Norethindrone acetate and Ethinyl estradiol: Difference between revisions
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|authorTag={{DB}} | |authorTag={{DB}} | ||
|genericName=Norethindrone acetate and Ethinyl estradiol | |genericName=Norethindrone acetate and Ethinyl estradiol | ||
|blackBoxWarningTitle= | |indication=acne-contraception, contraception, moderate to severe abnormal vasomotor function in menopause, postmenopausal osteoporosis, in women with an intact uterus | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;"> | |adverseReactions=abdominal cramps, abdominal pain, bloating symptom, nausea | ||
headache, break-through bleeding, pain of breast | |||
|blackBoxWarningTitle=<span style="color:#FF0000;">Cigarette smoking and cardiovascular risk</span> | |||
|blackBoxWarningBody=<i><span style="color:#FF0000;">Cigarette smoking and cardiovascular risk:</span></i> *Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. | |||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Norethindrone acetate and Ethinyl estradiol tablet in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Norethindrone acetate and Ethinyl estradiol tablet in adult patients. | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Norethindrone acetate and Ethinyl estradiol tablet in adult patients. | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Norethindrone acetate and Ethinyl estradiol tablet in adult patients. | ||
Revision as of 18:55, 6 October 2014
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
Norethindrone acetate and Ethinyl estradiol is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of acne-contraception, contraception, moderate to severe abnormal vasomotor function in menopause, postmenopausal osteoporosis, in women with an intact uterus. Common adverse reactions include abdominal cramps, abdominal pain, bloating symptom, nausea headache, break-through bleeding, pain of breast.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Norethindrone acetate and Ethinyl estradiol FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Norethindrone acetate and Ethinyl estradiol tablet in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Norethindrone acetate and Ethinyl estradiol tablet in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Norethindrone acetate and Ethinyl estradiol 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 Norethindrone acetate and Ethinyl estradiol tablet in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Norethindrone acetate and Ethinyl estradiol tablet in pediatric patients.
Contraindications
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Contraindications in the drug label.
Warnings
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Norethindrone acetate 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 Norethindrone acetate and Ethinyl estradiol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Norethindrone acetate and Ethinyl estradiol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Norethindrone acetate and Ethinyl estradiol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol in geriatric settings.
Gender
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Norethindrone acetate and Ethinyl estradiol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Norethindrone acetate and Ethinyl estradiol in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Administration in the drug label.
Monitoring
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Norethindrone acetate and Ethinyl estradiol and IV administrations.
Overdosage
There is limited information regarding Norethindrone acetate 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 Norethindrone acetate and Ethinyl estradiol Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Mechanism of Action in the drug label.
Structure
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Structure in the drug label.
Pharmacodynamics
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Clinical Studies in the drug label.
How Supplied
There is limited information regarding Norethindrone acetate and Ethinyl estradiol How Supplied in the drug label.
Storage
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Norethindrone acetate and Ethinyl estradiol |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Norethindrone acetate and Ethinyl estradiol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Norethindrone acetate and Ethinyl estradiol Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Norethindrone acetate and Ethinyl estradiol tablet 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 Norethindrone acetate and Ethinyl estradiol Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Norethindrone acetate 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.