Drospirenone and estetrol

Drospirenone and estetrol
Black Box Warning
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: Parth Vikram Singh, MBBS[2]

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Black Box Warning

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete Boxed Warning. Condition Name: (Females over 35 years old who smoke should not use NEXTSTELLIS (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) )

Overview

Drospirenone and estetrol is a combination of drospirenone, a progestin, and estetrol, an estrogen, that is FDA approved for the treatment of reproductive potential to prevent pregnancy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased ..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Recommended Dosage and Administration

Start NEXTSTELLIS using a Day 1 start. Take one tablet by mouth at the same time every day with or without food.

Additional Administration Information

To achieve maximum contraceptive effectiveness, take one tablet every day at about the same time each day. The recommended dosage of NEXTSTELLIS is one tablet daily for 28 consecutive days: one pink active tablet daily during the first 24 days followed by one white inactive tablet daily during the 4 following days (see TABLE 1).

NEXTSTELLIS Administration Instructions

NEXTSTELLIS Administration Instructions

Missed Doses

Instructions for Missed NEXTSTELLLIS Tablets in a Monthly Dosing Regimen

Administration Recommendations after Vomiting or Acute Diarrhea

• If vomiting or acute diarrhea occurs within 3 to 4 hours after taking an active tablet, take the new active tablet (scheduled for the next day) as soon as possible. Take the new tablet within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, follow the advice concerning missed tablets, including using backup non-hormonal contraception. For additional recommendations, refer to the table above.

3 DOSAGE FORMS AND STRENGTHS

• NEXTSTELLIS (drospirenone and estetrol tablets) is available in a blister card, with 28 6-mm round, bi-convex film-coated tablets in the following order:
  • 24 pink active tablets containing 3 mg drospirenone and 14.2 mg estetrol embossed with a drop-shaped logo on one side.
  • 4 white inert tablets embossed with a drop-shaped logo on one side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Drospirenone and estetrol FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete Boxed Warning. Condition Name: (Females over 35 years old who smoke should not use NEXTSTELLIS (4) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) )

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

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

Brand Names

There is limited information regarding Drospirenone and estetrol Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Drospirenone and estetrol 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.