How long does it take for norethindrone to work?

Norethindrone Tablets USP, 0.35 mg

DETAILED INFORMATION FOR THE PATIENT

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INTRODUCTION

This leaflet is about birth control pills that contain one hormone, a progestin. Please read this leaflet before you begin to take your pills. It is meant to be used along with talking with your doctor or clinic.

Progestin-only pills are often called “POPs” or “the minipill.” POPs have less progestin than the combined birth control pill (or “the pill”) which contains both an estrogen and a progestin.

HOW EFFECTIVE ARE POPS?

About 1 in 200 (0.5%) POPs users will get pregnant in the first year if they all take POPs perfectly (that is, on time, every day). About 1 in 20 (5%) “typical” POPs users (including women who are late taking pills or miss pills) gets pregnant in the first year of use. The following table will help you compare the efficacy of different methods.

HOW DO POPS WORK?

• They make the cervical mucus at the entrance to the womb (the uterus) too thick for the sperm to get through to the egg. • They prevent ovulation (release of the egg from the ovary) in about half the time. • They also affect other hormones, the fallopian tubes and the lining of the uterus.

YOU SHOULD NOT TAKE POPS

• If there is any chance you may be pregnant. • If you have breast cancer. • If you have bleeding between your periods which has not been diagnosed. • If you are taking certain drugs for epilepsy (seizures) or for TB. (See USING POPS WITH OTHER MEDICINES below.) • If you are hypersensitive or allergic to any component of this product. • If you have liver tumors, either benign or cancerous. • If you have acute liver disease.

RISKS OF TAKING POPS

WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your doctor or clinic immediately.

1. Ectopic pregnancy. An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.

2. Ovarian cysts. These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.

3. Cancer of the reproductive organs and breasts. Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.

4. Liver tumors. In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with combined oral contraceptives and liver cancers in studies in which a few women who developed these very rare cancers were found to have used combined oral contraceptives for long periods of time. There is insufficient data to determine whether POPs increase the risk of liver tumors.

SEXUALLY TRANSMITTED DISEASES (STDS)

WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as Chlamydia, gonorrhea, genital warts or herpes.

SIDE EFFECTS

1. Irregular bleeding. The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can also result in some spotting or bleeding.

2. Other side effects. Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare.

If you are concerned about any of these side effects, check with your doctor or clinic.

USING POPS WITH OTHER MEDICINES

Before taking a POP, inform your health care provider of any other medication, including over-the-counter medicine, that you may be taking.

If you are taking medicines for seizures (epilepsy) or tuberculosis (TB), tell your doctor or clinic. These medicines can make POPs less effective:

Medicines for seizures:

• Phenytoin (Dilantin® )

• Carbamazepine (Tegretol ®)

• Phenobarbital

Medicine for TB:

• Rifampin (Rifampicin)

Before you begin taking any new medicines be sure your doctor or clinic knows you are taking birth control pills that contain a progestin.

HOW TO TAKE POPS

IMPORTANT POINTS TO REMEMBER

• POPs must be taken at the same time every day, so choose a time and then take the pill at the same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant. • Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready. • You may have some menstrual spotting between periods. Do not stop taking your pills if this happens. • If you vomit soon after taking a pill, use a backup method (such as condom and/or spermicide) for 48 hours. • If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don’t wish to become pregnant, be certain to use another birth control method. • If you are not sure about how to take POPs, ask your doctor or clinic.

STARTING POPS

• It’s best to take your first POP on the first day of your menstrual period. • If you decide to take your first POP on another day, use a backup method (such as condom and/or spermicide) every time you have sex during the next 48 hours. • If you have had a miscarriage or an abortion, you can start POPs the next day.

IF YOU ARE LATE OR MISS TAKING YOUR POPS

• If you are more than 3 hours late or you miss one or more POPs:

1. TAKE a missed pill as soon as you remember that you missed it,

2. THEN go back to taking POPs at your regular time,

3. BUT be sure to use a backup method (such as condom and/or spermicide) every time you have sex for the next 48 hours.

• If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your doctor or clinic.

IF YOU ARE BREASTFEEDING

• If you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery. • If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery.

IF YOU ARE SWITCHING PILLS

• If you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected. • If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished. • If you switch to another brand of POPs, start the new brand anytime. • If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery.

PREGNANCY WHILE ON THE PILL

If you become pregnant, or think you might be, stop taking POPs and contact your physician. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don’t need when you are pregnant.

You should get a pregnancy test:

• If your period is late and you took one or more pills late or missed taking them and had sex without a backup method. • Anytime you miss 2 periods in a row.

WILL POPS AFFECT YOUR ABILITY TO GET PREGNANT LATER?

If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.

BREASTFEEDING

If you are breastfeeding, POPs will not affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported. If you suspect that you are not producing enough milk for your baby, contact your doctor or clinic.

OVERDOSE

No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.

OTHER QUESTIONS OR CONCERNS

WARNING: Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions.

If you have any questions or concerns, check with your doctor or clinic. You can also ask for the more detailed “professional package labeling” written for doctors and other health care providers.

HOW TO STORE YOUR POPS

Store at 20° to 25°C (68° to 77°F).

This product’s label may have been updated. For current package insert and further product information, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX.)

Keep out of reach of children.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Manufactured by:

Mylan Laboratories Limited

Ahmedabad- 382 213, India

Code No.: GUJ-DRUGS/G/28/1297

Revised: 1/2017

FC:OT:7292:R3

Nearly 13,000 cartons of Fayosim birth control pills are being recalled because they do not meet specifications and could be less effective at preventing pregnancy than expected.

The FDA announced the Fayosim recall on March 22, indicating that the combination birth control pills failed an ingredient stability test, which may mean that women taking the pills face a risk of becoming pregnant without intending to.

Fayosim is a birth control product that combines levonorgestrel and ethanol estradiol, which are taken on a 90-day cycle, or three months at a time, to regulate a woman’s period. This often results in a woman having only four periods per 12 months. Fayosim can also be taken for other conditions such as to help reduce premenstrual symptoms, decrease the risk of ovarian cysts, and reduce acne.

According to the FDA recall report, the pills were pulled from the market due to “Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01 mg at 12 month long term stability study.”.

The recalled Fayosim pills contain a combination of levonorgestrel and ethanol estradiol at strengths of 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, and 0.15 mg/0.03 mg pills within the pack. Each package contains one extended-cycle wallet of 91 tablets with one pouch per carton. The recall includes lot number L800016 with an expiration of 12/2019 and lot number L800721 with and expiration date of 05/2020.

The recall affects more than 12,500 cartons manufactured by Lupin Ltd. at the Pithampur facility in Madhya Pradesh and distributed by Lupin Pharmaceuticals Inc. in Baltimore, Maryland.

This has been classified as a class II recall, which means the FDA believes use of the product or exposure to the product may cause “temporary or medically reversible adverse health consequences” or a remote risk of serious adverse health effects.

Women taking Fayosim should not stop taking the birth control pills, but should contact their doctor immediately to discuss replacing the pills or an alternative form of birth control. Backup contraceptive methods should also be used in the meantime to prevent unintended pregnancy.

Consumers can report any side effects linked to the use of recalled Fayosim to the FDA MedWatch Adverse Event Reporting Program.

Aygestin

Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

  • Aygestin
  • Camila
  • Crinone
  • Errin
  • First-Progesterone VGS
  • Jolivette
  • Megace
  • Megace ES
  • Next Choice
  • Ovrette
  • Plan B
  • Prochieve
  • Prometrium

In Canada

  • Alti-Mpa
  • Megace Os
  • Option 2

Available Dosage Forms:

  • Tablet
  • Suspension
  • Gel/Jelly
  • Capsule, Liquid Filled
  • Capsule
  • Suppository
  • Kit

Uses for Aygestin

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

  • To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. .
  • To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body.
  • To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT).
  • To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs.
  • To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle.
  • To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell’s ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor.
  • To test the body’s production of certain hormones such as estrogen.
  • To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor’s prescription.

Before using Aygestin

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breastfeeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother’s breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Interactions with medicines

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

  • Boceprevir
  • Dofetilide
  • Tranexamic Acid

Using medicines in this class 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
  • Aprepitant
  • Aprobarbital
  • Bosentan
  • Butabarbital
  • Butalbital
  • Carbamazepine
  • Ceritinib
  • Conivaptan
  • Dabrafenib
  • Darunavir
  • Dexamethasone
  • Efavirenz
  • Encorafenib
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Eterobarb
  • Etravirine
  • Felbamate
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Griseofulvin
  • Heptabarbital
  • Hexobarbital
  • Isotretinoin
  • Ivosidenib
  • Lesinurad
  • Lixisenatide
  • Lumacaftor
  • Mephobarbital
  • Methohexital
  • Mitotane
  • Modafinil
  • Nafcillin
  • Netupitant
  • Nevirapine
  • Oxcarbazepine
  • Pentobarbital
  • Phenobarbital
  • Phenytoin
  • Pitolisant
  • Prednisone
  • Primidone
  • Rifabutin
  • Rifampin
  • St John’s Wort
  • Sugammadex
  • Theophylline
  • Thiopental
  • Tizanidine
  • Topiramate
  • Ulipristal

Interactions with food/tobacco/alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Epilepsy (or history of) or
  • Heart or circulation problems or
  • Kidney disease (severe) or
  • Migraine headaches—Progestins may cause fluid retention which may cause these conditions to become worse.
  • Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding—May make diagnosis of these problems more difficult.
  • Blood clots, or history of or
  • Breast cancer, or history of or
  • Deep vein thrombosis (blood clot in the leg), active or history of or
  • Heart attack, active or history of or
  • Liver disease, including jaundice, or history of or
  • Pulmonary embolism (clot in the lung), active or history of or
  • Stroke , active or history of or
  • Venous thromboembolism (clot in the veins), or history of—Progestins should not be used in patients with these conditions.
  • Breast disease (such as breast lumps or cysts), history of—May make this condition worse for diseases that do not react in a positive way to progestins.
  • Diabetes mellitus—May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem.
  • Memory loss (dementia)—May make this condition worse.
  • Vision changes—This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse.

Proper use of progestin

This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Aygestin. Please read with care.

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

Dosing

The dose medicines in this class 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 these medicines. 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 medroxyprogesterone

  • For oral dosage form (tablets):
    • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
      • Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor.
    • For preparing the uterus for the menstrual period:
      • Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor.
    • For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
      • Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them.
  • For intramuscular injection dosage form:
    • For treating cancer of the kidneys or uterus:
      • Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month.
  • For subcutaneous injection dosage form:
    • For treating pain related to endometriosis:
      • Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years.
    For megestrol

  • For oral dosage form (suspension):
    • For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS):
      • Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months.
  • For oral dosage form (tablets):
    • For treating cancer of the breast:
      • Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months.
    • For treating cancer of the uterus:
      • Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months.
    • For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer:
      • Adults and teenagers—400 to 800 milligrams (mg) a day.
    For norethindrone

  • For oral dosage form (tablets):
    • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
      • Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed.
    • For treating endometriosis:
      • Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time.
    For progesterone

  • For oral dosage form (capsules):
    • For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
      • Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month.
    • For treating unusual stopping of menstrual periods (amenorrhea):
      • Adults—400 milligrams (mg) per day at bedtime for ten days.
  • For vaginal dosage form (gel):
    • For treating unusual stopping of menstrual periods (amenorrhea):
      • Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed.
    • For use with infertility procedures:
      • Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks.
  • For injection dosage form:
    • For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
      • Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine.
  • For vaginal dosage form (suppositories):
    • For maintaining a pregnancy (at ovulation and at the beginning of pregnancy):
      • Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks.

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.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose 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.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions while using Aygestin

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Unusual or unexpected 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 menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

  • If unusual or unexpected vaginal bleeding continues for an unusually long time.
  • If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Aygestin side effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare

  • Symptoms of blood clotting problems, usually severe or sudden, such as:
  • headache or migraine
  • loss of or change in speech, coordination, or vision
  • numbness of or pain in chest, arm, or leg
  • unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common

  • Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods)
  • symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)

Less common

  • Mental depression
  • skin rash
  • unexpected or increased flow of breast milk

Rare

For megestrol—During chronic treatment

  • Backache
  • dizziness
  • filling or rounding out of the face
  • irritability
  • mental depression
  • nausea or vomiting
  • unusual decrease in sexual desire or ability in men
  • unusual tiredness or weakness

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

  • Abdominal pain or cramping
  • bloating or swelling of ankles or feet
  • blood pressure increase (mild)
  • dizziness
  • drowsiness (progesterone only)
  • headache (mild)
  • mood changes
  • nervousness
  • pain or irritation at place of injection site
  • swelling of face, ankles, or feet
  • unusual or rapid weight gain

Less common

  • Acne
  • breast pain or tenderness
  • brown spots on exposed skin, possibly long-lasting
  • hot flashes
  • loss or gain of body, facial, or scalp hair
  • loss of sexual desire
  • trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol

  • Dizziness
  • nausea or vomiting
  • unusual tiredness or weakness
  • Delayed return to fertility
  • stopping of menstrual periods
  • unusual menstrual bleeding (continuing)

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.

Further information

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

About norethindrone

Type of medicine Progestin (female hormone)
Used for Endometriosis, painful or heavy menstrual periods
Also called Aygestin®
Available as Tablets

Norethindrone (also known as norethisterone) is a man-made form of progesterone, a naturally occurring female sex hormone. It is referred to as a progestin and it has a number of uses. Low doses are used to prevent pregnancy, or as hormone replacement therapy (HRT). Medium-strength tablets (5 mg) such as Aygestin® are used to treat heavy and painful menstrual periods particularly if they are associated with a condition called endometriosis. Aygestin® tablets are also used to treat endometriosis itself. Higher doses are used in the treatment of some female cancers, such as breast cancer.

Endometriosis is a condition where tissue which is normally only found inside the womb (uterus), becomes ‘trapped’ in other parts of the body, often in the pelvic area or lower abdomen. This causes symptoms such as painful and heavy periods. Treatment aims to reduce the pain and amount of blood loss. Norethindrone can also be considered for heavy periods not associated with endometriosis.

This leaflet discusses norethindrone when it is used to treat endometriosis or painful or heavy periods. There are a number of other medicine leaflets which will give you more information about norethindrone if you are taking it for birth control or as HRT. These are: Progestin-only contraceptive tablets, Combination oral contraceptives and Estrogen and progestin for HRT.

Before taking norethindrone

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking norethindrone it is important that your physician knows:

  • If you are pregnant or breast-feeding.
  • If you have any problems with the way your liver works, or any kidney problems.
  • If you have heart or blood vessel problems, or if you have ever had a blood clot in an artery or vein.
  • If you have any of the following: diabetes, epilepsy, migraine, high blood pressure (hypertension), or asthma.
  • If you smoke, are overweight or have high cholesterol levels.
  • If you have ever had cancer.
  • If you have ever had a depressive illness.
  • If you have ever had yellowing of your skin or the whites of your eyes (jaundice), severe itching, or a skin condition called pemphigoid gestationis during a pregnancy.
  • If you have a rare inherited blood disorder called porphyria.
  • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine.

How to take norethindrone tablets

  • Before you start this treatment, read the manufacturer’s printed information leaflet from inside your pack. The manufacturer’s leaflet will give you more information about norethindrone and a full list of side-effects which you may experience from taking it.
  • Take norethindrone exactly as your physician tells you to. You may be asked to take the tablets regularly each day, or to take them just on certain days of your monthly cycle. This information will be printed on the label of your pack of tablets to remind you, but if you are still unsure ask your pharmacist for further advice.
  • For treatment of endometriosis it is usual to start with a low dose of half to one tablet (2.5 mg-5 mg) each day. Your physician will ask you to increase your dose slightly every two weeks until you are taking three tablets (15 mg) each day.
  • If you are taking norethindrone for painful or heavy menstrual periods, the usual dose is between half and two tablets each day (2.5 mg-10 mg) for five to ten days in each menstrual cycle.
  • Swallow the tablets with a drink of water. You can take norethindrone tablets either before or after meals.
  • Try to take your doses at the same times of day, as this will help you to remember to take them.
  • If you do forget to take a dose at your usual time, take it as soon as you remember, unless it is nearly time for your next dose in which case leave out the forgotten dose. Remember to take your next dose when it is due but do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

  • Try to keep all your regular appointments with your physician. This is so your physician can check on your progress.
  • You should avoid getting pregnant as norethindrone can affect a developing baby. Use barrier methods of birth control (such as a condom) if you have sex whilst taking norethindrone. If you need further birth control (contraception) advice, speak with your physician.
  • If you have diabetes you may need to check your blood sugar (glucose) more frequently, as norethindrone can affect the levels of sugar in your blood. Your physician will be able to advise you about this.
  • If you are due to have surgery or any medical treatment, tell the person carrying out the treatment that you are taking norethindrone.

Can norethindrone cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with norethindrone. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your physician or pharmacist if any of the following continue or become troublesome.

Common norethindrone side-effects What can I do if I experience this?
Shorter menstrual periods, no periods, breakthrough bleeding, ‘spotting’ Your physician will discuss this with you before you start treatment
Nausea Stick to simple meals – avoid rich and spicy foods. If you are not already doing so, try taking the tablets after a meal
Headache Ask your pharmacist to recommend a suitable painkiller. If the headache is unusually severe or continues, speak with your physician straightaway
Bloating, fluid retention If troublesome, speak with your physician
Less common norethindrone side-effects What can I do if I experience this?
Feeling dizzy, breast tenderness, changes in weight, feeling tired or difficulty sleeping, feeling depressed, lack of interest in sex, skin reactions If any of these become troublesome, speak with your physician

Important: norethindrone can also have some serious side-effects, although these occur only rarely. If you experience any of the following symptoms, stop taking the tablets and contact your physician for advice straightaway:

  • Any feeling of pain or tightness in your chest.
  • Any disturbances of your vision or hearing.
  • Any unusually severe headaches.
  • Any yellowing of your skin or the whites of your eyes (jaundice).

If you experience any other symptoms which you think may be due to this medicine, speak with your physician or pharmacist.

How to store norethindrone tablets

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the Emergency Room of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

If you buy any medicines ‘over the counter’, always check with a pharmacist that they are suitable to take with your other medicines.

Do not keep out-of-date or unwanted medicines. Ask your pharmacist about ways to dispose of medicines safely in your local area.

If you have any questions about this medicine ask your pharmacist.

Norethindrone 0.35mg

Always Be Ready. Affordable Birth Control

This progestin-only (POP) birth control pill does not contain estrogen. It is an alternative for women who cannot take an estrogen-based hormone due to their health history or issues, sensitivity to estrogen or are advised not to take hormonal contraceptives with estrogen because they are over age 35 and smoke.

What Is Norethindrone 0.35mg?

This POP pill, also known as the mini pill, contains .35mg of norethindrone, a synthetic version of the sex hormone progesterone. There are several different progestins used in hormonal birth control. Lab-made progestins are isolated and weakened forms of progesterone.

Norethindrone is a daily birth control pill, which means it is taken every day. Each pack has 28 pills. Seven of the pills are inactive and are used as reminder pills.

Norethindrone has just enough properties of progesterone to prevent the hypothalamus from sensing a need for more progesterone. A a result, the ovaries do not surge production of progesterone that is necessary to create an optimum environment for fertilization and attachment of the egg to the uterine lining.

Progestin-Only vs Combined Birth Control Pills

A POP pill contains only a progestin. A Combined Oral Contraceptive (COC) contains an estrogen and a progestin.

Why Does It Matter If Take A POP Or A Combo Pill?

If any of these conditions apply to you, a POP birth control pill may be a better choice for you than a combination birth control pill:

  • Over 35 who smoke
  • Have experienced unpleasant side effects from estrogen
  • Are breastfeeding
  • Have a history of certain types of cancers such as breast cancer
  • Are at risk for heart disease
  • Have high blood pressure
  • Have a history of blood clots
  • Have migraines with aura

How Do I Take Norethindrone?

Take the mini pill norethindrone once daily for 28 consecutive days. It is recommended to take the pill at the exact time each day. During the last week of your cycle, the last 7 pills will contain inactive ingredients. These placebos are included as a reminder to take the pill each day.

How Effective Is The Mini Pill?

Although no contraceptive is 100% effective, norethindrone .35mg is considered 99% effective at preventing pregnancy when it is taken exactly as instructed. Studies show that near perfect medication use puts the mini pill’s effectiveness at 91%.

What If I Miss A Dose Of The Mini Pill?

Refer to your patient information package but this is a guideline for one missed dose. If it is within 3 hours of your regularly scheduled time, take the pill ASAP but use a back up non-hormonal contraception for the next 48 hours. If you miss a dose and it is close to the time for your next scheduled dose do not take the missed pill. Just take the regularly scheduled pill.

What Are Off-Label Uses For Norethindrone?

  • Help reduce the risk of endometriosis
  • Alleviate menstrual migraines
  • Treat difficult symptoms of menopause
  • Hormone therapy
  • Reduce excess uterine bleeding
  • Suppress the overgrowth of the uterine lining in women on estrogen replacement therapy
  • Reduce pain during menstruation (dysmenorrhea)

What Can I Expect When Taking Norethindrone?

Refer to the patient pamphlet for a full list of possible side effects. A partial list includes

  • Less frequent periods
  • Weight change
  • Breast tenderness or swelling
  • Darkening of the skin
  • Worsening of acne
  • Increased hair growth

To ensure that we provide you with the best price, we may substitute one generic for another.

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