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Diane 35, Tina

Generic name: Cyproterone acetate and Ethinylestradiol

Description

Contraceptives are designed to prevent pregnancy. The combination of medroxyprogesterone ( me-DROX-ee-proe-JES-ter-rone) and estradiol ( es-tra-DYE-ole) are two types of hormones that work by stopping a women's egg from fully developing each month. The egg can no longer accept sperm and fertilization is prevented. Although contraceptives have other effects that help prevent a pregnancy from occurring, this is the main action

This medicine is available only with your doctor's prescription, in the following dosage forms:

Parenteral

  • Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. If you are using injectable contraceptives you should understand how their benefits and risks compare to those of other birth control methods. This is a decision you, your sexual partner, and your doctor will make. For medroxyprogesterone and estradiol combination, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to progesterones or estrogens. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Contraceptives are not recommended for use during pregnancy and should be discontinued if you become pregnant or if you think that you are pregnant. In rare cases when oral contraceptives have been taken early in a pregnancy, problems in the fetus have not occurred.

Breast-feeding It is not known whether monthly injectable contraceptives pass into breast milk, but oral contraceptives do pass into the breast milk and can change the content or lower the amount of breast milk. Injectable contraceptives may be used by women who are breast-feeding and they may begin their contraceptive six weeks after having their baby.

Teenagers This medicine can be used for birth control in teenage females and is not expected to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

Other 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 medroxyprogesterone and estradiol, it is especially important that your health care professional know if you are taking any of the following:

  • Aminoglutethamide (e.g., Cytadren). These medicines may decrease the effectiveness of the contraceptive
  • Carbamazepine (e.g., Tegretol) or
  • Phenobarbital (e.g., Luminal) or
  • Phenytoin (e.g., Dilantin). These medicines may increase the removal of medroxyprogesterone and estradiol from the body, resulting in a decrease in the ability to protect against pregnancy.
  • Rifampin (e.g., Rifadin). These medicines may increase the removal of medroxyprogesterone and estradiol from the body, resulting in a decrease in the ability to protect against pregnancy

Other medical problems The presence of other medical problems may affect the use of medroxyprogesterone and estradiol. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal changes in menstrual or uterine bleeding
  • Blood clots (or history of) or
  • Gallbladder disease or gallstones (or history of) or
  • Heart or circulation problems or
  • High blood cholesterol or
  • High blood pressure (hypertension) or
  • Liver disease (or history of) or
  • Mental problems. Combination contraceptives may make these conditions worse or, rarely, cause them to occur again.
  • Cancer, including breast cancer. Contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of monthly injectable contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, injectable contraceptives may still be a good choice but you may need to be tested more often
  • Diabetes mellitus (sugar diabetes). Use of combination contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take.
  • Migraine headaches. Combination contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use contraceptives

Proper Use of This Medicine

Dosing

To make monthly injectable contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected. Follow your doctor's orders.

  • For injection dosage form:
    • For contraception
      • Adults 0.5 milliliters (mL) injected into a muscle in the upper arm, upper thigh or in the buttocks every 28 to 30 days.

Missed dose

If you miss having your next injection by day 33 your doctor will want to rule out pregnancy before the medicine is given to you again. Another method of birth control should be used until your period begins or until your doctor determines that you are not pregnant, and you are able to have the medicine again.

Precautions While Using This Medicine

It is very important that your health care professional check your progress at regular visitsto make sure this medicine does not cause unwanted effects. These physical exams will usually be every 12 months, but you need to visit your doctor every 28 to 30 days to get your injection.

This medicine does not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).

Side Effects of This Medicine

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
    • Bloating or swelling of face, hands, lower legs and/or feet; cough; difficulty swallowing; dizziness; fast heartbeat; hives ; itching; loss of appetite and nausea; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; rapid weight gain; shortness of breath; tightness in chest; unusual tiredness or weakness; vomiting blood; wheezing
  • yellow eyes or skin
  • Symptoms of overdose

More common

  • Nausea; menstrual irregularities; vaginal bleeding; vomiting

Other 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 enlarged abdomen; absent or missed menstrual periods; acne; allergic rash; brown, blotchy spots on skin; decreased sex drive; depression ; hair loss/thinning of hair; headache; increased amount of menstrual bleeding, or normal bleeding that comes earlier; lack or loss of strength
  • nervousness ; quick to react or overact emotionally; rapidly changing moods; stopping of menstrual bleeding over several months; vaginal yeast infection; weight change

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