2012年2月29日，FDA批准该公司治疗中至重度绝经妇女血管萎缩症药ANGELIQ（屈螺酮和雌二醇）更低剂量的配方，新配方含0.25mg 屈螺酮和0.5 mg 雌二醇，此药即将在美国上市。

过去批准的ANGELIQ处方组成为0.5mg 屈螺酮和1mg 雌二醇，用于治疗中至重度血管萎缩症状和中至重度绝经妇女外阴和阴道萎缩症状。

ANGELIQ（屈螺酮和雌二醇）片剂，薄膜包衣

最初美国批准：2005

生产商：拜耳医药保健制药公司]

适应症
angeliq 0.25毫克屈螺酮（DRSP）/ 0.5毫克的雌二醇（E2），雌激素/孕激素治疗子宫完好的妇女表示：

由于更年期血管舒缩症状。

angeliq 0.5的DRSP毫克/ 1毫克E2的雌激素/孕激素治疗子宫完好的妇女表示：

由于更年期血管舒缩症状。

外阴和阴道萎缩等症状，由于更年期。
 
剂量和用法

angeliq 0.25毫克DRSP/0.5毫克素E2口，每天一次一粒

DRSP angeliq 0.5毫克/ 1毫克素E2：口，每天一次一粒。
 
剂型和优势

angeliq 0.25毫克DRSP/0.5毫克素E2片剂：一个片含0.25毫克屈螺酮和雌二醇0.5毫克。
DRSP angeliq 0.5毫克/ 1毫克E2片剂：一粒含有0.5毫克的屈螺酮和雌二醇1毫克。
 
禁忌
确诊的异常生殖器出血
众所周知，怀疑，或历史乳腺癌
已知或怀疑的雌激素依赖性肿瘤
活跃​​的深静脉血栓形成，体育，或对这些条件的历史
积极动脉血栓栓塞性疾病（例如，中风和心肌梗死），这些条件或历史。
肾功能不全
已知的肝损伤或疾病
肾上腺皮质功能不全
已知或怀疑妊娠
已知的蛋白C，蛋白S或抗凝血酶缺乏症，或其他已知的血栓形成倾向的疾病。
已知的过敏性反应，血管神经性水肿，或过敏为Angeliq。
 
注意事项：
不要使用条件，诱发高钾血症。
雌激素增加胆囊疾病的风险。
停止雌激素，如果发生严重高钙血症，视力减退，严重的高甘油三酯血症或胆汁淤积性黄疸。
监视器在甲状腺替代疗法的妇女的甲状腺功能。
 
不良反应
 发生与Angeliq的临床试验中至少有1％的用户最常见的不良反应是胃肠道和腹部疼痛，女性生殖道出血，乳房疼痛和不适，头痛。

药物相互作用
诱导CYP3A4抑制剂可能影响雌激素药物代谢，增加或减少雌激素的血药浓度。
血清钾浓度可能会增加妇女服用屈螺酮与其他药物有可能增加钾。
 
在特殊人群中使用
母亲哺乳：行政哺乳期妇女雌激素已被证明，以减少母乳的数量和质量。
据报道，在妇女健康倡议内存配套的“妇女健康倡议研究老年医​​学：65岁以上的女性可能患有痴呆症的风险增加。

更新日期：02/2012

Description:
What Angeliq is

Angeliq is a Hormone Replacement Therapy (HRT). It contains two types of female hormone, an oestrogen and a progestogen. Your ovaries no longer make these hormones after the menopause.

Angeliq is used for the treatment of symptoms of the menopause such as hot flushes or vaginal dryness in postmenopausal women with at least 12 months since their last natural period. Angeliq is also used for prevention of osteoporosis in postmenopausal women who have a high risk of fractures and who cannot be given other osteoporosis treatments. There is only limited experience of treating women older than 65 years.

Important information about Angeliq

Angeliq 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 Angeliq, tell your doctor about all of your current and past medical conditions, and about all the medicines you use. Stop using Angeliq 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).

Before taking Angeliq

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using Angeliq, tell your doctor if you have any of the following:
- a history of liver disease;
- a history of jaundice (yellowing of the skin or eyes) during a pregnancy or while using birth control pills;
- kidney disease;
- adrenal insufficiency;
- hemophilia or other bleeding disorder;
- a history of stroke or blood clot;
- unusual vaginal bleeding; or
- any type of breast, uterine, or hormone-dependent cancer.
Certain medicines can also affect potassium levels. Tell your doctor if you use any of the following drugs:
- heparin;
- aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), ibuprofen (Motrin, Advil), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene);
- a diuretic ("water pill") such as spironolactone (Aldactone), triamterene (Dyrenium, Dyazide, Maxzide), amiloride (Midamor), or eplerenone (Inspra);
- a potassium supplement such as Klor-Con, K-Dur, K-Tab;
- an ACE inhibitor such as benazepril (Lotensin), lisinopril (Prinivil, Zestril), enalapril (Vasotec); or
- blood pressure medicine such as candesartan (Atacand), losartan (Cozaar), telmisartan (Micardis).

If you have any of the following conditions, you may not be able to use Angeliq, or you may need a dosage adjustment or special tests during treatment:
- high blood pressure, angina, heart disease, high cholesterol or triglycerides;
- liver or kidney disease;
- asthma;
- epilepsy;
- migraines, depression;
- diabetes
- gallbladder disease;
- uterine fibroids; or
- you have had a hysterectomy (uterus removed).
FDA pregnancy category X. Angeliq can cause birth defects. Do not use this medicine if you are pregnant.Angeliq is for use in postmenopausal women. Do not take Angeliq if you are pregnant or breast-feeding. If you become pregnant, stop taking Angeliq immediately and tell your doctor.
 
How to take Angeliq

Always take Angeliq exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide how long you should take Angeliq for. Take one tablet a day, preferably at the same time. Swallow the tablet whole with a drink of water. You can take Angeliq with or without food. Start your next calendar pack of tablets the day after you finish your current pack. Do not take a break between packs.

Possible side effects

Like all medicines, Angeliq can cause side effects, although not everybody gets them.
Serious side effects associated with Hormone Replacement Therapy:
 - blood clots in the veins
 - cancer of the lining of the
 - womb
 - breast cancer
 - ovarian cancer
 - heart disease
 - stroke
 - dementia

The following is a list of side effects that have been linked to the use of Angeliq.Most frequent side effects:
 - unexpected menstruation-like bleeding
 - breast tenderness
 - breast pains
Unexpected menstruation-like bleeding occurs during the first few months of treatment with Angeliq. It is usually temporary and normally disappears with continued treatment. If it does not, contact your doctor.
Common side effects:
 - depression, mood changes, nervousness
 - headache
 - stomach ache, nausea, stomach enlargement
 - lumpy breast (benign breast neoplasm), swollen breasts
 - increase in size of uterine fibroids
 - non-cancerous growth of cells at the neck of the
 - womb (benign cervical growth)
 - vaginal discharge
 - loss of energy, localised fluid retention.

What happens if I miss a dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take Angeliq at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
 
General advice about Angeliq

Medicines are sometimes prescribed for purposes other than those listed  above. Use Angeliq only for the condition for which it was prescribed. Do not give Angeliq to other people even if they have the same symptoms you have, as it may not be right for them.