Angeliq

DRUG DESCRIPTION

ANGELIQ (drospirenone and estradiol) TABLETS provide a hormone regimen consisting of film coated tablets each containing 0.5 mg of drospirenone and 1 mg of estradiol. The inactive ingredients are lactose monohydrate NF, corn starch NF, modified starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and ferric oxide pigment NF.

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 (CAS) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3.

Estradiol USP, (Estra–1,3,5(10)–triene–3,17–diol,17?), has a molecular weight of 272.39 and the molecular formula is C18H24O2. The structural formulas are as follows:

ANGELIQ®  (Drospirenone and Estradiol)  Structural Formula Illustration

What are the possible side effects of drospirenone and estradiol (Angeliq)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • shortness of breath;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • unusual vaginal bleeding;
  • ...

Read All Potential Side Effects and See Pictures of Angeliq »

What are the precautions when taking drospirenone and estradiol (Angeliq)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone or estradiol; or to spironolactone; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain types of cancer (breast, ovary, uterus), current/history of blood clots, history of stroke or heart attack, liver disease, kidney disease, adrenal gland problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical...

Read All Potential Precautions of Angeliq »


Angeliq Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, nausea, weight changes, increased/decreased interest in sex, change in vaginal discharge, or breast tenderness may occur. If any of these persist or worsen, tell your doctor promptly.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, memory loss), breast lumps, nipple discharge, swelling of the hands/feet, unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged/returning bleeding), yellowing eyes/skin, stomach/abdominal pain, worsening of a seizure condition, muscle weakness, signs of worsening diabetes control (e.g., increased thirst and urination).

This medication may rarely cause very serious problems such as heart attacks, stroke, and blood clots. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision), pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to drospirenone or estradiol; or to spironolactone; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause, certain types of cancer (breast, ovary, uterus), current/history of blood clots, history of stroke or heart attack, liver disease, kidney disease, adrenal gland problems.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (including blood clots, breast lumps/cancer), asthma, diabetes, seizures, migraine headaches, heart disease (e.g., high blood pressure, congestive heart failure), underactive thyroid (hypothyroidism), a certain hormone problem (hypoparathyroidism), mineral imbalance (high or low calcium blood level, high potassium blood level, low sodium blood level), mental/mood disorders (e.g., depression, memory loss), high blood pressure during pregnancy (toxemia), yellowing eyes/skin (cholestatic jaundice) during pregnancy or with past estrogen use, uterus problems (e.g., uterine fibroids, endometriosis), high blood cholesterol/fat (triglyceride) levels, gallbladder disease, obesity, a certain metabolic disorder (porphyria), lupus.

This drug may make you dizzy or lightheaded. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Consult your eye doctor if these problems occur.

This drug may cause a patchy darkening of the skin on the face (melasma). Sunlight may worsen this darkening. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not smoke cigarettes or use tobacco. Smoking/using tobacco while taking this medication further increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35.

If you will be having surgery or will be confined to a chair or bed for a long time (e.g., a long plane flight), tell your doctor beforehand. Special precautions may need to be taken in these circumstances while you are taking this drug because of the increased risk for blood clots.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication is not effective for preventing a miscarriage and should not be used for this purpose.

Small amounts of this medication pass into breast milk. This drug may reduce the quality and amount of breast milk. Consult your doctor before breast-feeding.


Angeliq Patient Information Including Side Effects

Brand Names: Angeliq

Generic Name: drospirenone and estradiol (Pronunciation: droh SPYE re none ES tra dye ole)

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

What is drospirenone and estradiol (Angeliq)?

Drospirenone is a female hormone that helps regulate ovulation and menstruation.

Estradiol is a female hormone involved in development and maintenance of the female reproductive system.

Drospirenone and estradiol is used to treat the symptoms of menopause such as hot flashes or vaginal changes (itching, burning, dryness, urination problems). It is also used to prevent thinning of the bones (osteoporosis).

Drosperinone and estradiol also treats the symptoms of premenstrual dysphoric disorder (PMDD). The symptoms of PMDD include depression, anxiety, persistent anger or irritability, trouble concentrating, sleep or appetite changes, and feeling out of control. PMDD also includes physical symptoms such as breast tenderness, headache, joint or muscle pain, bloating, and weight gain.

PMDD is not the same condition as premenstrual syndrome (PMS). This medication is not meant to treat PMS.

Drospirenone and estradiol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of drospirenone and estradiol (Angeliq)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • shortness of breath;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • unusual vaginal bleeding;
  • stomach pain, swelling, or tenderness;
  • jaundice (yellowing of the skin or eyes); or
  • breast lump.

Continue using drospirenone and estradiol and talk with your doctor if you have any of these less serious side effects:

  • nausea and vomiting;
  • breast tenderness or enlargement;
  • swelling of your hands or feet;
  • darkened skin, especially on your face;
  • changes in your menstrual periods;
  • headache, migraine, dizziness, or fainting;
  • problems with contact lenses;
  • depression;
  • vaginal yeast infections; or
  • enlargement of uterine fibroids.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about drospirenone and estradiol (Angeliq)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using drospirenone and estradiol, tell your doctor about all of your current and past medical conditions, and about all the medicines you use.

Stop using this medication and call your doctor at once if you feel short of breath, have sudden numbness or weakness on one side of the body, sudden headache, confusion, or problems with vision, speech, or balance.

Call your doctor right away if you have a breast lump, unusual vaginal bleeding, or jaundice (yellowing of the skin or eyes).

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