英文药名:LANTUS XR Inj SoloStar(Insulin Glargine(Genetical Recombination))
中文药名:重组甘精胰岛素注射笔
生产厂家:赛诺菲
药品介绍
甘精胰岛素是通过基因重组技术生产的长效胰岛素类似物,其降糖效果与胰岛素泵相似。甘精胰岛素作为一种新型的长效基础胰岛素类似物,能安全、稳定而持久的控制空腹血糖,减少低血糖发生率,与餐前速效胰岛素或口服降糖药合用,更能有效的控制血糖,实现血糖达标
治疗类别名称
长效溶解胰岛素类似物制剂
一般名 インスリン グラルギン(遺伝子組換え)
一般名(欧名) Insulin Glargine(Genetical Recombination)
分子式 C267H404N72O78S6
分子量 6062.89
性状
本品是一种白色粉末。
本品在水或乙醇(99.5)几乎不溶。
此产品是稍显不足溶于0.01摩尔/ L的盐酸试液。
本产品是吸湿。
本产品是由轻渐分解
临床应用
甘精胰岛素很适合于低基础胰岛素的替代治疗,在1型糖尿病和2型糖尿病患者使用甘精胰岛素治疗后都报道了较高的治疗满意度。尤其是在胰岛素强化治疗中,甘精胰岛素是首选。
口服降糖药物失败的患者,可以加入甘精胰岛素治疗。
用法用量
成人中,早期的4-20单元的第一至皮下注射,其可以与其它胰岛素制剂时组合使用。注射时间可以是前或睡前早饭前,每天都恒定。剂量增加或根据症状和患者的实验室研究结果降低。此外,维持剂量,包括剂量的其他胰岛素制剂通常都是第一4-80单位。
但是,它也可以使用超出必要的剂量
给药途径
皮下和静脉给药,甘精胰岛素的吸收历程不同,而只有采取皮下给药时,甘精胰岛素才能发挥其长效胰岛素的作用,若采取静脉给药,甘精胰岛素的生理效应则与常规胰岛素几乎没有差别。
不良反应
低血糖是最常见的不良反应,特别是在改用甘精胰岛素的前4周较易发生。其他不良反应较为少见。
药物相互作用
与其他类型的胰岛素相似,能增强甘精胰岛素作用的药物有:口服抗凝血药、水杨酸盐、磺胺类药物、甲氨蝶呤等可与胰岛素竞争血浆蛋白,使血中游离胰岛素升高;
口服降糖药与胰岛素有协同作用;
同用蛋白同化激素能减低葡萄糖耐量,增强胰岛素的作用;
乙醇、氯霉素等据称可加强胰岛素作用。
能阻滞甘精胰岛素作用的药物有:肾上腺皮质激素、甲状腺素、生长激素等均能升高血糖,合用时可对抗胰岛素的降血糖作用,噻嗪类利尿药、口服避孕药及烟酸衍生物,据称亦可减低胰岛素的降血糖作用,B受体阻滞剂,可阻断肾上腺素的升高血糖反应,干扰机体调节血糖功能,与胰岛素合用时,要注意调整剂量,否则易引起低血糖。
包装
450単位/1.5×2本
LANTUS XR Inj. SoloStar(ランタスXR注ソロスター)
Brand name : LANTUS XR Inj. SoloStar
Active ingredient: Insulin Glargine(Genetical Recombination)
Dosage form: limpid and colorless injection, (band/injection button) apple green
Print on wrapping:
Brand name : LANTUS XR Inj. SoloStar
Active ingredient: Insulin Glargine(Genetical Recombination)
Dosage form: limpid and colorless injection, (band/injection button) apple green
Print on wrapping:
Effects of this medicine
This medicine is a human insulin analogue (insulin with a different amino-acid sequence) that lowers blood glucose levels by inhibiting glucose production in the liver and promoting uptake of glucose in the muscle and fatty tissue.
It is usually used to treat diabetes mellitus for which insulin therapy is indicated.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have been eating poorly due to hypoglycemic symptoms, gastrointestinal disorders such as diarrhea and vomiting, or cold.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
In general, for adults, in the early phase, inject 4 to 20 units subcutaneously at a time, once a day. In some cases, this medicine may be used concomitantly with other insulin preparations. This medicine should be injected at the same time every day. Although the dosage may be adjusted according to the symptoms or examination findings, the maintenance dose, including that of other insulin preparations, is 4 to 80 units a day in general. However, the dose may exceed 80 units if necessary. Strictly follow the instructions.
Use a type A disposable syringe needle (compliant with JIS T3226-2) intended for exclusive use with this medicine.
If you find any problem when you attach the type A needle to Lantus XR Inj. SoloStar, such as leakage of the solution for injection, change the needle to a new one.
Make sure to attach a new needle every time immediately before injection.
Inject this medicine subcutaneously into an upper arm or the femoral, abdominal or lumbar region. If a next dose is to be injected in the same region, the injection site should be at least 2 to 3 cm apart from the previous site. Do not inject into a vein.
Do not share Lantus XR Inj. SoloStar with anyone.
Do not use this medicine without the cartridge. Do not remove the medicinal solution from the cartridge using the syringe.
If you miss a dose, consult with your doctor. You should never inject two doses at one time.
If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
Strictly follow the instructions on dietary/exercise therapy.
Pay extra attention when you engage in dangerous operations such as working at heights or driving a car, since development of hypoglycemia during such operations may lead to an accident.
You may become susceptible to hypoglycemia by not eating or after heavy exercise, and persistent hypoglycemia may result in a fatal accident.
Be aware of the preventive methods and treatments for hypoglycemia (taking supplemental sugar, beverage, etc., immediately in case you notice any symptoms), and inform your family and persons around you about these methods.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hypoglycemia, insomnia, hypoesthesia, vitreous bleeding, hepatic steatosis, generalized itch, injection site reaction, injection site swelling and injection site bleeding. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
lassitude, a strong sense of hunger, cold sweat [hypoglycemia]
generalized skin reaction (rash), angioneurotic edema (swelling of eyelids/lips), bronchospasm [shock, anaphylaxis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep out of the reach of children.
Do not freeze unused Lantus XR Inj. SoloStar. Store it in a light shielding condition (at 2 to 8 degrees Celsius). When taking this medicine out of the refrigerator for subcutaneous injection, warm it back up to room temperature before use.
After you start using this medicine, store away from light and freezing. Do not store in the refrigerator.
Do not use this medicine that has passed for more than 6 weeks since started using.
Ask your pharmacy or medical institution on how to discard them.
Sanofi K.K. Self-injection
Published: 9/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.kegg.jp/medicus-bin/japic_med?japic_code=00054950