How does this medication work? What will it do for me?

Drospirenone belongs to the class of medications called oral contraceptives (birth control pills). It is a progestin birth control medication used for the prevention of pregnancy.  It works by preventing the release of the egg from the ovary.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each round, white, film-coated tablet, debossed with an “E” on one side and a “D” on the other side, contains 4 mg of drospirenone. Nonmedicinal ingredients: Anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc and titanium dioxide.

Each round, green, film-coated tablet, debossed with an “E” on one side and a “4” on the other side is inert and does not contain any medicinal ingredients: Nonmedicinal ingredients: Colloidal silicon dioxide, corn starch, FD&C blue 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polysorbate, povidone, titanium dioxide, triacetin, and yellow ferric oxide

Each blister card contains 24 white tablets and 4 green tablets.

How should I use this medication?

Drospirenone is taken as one tablet daily, at the same time every day. It may be taken with or without food. When you start taking this medication, the first active (white) tablet should be taken on the first day of menstrual bleeding. Take 1 white tablet daily for 24 days, then take 1 green tablet daily for 4 days. Your period should start during this time.  After you take the last green pill on day 28, the next day start a new package of pills.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Many women have spotting or light bleeding or may feel sick to their stomach during the first 3 months of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.

If you have vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If you start a new medication while taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a backup method of birth control, such as latex, until you can check with your doctor or pharmacist.

It is important to take this medication exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases. 

If you miss 1 white pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day. With one missed pill, you do not need to use a back-up birth control method if you have sex.

If you miss 2 or more white pills in a row, take the missed pill as soon as you remember and take the next pill at your regular time. Then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.

If you miss any of the green pills, safely dispose of the pills you missed and keep taking one pill each day until the pack is empty. Begin a new pack as you would normally.

See package insert for additional information on when to start and what to do if you forget to take a pill, or if you experience vomiting or diarrhea within 3 to 4 hours after taking a pill.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to drospirenone or any ingredients of this medication
  • have decreased kidney function
  • have decreased function of the adrenal glands
  • have, may have, or have had cervical cancer
  • have, may have or have had cancer that is sensitive to progestins
  • have decreased liver function
  • have or have had benign or malignant liver tumours
  • have undiagnosed abnormal vaginal bleeding

This medication should not be taken by adolescents who have not experienced their first menstrual bleed.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne
  • back or body pain
  • bloating
  • breast enlargement
  • breast pain or tenderness
  • change in appetite
  • changes menstrual bleeding
  • constipation
  • decreased amounts of menstrual bleeding at monthly periods
  • diarrhea
  • difficulty wearing contact lenses
  • dizziness
  • fatigue
  • feeling gassy
  • hair loss
  • heavy sweating
  • hot flushes
  • metallic taste in mouth
  • mild headache
  • mood swings
  • mouth pain or burning
  • muscle spasms
  • nausea
  • nose bleeds
  • oily skin
  • painful menstrual cramps
  • skin rash, red and itchy skin
  • spinning sensation
  • swelling
  • vaginal dryness
  • vomiting
  • weakness
  • weight gain

 

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur: 

  • behaviour or mood changes (e.g., agitation, aggression, anxiety, hostility, nervousness, changes in sexual interest or ability)
  • increased blood pressure
  • migraine
  • signs of anemia (low red blood cells; e.g., dizziness,  pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • stopping of menstrual periods
  • sudden lower abdominal pain
  • symptoms of ovarian cysts (e.g., pelvic pain, pain during intercourse, abdominal bloating, pain during bowel movements)
  • symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
  • symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
  • symptoms of uterine fibroids (e.g., abdominal pain, constipation, increased need to urinate, vaginal bleeding)
  • symptoms of vaginal infections (e.g., itching, burning, increased or unusual vaginal discharge)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, weakness or numbness, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • sudden change in vision
  • symptoms of ectopic pregnancy or miscarriage (e.g., breast tenderness, nausea, persistent lower abdominal pain, spotting or vaginal bleeding)

 

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Breast cancer: Some studies have suggested the possibility of a link between birth control pills and breast cancer, but nothing conclusive has been found involving this medication.  If you are taking birth control pills you should learn how to do a breast self-exam. Notify your doctor of any unusual changes. A yearly clinical breast examination is also recommended.

Cervical cancer: Some studies have suggested the possibility of a link between birth control pills and cervical cancer, but nothing conclusive has been found involving this medication. Women with cervical cancer should not use birth control pills, as the role of female sex hormones in cervical cancer has not been fully determined.

Depression: Women with a history of depression may be more likely to have a recurrence while taking birth control pills. If you have a history of depression or other mental health conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: Drospirenone may cause slight increases in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

Irregular menstruation: Irregular menstrual patterns are common among women using progestin-only birth control pills. If you notice changes in your usual menstrual patterns, check with your doctor. If you go a prolonged time without bleeding, you should have a pregnancy test.

Kidney function: Decreased kidney function can cause this medication to build up in the body, causing side effects. If you have a history of decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Laboratory tests: Progestin-only birth control pills may affect how some laboratory tests work. If you are having blood tests to check your thyroid, kidney or liver function, let your doctor know that you are taking drospirenone.

Liver function:  This medication may cause changes in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Migraine and headache: If you currently suffer from severe headaches or migraines that become more frequent or increase in intensity, or if you develop migraines or headaches that become persistent and bothersome after starting norethindrone, contact your doctor.

Potassium: Drospirenone may increase potassium levels in women who are have a high risk for this condition. Women with reduced adrenal gland, kidney or liver function are at an increased risk.

If you receive other medications that can increase your potassium you should have your potassium levels checked by your doctor when you first start taking this medication. Some of these medications include potassium supplements, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), some diuretics, heparin, and spironolactone.

Regular checkups: While you are taking this medication, have follow-up visits and a physical examination done every year by your doctor.

Sexually transmitted infections (STIs): Birth control pills do not protect against STIs, including HIV/AIDS. For protection against STIs, use latex condoms.

Pregnancy: Birth control pills should not be taken by pregnant women. If you are taking birth control pills and discover that you are pregnant, stop the birth control pills and see your doctor. However, there is no conclusive evidence that the progestin contained in this medication will be harmful to the unborn child.

Breast-feeding: If the use of birth control pills is started after breast-feeding has begun, there does not appear to be any effect on the quantity and quality of the milk. There is no evidence that progestin-only birth control pills such as this medication are harmful to the nursing infant. No side effects have been found on breast-feeding performance or on the health, growth, or development of the infant. 

Children: This medication should not be used by adolescent females who have not yet had their first menstrual period.

What other drugs could interact with this medication?

There may be an interaction between drospirenone and any of the following:

  • acitretin
  • aliskiren
  • alitretinoin
  • amiloride
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
  • aprepitant
  •  ‘azole’ antifungals (e.g., itraconazole, ketoconazole)
  • bosentan
  • celecoxib
  • cobicistat
  • cyclosporine
  • deferasirox
  • dexamethasone
  • diabetes medications (e.g., acarbose, exenatide, glyburide, insulin, metformin, rosiglitazone, sitagliptin)
  • echinacea
  • eplerenone
  • flibanserin
  • gingko biloba
  • heparin
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., indinavir, lopinavir, ritonavir, saquinavir)
  • isotretinoin
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • mifepristone
  • modafinil
  • mycophenolate
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, ketorolac, naproxen)
  • octreotide
  • potassium supplements
  • protein kinase inhibitors (e.g., ceritinib, dabrafenib, erlotinib, vemurafenib)
  • rifabutin
  • rifampin
  • St. John’s Wort
  • seizure medications (e.g., carbamazepine, clobazam, eslicarbazepine, oxcarbazepine, lamotrigine, phenobarbital, phenytoin, primidone, rufinamide, topiramate)
  • spironolactone
  • thalidomide
  • tocilizumab
  • tranexamic acid
  • triamterene
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

 

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

All material copyright MediResource Inc. 1996 – 2022. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Slynd