leuprolide and norethindrone

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Pronunciation: LOO proe lide and NOR eth IN drone

Brand: Lupaneta Pack

What is the most important information I should know about leuprolide and norethindrone?

You should not use this medication if you have abnormal vaginal bleeding that has not been checked by a doctor, hormone-related cancer (such as breast or uterine cancer), uncontrolled or untreated high blood pressure, heart disease, a blood-clotting disorder, liver disease, or liver cancer.

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

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 overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of estrogen produced by the pituitary gland. Without enough estrogen, growth of endometrial tissue in the uterus slows down.

Norethindrone is a form of progesterone, a female hormone. Norethindrone helps leuprolide in the treatment of endometriosis by causing changes in your cervical mucus and uterine lining.

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.

What should I discuss with my healthcare provider before using leuprolide and norethindrone?

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

  • abnormal vaginal bleeding that has not been checked by a doctor;
  • past or present hormone-related cancer such as breast or uterine cancer;
  • uncontrolled or untreated high blood pressure;
  • heart disease (coronary artery disease, heart valve disorder, history of heart attack, stroke, or blood clot);
  • a blood-clotting disorder or circulation problems;
  • liver disease or liver cancer; or
  • if you are pregnant or breast-feeding.

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

To make sure leuprolide and norethindrone is safe for you, tell your doctor if you have:

  • risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, history of hysterectomy);
  • low bone mineral density (or risk factors such as smoking, drinking more than 3 alcoholic beverages per day, having a family history of osteoporosis, or long-term use of certain medicines);
  • epilepsy;
  • migraine headaches;
  • kidney disease;
  • a history of depression; or
  • if you may become pregnant.

FDA pregnancy category X. Leuprolide can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Stop taking the norethindrone tablets and tell your doctor right away if you become pregnant during treatment.

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.

Use an intrauterine device (IUD) or a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether leuprolide and norethindrone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give norethindrone to anyone under 18 years old without medical advice.

How should I take leuprolide and norethindrone?

This medication is a combined treatment that includes a leuprolide injection and norethindrone tablets taken by mouth.

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

A healthcare provider will give you the leuprolide injection. You will take the norethindrone tablets at home.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

You may need frequent medical tests to help your doctor determine how long to treat you with leuprolide and norethindrone.

Leuprolide can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using leuprolide and norethindrone.

Call your doctor at once if your endometriosis symptoms get worse when you start using this medication.

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 remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

What are the possible side effects of leuprolide and norethindrone?

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

Stop taking the norethindrone tablets and call your doctor at once if you have:

  • sudden vision problems, sudden eye changes or discomfort, sudden and severe headache;
  • unusual thoughts or behavior, thoughts about suicide or hurting yourself;
  • swelling, rapid weight gain;
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • sudden numbness or weakness (especially on one side of the body), slurred speech, sudden problems with vision or balance, sudden cough, wheezing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs; or
  • chest pain or heavy feeling, pain spreading to the jaw or shoulder, general ill feeling.

Common side effects may include:

  • headache, depressed mood, weakness, lack of energy;
  • minor vaginal bleeding or spotting, vaginal discharge or itching;
  • feeling anxious or nervous;
  • nausea, vomiting, diarrhea, constipation;
  • sleep problems (insomnia);
  • hot flashes, weight gain; or
  • acne, increased sweating.

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.

What other drugs will affect leuprolide and norethindrone?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with leuprolide and norethindrone, especially:

  • seizure medication; or
  • steroids (prednisone and others).

Other drugs may interact with leuprolide and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about leuprolide and norethindrone.

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.

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