Estradiol Cypionate, Medroxyprogesterone Acetate Suspension for injection
What is this medicine?
ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE (es tra DYE ole sip EYE oh nate; me DROX ee proe JES te rone) is a birth-control method to prevent an unwanted pregnancy. Each injection provides birth control for 1 month (30 days).
NOTE: This drug is discontinued in the United States.
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 or ever had any of these conditions:
abnormal vaginal bleeding
blood vessel disease or blood clots
breast, cervical, endometrial, ovarian, liver, or uterine cancer
heart disease or recent heart attack
high blood pressure
systemic lupus erythematosus (SLE)
an unusual or allergic reaction to estrogens, progestins, or other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for injection into a muscle. It is given by a health-care professional. The first injection is usually given during the first 5 days after the start of a menstrual period. This medicine will provide birth control for roughly 28 to 30 days.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.
A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
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 will need an injection once per month in order to maintain birth control. If you cannot keep an appointment call to reschedule. If it has been more than 4 weeks (33 days) since your last injection, you will need to have a pregnancy test before you can have another injection.
What may interact with this medicine?
antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
ascorbic acid (vitamin C)
barbiturate medicines, such as phenobarbital
medicines for anxiety or sleeping problems, such as diazepam or temazepam
medicines for diabetes, including pioglitazone
ritonavir or other medicines for HIV infection or AIDS
soy isoflavones supplements
St. John's wort
tamoxifen or raloxifene
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 doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine.
Smoking increases the risk of getting a blood clot or having a stroke while you are taking hormonal birth control, especially if you are more than 35 years old. You are strongly advised not to smoke.
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. Ask your health care professional how you can keep strong bones.
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. Another form of birth control may be a better choice.
If you are going to have elective surgery, you may need to stop taking this medicine before the surgery. Consult your health care professional for advice.
This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.
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 tissue changes or discharge
changes in vision
confusion, trouble speaking or understanding
general ill feeling or flu-like symptoms
pain, swelling, warmth in the leg
right upper belly pain
shortness of breath
sudden numbness or weakness of the face, arm or leg
trouble walking, dizziness, loss of balance or coordination
unusual vaginal bleeding
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):
depressed mood or mood swings
increased hunger or thirst
fluid retention and swelling
stomach cramps or bloating
symptoms of vaginal infection like itching, irritation or unusual discharge
unusually weak or tired
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.
March 21, 2017
U.S. FDA-approved Package Insert