Drospirenone

Generic name: drospirenone (test)
Brand name: Slynd
Dosage form: oral tablet (4 mg)
Drug class: Progestins

Medically reviewed by  A Ras MD.

What is drospirenone?

Drospirenone is a prescription medicine that is used to prevent pregnancy.

Description

Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg, provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below:

• 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE
• 7 inert white to off-white tablets

The inactive ingredients in the yellow tablets are corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc, titanium dioxide and yellow iron oxide. The inert white to off-white tablets contains corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch and titanium dioxide.

Drospirenone and ethinyl estradiol tablets are not USP for dissolution.

Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3′,4′,6,6a,7,8,9,10,11,12,13,14,15, 15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a] phenanthrene-17,2′(5H)-furan]-3,5′(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.

Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2.

The structural formulas are as follows:

 Mechanism of Action

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Before taking drospirenone, tell your doctor:

• If you are allergic to drospirenone; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Kidney disease, liver disease, liver tumor, or poor adrenal gland function.
• If you have or have ever had cervical cancer or other cancer where hormones make it grow.
• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take drospirenone if you are pregnant.

This is not a list of all drugs or health problems that interact with drospirenone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take drospirenone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take drospirenone?

• Tell all of your health care providers that you take drospirenone. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If drospirenone is stopped, your doctor will tell you when to start taking drospirenone again after your surgery or procedure.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• Certain drugs, herbal products, or health problems could cause drospirenone to not work as well. Be sure your doctor knows about all of your drugs and health problems.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
• The chance of getting cervical cancer may be higher in people who take hormone-based birth control. However, this may be due to other reasons. If you have questions, talk with the doctor.
• If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is drospirenone best taken?

Use drospirenone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Swallow whole with some water or other drink.
• Be sure you know when to start taking drospirenone. If you are not sure when to start taking drospirenone, talk with your doctor.
• After starting drospirenone, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control.
• Take drospirenone at the same time of day.
• Do not skip doses, even if you do not have sex very often.
• If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.
• If you throw up or have diarrhea, drospirenone may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after you take an active tablet, take another tablet. If it goes on for more than 1 day, use an extra form of birth control and call your doctor. Call your doctor if you throw up or have diarrhea and are not sure what to do.

What do I do if I miss a dose?

• If a dose is missed, check the package insert or call the doctor to find out what to do. If using drospirenone to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

What are the side effects of drospirenone that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad headache.
• Depression or other mood changes.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of drospirenone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Period (menstrual) changes. These include spotting or bleeding between cycles.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out drospirenone?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.