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Leuprolide and norethindrone

Generic name: leuprolide and norethindrone [ LOO-proe-lide-and-NOR-eth-IN-drone ]
Brand name: Lupaneta Pack
Dosage form: oral and injectable kit (11.25 mg-5 mg; 3.75 mg-5 mg)
Drug class: Sex hormone combinations

What is leuprolide and norethindrone?

Leuprolide and norethindrone is a combination medicine used to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus).

Leuprolide helps treat pain caused by endometriosis.

Norethindrone helps prevent thinning bones (a side effect of leuprolide).

Leuprolide and norethindrone is not for use in women who are older than 65.

Leuprolide and norethindrone may also be used for purposes not listed in this medication guide.

Warnings

You should not use leuprolide and norethindrone if you have: undiagnosed vaginal bleeding, liver disease or liver cancer, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant or breast-feeding.

Before taking this medicine

You should not use this medicine if you are allergic to leuprolide or norethindrone, or if you have:

  • abnormal vaginal bleeding that has not been checked by a doctor;

  • liver disease or liver cancer;

  • a history of heart attack, stroke, or blood clot; or

  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Tell your doctor if you have ever had:

You may need to have a negative pregnancy test before starting this treatment.

Do not use leuprolide and norethindrone if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor right away if you become pregnant.

Do not use a hormonal form of birth control (pills, injections, implants, skin patches, vaginal rings) to prevent pregnancy while you are receiving leuprolide injections. Use nonhormonal birth control such as a copper intrauterine device (IUD), or a condom or diaphragm with spermicide.

Leuprolide is likely to cause you not to ovulate or have menstrual periods during the 6-month treatment period. However, you may still be able to get pregnant.

Do not breast-feed while using this medicine.

Leuprolide and norethindrone is not approved for use by anyone younger than 18 years old.

How should I take leuprolide and norethindrone?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

This medication is a combined treatment that includes a leuprolide injection and norethindrone tablets taken by mouth. A healthcare provider will give you the leuprolide injection. You will take the norethindrone tablets at home.

Leuprolide is usually given as a single injection into a muscle every 1 to 3 months for up to 6 months. Norethindrone tablets are taken every day for 1 to 3 months after your leuprolide injection.

You may have worsening symptoms of endometriosis when you first start using leuprolide and norethindrone. Symptoms should improve as you continue to use the medicine. Call your doctor if your symptoms do not eventually begin to improve.

You will need frequent medical tests.

leuprolide and norethindrone can affect the results of certain medical tests. Tell any doctor who treats you that you are using leuprolide and norethindrone.

Store norethindrone tablets at room temperature away from moisture and heat.

Based on your response to leuprolide and norethindrone treatment, your doctor may want you to have a second 6-month treatment.

What happens if I miss a dose?

Take the missed norethindrone dose as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss an appointment for your leuprolide injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using leuprolide and norethindrone?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Leuprolide and norethindrone side effects

Get emergency medical help if you have signs of an allergic reaction: hives, skin redness, severe itching; fast or pounding heartbeats; sweating, feeling like you might pass out; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention if you have signs of a pituitary gland problem: headache, vision problems, vomiting, changes in your mental status, severe weakness, cold or clammy skin, weak pulse, or feeling like you might pass out.

Call your doctor at once if you have:

  • sudden vision problems, sudden eye changes or discomfort;

  • sudden and severe headache;

  • mood changes, depression;

  • swelling, rapid weight gain;

  • ongoing symptoms of endometriosis;

  • a seizure;

  • chest pain or pressure, pain spreading to your jaw or shoulder;

  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or

  • signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg, cough, wheezing, coughing up blood.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Leuprolide / norethindrone side effects (more detail)

Leuprolide and norethindrone dosing information

Usual Adult Dose for Endometriosis:

1-Month Depot Formulation:
-Initial dose: leuprolide: 3.75 mg IM once a month plus norethindrone 5 mg orally once a day

3-Month Depot Formulation:
-Initial dose: leuprolide: 11.25 mg IM every 3 months plus norethindrone 5 mg orally once a day

Maximum Initial Duration of Therapy: 6 months
-If symptoms of endometriosis recur after the initial course of therapy, may consider retreatment for up to another 6 months; bone density should be assessed before retreatment begins
Maximum Duration of Therapy: 12 months

Comments:
-Leuprolide should be administered by a healthcare provider.
-Duration of treatment is limited to 2 six-month courses due to concerns about adverse impact on bone mineral density.
-Leuprolide 1-month depot and 3-month depot formulations are not interchangeable due to release characteristics; 3 doses of the 3.75 mg formulation should not be used to mimic the effect of the 11.25 mg 3-month formulation.

Uses: For the management of initial and recurrent painful symptoms of endometriosis.

Detailed Leuprolide / norethindrone dosage information

What other drugs will affect leuprolide and norethindrone?

Tell your doctor about all your other medicines, especially:

  • seizure medication; or

  • steroids (prednisone and others).

This list is not complete. Other drugs may affect leuprolide and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Leuprolide / norethindrone drug interactions (more detail)

More about leuprolide / norethindrone

Patient resources

Other brands

Lupaneta Pack

Related treatment guides

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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