英文药名: Angeliq(Drospirenone/Estradiol Tablets)

中文药名: 屈螺酮雌二醇片

生产厂家: Berlex Laboratories

药物名称

英文药名: Angeliq (Drospirenone/Estradiol Tablets)
中文药名: 屈螺酮/雌二醇片

生产厂家
Berlex Laboratories

简介
美国berlex公司的复方屈螺酮/雌二醇0.5 mg/1 mg片（商品名：angeliq），用于治疗妇女绝经引起的外阴和阴道萎缩等中至重度血管舒缩症状。总计包括1759例绝经后妇女的多项大规模临床研究证实，本品缓解中至重度血管舒缩症状安全、有效，出血量可接受。接受临床研究的妇女对angeliq的可接受性和依从性均高，因不良反应停药率低。

包装规格：
·0.5mg/1mg *84 片
·1mg/2mg *84 片

Brand names: Angeliq®
Drospirenone; Estradiol tablets

What are Drospirenone; Estradiol tablets?

DROSPIRENONE; ESTRADIOL (Angeliq®) tablets are a mixture of a natural estrogen female hormone and a progestin. Estradiol is essential for maintaining normal female functions and is normally produced by the ovaries. After menopause, the ovaries decrease their production of this hormone. Estradiol can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation). Drospirenone is a progestin that is helpful in reducing overgrowth of the lining of the uterus (the endometrium), which may help reduce your risk of endometrial cancer. Generic drospirenone; estradiol tablets are not yet available.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
• adrenal gland disease
• blood vessel disease, blood clotting disorder, or suffered a stroke
• breast, cervical, endometrial, or uterine cancer
• diabetes
• fibroids in the womb, or endometriosis
• heart, kidney or liver disease
• high blood lipids or cholesterol
• high blood pressure
• high level of calcium in the blood
• hysterectomy
• mental depression
• migraine
• porphyria
• systemic lupus erythematosus (SLE)
• tobacco smoker
• vaginal bleeding
• an unusual reaction to estrogens/progestins, other hormones, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding
How should this medicine be used?
Take drospirenone; estradiol tablets by mouth. Follow the directions on the prescription label. You will take one tablet daily. Try to take your dose at the same time each day. Swallow the tablet with a drink of water. You may take the tablets with food. Do not take your medicine more often than directed.
• For all uses of this medicine:
Before starting this medication, read the paper on your prescription provided by your pharmacist or health care professional. This paper will tell you about the product you are taking. Make certain you understand the instructions.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What drug(s) may interact with Drospirenone; Estradiol?
• aminocaproic acid
• aminoglutethimide
• amiodarone
• anastrozole
• aprepitant
• barbiturates or benzodiazepines used for inducing sleep or treating seizures (convulsions)
• bosentan
• bromocriptine
• chloramphenicol
• cimetidine
• cyclosporine
• danazol
• dantrolene
• diltiazem
• exemestane
• grapefruit juice
• hydrocortisone, cortisone, or prednisolone
• imatinib
• isoniazid (INH)
• letrozole
• medications for diabetes
• medicines for HIV infection or AIDS
• medicines for seizures (carbamazepine, phenobarbital, phenytoin, primidone, topiramate)
• methotrexate
• mifepristone, RU-486
• raloxifene or tamoxifen
• rifabutin, rifampin, or rifapentine
• somatropin, growth hormone
• some antibiotics (chloramphenicol clarithromycin, dalfopristin; quinupristin, erythromycin, telithromycin, troleandomycin)
• some medicines for depression or mental problems (fluoxetine, fluvoxamine, nefazodone, St. John's Wort)
• some medicines used to treat fungal infections (griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)
• testolactone
• thyroid hormones
• tricyclic antidepressants
• ursodiol
• verapamil
• warfarin
• zafirlukast
• zileuton
Angeliq® is different from hormone replacement combinations because it contains the progestin drospirenone. Drospirenone may increase potassium levels and interactions with other drugs that increase potassium may increase the chance you may get an elevated potassium level. You may need blood tests to check for this effect. Drugs that can increase your potassium level include:
• certain medications for high blood pressure or heart conditions (examples include ACE-inhibitors like Altace®, Capoten®, Lotensin®, Mavik®, Monopril®, Prinivil®, Univasc®, Vasotec®, Zestril®, and also Angiotensin-II receptor blockers like Atacand®, Avapro®, Cozaar®, Diovan®, Micardis®), as well as Eplerenone (Inspra™)
• dietary salt substitutes (these may contain potassium)
• heparin
• NSAIDs (antiinflammatory drugs which include Advil®, Aleve®, Ansaid®, Cataflam®, Clinoril®, Daypro®, Feldene®, Indocin®, Lodine®, Naprosyn®, Orudis®, Motrin®, Voltaren®, and others) if they are taken long-term and daily, like for arthritis
• potassium supplements
• some 'water pills' (diuretics like spironolactone or Aldactone®, Dyazide®, Midamor®, Moduretic®, and others)

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Drospirenone; Estradiol?

Visit your prescriber for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam and 'Pap' smear while on estradiol-norgestimate. Regular breast examinations by a health professional and monthly self-examination are recommended for all women. You should also discuss the need for regular mammograms with you health care prescriber.

Drospirenone; estradiol tablets can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop taking drospirenone; estradiol at once and contact your prescriber.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking estradiol-norgestimate, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice changes in vision, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

If you are going to have elective surgery, you may need to stop taking your estrogens one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

In women who still have their uterus, taking a progestin with your estrogens lowers the risk of developing overgrowth of the uterine lining. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you. This product contains both an estrogen and a progestin.

What side effects may I notice from receiving Drospirenone; Estradiol?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• breakthrough bleeding and spotting
• breast lumps or unusual discharge
• chest pain
• coughing up blood
• dizziness, fainting, or weakness
• leg, arm or groin pain
• nausea, vomiting
• severe headaches
• stomach or abdominal pain (severe), tenderness or swelling
• sudden loss of coordination, especially on one side of the body
• sudden shortness of breath
• swelling of the hands, feet or ankles, or rapid weight gain
• vision or speech problems
• yellowing of the eyes or skin
• weakness or numbness in the arms or legs, especially on one side of the body

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• breast tenderness
• change in sexual desire
• increased or decreased appetite
• mild stomach upset
• mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• skin rash, acne, or brown spots on the face
• tiredness
• vaginal yeast infection (irritation and white discharge)
• weight gain

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.