Drospirenone 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 this medicine and call your doctor at once if you have:

• abnormal vaginal bleeding;
• a breast lump;
• confusion, unusual thoughts or behavior;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;
• high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;
• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• 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 in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• light vaginal bleeding or spotting;
• breast pain or tenderness;
• headache, mood changes;
• nausea, stomach pain, diarrhea;
• swelling, weight gain; or
• vaginal itching or discharge.

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.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break a drospirenone and estradiol tablet. Swallow it whole.

Try to take drospirenone and estradiol at the same time each day.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are taking drospirenone and estradiol.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Have regular physical exams and mammograms, and self-examine your breasts for lumps every month.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

If you are less than 24 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Dosage Forms & Strengths

drospirenone/estradiol

tablet

• 0.25mg/0.5mg
• 0.5mg/1mg

Hormone Replacement Therapy

1 tablet PO daily

Use the lowest dose that will control symptoms

Renal Impairment

Do not administer

Hepatic Impairment

Do not administer

Other Indications & Uses

Hormone replacement therapy for women with intact uterus: Treatment of menopause-associated hot flashes and vulvar/vaginal atrophy

Safety and efficacy not established

Hormone replacement therapy

1 tablet PO daily

Use the lowest dose that will control symptoms