradiol vaginal system) Page 7 of 51 Unclassified / Non classifié Figure 4 – Removing RINGZA How to Start RINGZA IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of RINGZA.
No Hormonal Contraceptive Use in the Preceding Cycle and after Copper Intrauterine Device (IUD) Removal: The woman should insert RINGZA between days 2 and 5 of her regular menstrual bleeding; no back-up contraception is needed. If menstrual cycles are irregular or if the start is more than 5 days from the last menstrual bleeding, the woman should use an additional barrier method, such as a male condom or spermicide, for the first 7 days of RINGZA use.
Switching from a CHC:
A woman who has been using her CHC method consistently and correctly, and if it is reasonably certain that she is not pregnant, may switch from her previous CHC to RINGZA on any day of the CHC cycle (Day 1-28), without the need for back-up contraception, but no more than 7 hormone-free days should occur before starting RINGZA.
Switching from a Progestin-Only Method [Progestin-only pills (POP), Progestin Injection, Progestin Implant, Progestin Intrauterine System (IUS)]: If a woman has no contraindications to the use of ethinyl estradiol (EE), she may elect to switch from a progestin-only method to RINGZA.
If switching from progestin-only pills, she should begin RINGZA at the time she would have taken her next POP pill. If switching from an injection, she should begin RINGZA at the time of her next scheduled injection. If switching from an implant or an IUS, she should begin RINGZA at the time of implant or IUS removal.
In all of these cases, an additional barrier method should be used, such as a male condom or spermicide, for the first 7 days of RINGZA use.
Use after Abortion or Miscarriage:
If a woman has no contraindications to the use of EE, RINGZA may be initiated for contraception within the first 5 days following a complete first trimester abortion or miscarriage without additional back-up contraception. If more than 5 days have elapsed from the first trimester abortion or miscarriage, then follow the instructions for “No Hormonal Contraceptive Use in the Preceding Cycle” and a barrier method should be used from the time of the first trimester abortion or miscarriage to the initiation of RINGZA.
RINGZA should not be started earlier than 4 weeks after a second trimester abortion or miscarriage due to the increased risk of thromboembolism.
See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS:
Cardiovascular. RINGZA (segesterone acetate and ethinyl estradiol vaginal system) Page 8 of 51 Unclassified / Non classifié Following Childbirth: RINGZA should not be started sooner than 4 weeks postpartum and only in women who choose not to breastfeed.
Prior to 4 weeks postpartum there is an increased risk of thromboembolism.
See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS:
Cardiovascular. The initiation of RINGZA 4 weeks or more postpartum should be accompanied by an additional method of contraception, such as male condoms or spermicide, for the first 7 days if the woman has not yet had a period. Consider the possibility of ovulation and conception occurring prior to initiating RINGZA.
Women who are breastfeeding should not use RINGZA until after weaning. 2 BREAST-FEEDING. Tampon Use Tampons can be used with RINGZA. The effect of RINGZA and tampon co-usage on the pharmacokinetic (PK) of segesterone […]