英文药名：Apidra（Insulin Glulisine Injection）

中文药名：艾倍得(谷赖胰岛素注射液)

给药说明
APIDRA®是一种新型、速效胰岛素类似物，用于1型和2型糖尿病成人患者，控制高血糖。APIDRA® 给患者带来灵活的餐时剂量胰岛素—可以在餐前或餐后15分钟给药。APIDRA® 还可以为各种体型的患者带来方便，不论是胖还是瘦均适用。

药品英文名
rDNA Origin
 
药品别名
Insulin Glulisine、Apidra  艾倍得
 
药物剂型
注射剂(Apidra)：100U/ml，10ml/支。
预充注射剂:300 iu x 3 mL/支  1支/盒（预填充笔）

药理作用
本品为一种速效的重组DNA人胰岛素类似物，用非病原的大肠埃希菌实验室毒株经重组DNA技术合成。本品与人胰岛素结构不同之处在于，B3位的天冬酰胺置换成赖氨酸，B29位的赖氨酸置换成谷氨酸。本品作用与胰岛素相同，主要调节葡萄糖代谢，本品静脉给药的降糖作用与正规人胰岛素相当，皮下注射比正规人胰岛素起效快，维持时间短。
 
药动学
本品比正规人胰岛素吸收迅速，皮下注射生物利用度为70%，1型糖尿病患者皮下注射0.15IU/kg，本品的达峰时间(Tmax)、峰浓度(Cmax)和作用持续时间分别为55min、82μIU/ml和98min，正规人胰岛素为82min、46μIU/ml和161min。本品皮下注射后的分布及消除与正规人胰岛素相似，表观分布容积分别为13L和21L，半衰期分别为13min和17min。严重肾功能降低患者本品循环药物浓度升高，清除减慢。
 
适应证
本品用于控制糖尿病患者的高血糖。该药通过皮下给药，比常规的人胰岛素起效快，应与饮食控制、长效胰岛素或胰岛素类似物同时使用。
 
禁忌证
1．对本品及其辅料过敏者禁用。
2．糖尿病患者血糖过低时禁用。
 
注意事项
1．本品生殖毒性分级为C，只有当对母体的益处高于对胎儿的危险时方可用于孕妇。尚不知本品是否经人乳汁分泌，哺乳期妇女慎用，并应适当调整给药剂量和饮食。
2．该药皮下给药比正规人胰岛素起效快，但维持时间短，应与饮食控制、长效胰岛素或胰岛素类似物同时使用，以维持正常血糖水平。
3．给药剂量应根据体力活动及饮食改变而进行调整，也需要根据病情、情绪紊乱或紧张状态进行改变。
4．肝、肾功能降低患者本品需要量会降低。
5．儿童用药安全性尚未评价。
6．本品过量可引起低血糖，轻度至中度低血糖患者应口服葡萄糖治疗，必要时调整给药剂量、饮食结构或体力活动。严重低血糖引起的昏迷、癫痫发作或神经功能缺损可肌注或皮下注射胰高血糖素，或静注高浓度葡萄糖。
7．2～8℃冷藏避光保存，避免冷冻。开启后可使用28天。
 
不良反应
本品最常见的不良反应为低血糖，其他不良反应包括：过敏反应、注射部位反应、脂肪营养障碍、瘙痒、药疹。局部变态反应包括注射部位发红、肿大和瘙痒，全身变态反应很少见，包括全身药疹、呼吸急促、喘鸣、血压降低、脉搏加快、出汗，严重时可危及生命。
 
用法用量
皮下注射或经外部胰岛素泵给药，其效价与正规人胰岛素相当，就餐前15min或进餐开始后20min内给药，根据个体情况确定给药剂量，应对患者血糖进行监测。
 
药物相应作用
1．以下药物可降低本品的降血糖作用：皮质激素、丹那唑、二氮嗪、利尿药、拟交感神经药(如肾上腺素、沙丁胺醇、特布他林等)、胰高血糖素、异烟肼、酚噻嗪类、生长激素、甲状腺素、雌激素、孕激素(如口服避孕药)、蛋白酶抑制剂及抗精神病药。
2．以下药物可增强本品的降血糖作用，降低血糖敏感性：口服降血糖药、ACEI、丙吡胺、氯贝特、氟西汀、单胺氧化酶抑制剂、己酮可可碱、丙氧酚、水杨酸盐、氨苯磺胺。β受体阻滞剂、可乐定、锂盐和乙醇可增强或降低本品的降血糖作用。与喷他脒合用可引起低血糖，有时转为高血糖。
 
Drug Forms:
Insulin Glulisine Solution for injection (below)
Insulin Glulisine injection
Insulin Glulisine Solution for injection
Español:
Insulina Glulisina, Solución para inyección
Inyección de Insulina Glulisina
Insulin Glulisine Solution for injection
What is this medicine?
INSULIN GLULISINE (IN su lin; GLOO lis een) is a human-made form of insulin. This medicine lowers the amount of sugar in your blood. It is a fast acting insulin that starts working faster than regular insulin. It will not effect your blood sugar as long as regular insulin.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•episodes of hypoglycemia
•kidney disease
•liver disease
•an unusual or allergic reaction to insulin, metacresol, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
This medicine is for injection under the skin. Use exactly as directed. Your health care professional or doctor will tell you how long to wait after you inject your dose before eating a meal. Most of the time, you should wait about 5 to 10 minutes or less. You will be taught how to use this medicine and how to adjust doses for activities and illness. Do not use more insulin than prescribed. Do not use more or less often than prescribed.
Always check the appearance of your insulin before using it. This medicine should be clear and colorless like water. Do not use it if it is cloudy, thickened, colored, or has solid particles in it.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
•other medicines for diabetes
Many medications may cause an increase or decrease in blood sugar, these include:
•alcohol containing beverages
•aspirin and aspirin-like drugs
•chloramphenicol
•chromium
•diuretics
•female hormones, like estrogens or progestins and birth control pills
•heart medicines
•isoniazid
•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
•male hormones or anabolic steroids
•medicines for weight loss
•medicines for allergies, asthma, cold, or cough
•medicines for mental problems
•niacin
•NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
•pentamidine
•phenytoin
•probenecid
•quinolone antibiotics like ciprofloxacin, levofloxacin, ofloxacin
•some herbal dietary supplements
•steroid medicines like prednisone or cortisone
•thyroid medicine
Some medications can hide the warning symptoms of low blood sugar. You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:
•beta-blockers such as atenolol, metoprolol, propranolol
•clonidine
•guanethidine
•reserpine
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your health care professional or doctor for regular checks on your progress. To control your diabetes you must use this medicine regularly and follow a diet and exercise schedule. Checking and recording your blood sugar and urine ketone levels regularly is important. Use a blood sugar measuring device before you treat high or low blood sugar.
Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure family members know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.
Make sure that you have the right kind of syringe for the type of insulin you use. Try not to change the brand and type of insulin or syringe unless your health care professional or doctor tells you to. Switching insulin brand or type can cause dangerously high or low blood sugar. Always keep an extra supply of insulin, syringes, and needles on hand. Use a syringe one time only. Throw away syringe and needle in a closed container to prevent accidental needle sticks.
Insulin pens and cartridges should never be shared. Sharing may result in passing of viruses like hepatitis or HIV.
Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.
Many nonprescription cough and cold products contain sugar or alcohol. These can affect diabetes control or can alter the results of tests used to monitor blood sugar. Avoid alcohol. Avoid products that contain alcohol or sugar.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your health care professional or doctor as soon as possible:
Symptoms of low blood sugar:
•You may feel nervous, confused, dizzy, hungry, weak, sweaty, shaky, cold, and irritable. You may also experience headache, blurred vision, rapid heartbeat and loss of consciousness.
Symptoms of high blood sugar:
•You may experience dizziness, dry mouth, dry skin, fruity breath, loss of appetite, nausea, stomach ache, unusual thirst, frequent urination
Insulin also can cause rare but serious allergic reactions in some patients, including:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•breathing problems
Side effects that usually do not require medical attention (report to your health care professional or doctor if they continue or are bothersome):
•increase or decrease in fatty tissue under the skin, through overuse of a particular injection
•itching, burning, swelling, or rash at the injection site
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store unopened insulin vials in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the insulin has been frozen. Opened vials (vials currently in use) may be stored in the refrigerator or at room temperature, below 25 degrees C (77 degrees F). Keeping your insulin at room temperature decreases the amount of pain during injection. Once opened, your insulin can be used for 28 days. After 28 days, the vial of insulin should be thrown away.
Protect from light and excessive heat. Throw away any unused medicine after the expiration date or after the specified time for room temperature storage has passed.