Norethindrone Acetate/Ethinyl Estradiol

Norethindrone Acetate/Ethinyl Estradiol is a prescription medication used for contraception and hormone replacement therapy.

• Norethindrone Acetate/Ethinyl Estradiol is available under the following different brand names: Femhrt, Jinteli, Loestrin 1.5/30, Loestrin 1/20, Microgestin 1.5/30, Microgestin 1/20, Junel 1.5/30, Junel 1/20, Larin 1/20, Larin 1.5/30, Fyavolv, Jevantique Lo, Hailey 1.5/30

Common side effects of the Norethindrone Acetate/Ethinyl Estradiol include:

• injection site reactions (redness, pain, bruising, irritation),
• tiredness,
• weakness,
• diarrhea,
• headache,
• dizziness,
• anxiety,
• trouble sleeping (insomnia),
• constipation,
• stomach pain,
• nausea and vomiting (may be severe),
• loss of appetite,
• joint or muscle pain, or
• cold symptoms such as stuffy nose, sneezing, or sore throat.

Serious side effects of the Norethindrone Acetate/Ethinyl Estradiol include:

• nausea,
• vomiting,
• breast tenderness,
• breakthrough bleeding,
• headache, and
• problems with contact lenses.

Rare side effects of the Norethindrone Acetate/Ethinyl Estradiol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult  dosage

Tablet, hormone replacement

• 0.5 mg /2.5 mcg (Femhrt, Fyavolv, Jevantique Lo)
• 1 m g/5 mcg (Jinteli, Fyavolv)

Tablet, monophasic

• 1 mg / 20 mcg (Larin 1/20, Loestrin 1/20, Microgestin 1/20, Junel 1/20)
• 1.5 mg /30 mcg (Hailey 1.5/30, Larin 1.5/30, Loestrin 1.5/30, Microgestin 1.5/30, Junel 1.5/30)

Contraception

Adult dosage

Monophasic formulation

• Take 1 tablet orally every day for days 1-21, then take 1 inert tablet every day (or no tablets) for days 22-28, and then restart the new pill pack

Biphasic formulation

• Take 1 tablet orally every day for days 1-10, then take another tablet every day with a different hormone combination ratio for days 11-21; then take 1 inert tablet every day for days 22-28

Triphasic formulation

• Take 1 tablet orally every day for days 1-7; then take another tablet every day with a different hormone combination ratio for days 8-16; then take 1 tablet of the original form

Hormone Replacement Therapy

Adult dosage

• 1 tablet (Femhrt 0.5 mg norethindrone/2.5 mcg Ethinyl estradiol) orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Norethindrone Acetate/Ethinyl Estradiol has severe interactions with the following drugs:
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tranexamic acid oral
• Norethindrone Acetate/Ethinyl Estradiol has serious interactions with at least 69 other drugs.
• Norethindrone Acetate/Ethinyl Estradiol has moderate interactions with at least 154 other drugs.
• Norethindrone Acetate/Ethinyl Estradiol has minor interactions with at least 27 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Active or history of breast cancer
• Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• Jaundice with prior oral contraceptive use

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Norethindrone Acetate/Ethinyl Estradiol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Norethindrone Acetate/Ethinyl Estradiol?”

Cautions

• Acitretin inhibits the contraceptive efficacy of norethindrone preparations
• Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery
• Discontinue 4 weeks before major surgery or prolonged immobilization
• Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
• Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk; a woman's risk depends on conditions where naturally high hormone levels persist for long periods including early-onset menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity
• Increased risk of cervical cancer with OCP use, however, HPV remains the main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk
• Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease the risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

Pregnancy and Lactation

• Do not use it in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist
• Lactation
  • Small amounts of steroids are excreted in breast milk; estrogens may reduce the quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)