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 部分中文APRI处方资料（仅供参考）
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【通用名】去氧孕烯炔雌醇片

【禁忌】避孕和月经周期调控。

【注意事项】如有下列情况之一，应禁服本品：如服用本品后出现下列情况之一，应立即停服本品。
血栓（静脉或动脉）发生或有血栓病史（如深部静脉血栓、血栓塞、心肌梗塞、脑血管病变）。
血栓先兆史或有血栓先兆存在（如短暂性缺血、心绞痛）。
伴血管损害的糖尿病及伴有局部神经病灶的偏头痛。
伴有高甘油三酯血症的胰腺炎。
存在血栓高危因素（见注意事项）。
严重的肝病或既往病史，肝功能尚未恢复。肝脏肿瘤（良性或恶性）或既往病史。
已知或怀疑有性激素依赖的生殖器官或乳腺恶性肿瘤。
原因不明的阴道出血。
已知或怀疑妊娠。
对本品有效成份或赋形剂过敏者。

【不良反应】警告：
如果有下列情况/危险因素存在，应在服药前，评估服用本品的利弊，并与服用者进行讨论。如果出现下列情况/危险因素或有加重、恶化的表现，应考虑是否停止服用本品。
周期调控：
服用所以避孕药都有可能出现不规则出血（点滴或突破性出血），特别是在服药的前几个月。因此只有在服药3个月以后对不规则出血的评估才有意义。
如果周期正常以后出现不规则出血或持续存在不规则出血的情况，应考虑存在非激素的原因，应采取刮宫术等诊断措施以排除恶心肿瘤或妊娠。
按照说明书服药，一些妇女在停药期间可能不出现撤退性出血，但一般不会出现妊娠。如果未正确服药后在停药期无撤退性出血，或者正确服药时连续两个周期无撤退性出血，这时必须先排除妊娠，再继续服用复合口服避孕药。

【包装规格】严重不良反应参见【注意事项】警告部分。
服用复合口服避孕药的妇女可能出现如下列不良反应：乳房触痛、乳房疼痛、乳汁分泌、头疼、偏头痛、性欲改变、抑郁、戴隐形眼镜不适、恶心、呕吐、阴道分泌物改变、各种皮肤病、体液潴留、体重改变、过敏等。

【用法用量】口服，一次1片，一天1次，连服21天，然后停药7天，从停药第8天开始服用下一盒药。最好每天在同一时间服用。在停药期间，通常在服用最后1片药物之后2-3天开始出现撤退性出血，且可能持续到服用下一盒药时还未结束。
如何开始服用第1盒去氧孕烯炔雌醇片：
从未服过激素类避孕药：在自然月经的第1天（月经来潮的第1天）开始服用本品。也可以从月经来潮的第2-5天开始服用。但建议在第1个服药周期的最初7天，同时采用屏障避孕法（如安全套）。
从其他复合口服避孕药改服本品时，最好在服完原避孕药最后1片活性片的次日开始服用本品（无停药期），但不能晚于原避孕药最后1天停药期（或原避孕药最后1片非活性片）的次日。
从单一孕激素避孕药（口服、注射或皮下埋植）或释放孕激素的宫内节育器改服本品时，可随时改服本品，但在服用本品的最初7天建议加用屏障避孕法。如果原避孕药为埋植剂或宫内节育器的当天开始服用本品。
妊娠早期（妊娠<12周）流产后，可在流产当日立即服用，不必加用其它避孕方法。
分娩或妊娠中期（妊娠>12周）流产后，哺乳期妇女请参阅【孕妇及哺乳期妇女用药】，分娩或妊娠中期流产后，建议在第21-28天开始服用。若在此之后开始服用，建议在服药最初7天内加用屏障避孕法。如果在服用本品前已发生性生活，应先排除妊娠，否则应等到首次月经恢复时间开始服用。
漏服的处理方法：与常规服药时间相比，如果推迟12小时以内服药，避孕效果并不会降低，应立即补服然后在常规时间服用下1片。
与常规服药时间相比，如果推迟12小时以上服药，避孕效果可能会降低。
因为漏服的处理方法遵循以下2个基本原则，停药期绝对不能超过7天，连续7天服药对充分抑制下丘脑-垂体-卵巢轴是必需的。
因此补服方法如下：
漏服发生在第1周：若发现漏服，应立即补服，可能需要同时服用2片。然后在常规服药时间继续服用剩余的药片。在随后7天（包括漏服的当天），应加用屏障避孕法如避孕套。若在漏服前7天内发生无防护的性生活，应考虑有妊娠的可能。漏服的片数越多及漏服的时间越接近停药期，妊娠发生的可能性越大。
漏服发生在第2周：若发现漏服，应立即补服，可能需要同时服用2片。然后在常规服药时间继续服用剩余的药片。如果在首次漏服前7天服用方法正确，就不必加用其它避孕措施。但如果漏服前7天服用方法不正确或漏服≥2片，建议在随后7天加用屏障避孕法。
漏服发生在第3周：只要在首次漏服前7天服用方法正确，采用下面任意一种方法即可。否则，建议在采用第一种方法的同时，在随后7天加用屏障避孕法。
1、若发现漏服，应立即补服，可能需要同时服用2片。然后在常规服药时间继续服用剩余的药片。之后，应立即开始服用下一盒，无停药期。在服完第二盒前可能没有撤退性出血，但在服药期间可能发生点滴出血或突破性出血。
2、也可建议立即停服本品。然后停药7天（包括漏服天数），再继续服用下一盒。
如果发生漏服，且在第一个常规停药期无撤退性出血，则应考虑妊娠的可能。
呕吐的处理方法：如果服药后3-4个小时内发生呕吐，药物吸收可能不完全，在这种情况下，需补服1片。
如何改变月经周期或推迟月经。
为推迟月经，服完1盒后应继续服用下一盒，无停药期。根据拟定月经来潮时间，可在其2-5天前停药，一般月经将大约在拟定时间来潮，停药7天后继续服用下一盒。在服用第二盒药物期间，可能会有突破性出血或点滴出血。
为改变月经周期，可以随意缩短停药期。停药期越短，无撤退性出血的可能性越大，且在第2个服药期间可能会有突破性出血或点滴出血。
服药与进食：
服药不受进食影响。

【产品特点及描述】去氧孕烯、乙炔雌二醇。

【作用类别】新一代口服避孕药。

【孕妇及哺乳期妇女】用药妊娠期间不应服用本品。如果服药期间发现已妊娠，应停止服用本品。大量流行病学研究显示，妇女在怀孕前服用避孕药不会增加婴儿出生缺陷的发生风险，在妊娠早期不慎服用复合口服避孕药也不会有致畸作用。

【儿童用药】尚不明确。

【老年用药】尚不明确。

【药理作用】遮光、密封保存。

【执行标准】避孕药与某些药物之间的相互作用可导致突破性出血和/或避孕失败。可诱导肝药酶的药物与避孕药相互作用，可能导致性激素清除增加。这些药物包括：乙内酰脲、巴比妥盐、去氧苯巴比妥、酰胺咪嗪、利福平、奥卡西平、托吡酯、非氨酯、和灰黄霉素也可能有次作用。另有报道显示，如同时服用氨苄西林和四环素等抗生素，可降低雌激素的肝肠循环作用，引起炔雌醇血药浓度降低，从而导致避孕失败。如果需要服用上述药物，则应在服用抗生素的同时及停用抗生素的7天内，加用屏障避孕法。在服用利福平期间及其停药后28天内，妇女需在服用避孕药的同时加用屏障避孕法。
如果在服完本品一盒后仍需服用上述药物，则无停药期，须立即开始服用下一盒。
妇女服用上述肝药酶诱导剂进行长期治疗时，专家建议增加本品剂量。如果高剂量服用本品效果不理想或似乎不满意，例如有不规则出血的情况发生，建议采取其他避孕措施。

【说明书核准日期】未见报道服用本品过量后对身体产生毒性作用。服用本品过量后可能的症状有恶心、呕吐，在年轻妇女中有轻微阴道出血。无解毒药，应进一步对症治疗。

Apri
Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)
Brand Names: Apri, Azurette, Caziant, Cesia, Cyclessa, Desogen, Emoquette, Kariva, Mircette, Ortho-Cept, Reclipsen, Solia, Velivet, Viorele

What is Apri (ethinyl estradiol and desogestrel)?
Ethinyl estradiol and desogestrel is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and desogestrel is used as contraception to prevent pregnancy.

Ethinyl estradiol and desogestrel may also be used for purposes not listed in this medication guide.

What is the most important information I should know about birth control pills?
Do not use birth control pills if you are pregnant or if you have recently had a baby. You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.
You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your birth control pills.

Some drugs can make birth control pills less effective in preventing pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. Tell your doctor about all other medications you use.

What should I discuss with my healthcare provider before taking birth control pills?
This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills. You should not take birth control pills if you have:
untreated or uncontrolled high blood pressure;
heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
a blood-clotting disorder or circulation problems;
problems with your eyes, kidneys or circulation caused by diabetes;
a history of hormone-related cancer such as breast or uterine cancer;
unusual vaginal bleeding that has not been checked by a doctor;
liver disease or liver cancer;
severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
a history of jaundice caused by pregnancy or birth control pills; or
if you smoke and are over 35 years old.

To make sure you can safely take birth control pills, tell your doctor if you have any of these other conditions:
high blood pressure, varicose veins;
high cholesterol or triglycerides, or if you are overweight;
a history of depression;
underactive thyroid;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles;
tuberculosis; or
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

How should I take birth control pills?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

The 28 day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?
Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss one active pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

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

What should I avoid while taking birth control pills?
Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35.

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Birth control pills side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using birth control pills and call your doctor at once if you have a serious side effect such as:
sudden numbness or weakness, especially on one side of the body;
sudden and severe headache, confusion, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden cough, wheezing, rapid breathing, coughing up blood;
pain, swelling, warmth, or redness in one or both legs;
a change in the pattern or severity of migraine headaches;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet;
a breast lump; or
symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects may include:
mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
breast tenderness or swelling, nipple discharge;
freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge; or
changes in your menstrual periods, decreased sex drive.

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.

What other drugs will affect birth control pills?
Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:
bosentan (Tracleer);
an antibiotic or tuberculosis medication;
drugs to treat hepatitis C, HIV, or AIDS;
phenobarbital (Solfoton) and other barbiturates;
St. John's wort; or
seizure medications.

Tell your doctor about all other medicines you use, especially:
dantrolene (Dantrium);
tizanidine (Zanaflex); or
tranexamic acid (Cyklokapron, Lysteda).

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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