部分中文骨穩处方资料（仅供参考）
英文藥名：Forteo
中文藥名：骨穩  預充注射器
廠商名稱：禮來製藥

药品英文名
Teriparatide

药品别名:特立帕肽、骨穩 FORTEO INJECT DELIVERY
 
药物剂型
預充注射器：20mcg：2.4ml
 
药理作用
本药[hPTH(1-34)]是一种合成的多肽激素，为人甲状旁腺素PTH的1-34氨基酸片段，该片段是含有84个氨基酸的内源性甲状旁腺素PTH具有生物活性的N-末端区域。本药的免疫学和生物学特性与内源性甲状旁腺素PTH以及牛甲状旁腺素PTH(bPTH)完全相同。本药刺激骨形成和骨吸收，可减少绝经后妇女骨折的发生率，根据给药方式的不同，还能提高或降低骨密度。连续输注可导致甲状旁腺素PTH浓度持续增高，因此比仅引起血清甲状旁腺素PTH浓度短暂增高的每日注射法产生的骨吸收作用更强。此外，本药不抑制二磷酸腺苷诱导途径或者胶原诱导途径的血小板聚集反应。
 
药动学
本药皮下注射后0.5小时达血药浓度峰值，3个月起效(骨矿物质密度)，生物利用度为95%。肌内注射单次给药后持续时间为6小时。静脉注射后分布容积为0.1L/kg。本药可能经肝非特异性蛋白水解酶分解为片段，然后经肾脏排泄，肾清除率为90%。而本药总体清除率男性约为90L/h，女性约为60L/h。母体化合物消除半衰期皮下给药为1小时，静脉注射为5分钟。
 
适应证
用于原发性骨质疏松及性腺功能减退性骨质疏松、绝经后骨质疏松。
 
禁忌证
对本药过敏者。
 
注意事项
1.慎用：
(1)活动性或者新近发生的尿石症。
(2)肿瘤骨转移或者有骨恶性肿瘤病史者。
(3)除骨质疏松症以外的代谢性骨病。
(4)骨骺开放者。
(5)佩吉特病患者。
(6)先前已有高钙血症患者。
(7)先前接受过骨骼放射治疗者。
(8)碱性磷酸酶不明原因增高者。
(9)有增加骨肉瘤基线风险的患者。
2.药物对儿童的影响：
儿童用药安全性资料有限，应慎用。
3.药物对妊娠的影响：美国药品和食品监督管理局(FDA)对本药的妊娠安全性分级为C级。孕妇用药安全性尚不明确，孕妇用药应权衡利弊。
4.药物对哺乳的影响：尚不明确本药是否泌入乳汁，哺乳期妇女用药应权衡利弊。
5.用药前后及用药时应当检查或监测：
(1)血清钙、磷及尿钙浓度(静脉输注后应检测患者血清1，25-二羟维生素D、钙离子和磷酸盐浓度变化)。
(2)骨形成及骨吸收特异指标检测[如血清骨特异性碱性磷酸酶(骨形成)、前胶原1-羧基末端前肽(骨形成)、尿N-末端肽(骨吸收)]。
(3)骨矿物质密度测定(吸光光度法)。
(4)检测患者是否有甲状腺功能减退。
6.皮下给药时可能造成直立性低血压，患者应在坐下或躺下的条件下给予初次用量。
7.本药不推荐使用2年以上。
8.患者接受洋地黄治疗时慎用本药。
 
不良反应
1.心血管系统：可见血压降低(包括有症状的直立性低血压，出现该症状时应谨慎)，该症状通常出现在开始几次给药时。
2.中枢神经系统：可见头晕(8%)、抑郁(4%)、肢端麻刺感(小于2%)以及短暂而轻微的头痛。
3.代谢/内分泌系统：可出现血钙增高(短暂性增高，男性为6%，女性为11%)、血钙降低(仅有个案报道)、血尿酸增高(约3%)、甲状旁腺功能减退(仅有个案报道)。
4.肌肉骨骼系统：本药治疗骨质疏松症时可出现腿痛性痉挛(3%)、关节痛(10%)。
5.胃肠道：本药治疗骨质疏松症时8.5%的患者出现恶心。使用本药醋酸注射剂有不到2%的患者出现恶心、腹部痛性痉挛、排便欲、腹泻、口中金属味。
6.皮肤：可见注射时疼痛(静脉注射)、红斑(皮内、皮下注射)、瘙痒(皮下注射)、荨麻疹(肌内注射)。
7.其他：约3%的骨质疏松症患者用药后1年产生抗特立帕肽抗体[患者似乎未出现不良后遗症或药物效力降低(如骨矿物质密度)的情况]。
 
用法用量
1.常规剂量：
(1)静脉滴注：骨质疏松症：速度为75ng/(kg·h)，持续24小时。
(2)肌内注射：骨质疏松症：1天100µg，持续5～6个月。
(3)皮下注射：妇女绝经后骨质疏松症或男性原发性或性腺功能减退性骨质疏松症：推荐剂量为20µg/次，1次/d。
2.肾功能不全时剂量：轻中度肾功能损害者单次剂量药动学不会受到显著影响，这提示这些患者无需调整用量。严重肾功能损害者观察到消除半衰期和曲线下面积显著增高(约75%)，尚不明确是否造成与临床有关的不良反应发生率增加，尚无用量指导原则。
3.老年人剂量：在31～85岁范围内，年龄增加对本药药动学无显著影响，无需调整剂量。
廠商名稱：禮來製藥

Forteo Generic Name: Teriparatide (TER-i-PAR-a-tide)Brand Name: Forteo
Forteo has been shown to increase the rate of bone tumors in lab animals. It is not known if there is a higher risk of bone tumors in humans. Forteo should not be used in patients who are at risk for bone tumors, including patients with Paget disease, children and young adults with open epiphyses, prior radiation involving the skeleton, or unexplained high levels of alkaline phosphatase in their blood.
Forteo is used for:
Treating bone weakening (osteoporosis) in men and postmenopausal women who are at high risk for having fractures, have had fractures, or cannot use other osteoporosis treatments. It is also used to treat patients with osteoporosis due to prolonged use of glucocorticoid medicines (eg, prednisone).
Forteo is a man-made (synthetic) form of parathyroid hormone. It works by increasing bone mass and bone strength, which helps decrease your chance of getting a fracture.
Do NOT use Forteo if:
you are allergic to any ingredient in Forteo
you have high levels of alkaline phosphatase, calcium, or parathyroid hormone in your blood
you have deformed bones, softening of the bones (osteomalacia), Paget disease, pseudohypoparathyroidism, or rickets
you have a history of bone tumors, bone cancer, or other cancers that have spread to your bones
you have had radiation therapy involving the bones
you have a bone disease other than osteoporosis
the patient is a child or young adult whose bones may still be growing
you are pregnant or breast-feeding
Contact your doctor or health care provider right away if any of these apply to you.
Before using Forteo :
Some medical conditions may interact with Forteo . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of kidney stones
if you smoke, drink alcohol, or have a history of alcohol abuse or dependence
Some MEDICINES MAY INTERACT with Forteo . Tell your health care provider if you are taking any other medicines, especially any of the following:
Digoxin because the risk of its side effects may be increased by Forteo
This may not be a complete list of all interactions that may occur. Ask your health care provider if Forteo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Forteo :
Use Forteo as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Forteo comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Forteo refilled.
Forteo is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Forteo at home, a health care provider will teach you how to use it. Be sure you understand how to use Forteo . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Forteo if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
Using Forteo at the same time each day will help you remember to use it.
Use Forteo on a regular schedule to get the most benefit from it.
Use of Forteo for more than 2 years is not recommended.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Forteo , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Forteo .
Important safety information:
Forteo may cause dizziness or lightheadedness. These effects may be worse if you use it with alcohol or certain medicines. Use Forteo with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Forteo may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Some patients experience dizziness or a fast heartbeat after the first few doses of Forteo . For the first few doses, inject Forteo where you can sit or lie down right away if you get dizzy or have a fast heartbeat.
Learn about other means of preventing bone loss, including taking regular calcium or vitamin D supplements, doing weight-bearing exercise, quitting smoking, and limiting alcohol intake.
Lab tests, including blood calcium levels, uric acid levels, and bone density tests, may be performed while you use Forteo . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Forteo should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Forteo may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Forteo while you are pregnant. It is not known if Forteo is found in breast milk. Do not breast-feed while using Forteo .
Possible side effects of Forteo :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; headache; increased cough; indigestion; joint pain; leg or back cramps; mild dizziness or fast heartbeat; minor bruising, itching, pain, redness, and swelling at the injection site; nausea; runny nose; sore throat; weakness.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision; chest pain; depression; fainting; persistent fast heartbeat; persistent trouble sleeping; severe or persistent dizziness or lightheadedness when sitting or standing; severe or persistent nausea, vomiting, constipation, muscle weakness, or tiredness; shortness of breath; sudden, severe headache; tooth problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center,or emergency room immediately. Symptoms may include dizziness or weakness, especially when standing; headache; nausea; vomiting.
Proper storage of Forteo :
Store Forteo in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use Forteo if it has been frozen. Recap the pen after each use. Discard Forteo after 28 days of use, even if it is not completely empty. Keep Forteo out of the reach of children and away from pets.

附件：

20111620184521.pdf
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
FORTEO INJECT DELIVERY DEVICE 20mcg/dose 2.4ml(28doses)/box
原产地英文药品名:
TERIPARATIDE
中文参考商品译名:
骨穩注射装置 20微克/剂 2.4毫升(28剂量)/盒
中文参考药品译名:
特立帕肽
生产厂家中文参考译名:
礼来
生产厂家英文名:
LILLY