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All about: Norethindrone acetate

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Generic name: Norethindrone acetate
Brand names: Aygestin

Why is Norethindrone acetate prescribed?

Aygestin contains a type of hormone known as progesterone. It is used to restore menstruation in women who have stopped having menstrual cycles (also called amenorrhea). Aygestin can also help treat endometriosis, a condition where the endometrium (the lining of the uterus) doesn't shed properly and attaches to the outside of the uterus or other areas such as the ovaries or bowels. Aygestin also helps control unusual and heavy bleeding of the uterus caused by hormonal imbalance. However, the drug is not used to control bleeding caused by fibroids or cancer.

Most important fact about Norethindrone acetate

Aygestin increases the risk of blood clots, which can lead to phlebitis, breathing problems, vision problems, or stroke. If you experience any symptoms that might suggest the onset of a clot-related disorder--pain with swelling, warmth and redness in a leg vein, coughing or shortness of breath, loss of vision or double vision, migraine, or weakness or numbness in an arm or leg--stop taking Aygestin and see your doctor immediately.

How should you take Norethindrone acetate?

Take Aygestin as directed by your doctor.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

--Storage instructions...

Store at room temperature in a tightly closed container.

What side effects may occur?

All progesterone drugs are associated with certain side effects, none of which can be anticipated. If any side effects develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine whether it is safe for you to continue taking Aygestin.

  • Side effects caused by progesterone drugs may include:
    Acne, allergic reaction, blood clots in the arteries, veins, eyes, or lungs, breakthrough menstrual bleeding, breast enlargement or tenderness, bulging eye, depression, double vision, cervical changes or secretions, change in menstrual flow, headache, hives, inflammation of the optic nerve, insomnia, menstrual spotting, migraine, mood swings, nausea, rash with or without itchy spots, skin discoloration, stopping of menstrual flow, swelling, vision loss, weight increase or decrease, yellowing of the skin or eyes
  • Side effects caused by estrogen/progesterone combinations may include:
    Appetite changes, backache, blood pressure increase, bull's-eye rash, changes in appetite, changes in sex drive, dizziness, fatigue, hair growth or loss, headache, inflammation of the urinary tract, itching, nervousness, skin bruising, symptoms similar to premenstrual syndrome, red or tender skin nodules

Why should Norethindrone acetate not be prescribed?

Do not take Aygestin if you have ever had an allergic reaction to it.

Do not take Aygestin if you are pregnant or have had an incomplete miscarriage. Avoid it if you have ever had a blood clotting disorder or a stroke. Do not take Norethindrone acetate if you have breast cancer, unexplained vaginal bleeding, or severe liver disease.

Aygestin should not be used to test for pregnancy.

Special warnings about Norethindrone acetate

Remember that Aygestin can cause clot-related disorders. Check with your doctor immediately if you experience any of the warning signs listed in "Most important fact about Norethindrone acetate."

To rule out cancer and other problems before you start taking Aygestin, your doctor will give you a complete physical exam, including examination of your breasts and pelvic organs. You also should have a Pap test (cervical smear).

Aygestin may cause some degree of fluid retention. If you have a medical condition that could be made worse by fluid retention--such as epilepsy, migraine, asthma, or a heart or kidney problem--make sure your doctor knows about it.

Be sure to tell your doctor if you experience any irregular or unexplained vaginal bleeding while taking Norethindrone acetate.

Aygestin makes some women depressed. If you've suffered from serious depression in the past, alert your doctor if you think you're having a relapse. You will probably need to stop taking Aygestin.

The long-term effects of drugs such as Aygestin on the function of certain organs--including the pituitary, ovaries, adrenal glands, liver, and uterus--are unknown.

Aygestin may affect cholesterol and blood-sugar levels. If you have diabetes or high cholesterol, your doctor will want to watch you closely while you are taking Norethindrone acetate.

Aygestin may mask the onset of menopause. However, women who are of menopausal age are still eligible to take the drug.

If you're being screened for cancer, make sure the doctor or lab technician knows you are taking Aygestin.

Possible food and drug interactions when taking Norethindrone acetate

If Aygestin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Make sure your doctor knows about all the prescription and over-the-counter drugs you are taking.

In general, when you are taking a progesterone drug such as Aygestin, it is especially important to check with your doctor before taking the following:

Aminoglutethimide (Cytadren)
Carbamazepine (Tegretol)
Phenobarbital
Phenytoin (Dilantin)
Rifabutin (Mycobutin)
Rifampin (Rifadin, Rimactane)

Special information if you are pregnant or breastfeeding

Do not take Aygestin if you are pregnant or trying to become pregnant, since the drug may cause harm to a developing baby.

Aygestin appears in breast milk. Because the effect of Aygestin on a nursing infant is unknown, it is best to avoid the drug while breastfeeding unless it's clearly necessary.

Recommended dosage

To prevent abnormal uterine bleeding due to hormonal imbalance or to restore menstrual periods

The usual dose is 2.5 to 10 milligrams a day taken for 5 to 10 days during the second half of a 28-day cycle. Your period should start 3 to 7 days after you stop taking Aygestin.

To treat endometriosis

The recommended starting dose is 5 milligrams a day for 2 weeks. The doctor may increase your dose by 2.5 milligrams a day every 2 weeks up to a maximum of 15 milligrams a day. Treatment may continue for 6 to 9 months or until intolerable breakthrough bleeding occurs.

Overdosage

Although no specific information is available on Aygestin overdose, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

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