What is Safyral (Drospirenone-E.Estradiol-Lm.FA) used for?
Safyral (Drospirenone-E.Estradiol-Lm.FA) is used to prevent pregnancy. It contains 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg.
This product also contains a folate supplement (such as l-methylfolate, levomefolate). Folate is a B-vitamin that women of childbearing age use to help prevent spinal cord defects in an unborn baby. The folate supplement in this medication, along with a diet rich in folate, lowers this risk if you become pregnant while taking this drug or soon after you stop taking it.
Besides preventing pregnancy, birth control pills may make your periods more regular, and may decrease blood loss, painful periods, and the risk of ovarian cysts.
Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).
How should I take Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Take this medication by mouth with or without food as directed by your doctor, usually once daily. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. Taking this medication after your evening meal or at bedtime may help decrease stomach upset and nausea.
It is very important to continue taking this medication exactly as prescribed by your doctor. Follow the package instructions to find the first tablet, start with the first tablet in the pack, and take them in the correct order. Do not skip any doses. Pregnancy is more likely if you miss pills, start a new pack late, or take your pill at a different time of the day than usual.
Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (such as patch, vaginal ring, other birth control pills) to this product.
How do I store Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Safyral (Drospirenone-E.Estradiol-Lm.FA) is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Safyral (Drospirenone-E.Estradiol-Lm.FA) in the bathroom or the freezer. There may be different brands of Safyral (Drospirenone-E.Estradiol-Lm.FA) that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.
You should not flush Safyral (Drospirenone-E.Estradiol-Lm.FA) down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.
Precautions & warnings
What should I know before using Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone, ethinyl estradiol, or folate supplements; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this product, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems, blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, high cholesterol or triglyceride (blood fat) levels, abnormal breast exam, cancer (especially endometrial or breast cancer), depression, diabetes, family medical history (especially angioedema), gallbladder problems, severe headaches/migraines, heart problems (such as heart valve disease, irregular heartbeat, previous heart attack), kidney disease, liver disease (including tumors), history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch), swelling (edema), stroke, thyroid problems, unexplained vaginal bleeding.
If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
Tell your doctor if you just had or will be having surgery or if you will be confined to a chair or bed for a long time (such as on a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormonal birth control. You may need to stop this medication for a time or take special precautions.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Contact your eye doctor if these problems occur.
It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor.
This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.
This medication may decrease breast milk production. A small amount passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Is it safe during pregnancy or breast-feeding?
There are no adequate studies in women for determining risk when using this Safyral (Drospirenone-E.Estradiol-Lm.FA) during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Safyral (Drospirenone-E.Estradiol-Lm.FA). Safyral (Drospirenone-E.Estradiol-Lm.FA) is pregnancy risk category X according to the US Food and Drug Administration (FDA).
FDA pregnancy risk category reference below:
- A=No risk,
- B=No risk in some studies,
- C=There may be some risk,
- D=Positive evidence of risk,
What side effects can occur from Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Nausea, vomiting, headache, abdominal cramps, bloating, breast tenderness, swelling of the ankles/feet (retaining fluid), or weight change may occur. Vaginal bleeding between periods (spotting) or missed/irregular periods may occur, especially during the first few months of use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding), severe stomach/abdominal pain, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), dark urine, yellowing eyes/skin.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Talk to your doctor about the risks and benefits of this birth control pill. Get medical help right away if you have: pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, sudden shortness of breath/rapid breathing, coughing up blood, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, confusion, slurred speech, weakness on one side of the body, sudden vision changes (such as partial/complete blindness), unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.
What drugs may interact with Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Some products that may interact with this drug include: aromatase inhibitors (such as anastrozole, exemestane, letrozole), atazanavir/cobicistat, ospemifene, tamoxifen, tranexamic acid, certain combination products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir).
Drospirenone may raise your potassium blood level. Tell your doctor if you are regularly taking other drugs/products that can also raise your potassium level (including aliskiren, ACE inhibitors such as benazepril/lisinopril, angiotensin receptor blockers such as losartan/valsartan, heparin, NSAIDs such as ibuprofen/naproxen, potassium-sparing “water pills”/diuretics such as spironolactone/triamterene).
Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
This medication may interfere with certain laboratory tests (such as blood clotting factors, thyroid), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this medication.
Safyral (Drospirenone-E.Estradiol-Lm.FA) may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.
Does food or alcohol interact with Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Safyral (Drospirenone-E.Estradiol-Lm.FA) may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with Safyral (Drospirenone-E.Estradiol-Lm.FA)?
Safyral (Drospirenone-E.Estradiol-Lm.FA) may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Safyral (Drospirenone-E.Estradiol-Lm.FA).
What is the dose of Safyral (Drospirenone-E.Estradiol-Lm.FA) for an adult?
Usual Adult Dose for Contraception
1 tablet orally each day. A patient should begin taking either on the first day of the menstrual period (Day 1 Start) or on the first Sunday after the onset of the menstrual period (Sunday Start). The patient should begin the next and all subsequent 28-day regimens on the same day of the week as she began the first regimen, following the same schedule.
Usual Adult Dose for Premenstrual Dysphoric Disorder
1 tablet orally each day. A patient should begin taking either on the first day of the menstrual period (Day 1 Start) or on the first Sunday after the onset of the menstrual period (Sunday Start). The patient should begin the next and all subsequent 28-day regimens on the same day of the week as she began the first regimen, following the same schedule. Drospirenone-ethinyl estradiol is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone/ethinyl estradiol/levomefolate for premenstrual dysphoric disorder when used for more than three menstrual cycles has not been evaluated.
Usual Adult Dose for Acne
1 tablet orally each day. A patient should begin taking either on the first day of the menstrual period (Day 1 Start) or on the first Sunday after the onset of the menstrual period (Sunday Start). The patient should begin the next and all subsequent 28-day regimens on the same day of the week as she began the first regimen, following the same schedule. Drospirenone-ethinyl estradiol is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone/ethinyl estradiol/levomefolate should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Renal Dose Adjustments
The medication is contraindicated in patients with renal insufficiency.
Liver Dose Adjustments
The medication is contraindicated in patients with hepatic dysfunction.
It is recommended to take at the same time each day, preferably after the evening meal or at bedtime.
What is the dose of Safyral (Drospirenone-E.Estradiol-Lm.FA) for a child?
The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.
How is Safyral (Drospirenone-E.Estradiol-Lm.FA) available?
Safyral (Drospirenone-E.Estradiol-Lm.FA) is available in the following dosage forms and strengths:
- Oral tablet.
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.
What should I do if I miss a dose?
If you miss a dose of Safyral (Drospirenone-E.Estradiol-Lm.FA), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.
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