Drospirenone and Ethinyl estradiol

Drospirenone and Ethinyl estradiol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Drospirenone and Ethinyl estradiol is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of premenstrual dysphoric disorder (PMDD), acne, and contraception. Common adverse reactions include headache/migraine, menstrual irregularities, nausea/vomiting, breast pain/tenderness and mood changes.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acne vulgaris (Moderate)

• Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

• Dosing information

• Dosage

Contraception

• Nikki™ (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for use by women to prevent pregnancy.

• Dosing information

• How to Take Nikki

• Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

• To achieve maximum contraceptive effectiveness, Nikki must be taken exactly as directed, in the order directed on the wallet. Single missed pills should be taken as soon as remembered.

How to Start Nikki

• Instruct the patient to begin taking Nikki either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).

• Day 1 Start:

• During the first cycle of Nikki use, instruct the patient to take one pink Nikki daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink Nikki daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Nikki should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Nikki can be taken without regard to meals. If Nikki is first taken later than the first day of the menstrual cycle, Nikki should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

• Sunday Start:

• During the first cycle of Nikki use, instruct the patient to take one pink Nikki daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Nikki daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Nikki should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Nikki can be taken without regard to meals. Nikki should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

• The patient should begin her next and all subsequent 28-day regimens of Nikki on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Nikki is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a pink Nikki daily for seven consecutive days.

• When switching from a different birth control pill:

• When switching from another birth control pill, Nikki should be started on the same day that a new pack of the previous oral contraceptive would have been started.

• When switching from a method other than a birth control pill:

• When switching from a transdermal patch or vaginal ring, Nikki should be started when the next application would have been due. When switching from an injection, Nikki should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Nikki should be started on the day of removal.

• Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking Nikki, instruct the patient to continue taking Nikki by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.

• Although the occurrence of pregnancy is low if Nikki is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Nikki if pregnancy is confirmed.

• The risk of pregnancy increases with each active pink tablet missed. For additional patient instructions regarding missed pills, see the "What to Do if You Miss Pills" section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day.

• For postpartum women who do not breastfeed or after a second trimester abortion, start Nikki no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Nikki 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 Nikki for 7 consecutive days.

• Advice in Case of Gastrointestinal Disturbances

• In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet.

Premenstrual dysphoric disorder

• Dosing information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Drospirenone and Ethinyl estradiol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Drospirenone and Ethinyl estradiol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Acne vulgaris (Moderate)

1) The recommended dose to treat moderate acne vulgaris in women at least 14 years of age is one active (pink) Yaz(R) tablet orally every day for 24 consecutive days, followed by one inert (white) tablet daily for 4 days per menstrual cycle. Therapy should start either on the first day of menstrual period or on the first Sunday after the onset of menstruation. Next or all subsequent 28-day regimens of therapy should be started on the same day of the week as the first regimen began and must follow the same schedule [1].

Contraception

Premenstrual dysphoric disorder

1) The recommended dose to treat premenstrual dysphoric disorder in females who have achieved menarche is one active (pink) Yaz(R) tablet orally every day for 24 consecutive days, followed by one inert (white) tablet daily for 4 days per menstrual cycle. Therapy should start either on the first day of menstrual period or on the first Sunday after the onset of menstruation. Next or all subsequent 28-day regimens of therapy should be started on the same day of the week as the first regimen began and must follow the same schedule. Efficacy for premenstrual dysphoric disorder has not been assessed beyond 3 menstrual cycles [1].

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Drospirenone and Ethinyl estradiol in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Drospirenone and Ethinyl estradiol in pediatric patients.

Contraindications

There is limited information regarding Drospirenone and Ethinyl estradiol Contraindications in the drug label.

Warnings

There is limited information regarding Drospirenone and Ethinyl estradiol Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Drospirenone and Ethinyl estradiol Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Drospirenone and Ethinyl estradiol Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Drospirenone and Ethinyl estradiol Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Drospirenone and Ethinyl estradiol in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Drospirenone and Ethinyl estradiol in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Drospirenone and Ethinyl estradiol during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol in geriatric settings.

Gender

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol with respect to specific gender populations.

Race

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Drospirenone and Ethinyl estradiol in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Drospirenone and Ethinyl estradiol in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Drospirenone and Ethinyl estradiol Administration in the drug label.

Monitoring

There is limited information regarding Drospirenone and Ethinyl estradiol Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Drospirenone and Ethinyl estradiol and IV administrations.

Overdosage

There is limited information regarding Drospirenone and Ethinyl estradiol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Drospirenone and Ethinyl estradiol Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Drospirenone and Ethinyl estradiol Mechanism of Action in the drug label.

Structure

There is limited information regarding Drospirenone and Ethinyl estradiol Structure in the drug label.

Pharmacodynamics

There is limited information regarding Drospirenone and Ethinyl estradiol Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Drospirenone and Ethinyl estradiol Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Drospirenone and Ethinyl estradiol Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Drospirenone and Ethinyl estradiol Clinical Studies in the drug label.

How Supplied

There is limited information regarding Drospirenone and Ethinyl estradiol How Supplied in the drug label.

Storage

There is limited information regarding Drospirenone and Ethinyl estradiol Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Drospirenone and Ethinyl estradiol Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Drospirenone and Ethinyl estradiol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Yasmin YAZ Yaz 28 Ocella Gianvi Zarah Syeda Loryna

Look-Alike Drug Names

There is limited information regarding Drospirenone and Ethinyl estradiol Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.