Norelgestromin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara E.Dagsali
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Black Box Warning
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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and
CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with a BMI ≥ 30 kg/m . Women with a BMI ≥ 30 kg/m who use norelgestromin and ethinyl estradiol transdermal system may have a higher risk of venous thromboembolic events compared with women with a lower BMI.See full prescribing information for complete Boxed Warning.
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Overview
Norelgestromin is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the prevention of Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m for whom a combined hormonal contraceptive is appropriate.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include The following serious adverse reactions with the use of combination hormonal contraceptives, including norelgestromin and ethinyl estradiol, are discussed elsewhere in the labeling: Serious cardiovascular events and stroke Vascular events, including venous and arterial thromboembolic events Liver disease
Adverse reactions commonly reported by users of combination hormonal contraceptives are: Irregular uterine bleeding Nausea Breast tenderness Headache Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure to norelgestromin and ethinyl estradiol transdermal system in 3,330 sexually active women (3,322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%).
The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
To achieve maximum contraceptive effectiveness, norelgestromin and ethinyl estradiol transdermal systems must be used exactly as directed. Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Norelgestromin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Norelgestromin Contraindications in the drug label.
Warnings
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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and
CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m Norelgestromin and ethinyl estradiol transdermal system is contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with a BMI ≥ 30 kg/m . Women with a BMI ≥ 30 kg/m who use norelgestromin and ethinyl estradiol transdermal system may have a higher risk of venous thromboembolic events compared with women with a lower BMI.See full prescribing information for complete Boxed Warning.
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There is limited information regarding Norelgestromin Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Norelgestromin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Norelgestromin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Norelgestromin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Norelgestromin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Norelgestromin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Norelgestromin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Norelgestromin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Norelgestromin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Norelgestromin in geriatric settings.
Gender
There is no FDA guidance on the use of Norelgestromin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Norelgestromin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Norelgestromin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Norelgestromin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Norelgestromin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Norelgestromin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Norelgestromin Administration in the drug label.
Monitoring
There is limited information regarding Norelgestromin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Norelgestromin and IV administrations.
Overdosage
There is limited information regarding Norelgestromin 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 Norelgestromin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Norelgestromin Mechanism of Action in the drug label.
Structure
There is limited information regarding Norelgestromin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Norelgestromin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Norelgestromin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Norelgestromin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Norelgestromin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Norelgestromin How Supplied in the drug label.
Storage
There is limited information regarding Norelgestromin 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 Norelgestromin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Norelgestromin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Norelgestromin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Norelgestromin 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.