Levonorgestrel and Ethinyl estradiol

Levonorgestrel 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

Levonorgestrel and Ethinyl estradiol is a contraceptive agent that is FDA approved for the {{{indicationType}}} of contraception. Common adverse reactions include acne, increased weight,nausea, vomiting, headache, migraine, anxiety, depression, mood swings, panic attack, break-through bleeding, breast tenderness, dysmenorrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Levonorgestrel 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 Levonorgestrel and Ethinyl estradiol in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Levonorgestrel 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 Levonorgestrel and Ethinyl estradiol in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

Combination oral contraceptives should not be used in women with any of the following conditions:

• Thrombophlebitis or thromboembolic disorders
• A history of deep-vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or past history)
• Valvular heart disease with thrombogenic complications
• Thrombogenic rhythm disorders
• Hereditary or acquired thrombophilias
• Major surgery with prolonged immobilization
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Uncontrolled hypertension
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Hepatic adenomas or carcinomas, or active liver disease
• Known or suspected pregnancy
• Hypersensitivity to any of the components of Aviane

Warnings

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• To achieve maximum contraceptive effectiveness, Aviane® (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Aviane - 28 is one orange tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days, according to the prescribed schedule. It is recommended that Aviane - 28 tablets be taken at the same time each day.

• The dispenser should be kept in the wallet supplied to avoid possible fading of the pills. If the pills fade, patients should continue to take them as directed.

During The First Cycle Of Use

• The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should be instructed to begin taking Aviane on either the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).

Sunday Start

• The patient is instructed to begin taking Aviane - 28 on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (orange) is taken that day. One orange tablet should be taken daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Aviane - 28 until an orange tablet has been taken daily for 7 consecutive days, and a nonhormonal backup method of birth control should be used during those 7 days.

Day 1 Start

• During the first cycle of medication, the patient is instructed to begin taking Aviane - 28 during the first 24 hours of her period (day one of her menstrual cycle). One orange tablet should be taken daily for 21 consecutive days, followed by one light-green inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within 3 days following discontinuation of orange tablets and may not have finished before the next pack is started. If medication is begun on day one of the menstrual cycle, no backup contraception is necessary. If Aviane - 28 tablets are started later than day one of the first menstrual cycle or postpartum, contraceptive reliance should not be placed on Aviane - 28 tablets until after the first 7 consecutive days of administration, and a nonhormonal backup method of birth control should be used during those 7 days.

After the First Cycle of Use

• The patient begins her next and all subsequent courses of tablets on the day after taking her last light-green tablet. She should follow the same dosing schedule: 21 days on orange tablets followed by 7 days on light-green tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a nonhormonal backup method of birth control until she has taken an orange tablet daily for 7 consecutive days.

Switching from Another Hormonal Method of Contraception

• When the patient is switching from a 21 day regimen of tablets, she should wait 7 days after her last tablet before she starts Aviane. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21 day regimen. When the patient is switching from a 28 day regimen of tablets, she should start her first pack of Aviane on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Aviane the next day. If switching from an implant or injection, the patient should start Aviane on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a nonhormonal backup method of birth control for the first 7 days of tablet taking.

If Spotting or Breakthrough Bleeding Occurs

• If spotting or breakthrough bleeding occur, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician.

Risk of Pregnancy if Tablets are Missed

• While there is little likelihood of ovulation occurring if only one or two orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled orange tablets are missed. Although the occurrence of pregnancy is unlikely if Aviane is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

• The risk of pregnancy increases with each active (orange) tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.

Use After Pregnancy, Abortion or Miscarriage

• Aviane may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a nonhormonal backup method for the first 7 days of tablet taking.

• Aviane may be initiated immediately after a first trimester abortion or miscarriage. If the patient starts Aviane immediately, backup contraception is not needed.

Monitoring

• If women with hypertension elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued.
• Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.
• Oral contraceptives should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

IV Compatibility

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

Overdosage

• Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

Pharmacology

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Levonorgestrel and Ethinyl estradiol 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 Levonorgestrel and Ethinyl estradiol Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Levonorgestrel 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.