Medroxyprogesterone Acetate Oral tablet

What is this medicine?

MEDROXYPROGESTERONE (me DROX ee proe JES te rone) is a hormone in a class called progestins. It is commonly used to prevent the uterine lining from overgrowth in women taking an estrogen after menopause. It is also used to treat irregular menstrual bleeding or a lack of menstrual bleeding in women.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease or a history of a blood clot in the lungs or legs

• breast, cervical or vaginal cancer

• heart disease

• kidney disease

• liver disease

• migraine

• recent miscarriage or abortion

• mental depression

• migraine

• seizures (convulsions)

• stroke

• vaginal bleeding that has not been evaluated

• an unusual or allergic reaction to medroxyprogesterone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• barbiturate medicines for inducing sleep or treating seizures (convulsions)

• bosentan

• carbamazepine

• phenytoin

• rifampin

• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. You will need a regular breast and pelvic exam.

If you have any reason to think you are pregnant, stop taking this medicine at once and contact your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• breast tenderness or discharge

• changes in mood or emotions, such as depression

• changes in vision or speech

• pain in the abdomen, chest, groin, or leg

• severe headache

• skin rash, itching, or hives

• sudden shortness of breath

• unusually weak or tired

• yellowing of skin or eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne

• change in menstrual bleeding pattern or flow

• changes in sexual desire

• facial hair growth

• fluid retention and swelling

• headache

• upset stomach

• weight gain or loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Medroxyprogesterone Acetate Suspension for injection [Contraception]

What is this medicine?

MEDROXYPROGESTERONE (me DROX ee proe JES te rone) contraceptive injections prevent pregnancy. They provide effective birth control for 3 months. Depo-subQ Provera 104 is also used for treating pain related to endometriosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• frequently drink alcohol

• asthma

• blood vessel disease or a history of a blood clot in the lungs or legs

• bone disease such as osteoporosis

• breast cancer

• diabetes

• eating disorder (anorexia nervosa or bulimia)

• high blood pressure

• HIV infection or AIDS

• kidney disease

• liver disease

• mental depression

• migraine

• seizures (convulsions)

• stroke

• tobacco smoker

• vaginal bleeding

• an unusual or allergic reaction to medroxyprogesterone, other hormones, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Depo-Provera Contraceptive injection is given into a muscle. Depo-subQ Provera 104 injection is given under the skin. These injections are given by a health care professional. You must not be pregnant before getting an injection. The injection is usually given during the first 5 days after the start of a menstrual period or 6 weeks after delivery of a baby.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. These injections have been used in female children who have started having menstrual periods.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Try not to miss a dose. You must get an injection once every 3 months to maintain birth control. If you cannot keep an appointment, call and reschedule it. If you wait longer than 13 weeks between Depo-Provera contraceptive injections or longer than 14 weeks between Depo-subQ Provera 104 injections, you could get pregnant. Use another method for birth control if you miss your appointment. You may also need a pregnancy test before receiving another injection.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

This medicine may also interact with the following medications:

• aminoglutethimide

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin

• aprepitant

• barbiturate medicines such as phenobarbital or primidone

• bexarotene

• carbamazepine

• medicines for seizures like ethotoin, felbamate, oxcarbazepine, phenytoin, topiramate

• modafinil

• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug does not protect you against HIV infection (AIDS) or other sexually transmitted diseases.

Use of this product may cause you to lose calcium from your bones. Loss of calcium may cause weak bones (osteoporosis). Only use this product for more than 2 years if other forms of birth control are not right for you. The longer you use this product for birth control the more likely you will be at risk for weak bones. Ask your health care professional how you can keep strong bones.

You may have a change in bleeding pattern or irregular periods. Many females stop having periods while taking this drug.

If you have received your injections on time, your chance of being pregnant is very low. If you think you may be pregnant, see your health care professional as soon as possible.

Tell your health care professional if you want to get pregnant within the next year. The effect of this medicine may last a long time after you get your last injection.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast tenderness or discharge

• breathing problems

• changes in vision

• depression

• feeling faint or lightheaded, falls

• fever

• pain in the abdomen, chest, groin, or leg

• problems with balance, talking, walking

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne

• fluid retention and swelling

• headache

• irregular periods, spotting, or absent periods

• temporary pain, itching, or skin reaction at site where injected

• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This does not apply. The injection will be given to you by a health care professional.

Medroxyprogesterone Acetate Suspension for injection [Malignancy]

What is this medicine?

MEDROXYPROGESTERONE (me DROX ee proe JES te rone) is a man-made hormone. It is used to treat the symptoms of endometrial and renal cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease

• breast cancer

• history of a blood clot in the lungs or legs

• liver disease

• mental depression

• migraine

• seizures

• stroke

• vaginal bleeding

• an unusual or allergic reaction to medroxyprogesterone, other hormones, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bosentan

This medicine may also interact with the following medications:

• aminoglutethimide

• antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin

• aprepitant

• barbiturate medicines such as phenobarbital or primidone

• bexarotene

• carbamazepine

• medicines for seizures like ethotoin, felbamate, oxcarbazepine, phenytoin, topiramate

• modafinil

• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast tenderness or discharge

• breathing problems

• changes in vision

• depression

• feeling faint or lightheaded, falls

• fever

• pain in the abdomen, chest, groin, or leg

• problems with balance, talking, walking

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• fluid retention, swelling

• headache

• irregular periods, spotting, or absent periods

• irritation at site where injected

• nausea

• trouble sleeping

• weight gain or loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.