Loryna birth control review

Contents

drospirenone and ethinyl estradiol (Gianvi, Jasmiel, Loryna)

Brand Names: Gianvi, Jasmiel, Loryna, Lo-Zumandimine, Nikki, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah

Generic Name: drospirenone and ethinyl estradiol

  • What is drospirenone and ethinyl estradiol?
  • What are the possible side effects of drospirenone and ethinyl estradiol?
  • What is the most important information I should know about drospirenone and ethinyl estradiol?
  • What should I discuss with my healthcare provider before taking drospirenone and ethinyl estradiol?
  • How should I take drospirenone and ethinyl estradiol?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking drospirenone and ethinyl estradiol?
  • What other drugs will affect drospirenone and ethinyl estradiol?
  • Where can I get more information?

What is drospirenone and ethinyl estradiol?

Drospirenone and ethinyl estradiol is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Drospirenone and ethinyl estradiol is used as contraception to prevent pregnancy. This medicine is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills.

Yaz is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.

Drospirenone and ethinyl estradiol may also be used for purposes not listed in this medication guide.

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Drospirenone-ethinyl estradiol 605054183

What are the possible side effects of drospirenone and ethinyl estradiol?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

  • signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot–sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems–loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure–severe headache, blurred vision, pounding in your neck or ears;
  • swelling in your hands, ankles, or feet;
  • a change in the pattern or severity of migraine headaches; or
  • symptoms of depression–sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

  • nausea, vomiting;
  • breast tenderness;
  • headache, mood changes, feeling tired or irritable;
  • weight gain; or
  • changes in your menstrual periods, decreased sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about drospirenone and ethinyl estradiol?

Do not use if you are pregnant or if you recently had a baby.

You should not take this medicine if you have: an adrenal gland disorder, kidney disease, uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Thanks to breakthroughs in science, there are more birth control types than ever to choose from, so it’s always a good idea to study up on all the pros and side effects of each to make a game plan with your doctor. Below, read our primer on the best birth control Pills for your needs, from options for clearer skin to ones that allow you to get your period just once a year 🙌. Plus, check out our guide on what to expect once you decide it’s time to stop using the Pill for good.

GET-YOUR-PERIOD-ONCE-A-YEAR PILLS

WHAT THEY ARE: Lybrel is the first FDA-approved no-period Pill to give you the same amount of synthetic estrogen and progestin every day so there’s no monthly “withdrawal bleed” (the period you get with regular Pills). Currently, it’s discontinued by the manufacturer, but is still sold in its generic form, Amethyst.

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The once-a-year-period Pills are ideal for women who experience cramping, heavy bleeding, or pain with their periods and/or for those who just think they’re a drag.

If you’re already taking monophasic Pills (which are all the same except for during your period week), you can build a do-it-yourself Lybrel by just skipping the placebos. One caveat: Insurance usually won’t cover the Pills, since it only funds one pack per month.

THE DOWNSIDE: Breakthrough bleeding. When you’re on other Pills, the lining of the uterus remains thin (that’s why Pill Periods are so light). On continuous hormones, the lining is even thinner and can become unstable and shed at random. Give it time: One study in the journal Contraception showed that 93.9 percent of women experienced bleeding in their first Pill pack, but by pack 13, that percentage had dropped to 21. “If you are flipped out by being surprised, don’t use this Pill,” says Yale University OB/GYN Dr. Mary Jane Minkin. Also, many women feel nauseated during the first few packs of these.

Without a period, will you know if you’re one of the 1 to 2 percent of women who get knocked up even with perfect use? Not unless you stay alert to other symptoms of pregnancy.

IS IT BAD FOR YOU? These Pills are still controversial, despite their FDA approval. Most doctors believe there’s no scientific reason you need to have a period every month. The Pill was designed to give you one so it would gain approval from the public and from religious leaders — and to reassure women that they weren’t pregnant. (When the Pill came on the market 48 years ago, there were no at-home pregnancy tests.) Detractors are concerned that the two big studies published so far followed women for only one year and that there’s still a possibility that the lining could build up and raise the risk of endometrial cancer. But Minkin notes that doctors have been prescribing constant-use birth-control pills “off label” for decades, with no known ill effects.

PMS-BE-GONE PILLS

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WHAT THEY ARE: Yaz is the only oral contraceptive allowed to state on the label that it’s approved for the prevention of premenstrual mood disturbances such as irritability, moodiness, bloating, fatigue, headaches, and muscle aches. (It’s the only one that has submitted the required studies to the FDA.) Many doctors think other oral contraceptives may also help with severe PMS (called PMDD), since they prevent hormonal swings.

THE DOWNSIDE: The Pill doesn’t counter PMS in everyone, and for some, PMS may get worse, says Minkin.

NO-BLOAT PILLS

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WHAT THEY ARE: Yaz and Yasmin use a new kind of progestin called drospirenone. (Actually, it’s a diuretic that acts as a progestin.) It eliminates sodium from your tissues, preventing the water retention that many women swear comes with other Pills. While it may prevent bloating, “it’s not a weight-loss pill,” says Northwestern University OB/GYN Dr. Lee Shulman. The difference between Yaz and Yasmin: Yaz contains fewer placebos (see “Pills for Shorter Periods,” next page) and slightly less estrogen.

THE DOWNSIDE: Drospirenone helps your body hold on to potassium, which is usually a good thing. But if you’re a heavy user of anti-inflammatories such as ibuprofen (Motrin, Advil) or naproxen (Aleve, Naprosyn) or if you have kidney, liver, or adrenal disease, extra potassium could cause serious heart and health problems.

NO-ACNE PILLS

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WHAT THEY ARE: All contraceptives that contain both estrogen and progestin increase the amount of a molecule called sex-hormone-binding globulin, which acts like a sponge that mops up free testosterone. Less testosterone means less acne. Currently, only brands like Yaz, Estrostep, and Ortho Tri-Cyclen have received FDA approval for acne claims (because they’re the only ones that have submitted the clinical studies needed for FDA approval). But it’s likely other combination Pills will reduce it, too

THE DOWNSIDE: It’s theoretically possible that lower levels of free testosterone may result in lower libido. But so far studies fail to prove it. And many women feel a greater sex drive on any Pill since they’re no longer worried about getting pregnant.

PILLS FOR SHORTER PERIODS

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WHAT THEY ARE: All Pill packs used to contain 21 “active” Pills and seven placebos. Now, some—like Yaz and Loestrin 24 Fe—offer 24 days of hormones and four of placebos. That may mean shorter, lighter periods.These Pills may be more effective at preventing pregnancy for women who forget to take theirs on time. “With seven days of placebo, a certain percentage of women will start to get some development of follicles ,” says Dr. Paula Hillard, OB/GYN professor at Stanford University. But having only four hormone-free days prevents that.These pills may also lower your risk of headaches and PMDD. Many women feel their worst—with bloating, headaches, and breast tenderness—during the hormone-free segment of the Pill pack. By being on hormones longer, you may suppress these symptoms.

THE DOWNSIDE: Yaz may cause high potassium levels, which aren’t healthy for your heart (see “No-Bloat Pills”).

PILLS FOR ESTROGEN-PHOBES

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WHAT THEY ARE: They’re not new, but women don’t always know about Pills (including Ortho Micronor, Ovrette, and Errin) that contain no estrogen, only progestin. Unlike combination estrogen-progestin pills, they don’t suppress ovulation—these just thicken the cervical mucus so it’s difficult for sperm to unite with an egg. They can cause breakthrough bleeding, especially if they’re not taken at the same time each day.

These Pills, often called “mini pills,” are best for nursing moms (estrogen impairs milk flow) and for people who shouldn’t take estrogen, such as those with high blood pressure, a risk of blood clots and strokes, or extreme migraines, or those over age 35 who smoke or are obese. The progestin-onlys also help lower LDL (bad) cholesterol and triglycerides. (The trade-off is that they lower “good” HDL too.)

THE DOWNSIDE: These may worsen acne, and they’re less reliable at preventing pregnancy than combination Pills.

Loryna (Oral)

Generic Name: drospirenone and ethinyl estradiol (Oral route)

droe-SPYE-re-none, ETH-i-nil es-tra-DYE-ol

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. Women who are over 35 years of age and smoke should not use oral contraceptives .

Medically reviewed by Drugs.com. Last updated on Jan 21, 2019.

  • Overview
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Commonly used brand name(s)

In the U.S.

  • Gianvi
  • Loryna
  • Nikki
  • Ocella
  • Syeda
  • Vestura
  • Yasmin
  • YAZ
  • Yaz 28
  • Zarah

Available Dosage Forms:

  • Tablet

Therapeutic Class: Monophasic Contraceptive Combination

Pharmacologic Class: Progestin

Uses for Loryna

Drospirenone and ethinyl estradiol combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and drospirenone, and when taken properly, prevents pregnancy. It works by stopping a woman’s egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women at least 14 years of age. PMDD is a severe form of premenstrual syndrome (PMS). Patients with PMDD may have severe emotional and physical symptoms 10 to 14 days before their menstrual flow starts.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor’s prescription.

Before using Loryna

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of drospirenone and ethinyl estradiol combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of drospirenone and ethinyl estradiol combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

Drospirenone

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with 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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Boceprevir
  • Dasabuvir
  • Ombitasvir
  • Paritaprevir
  • Ritonavir
  • Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Anagrelide
  • Aprepitant
  • Boceprevir
  • Bosentan
  • Bupropion
  • Carbamazepine
  • Ceritinib
  • Dabrafenib
  • Darunavir
  • Dexamethasone
  • Donepezil
  • Encorafenib
  • Enzalutamide
  • Fosaprepitant
  • Fosphenytoin
  • Glecaprevir
  • Griseofulvin
  • Isotretinoin
  • Ivosidenib
  • Lesinurad
  • Lixisenatide
  • Lumacaftor
  • Mitotane
  • Modafinil
  • Nafcillin
  • Nevirapine
  • Oxcarbazepine
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Phenobarbital
  • Phenytoin
  • Pibrentasvir
  • Piperaquine
  • Pitolisant
  • Prednisone
  • Primidone
  • Rifabutin
  • Rifampin
  • St John’s Wort
  • Sugammadex
  • Theophylline
  • Tizanidine
  • Topiramate
  • Ulipristal
  • Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Amprenavir
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Colesevelam
  • Cyclosporine
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etoricoxib
  • Fosamprenavir
  • Ginseng
  • Lamotrigine
  • Levothyroxine
  • Licorice
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Parecoxib
  • Prednisolone
  • Rifapentine
  • Ritonavir
  • Roflumilast
  • Rufinamide
  • Selegiline
  • Telaprevir
  • Tipranavir
  • Troglitazone
  • Troleandomycin
  • Valdecoxib
  • Voriconazole
  • Warfarin

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding or
  • Adrenal disease or
  • Blood disorders (eg, hypercoagulopathy) or
  • Breast cancer, active or history of or
  • Diabetes with kidney, eye, nerve, or blood vessel damage or
  • Heart attack, history of or
  • Heart or blood vessel disease (eg, coronary artery disease, heart valve problems), or history of or
  • Heart rhythm problems or
  • Hypertension (high blood pressure), uncontrolled or
  • Kidney disease or
  • Liver disease, including tumors or cancer or
  • Migraine headache, new or worse or a new kind of headache or
  • Problems with circulation or blood clots, now or in the past or
  • Stroke, history of—Should not be used in patients with these conditions.
  • Angioedema (swelling of the face, tongue, or throat), inherited or
  • Chloasma gravidarum (skin disorder during pregnancy), history of or
  • Cholestasis (bile problem) during pregnancy, history of or
  • Depression, history of or
  • Diabetes or
  • Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
  • Gallbladder disease or
  • Hyperkalemia (high potassium in the blood) or
  • Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.

Proper use of drospirenone and ethinyl estradiol

This section provides information on the proper use of a number of products that contain drospirenone and ethinyl estradiol. It may not be specific to Loryna. Please read with care.

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day, after the evening meal or at bedtime. You may take this medicine with or without food.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (eg, another pill, patch, vaginal ring) to using YasminÂŽ or YazÂŽ, take the medicine on the day you would have usually taken your next pill If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you are switching from a progestin-only method (eg, progestin-only pill, implant, injection, intrauterine system) to using YasminÂŽ or YazÂŽ, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you have a miscarriage or abortion after the second trimester or if you gave birth and chose not to breastfeed, you may start using this medicine after 4 weeks to prevent the risk of having blood clots.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

  • For oral dosage form (tablets):
    • For contraception (to prevent pregnancy), PMDD, or acne:
      • Adults and teenagers—
        • YasminÂŽ: One yellow tablet (active) taken at the same time each day for 21 consecutive days followed by one white (inert) tablet daily for 7 days per menstrual cycle.
        • YazÂŽ: One pink tablet (active) taken at the same time each day for 24 consecutive days followed by one white (inert) tablet daily for 4 days per menstrual cycle.
        • Children—Use and dose must be determined by your doctor.

Missed dose

Call your doctor or pharmacist for instructions.

  • If you miss one yellow pill: Take the pill as soon as possible and take the next pill at your regular schedule.
  • If you miss two yellow pills in week 1 or 2: Take the two pills as soon as possible and the next two pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose.
  • If you miss two yellow pills in week 3 or 4, or if you miss three or more yellow pills in a row in any week:
    • Day 1 start: Throw out the rest of the pack and start a new pack that same day.
    • Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss your menstrual period 2 months in a row, check with your doctor because you might be pregnant.
  • If you miss any of the seven white pills in week 4: Throw away the pills you missed. Continue taking one pill a day until you finish the pack.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Loryna

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (TechnivieÂŽ, Viekira PakÂŽ).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

  • If this should occur, continue with your regular dosing schedule.
  • The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
  • If the bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, and check with your doctor immediately.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using birth control pills containing drospirenone, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems, especially in the first 6 months of use. This risk may be higher if you are using a birth control pill containing drospirenone and ethinyl estradiol. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you wear contact lenses or if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, dark urine or pale stools, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter ) medicines and herbal (eg, St. John’s wort) or vitamin supplements.

Loryna side effects

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

  • Breast pain or tenderness
  • headache, severe and throbbing
  • heavy non-menstrual vaginal bleeding
  • irregular menstrual periods
  • nausea
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected

Less common

  • Longer or heavier menstrual periods
  • unusual tiredness or weakness
  • vomiting

Incidence not known

  • Chills
  • clay-colored stools
  • dark urine
  • difficulty with breathing
  • dizziness
  • fever
  • headache
  • itching
  • loss of appetite
  • pain in the chest, groin, or legs, especially the calves
  • rash
  • slurred speech
  • stomach pain
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vision changes
  • vomiting of blood
  • yellow eyes or skin

Some 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:

Less common

  • Crying
  • decreased interest in sexual intercourse
  • delusions of persecution, mistrust, suspiciousness, or combativeness
  • false or unusual sense of well-being
  • inability to have or keep an erection
  • irritability
  • loss in sexual ability, desire, drive, or performance
  • mental depression
  • quick to react or overreact emotionally
  • rapidly changing moods
  • weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

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Loryna

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Thromboembolic Disorders And Other Vascular Problems

Stop Drospirenone and ethinyl estradiol tablets if an arterial or venous thrombotic (VTE) event occurs.

Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of drospirenone and ethinyl estradiol in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs .

A number of studies have compared the risk of VTE for users of Yasmin (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel. Those that were required or sponsored by regulatory agencies are summarized in Table 1.

Table 1: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin Compared to Users of Oral Contraceptives that Contain Other Progestins

Epidemiologic Study (Author, Year of Publication) Population Studied Comparator Product (all are low-dose COCs; with ≤0.04 mg of EE) Hazard Ratio (HR) (95% CI)
i3 Ingenix (Seeger 2007) Initiators, including new users* All COCs available in the US during the conduct of the study† HR: 0.9 (0.5-1.6)
EURAS (Dinger 2007) All COCS available in Europe during the conduct of the study‡ HR: 0.9 (0.6-1.4)
Initiators, including new users Levonorgestrel/EE HR: 1 (0.6-1.8)
“FDA-funded study” (2011) New users Other COCs available during the course of the study § HR: 1.8 (1.3-2.4)
All users (i.e., initiation and continuing use of study combination hormonal contraception) Levonorgestrel/0.03 mg EE Other COCs available during the course of the study HR: 1.6 (1.1-2.2)
HR: 1.7 (1.4-2.1)
Levonorgestrel/0.03 mg EE HR: 1.5 (1.2-1.8)
*“New users” – no use of combination hormonal contraception for at least the prior 6 months
†Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate
‡Includes low-dose COCs containing the following progestins: levonorgestrel, desogestrel, dienogest, chlormadinone acetate, gestodene, cyproterone acetate, norgestimate, or norethindrone
§Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel

In addition to these “regulatory studies,” other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 1): the US post-approval safety study Ingenix , the European post-approval safety study EURAS (European Active Surveillance Study) . An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 1), and two from Denmark . There are two case-control studies: the Dutch MEGA study analysis and the German case-control study . There are two nested casecontrol studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study and the GPRD study . The results of all of these studies are presented in Figure 1.

Figure 1: VTE Risk with Drospirenone and Ethinyl Estradiol Relative to LNG-Containing COCs (adjusted risk#)

Although the absolute VTE rates are increased for users of hormonal contraceptives compared to nonusers, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2). The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk

Figure 2: Likelihood of Developin a VTE

If feasible, stop drospirenone and ethinyl estradiol at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start drospirenone and ethinyl estradiol no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop drospirenone and ethinyl estradiol tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

Hyperkalemia

Drospirenone and ethinyl estradiol tablets contain 3 mg of the progestin DRSP which has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. Drospirenone and ethinyl estradiol is contraindicated in patients with conditions that predispose to hyperkalemia (that is, renal impairment, hepatic impairment, and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked during the first treatment cycle. Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDS.

Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin .

Carcinoma Of The Breasts And Reproductive Organs

Women who currently have or have had breast cancer should not use drospirenone and ethinyl estradiol tablets because breast cancer is a hormonally-sensitive tumor.

There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.

Liver Disease

Discontinue drospirenone and ethinyl estradiol if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.

Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.

Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use.

Risk Of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment

During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue drospirenone and ethinyl estradiol prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir . Drospirenone and ethinyl estradiol can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

High Blood Pressure

For women with well-controlled hypertension, monitor blood pressure and stop drospirenone and ethinyl estradiol if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.

An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.

Gallbladder Disease

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

Carbohydrate And Lipid Metabolic Effects

Carefully monitor prediabetic and diabetic women who are taking drospirenone and ethinyl estradiol. COCs may decrease glucose intolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COC’s.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Headache

If a woman taking drospirenone and ethinyl estradiol develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue drospirenone and ethinyl estradiol if indicated.

An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.

Bleeding Irregularities

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC.

Based on patient diaries from two contraceptive clinical trials of drospirenone and ethinyl estradiol tablets, 8 to 25% of women experienced unscheduled bleeding per 28-day cycle. A total of 12 subjects out of 1,056 (1.1%) discontinued due to menstrual disorders including intermenstrual bleeding, menorrhagia, and metrorrhagia.

Women who use drospirenone and ethinyl estradiol tablets may experience absence of withdrawal bleeding, even if they are not pregnant. Based on subject diaries from contraception trials for up to 13 cycles, 6 to 10% of women experienced cycles with no withdrawal bleeding. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.

If withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

COC Use Before Or During Early Pregnancy

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy.

The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy .

Depression

Women with a history of depression should be carefully observed and drospirenone and ethinyl estradiol discontinued if depression recurs to a serious degree.

Interference With Laboratory Tests

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs. .

DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity.

Monitoring

A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

Other Conditions

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.

Patient Counseling Information

Advise the patient to read the “FDA-approved patient labeling.(PATIENT INFORMATION)”

  • Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs.
  • Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC.
  • Counsel patients about the information regarding the risk of VTE with DRSP-containing COCs compared to COCs that contain levonorgestrel or some other progestins.
  • Counsel patients that Loryna™ tablets do not protect against HIV-infection (AIDS) and other sexually transmitted diseases.
  • Counsel patients on Warnings and Precautions associated with COCs.
  • Counsel patients that Loryna™ tablets contain DRSP. Drospirenone may increase potassium. Patients should be advised to inform their healthcare provider if they have kidney, liver or adrenal disease because the use of Loryna™ tablets in the presence of these conditions could cause serious heart and health problems. They should also inform their healthcare provider if they are currently on daily, long-term treatment (NSAIDs, potassium-sparing diuretics, potassium supplementation, ACE inhibitors, angiotensin-II receptor antagonists, heparin or aldosterone antagonists) for a chronic condition or taking strong CYP3A4 inhibitors.
  • Inform patients that Loryna™ tablets are not indicated during pregnancy. If pregnancy occurs during treatment with Loryna™ tablets, instruct the patient to stop further intake .
  • Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See “WHAT TO DO IF YOU MISS PILLS” section in FDAAPPROVED PATIENT LABELING.
  • Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.
  • Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established.
  • Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a peach tablet for 7 consecutive days.
  • Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to 10 times the exposure of women taking a contraceptive dose, there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the group receiving the high dose of DRSP. Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed.

Use In Specific Populations

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion.

Women who do not breastfeed may start COCs no earlier than four weeks postpartum.

Nursing Mothers

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child. Estrogen-containing COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

After oral administration of 3 mg DRSP/0.03 mg EE (Yasmin), about 0.02% of the DRSP dose was excreted into the breast milk of postpartum women within 24 hours. This results in a maximal daily dose of about 0.003 mg DRSP in an infant.

Pediatric Use

Safety and efficacy of drospirenone and ethinyl estradiol have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.

Geriatric Use

Drospirenone and ethinyl estradiol have not been studied in postmenopausal women and is not indicated in this population.

Patients With Renal Impairment

Drospirenone and ethinyl estradiol is contraindicated in patients with renal impairment .

In subjects with creatinine clearance (CLcr) of 50 to 79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr, ≥80 mL/min. In subjects with CLcr of 30 to 49 mL/min, serum DRSP concentrations were on average 37% higher than those in the control group. In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs .

Patients With Hepatic Impairment

Drospirenone and ethinyl estradiol is contraindicated in patients with hepatic disease . The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Drospirenone and ethinyl estradiol has not been studied in women with severe hepatic impairment

Race

No clinically significant difference was observed between the pharmacokinetics of DRSP or EE in Japanese versus Caucasian women .

8. Jick, S.S., and Hernandez, R.K. (2011). Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 342, d2151.

Are you taking, or considering taking, a birth control pill? Nearly 12 million U.S. women do. And though you may simply call it “the pill,” there are many different types of birth control pills.

Each type of pill has pros and cons. But first, make sure that this form of contraception is right for you.

Here’s what to consider.

2 Questions to Ask Yourself First

  1. Will you still use a condom to protect against STDs? Male condoms offer the best protection against STDs. With all other methods of contraception, you should also use a condom.
  2. How likely are you to forget pills now and then? The answer matters, because it affects how well the pill works. “You should swallow a pill at the same time every day, whether or not you have sex,” the FDA’s web site states.

When taken correctly, the pill is highly effective at preventing pregnancy. But that phrase “when taken correctly” is key.

About 8% of women who take the pill become pregnant unintentionally each year. In most of those cases, the women forgot to take pills. Yet when used perfectly — every day at the same time of day — only 1 in 100 women have an unintended pregnancy during the first year of using the pill.

So yes, the pill works. But it’s not ideal for women wanting a contraception method that they don’t need to think about.

“It’s a very effective method for women who remember to take their pill each and every day at around the same,” says Elizabeth Micks, MD, an instructor and fellow in family planning at Oregon Health and Science University.

Birth control methods that don’t require daily action on the woman’s part, such as intrauterine devices (IUD) and contraceptive implants, have significantly lower failure rates.

If you’ve answered those questions and decided that you want birth control pills as your form of contraception, here are the options.

Types of Pills

There are two main types of birth control pills: combination pills and progestin-only pills. Most pills are available in both a 21-day or a 28-day pack. They are often classified on the amount of estrogen and/or the amount and type of progestin.

Combination pills. These contain the hormones estrogen and progestin. Most birth control pills are combination pills. They’re equally effective at preventing pregnancy — again, when taken correctly. They may also have other benefits, including:

  • Shorter, lighter, more regular, and less painful periods
  • May reduce the severity or frequency of menstrual migraines
  • Can improve bleeding and pain associated with endometriosis and fibroids
  • May improve acne
  • Can lower risk of ovarian and uterine cancer
  • Can lower risk of pelvic inflammatory disease
  • May improve bone density in the years just before menopause

All combination pills slightly raise the risk of heart attacks, stroke, and blood clots that start in a leg vein but could travel to other parts of the body — including the lungs, which could be fatal. That risk rises if you’re a smoker older than 35.

Women who smoke and are older than 35 should not take any type of combination birth control pill, according to the FDA. Other factors — such as being obese or having a family history of heart disease — also make those clots more likely. So consider your overall risk.

Still, those clots are rare, overall.

“Somewhere on the order of two to four more women per 10,000 might experience a nonfatal ,” says Sarah Prager, MD, MAS, an assistant professor of obstetrics and gynecology at University of Washington Medical Center.

The FDA advises women not to take any combination birth control pills if they have a history of blood clots, heart attack, or stroke.

The FDA is also investigating whether certain combination pills that contain drospirenone (a synthetic version of progestin) carry a higher risk than other pills of deep vein thrombosis (DVT) or pulmonary embolism — two rare but serious blood clots. Pills containing drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz, and Zarah.

Progestin-only pills (also called the “mini pill”). These pills are most commonly used by nursing mothers, women with pre-existing risks for blood clots, or other conditions that prevent them from taking estrogen.

If you don’t take them at the same time every day, they may not work. Being as little as three hours late could result in ovulation.

This type of pill works for nursing mothers because continuous breastfeeding already protects against pregnancy, and the mini pill simply provides added security. “Nursing moms have lower fertility. The mini pill’s efficacy may be unacceptably low in women who have normal fertility,” says Andrew Kaunitz, MD, who is associate chair of the ob-gyn department at the University of Florida College of Medicine in Jacksonville, Fla.

What’s in That Pill Packet?

Combination birth control pills come in different phases, depending on whether the level of hormones in the pills changes throughout the month.

  • Monophasic (one-phase) pills contain the same amount of estrogen and progestin in all of the active pills. Alesse, Loestrin, Ortho-cyclen, Seasonale, and Yaz are a few examples. Each active pill in the pack is the same. If you forget to take a pill one day, you take it as soon as you remember, and then take your next pill at your regularly scheduled time.
  • Biphasic (two-phase) pills change the level of hormones estrogen and progestin once during the menstrual cycle. Examples include Kariva and Mircette Ortho-Novum 10/11.
  • Triphasic (three-phase) pills contain three different doses of hormones in the active pills. Those levels change every seven days during the first three weeks of pills. This was the first type of birth control pill. Examples include Cyclessa, Ortho Tri-Cyclen, Nortel 7/7/7, Enpresse, and Ortho-Novum 7/7/7.
  • Quadraphasic (four-phase) pills. The hormone levels in these pills change four times per cycle. Natazia is the only quadraphasic pill on the U.S. market.

Multi-phase pills (biphasic, triphasic, or quadraphasic) have two disadvantages, compared to monophasic pills:

  1. They can be trickier to take. The more phases in the cycle, the more complicated the instructions are about what to do if you miss a day. Those instructions vary by pill.
  2. Be careful not to start the next pack late. Except for Natazia, Kariva, and Mircette, all multi-phase pill cycles include seven hormone-free days. Starting the next pack late means more than a week without hormones, making pregnancy more likely. One of the most common ways women become pregnant on the pill is to start the next pack late.

Extended-Cycle, Continuous-Cycle Pills

Extended-cycle pills and continuous-cycle pills mean fewer periods, or even no periods. They include Introvate, Jolessa, Lybrel, LoSeasonique, Seasonale, and Seasonique.

Women may wonder if it’s safe and healthy to skip periods. When a woman isn’t taking oral contraceptives, a menstrual period is necessary after ovulation to shed the lining that’s built up in her uterus.

Any birth control pill, regardless of cycle length, stops ovulation, so the lining of the uterus does not thicken — and there is nothing to shed. So though you do have several planned days of bleeding on most pills, it’s not really a menstrual period.

“Women often refer to the bleeding as menstruation, but in the case of birth control pills, it’s withdrawal bleeding ,” Kaunitz says. “So it’s OK for women using hormonal birth control to bleed less often.”

Longer cycles of pills simply cause this withdrawal less frequently, and many doctors encourage patients to try it.

“For a patient that wants to start birth control pills, I say, ‘And how about we miss periods, too?’ I think that’s appealing to more and more women,” Micks tells WebMD.

But there are some drawbacks:

  • You may be more likely to experience breakthrough bleeding than with other types of pills.
  • It may be harder to tell if you get pregnant, because you’re having fewer (or no) periods.
  • Extended-cycle and continuous-cycle pills are not available in generic form. But doctors often instruct patients on how to adjust generic pills containing seven placebo pills for extended or continuous use. This will require a prescription for more than 12 packs per year.

Pill Safety

Each woman is different and may have different experiences with the various types of birth control pills. Some side effects may include:

  • Light bleeding or “spotting” between periods. Spotting may be most common in pills with higher estrogen doses and cycles with higher numbers of active pills.
  • Nausea
  • Breast tenderness
  • Weight gain

But unwanted side effects tend to go away in time, so gynecologists recommend patients stay with a pill for three to six months before quitting because of side effects.

Combination pills may not be right for you if you have:

  • Risk factors for blood clots, stroke, or other cardiovascular conditions, such as women over 35 who smoke
  • Had liver or breast cancer, although it has no impact on future risk for breast cancer
  • Migraines with aura

Remember, although birth control pills make pelvic inflammatory disease less likely, they don’t protect against sexually transmitted infections.

Once you start the pill, be careful with other prescription and over-the-counter drugs. The following medications can interfere:

  • Antibiotics
  • Certain seizure medications
  • Certain HIV medications
  • St. John’s wort

Reviewed on March 19, 2012 Š 2012 WebMD, LLC. All rights reserved.

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