DROSPIRENONE AND ETHINYL ESTRADIOL (Systemic)*?
Some commonly used brand names are:
In the U.S.?
*? Not commercially available in the U.S. and Canada.
Category
Description
Drospirenone and Ethinyl Estradiol(draw-SPEER-a-none andETH-in-il es-tra-DYE-ole) This medicine is known also as thePill, OCs, BCs, BC tablets, or birth control pills. This medicine usuallycontains two types of hormones, estrogens (ES-troh-jenz ) and progestins (proh-JES-tins) and, when taken properly,prevents pregnancy. It works by stopping a woman's egg from fully developingeach month. The egg can no longer accept a sperm and fertilization is prevented.Although oral contraceptives have other effects that help prevent a pregnancyfrom occurring, this is the main action.
This medicine is available only with your doctor's prescription, in thefollowing dosage form:
Oral- Drospirenone and Ethinyl Estradiol
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For drospirenone andethinyl estradiol, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to estrogens or progestins. Also tell your health careprofessional if you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Drospirenone and ethinyl estradiol is not recommendedfor use during pregnancy and should be discontinued if you become pregnantor think you are pregnant. Women who are not breast-feeding may begin to takeoral contraceptives four weeks after having a baby.
Breast-feeding?Drospirenone and ethinyl estradiol pass intothe breast milk and can change the content or lower the amount of breast milk.Also, they may shorten a woman's ability to breast-feed. It may be necessaryfor you to use another method of birth control or to stop breast-feeding whiletaking drospirenone and ethinyl estradiol.
Children?This medicine is not designed for girls that havenot reached menarche. This medicine is frequently used for birth control inteenage females and has not been shown to cause different side effects orproblems than it does in adults. Some teenagers may need extra informationon the importance of taking this medication exactly as prescribed.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingdrospirenone and ethinyl estradiol, it is especially important that your doctorand pharmacist know if you are taking any of the following:
- Angiotensin-converting enzyme (ACE) inhibitors (e.g., Accupril, Aceon,Altace, Capoten, Lotensin, Mavik, Monopril, Prinivil, Univasc, Vasotec, andZestril)?Potassium in the blood may be increased by drospirenone
- Carbamazepine (e.g., Tegretol) or
- Phenobarbital (e.g., Barbita) or
- Phenytoin (e.g., Dilantin) or
- Rifampin (e.g., Rifadin)?These medicines may cause reducedbirth control effect of drospirenone and ethinyl estradiol and increased irregularmenstrual bleeding
- Cyclosporine (e.g., Neoral) or
- Theophylline (e.g., Elixophyllin)?Oral contraceptives may increasethe effects of these medicines and increase the chance of problems occurring
- Griseofulvin (e.g., Fulvicin)?May cause unplanned pregnancy;using additional birth control methods while taking griseofulvin
- Smoking tobacco? Smoking may decrease the effect of oral contraceptivesand increase the chance of causing serious blood clot, vein, or heart problems
Although certain medicines should not be used together at all, in othercases two different medicines may be used together even if an interactionmight occur. In these cases, your doctor may want to change the dose, or otherprecautions may be necessary. Tell your health care professional if you aretaking any other prescription or nonprescription (over-the-counter [OTC])medicine.
Other medical problems?The presence of other medicalproblems may affect the use of drospirenone and ethinyl estradiol. Make sureyou tell your doctor if you have any other medical problems, especially:
- Abnormal changes in menstrual or uterine bleeding or
- Fibroid tumors of the uterus?Oral contraceptives usually improvethese female conditions but sometimes they can make them worse or make thediagnosis of these problems more difficult
- Adrenal insufficiency or
- Liver problems or
- Kidney problems?these conditions may increase the risk of retainingtoo much potassium in the blood
- Blood clots (or history of) or
- Heart or circulation disease or
- Stroke (or history of)?If these conditions are already present,oral contraceptives may have a greater chance of causing blood clots or circulationproblems, especially in women who smoke tobacco. Otherwise, oral contraceptivesmay help prevent circulation and heart disease if you are healthy and do notsmoke
- Cancer, including breast cancer (or history of or family historyof)?Oral contraceptives may worsen some cancers, especially when breast,cervical, or uterine cancers already exist. Use of oral contraceptives isnot recommended if you have any of these conditions. If you have a familyhistory of breast disease, oral contraceptives may still be a good choicebut you may need to be tested more often
- Gallbladder disease or gallstones (or history of) or
- High blood cholesterol or
- High blood potassium or
- Liver disease (or history of, including jaundice during pregnancy)or
- Mental depression (or history of)?Oral contraceptives may makethese conditions worse or, rarely, cause them to occur again. Oral contraceptivesmay still be a good choice but you may need to be tested more often
- High blood pressure (hypertension) or
- Migraine headaches?Oral contraceptives may cause fluid build-upand may cause these conditions to become worse; however, some people havefewer migraine headaches when they use oral contraceptives
Proper Use of This Medicine
Make certainyour health care professional knows if you are on any special diet, such asa low-sodium or low-sugar diet.
To make using oral contraceptives as safe and reliable as possible, youshould understand how and when to take them and what effects may be expected.
A paper with information for the patient will be givento you with your filled prescription, and will provide many details concerningthe use of oral contraceptives. Read this paper carefully and ask yourhealth care professional if you need additional information or explanation.
When you begin to use oral contraceptives, yourbody will require at least 7 days to adjust before a pregnancy will be prevented.You will need to use an additional birth control method for at least 7 days.Some doctors recommend using an additional method of birth control for thefirst cycle (or 3 weeks) to ensure full protection. Follow the advice of yourdoctor or other health care professional.
Try to take the doses no more than 24 hours apart toreduce the possibility of side effects and to prevent pregnancy. Sinceone of the most important factors in the proper use of oral contraceptivesis taking every dose exactly on schedule, you should never let your tabletsupply run out. When possible, try to keep an extra month's supply of tabletson hand and replace it monthly.
It is very important that you keep the tablets in their original containerand take the tablets in the same order that they appear in the container.The containers help you keep track of which tablets to take next. Differentcolored tablets in the same package contain different amounts of hormonesor are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken outof order
Dosing? The dosing schedule is monophasic. You willbe taking tablets of one strength (color) for 21 days. You will also takean additional 7 inactive tablets, which are another color. Taking the last7 tablets is not required for full protection against pregnancy but they dohelp to replace estrogen.
Your health care professional may begin your dose on the first day of yourmenstrual period (called Day 1 start) or on Sunday after your period starts(called Sunday start). When you begin on a certain dayit is important that you follow that schedule, even when you miss a dose.Do not change your schedule on your own. If the schedule that you havebeen put on is not convenient, check with your health care professional aboutchanging schedules. For Sunday start you need to use another form of birthcontrol for the first 7 days.
- For oral dosage form (tablets):
- For contraception:
- Adults and teenagers:
- Take 1 tablet a day for twenty-eight days. Then repeat the cycle.
Missed dose?Follow your doctor's ordersor the directions on the label if you miss a dose of this medicine.
- If you miss 1 tablet during the cycle?Take it as soon as youremember and then take the next tablet at the normal time. You may take 2tablets in one day. Then continue your regular dosing schedule.
- If you miss 2 tablets in a row in the first or second week?Take2 tablets on the day you remember and 2 tablets the next day. Then continuetaking 1 tablet a day and use another form of birth control for seven daysafter the last missed dose.
- If you miss 2 tablets in a row in the third week or
- If you miss 3 or more tablets in a row (during the first three weeks)?
- Using Day 1 start: Throw out your current cycle and begin a new cycleon the same day. Also, use another birth control method for the next sevendays after the last missed dose. You may not have a menstrual period thismonth. But if you miss two menstrual periods in a row, call your health careprofessional.
- Using Sunday start: Keep taking 1 tablet a day from your currentpack until Sunday. Then, on Sunday, throw out your old pack and begin a newpack. Also use another birth control method for the next seven days afterthe last missed dose. You may not have a menstrual period this month. Butif you miss two menstrual periods in a row, call your health care professional.
If you miss any of the last 7 (inactive) tablets, there is no danger ofpregnancy. However, the first tablet (active) of the next month's cycle mustbe taken on the regularly scheduled day, in spite of any missed doses, ifpregnancy is to be avoided. The active and inactive tablets are colored differentlyfor your convenience.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat and moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is very important that your doctor check your progress atregular visits to make sure this medicine does not cause unwanted effects.These visits will usually be every 6 to 12 months, but some doctors requirethem more often.
Vaginal bleeding of various amounts may occur between your regular menstrualperiods during the first 3 months of use. This is sometimes called spottingwhen slight, or breakthrough bleeding when heavier. If this should occur:
- Continue on your regular dosing schedule.
- The bleeding usually stops within 1 week.
- Check with your doctor if the bleeding continues for more than 1week.
- After you have been taking oral contraceptives on schedule and formore than 3 months and bleeding continues, check with your doctor.
Missed menstrual periods may occur:
- If you have not taken the medicine exactly as scheduled. Pregnancymust be considered as a possibility.
- If the medicine is not the right strength or type for your needs.
- If you stop taking oral contraceptives, especially if you have takenoral contraceptives for 2 or more years.
Check with your doctor if you miss any menstrual periods so that the causemay be determined.
If you suspect that you may have become pregnant, stoptaking this medicine immediately and check with your doctor.
If you are scheduled for any laboratory tests, tell your doctor that youare taking birth control pills.
Check with your doctor before refilling an old prescription, especiallyafter a pregnancy. You will need another physical examination and your doctormay change your prescription.
Side Effects of This Medicine
Healthy women who do not smoke cigarettes have almost no chance of havinga severe side effect from taking oral contraceptives. For most women, moreproblems occur because of pregnancy than will occur from taking oral contraceptives.But for some women who have special health problems, oral contraceptives cancause some unwanted effects. Some of these unwanted effects include benign(not cancerous) liver tumors, liver cancer, or blood clots or related problems,such as a stroke. Although these effects are very rare, they can be seriousenough to cause death. You may want to discuss these effects with your doctor.
Smoking cigarettes during the use of oral contraceptiveshas been found to greatly increase the chances of these serious side effectsoccurring. To reduce the risk of serious side effects,do not smoke cigarettes while you are taking oral contraceptives.
The following side effects may be caused byblood clots. Get emergency help immediately ifany of the following side effects occur:
Rare
Abdominal or stomach pain (sudden, severe, or continuing); anxiety; burning pain in lower abdomen; changes in skin color; chill; coughing up blood; convulsions; fever; feelingof heat; feeling of warmth in lips and tongue; headache (severe or sudden); loss ofcoordination (sudden); loss of vision or change invision (sudden); nervousness; numbness of the fingertips; pain in lower back, pelvis,or stomach; pains in chest, groin, or leg (especiallyin calf of leg); ringing in th ears; shortness of breath (sudden or unexplained); slurring of speech (sudden); sudden loss of consciousness; swelling of foot or leg; weakness, numbness, or pain in arm or leg (unexplained)
Check with your doctor assoon as possible if any of the following side effects occur:
More common?usually less common after the first 3 months of oralcontraceptive use
Changes in the uterine bleeding pattern at menses or betweenmenses, such as decreased bleeding at menses, breakthrough bleeding or spottingbetween periods, prolonged bleeding at menses, complete stopping of menstrualbleeding that occurs over several months in a row, or stopping of menstrualbleeding that only occurs sometimes
Less common
Headaches or migraines (although headaches may lessen in manyusers, in others, they may increase in number or become worse); increased blood pressure; vaginal infectionwith vaginal itching or irritation, or thick, white, or curd-like discharge
Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:
More common
Abdominal cramping or bloating; acne(usually less common after first 3 months and may improve if acne alreadyexists); breast pain, tenderness, or swelling; dizziness; nausea; swelling of ankles and feet; unusual tiredness orweakness; vomiting
Other sideeffects not listed above may also occur in some patients. If you notice anyother effects, check with your doctor.
Developed: 07/25/2001
Revised: 07/25/2001
