Description
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 a sperm and fertilization (pregnancy) is prevented.
Norethindrone is also used to treat secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), endometriosis, and irregular menstrual periods caused by hormonal imbalance.
No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.
This medicine does not protect against HIV infection or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies on the relationship of age to the effects of Ortho Micronor® tablets have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
Use of norethindrone acetate tablets is not recommended in children.
Geriatric
Appropriate studies on the relationship of age to the effects of norethindrone have not been performed in the geriatric population. This medicine should not be used in elderly women.
Breastfeeding
Substance Name
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Substance Name
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Dasabuvir
- Fezolinetant
- Ombitasvir
- Paritaprevir
- Ritonavir
- Tranexamic Acid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amitriptyline
- Atazanavir
- Atorvastatin
- Clomipramine
- Diazepam
- Doxepin
- Imipramine
- Lamotrigine
- Licorice
- Lorazepam
- Parecoxib
- Selegiline
- Temazepam
- Triazolam
- Valdecoxib
- Voriconazole
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Tobacco
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Breast cancer, active or history of or
- Liver disease (eg, liver tumor or cancer)—Should not be used in patients with these conditions.
- Blood clots (eg, 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 risk for more serious side effects.
- Depression, history of or
- Heart disease or
- Kidney disease or
- Migraine headaches or
- Seizures—Use with caution. May make these conditions worse.
- Diabetes or
- Ovarian cyst—Use with caution. Ortho Micronor® may make these conditions worse.
Proper Use
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.
- For contraception (to prevent pregnancy):
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
Although 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 have become pregnant while using the medicine, tell your doctor right away.
Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.
- If this should occur, continue with your regular dosing schedule.
- The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
- If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.
Check with your doctor right away if you miss a menstrual period. Missed periods may occur 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 might need a pregnancy test.
If you suspect that you may be pregnant, stop using this medicine immediately and check with your doctor.
Check with 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 an ovarian cyst or an ectopic pregnancy (occurs outside the womb) if you get pregnant while using this medicine. These can be serious and life-threatening conditions. It can also cause problems that may make it harder for you to become pregnant in the future. Call your doctor right away if you have a sudden or severe lower abdominal or stomach pain.
Do not use this medicine if you smoke cigarettes. If you smoke while using birth control pills, you increase 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. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
Check with your doctor immediately if you have trouble wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Frequent and irregular bleeding
- menstrual changes
Incidence not known
- Blindness
- blue-yellow color blindness
- blurred vision
- breast pain
- changes in menstrual period
- changes in vision
- chest tightness
- chills
- clay-colored stools
- confusion
- cough
- dark urine
- decreased vision
- diarrhea
- difficulty with swallowing
- 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 of 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 of blood
- yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce 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 the 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 healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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