Premarin Adalah

Tác dụng phụ của thuốc Premarin

Nhận trợ giúp y tế khẩn cấp nếu bệnh nhân có dấu hiệu phản ứng dị ứng với thuốc Premarin: nổi mề đay, khó thở, sưng mặt, môi, lưỡi hoặc cổ họng.

Gọi bác sĩ ngay lập tức nếu bệnh nhân có:

Các tác dụng phụ phổ biến của thuốc Premarin có thể bao gồm:

Related treatment guides

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Premarin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Untuk wanita yang sudah memasuki masa menopause atau sudah menjalani histerektomi (pengangkatan rahim), obat berbentuk krim yang dimasukkan lewat vagina ini tentu sudah dikenalnya dengan baik. Namanya adalah Premarin, yaitu obat sulih hormon estrogen (hormone replacement therapy) untuk mengatasi gejala-gejala akibat tak berproduksinya estrogen, seperti rasa panas di wajah (hot flashes), rasa kering dan gatal pada vagina (itchy and dry vagina). Tahukah Anda bahwa kata Premarin adalah akronim dari ‘Pregnant Mare Urine’ atau air seni dari kuda betina yang hamil?

Ya, sesungguhnya obat yang mengandung estrogen ini memang diekstrak dari air seni kuda betina yang sedang hamil. Namun kontroversi tentang perlakuan yang tak manusiawi terhadap hewan yang malang ini sudah merebak bertahun-tahun lamanya. Untuk setengah tahun kuda ini dibiarkan di luar kandang untuk dihamili. Setengah tahun berikutnya kuda yang hamil ini dipasangi kantong penampung air seni sepanjang hari dan gerakannya dibatasi di dalam kandang (stall). Banyak diantaranya yang mengalami infeksi karena luka akibat kantong air seni dan juga kelumpuhan karena disekap di dalam kandang ini. Konon ribuan kuda betina ini mati muda karena perlakuan yang kejam ini.

Dewasa ini jumlah kuda yang diperlukan untuk diambil air seninya sudah jauh menurun jumlahnya berdasarkan riset yang menunjukkan bahwa dosis estrogen yang diperlukan pada wanita menopause jumlahnya dapat dikurangi. Namun penggiat hak satwa (animal right) masih belum merasa puas, karena praktek kekejaman pada kuda betina (mare dan foal) masih terus terjadi didalam ‘memanen’ air seninya ini. Wyeth sebagai perusahaan penghasil Premarin tentu menampik segala tuduhan tindakan yang tak manusiawi ini.

Kontroversi yang lain berkaitan dengan efek samping Premarin itu sendiri. Riset yang sudah dimulai semenjak tahun 1975 menunjukkan bahwa pemakaian Premarin meningkatkan jumlah kasus kanker pada endometrium (dinding rahim). Penelitian ini juga menemukan peningkatan kasus stroke, serangan jantung, pembekuan darah dan kanker payudara (breast cancer).

Wyeth sebagai produsen Premarin, selama kurun waktu 2002 – 2009 sudah menerima tuntutan ganti rugi (litigation) dari sebanyak 13.000 orang. Sebagian besar dari tuntutan ini dimenangkan oleh Wyeth berkat kepiawaian tim pengacaranya. Pemakaian Premarin yang menuai banyak kontroversi ini ternyata masih dipercaya sebagai terapi yang aman untuk gangguan post-menopause. Juga pemakaian Premarin ini terbukti dapat mengurangi terjadinya osteoporosis (pengeroposan tulang). Premarin juga terbukti bermanfaat untuk kanker prostat pada pria, untuk pengobatan pada kekurangan produksi estrogen seperti hypogonadisme, pengebirian (castration), kegagalan indung telur (ovarian failure). Mungkin yang baik diingat oleh pemakai Premarin ini adalah dibalik manfaat yang dirasakan, ada pengorbanan dari kuda-kuda yang sudah menyumbangkan air seninya ini.

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Lihat Healthy Selengkapnya

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

1. Medical examination/Follow up

Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual women. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see 'Breast Cancer' below). Investigations, including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

2. Conditions that need supervision

If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with this medicine, in particular:

- Leiomyoma (uterine fibroids) or endometriosis

- Risk factors for thromboembolic disorders (see below)

- Risk factors for oestrogen dependent tumours (e.g. first degree heredity for breast cancer)

- Liver disorders (e.g. liver adenoma)

- Diabetes mellitus with or without vascular involvement

- Migraine or (severe) headaches

- Systemic lupus erythematosus (SLE)

- A history of endometrial hyperplasia (see below)

3. Reasons for immediate withdrawal of therapy

Therapy should be discontinued if a contra-indication is discovered and in the following situations:

- Jaundice or deterioration in liver function

- Significant increase in blood pressure

- New onset of migraine-type headache

4. Endometrial Hyperplasia and Carcinoma

In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among oestrogen-only users varies from 2-to 12-fold greater compared with non-users, depending on the duration of treatment and oestrogen dose (see section 4.8). After stopping treatment risk may remain elevated for at least 10 years.

The addition of a progestogen for at least 12 days per month/28 day cycle or continuous combined oestrogen-progestogen therapy in non-hysterectomised women prevents the excess risk associated with oestrogen-only HRT.

For oral doses of conjugated equine oestrogens >0.625 mg the endometrial safety of added progestogens has not been demonstrated. The reduction in risk to the endometrium should be weighed against the increase in the risk of breast cancer of added progestogen (see 'Breast Cancer' below and section 4.8).

Breakthrough bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

Unopposed oestrogen stimulation may lead to pre-malignant or malignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to oestrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis (but see above).

The overall evidence shows an increased risk of breast cancer in women taking combined oestrogen-progestogen or oestrogen-only HRT, that is dependent on the duration of taking HRT.

The Women's Health Initiative trial (WHI) found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only HRT. Observational studies have mostly reported a small increase in risk of having breast cancer diagnosed that is lower than that found in users of oestrogen-progestogen combinations (see section 4.8).

Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.

HRT, especially oestrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.

Ovarian cancer is much rarer than breast cancer.

Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

Some other studies, including the WHI trial, suggest that the use of combined HRTs may be associated with a similar or slightly smaller risk (see section 4.8).

7. Venous thromboembolism

Hormone replacement therapy (HRT) is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE) i.e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of HRT than later (see section 4.8).

Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. HRT may add to this risk. HRT is therefore contraindicated in these patients (see section 4.3). Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition.

Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (Body Mass Index >30kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE) and cancer. There is no consensus about the possible role of varicose veins in VTE.

As in all postoperative patients scrupulous attention should be given to prophylactic measures to prevent VTE following surgery. If prolonged immobilisation is liable to follow elective surgery, particularly abdominal or orthopaedic surgery to the lower limbs temporarily stopping HRT 4 to 6 weeks earlier is recommended. Treatment should not be restarted until the woman is completely mobilised.

In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening). If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is 'severe' (e.g., antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.

Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they are aware of potential thromboembolic symptoms (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

8. Coronary Artery Disease (CAD)

There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined oestrogen-progestogen or oestrogen-only HRT. Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.

Combined oestrogen-progestogen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).

In the WHI oestrogen-alone substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) compared to women receiving placebo (45 versus 33 per 10,000 women-years). The increase in risk was demonstrated in year one and persisted. Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg) versus those receiving placebo (18 versus 21 per 10,000 women-years).

10. Oestrogens may cause fluid retention and therefore patients with cardiac or renal dysfunction should be carefully observed.

11. The use of oestrogen may influence the laboratory results of certain endocrine tests and liver enzymes.

Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radio-immunoassay) or T3 levels (by radio-immunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered.

Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).

Some patients dependent on thyroid hormone replacement therapy may require increased doses in order to maintain their free thyroid hormone levels in an acceptable range. Therefore, patients should have their thyroid function monitored more frequently when commencing concurrent treatment in order to maintain their free thyroid hormone levels in an acceptable range.

12. A worsening of glucose tolerance may occur in patients taking oestrogens and therefore diabetic patients should be carefully observed while receiving hormone replacement therapy.

13. There is an increase in the risk of gallbladder disease in women receiving HRT (see Conditions that need supervision).

14. Women with pre-existing hypertriglyceridemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.

15. Oestrogens should be used with caution in individuals with severe hypocalcaemia.

16. HRT use does not improve cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.

17. Exogenous oestrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema.

18. Laboratory monitoring

Oestrogen administration should be guided by clinical response rather than by hormone levels (e.g., estradiol, FSH).

19. This product contains lactose monohydrate and sucrose. Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Premarin Tablet belongs to the class of hormones used as ‘hormone replacement therapy’ to treat symptoms and conditions associated with menopause. During menopause, estrogen levels decrease, leading to hot flushes (feeling of heat over the face, neck, and chest). Women with menopause are at risk of developing osteoporosis (thinning of bones). Premarin Tablet can be used to prevent osteoporosis after menopause.

Premarin Tablet contains ‘conjugated estrogens’, which is used as hormone replacement therapy (HRT). It works by replacing the estrogen hormone in menopausal women. It also regulates the secretions of hormones such as luteinizing hormone (LH) (necessary for sexual function and the menstrual cycle) and follicle-stimulating hormone (FSH) (regulates the menstrual cycle). These effects help to improve the symptoms of menopause.

Premarin Tablet should be taken as advised by your doctor. The dose of medicine and duration of treatment will be decided by the doctor based on your medical condition. Premarin Tablet may cause certain side effects such as abnormal vaginal bleeding or spotting, vaginal discharge, pain and swelling in the breasts, discharge from the nipples, changes in breast tissue, feeling or being sick, bloating, abdominal pain, headache, dizziness, mood changes, irritability, joint pain, leg cramps, increased or decreased libido (sexual desire), swelling of face or ankles, rashes on the skin, changes in hair growth, eye, weight and triglyceride levels (fats), intolerance to glucose, memory loss and jaundice (yellowing of the skin or eyes).

Premarin Tablet should be avoided if you have a history of breast cancer, endometrial cancer (cancer of the lining of the womb), unexplained vaginal bleeding, untreated endometrial hyperplasia (thickening of the womb lining), have a blood clot in the veins (thrombosis), in the legs (deep vein thrombosis) or the lungs (pulmonary embolism), blood clotting disorder, heart attack or angina (chest pain), inherited porphyria (a blood disorder) or liver disease. It is not recommended for use in pregnant and breastfeeding women. Stop taking Premarin Tablet and consult your doctor immediately if you are allergic to it or if you develop jaundice (yellowing of the skin and eyes), high blood pressure and migraine-like headache, become pregnant or notice signs of a blood clot such as redness, swelling and pain in the legs, sudden chest pain or difficulty in breathing. Inform your doctor if you have any intolerance to sugar.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using conjugated estrogens.

Grapefruit and grapefruit juice may interact with conjugated estrogens and lead to unwanted side effects. Avoid the use of grapefruit products.

Premarin side effects

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

Call your doctor at once if you have:

Common Premarin side effects may include:

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.

Thuốc Premarin tác dụng gì?

Thuốc này là nội tiết tố nữ, được phụ nữ sử dụng để giảm các triệu chứng của thời kỳ mãn kinh, những triệu chứng này là do cơ thể tạo ra ít estrogen hơn. Nếu bạn chỉ sử dụng thuốc Premarin để điều trị các triệu chứng trong và xung quanh âm đạo thì nên cân nhắc sử dụng các sản phẩm bôi trực tiếp bên trong âm đạo trước khi dùng thuốc Premarin uống, các loại hấp thụ qua da hoặc tiêm. Phụ nữ cũng có thể sử dụng một số sản phẩm estrogen sau khi mãn kinh để ngăn ngừa mất xương (loãng xương).

Tuy nhiên, có những loại thuốc khác (chẳng hạn như raloxifene, bisphosphonates, kể cả alendronate) cũng có hiệu quả trong việc ngăn ngừa mất xương và có thể an toàn hơn, cần cân nhắc sử dụng trước khi điều trị bằng estrogen. Một số sản phẩm estrogen nhất định cũng có thể được sử dụng bởi nam giới và phụ nữ để điều trị ung thư (một số loại ung thư tuyến tiền liệt, ung thư vú đã lan sang các bộ phận khác của cơ thể) và phụ nữ không bị ung thư không có khả năng sản xuất đủ estrogen (ví dụ do thiểu năng sinh dục, suy buồng trứng nguyên phát).

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Thuốc Premarin là gì?

Viên nén Premarin chứa estrogen liên hợp hàm lượng 0,625mg, đây là một hỗn hợp các hormone estrogen - hormone sinh dục nữ do buồng trứng tiết ra, cần thiết cho nhiều quá trình trong cơ thể.

What other drugs will affect Premarin?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with conjugated estrogens. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Tương tác của thuốc Premarin

Hy vọng những thông tin trong bài viết trên đã giúp độc giả hiểu hơn về tác dụng của thuốc Premarin. Để nâng cao hiệu quả sử dụng, người dùng cần tuân thủ theo đúng hướng dẫn của bác sĩ, dược sĩ tư vấn.

Để đặt lịch khám tại viện, Quý khách vui lòng bấm số HOTLINE hoặc đặt lịch trực tiếp TẠI ĐÂY. Tải và đặt lịch khám tự động trên ứng dụng MyVinmec để quản lý, theo dõi lịch và đặt hẹn mọi lúc mọi nơi ngay trên ứng dụng.

Nguồn tham khảo: drugs.com, webmd.com

Generic name: conjugated estrogens (oral) [ KON-joo-gay-ted-ES-troe-jenz ] Drug class: Estrogens

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 1, 2024.

Premarin tablets contain conjugated estrogens, a mixture of estrogen hormones. Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Premarin is used to treat menopause symptoms such as hot flashes and vaginal changes, and to prevent osteoporosis (bone loss) in menopausal women.

Premarin is also used to replace estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body.

You should not use Premarin if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you will have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Premarin may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, or heart attack, or cancer of the breast, uterus, or ovaries. Estrogen should not be used to prevent heart disease, stroke, or dementia.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Premarin.