Lyza (Oral)

Norethindrone is used to prevent pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept sperm, which prevents fertilization (pregnancy).

Norethindrone is also used to treat secondary amenorrhea (the absence of menstrual periods in women who have had periods before and are not pregnant), endometriosis, and irregular menstrual periods caused by hormonal imbalance.

No contraceptive method is 100 percent effective. Birth control methods like surgery to become sterile or abstaining from sex are more effective than birth control pills. Discuss your birth control options with your doctor.

This medicine does not protect against HIV infection or other sexually transmitted diseases. It will not work as emergency contraception after unprotected sex.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working correctly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors may want to see you more often. You may need a pelvic exam, breast exam, and mammogram (breast x-ray) to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.

Even though you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you might be pregnant while using the medicine, tell your doctor right away.

Vaginal bleeding of different amounts may happen between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when it is slight, or breakthrough bleeding when it is heavier.

• If this occurs, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding lasts more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives as directed for more than 3 months, check with your doctor.

Contact your doctor right away if you miss a menstrual period. Missed periods may happen if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You may need a pregnancy test.

If you think you might be pregnant, stop using this medicine immediately and check with your doctor.

Consult your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination, and your doctor may change your prescription.

You may have a higher risk of developing an ovarian cyst or an ectopic pregnancy (which occurs outside the womb) if you become pregnant while using this medicine. These can be serious and life-threatening conditions. They can also cause issues that may make it harder for you to become pregnant in the future. Call your doctor right away if you experience sudden or severe lower abdominal or stomach pain.

Do not use this medicine if you smoke cigarettes. Smoking while using birth control pills increases your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Discuss ways to stop smoking with your doctor. Keep your diabetes under control. Ask your doctor about diet and exercise to manage your weight and blood cholesterol levels.

Contact your doctor immediately if you have trouble wearing contact lenses or if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

Before you undergo any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of some tests may be influenced by this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how Ortho Micronor® tablets affect children. However, no specific problems are expected that would limit the use of this medicine in teenagers. This medicine can be used for birth control in teenage females but should not be used before menstruation starts.

Using norethindrone acetate tablets is not recommended in children.

Geriatric

There have not been appropriate studies on how norethindrone affects older adults. This medicine should not be used in elderly women.

Breast Feeding

Studies suggest that this medication poses minimal risk to infants when used during breastfeeding.

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together, but your doctor may need to adjust doses or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and may not be a complete list.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Clobazam
• Cloxacillin
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Doxycycline
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Voxilaprevir

Using this medicine with any of the following may increase the risk of certain side effects, but using both may be necessary for treatment. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Imipramine
• Lamotrigine
• Licorice
• Lorazepam
• Parecoxib
• Selegiline
• Temazepam
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around meal times since interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are important and may not be a complete list.

Using this medicine with any of the following may increase the risk of certain side effects, but may be necessary in some cases. If used together, your doctor may adjust the dose or give special instructions about food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Abnormal or unusual vaginal bleeding or
• Breast cancer, active or history of or
• Liver disease (e.g., liver tumor or cancer)—Should not be used in patients with these conditions.

• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or history of or
• Heart attack, history of or
• Stroke, history of—Norethindrone acetate tablets should not be used in patients with these conditions.

• Diabetes or
• Hypercholesterolemia (high cholesterol or fats in the blood) or
• Hypertension (high blood pressure) or
• Obesity, or history of or
• Systemic lupus erythematosus (SLE, autoimmune disorder)—These conditions may increase the risk of serious side effects.

• Depression, history of or
• Heart disease or
• Kidney disease or
• Migraine headaches or
• Seizures—Use with caution. May worsen these conditions.

• Diabetes or
• Ovarian cyst—Use with caution. Ortho Micronor® may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical help.

Check with your doctor right away if any of the following side effects occur:

More common

• Frequent and irregular bleeding
• Changes in your menstrual cycle

Incidence not known

• Blindness
• Blue-yellow color blindness
• Blurred vision
• Breast pain
• Changes in your menstrual period
• Changes in vision
• Chest tightness
• Chills
• Clay-colored stools
• Confusion
• Cough
• Dark urine
• Decreased vision
• Diarrhea
• Difficulty swallowing
• Feelings of discouragement
• Dizziness
• Double vision
• Eye pain
• Fast heartbeat
• Feeling sad or empty
• Fever
• General tiredness and weakness
• Headache
• Heavy non-menstrual vaginal bleeding
• Hives, itching, or rash
• Irritability
• Lack of appetite
• Light-colored stools
• Light vaginal bleeding between regular menstrual periods
• Loss of interest or pleasure
• Migraine headache
• Nausea and vomiting
• Numbness in the hands
• Pain, redness, or swelling in the arm or leg
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Stomach pain
• Swelling
• Trouble concentrating
• Trouble sleeping
• Unpleasant breath odor
• Unusual tiredness or weakness
• Upper right abdominal or stomach pain
• Vomiting blood
• Yellowing of the eyes and skin

Some side effects may happen that usually do not need medical attention. These side effects might go away during treatment as your body gets used to the medicine. Your health care professional may also have suggestions on how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Breast tenderness
• Increased hair growth, especially on the face
• Pimples
• Weight gain

Incidence not known

• Brown, blotchy spots on exposed skin
• Enlarged breasts
• Loss or thinning of hair
• Mood swings
• Nervousness
• Weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Aygestin
• Camila
• Errin
• Jolivette
• Lyza
• Nora-BE
• Nor-QD
• Ortho Micronor

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive, Progestin

Pharmacologic Class: Progestin

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using Ortho Micronor®:

• This medicine is available in a blister card with a tablet dispenser. Each blister card contains 28 tablets.
• Take this medicine at the same time each day. You may take it with or without food.
• Start the next pack the day after the last pack is finished. There is no break between packs.
• Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start). When you begin on another day, you need to use another form of birth control (eg, condom, spermicide) for the first 48 hours. If you have a miscarriage or an abortion, you may start the taking the pill on the next day.
• You may have light bleeding or spotting when you first take the pill.

If you are switching from combined pills to using Ortho Micronor®, take the medicine the day after you finish the last active combined pill. Do not take any 7 inactive pills from your previous birth control pack.

If you are switching from a progestin-only pill to using combined pills, take the medicine on the first day of your period, even if your progestin-only pill pack is not finished.

If you are switching to another brand, you may start taking it anytime.

If you are breastfeeding, you may switch to another birth control method any time, except do not switch to the combined pills until you stop breastfeeding or at least 6 months after delivery.

If you are fully breastfeeding (no formula), you may start your pills 6 weeks after delivery. If you are partially breastfeeding (with some formula), you may start taking your pills 3 weeks after delivery.

If you have a miscarriage or abortion, you may take the pills the next day.

Take this medicine at least 5 days after using ulipristal acetate. Use another form of birth control (eg, condom, spermicide) until your next menstrual period.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For contraception (to prevent pregnancy): Adults and teenagers—One tablet taken at the same time each day for 28 days. Children—Use and dose must be determined by your doctor. For treatment of secondary amenorrhea or abnormal vaginal bleeding: Adults—2.5 to 10 milligrams (mg) once a day for 5 to 10 days. Children—Use is not recommended. For treatment of endometriosis: Adults—At first, 5 milligrams (mg) once a day for 2 weeks. Your doctor may increase your dose by 2.5 mg per day every 2 weeks up to 15 mg per day for 6 to 9 months. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully, and call your doctor if you have any questions.

If you miss a dose, and it is more than 3 hours from your scheduled dose, take the pill as soon as you can, then take your next pill at the next regular time. Use a second form of birth control (eg, condom, spermicide) for the next 48 hours.

If you vomit after taking the pills, use another form of birth control for the next 48 hours.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.