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Twynsta 80/10mg Tablets(氨氯地平/替米沙坦片)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 80/10毫克/片 30片/盒 
包装规格 80/10毫克/片 30片/盒 
计价单位: 盒 
生产厂家中文参考译名:
勃林格殷格翰
生产厂家英文名:
Boehringer Ingelheim
该药品相关信息网址1:
https://www.rxlist.com/twynsta-drug.htm
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Twynsta 80/10mg/Tablets 30Tablets/box
原产地英文药品名:
amlodipine/telmisartan
中文参考商品译名:
Twynsta 80/10毫克/片 30片/盒
中文参考药品译名:
氨氯地平/替米沙坦
曾用名:
简介:

 

部份中文氨氯地平/替米沙坦处方资料(仅供参考)
商品名 TWYNSTA 
英文名 Amlodipine+Telmisartan
中文名 氨氯地平/替米沙坦
藥理類別:血管收縮素II接受器拮抗
藥理類別:Telmisartan and Amlodipine
孕婦用藥分級
C 級:
在對照的動物研究試驗中顯示該藥學物對胚胎有不良反應(致畸胎性或殺胚胎性或其他),但未進行人體懷孕婦女研究;或者尚無對照的人體懷孕婦女或動物研究試驗。只有在可能的利益大於潛在的危險,才可使用此藥物。
結構式 
Amlodipine besylate的化學名稱為3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)
-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate,實驗式為
C20H25ClN2O5‧C6H6O3S,構造式為:
Telmisartan 的化學名稱為4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid,實驗式為 C33H30N4O2,構造式為:
UpToDate UpToDate連結 
藥理作用 
Telmisartan
血管收縮素II係在血管收縮素轉化酶(ACE,激肽酶[kininase]II)所催化的反應中,由血管收縮素I轉化形成。
血管收縮素II為腎素-血管收縮素系統的主要升壓劑,其作用包括血管收縮、激醛固酮的合成與釋放、心臟激作用,以及腎臟對鈉的再吸收作用。
Telmisartan可在許多組織(如血管平肌與腎上腺)中,選擇性地阻斷血管收縮素II與AT1受體的結合,進而阻斷血管收縮素II的血管收縮與醛固酮釋放作用。因此,其作用與血管收縮素II的合成徑無關。
Amlodipine
Amlodipine是一種dihydropyridine 鈣子通道阻斷劑,可抑制鈣子經膜入血管平肌與心肌的過程。 
適應症 
治高血壓,此複方藥品適用於起始治。 
用法用量 
1. 一天一次20-80mg劑的telmisartan為有效的高血壓法,amlodipine的有效劑範圍則為2.5-10mg。劑須個別調整,可於至少2週後調高。大部分的血壓效果可於2週內顯現,通常可於4週後達到最大幅。
2. TWYNSTA的最大建議劑為一天一次80/10mg。
3. TWYNSTA可與食物一起服用,亦可空腹服用。 
藥動力學 
TWYNSTA 錠劑
Amlodipine 與telmisartan 併用具有相近於其個別使用時的藥物動學性質。
TWYNSTA 80/10mg 錠劑與高脂餐食一起服用之後,telmisartan 的總血漿濃-時間曲線下面積(AUC)與Cmax 分別低大約24%與60%。Amlodipine 的AUC 與Cmax則未改變[請閱用法用]。
Telmisartan
口服之後,telmisartan的最高濃(Cmax)可於用藥後0.5至1小時達到。食物會稍微低telmisartan的生體可用,使用40mg錠劑時telmisartan的血漿濃-時間曲線下面積(AUC)低約6%,使用160mg劑後則低約20%。Telmisartan的絕對生體可用具有劑相關性。
Amlodipine
單獨使用amlodipine之後,amlodipine的最高血漿濃可於6-12小時後達到。絕對生體可用約在64%至90%之間。Amlodipine 的生體可用受食物影響。
Amlodipine 係以雙相方式(biphasic)從血漿中清除,末相排除半衰期約為30至50小時。Amlodipine可續7 至8天每日用藥一次之後,達到穩定態的血漿濃。
分布
Telmisartan
Telmisartan 與血漿蛋白質的結合高(>99.5%),主要為白蛋白與α1-酸性蛋白。在使用建議劑所達到的濃範圍內,血漿蛋白質的結合皆極穩定。
Amlodipine
Amlodipine 的擬似分布體積為21L/kg。高血壓病患循環中的amlodipine,約有93%與血漿蛋白質結合。
代謝與排除
Telmisartan
靜脈注射或口服14C所標記的telmisartan 後,大部分的用藥劑(>97%)皆以原型經由膽汁排出,而從糞中排除;僅極少出現於液中(分別為總放射活性的0.91%與0.49%)。
Telmisartan 的代謝係藉由共軛結合(conjugation),而形成具藥活性的醯基甘酸共軛化合物(acylglucuronide);此原型態的甘酸化合物為人血漿與液中,唯一獲得確認的代謝物。在使用單一劑之後,其甘酸化合物約佔血漿中所測得之放射活性的11%。細胞色素P450 同功酶並未與telmisartan的代謝。
Telmisartan的總血漿清除>800mL/min。末相半衰期與總清除,似乎具劑相關性。
Amlodipine
Amlodipine主要經由肝臟代謝(約90%)而轉變為無活性的代謝物,有10%的原始化合物與60%的代謝物於液中排除。 
副作用 
周邊水腫、眩與背痛。 
交互作用 
TWYNSTA錠劑尚未與其他藥物進藥物交互作用研究。 
禁忌 
TWYNSTA 錠劑禁用於已知對telmisartan、amlodipine,或本產品之任何其他成分過敏(如,全身性過敏反應或血管性水腫)的病患。 
注意事項 
由於使用TWYNSTA之的抗高血壓藥物可能出現厥、睏倦、眩或眩等副作用,因此病患在從事開或操作器具或機器等活動時,應特別謹慎。 
警語 
於懷孕期間使用直接作用於腎素-血管收縮素系統的藥物,可能對發育中的胎兒造成傷害,甚至導致胎兒死亡。一旦得知懷孕,須儘快停止服用TWYNSTA 錠劑。 
過量處理 
Telmisartan
在人體用藥過的現有資多。Telmisartan錠劑用藥過最可能出現的症,包括低血壓、眩與心搏過速;副交感經(迷走經)的激,則可能導致心搏徐緩。發生症性的低血壓,須給予支持性法。Telmisartan無法以血液透析方式移除。
Amlodipine
發生嚴重用藥過,即應密監測其心臟與呼吸況,並密集測血壓。發生低血壓,即應施予心血管支持性治(包括抬高四肢)與適當補充液體。 
藥品保存方式 
儲存於30°C以下。
TWYNSTA(telmisartan/amlodipine)Tablets
How does this medication work?
What will it do for me?
This is a combination medication that contains amlodipine and telmisartan. Amlodipine belongs to the group of medications called calcium channel blockers and telmisartan belongs to the group of medications called angiotensin II receptor blockers.
Amlodipine - telmisartan is used to treat mild to moderate high blood pressure for people who have been taking amlodipine and telmisartan as separate tablets. It works by relaxing blood vessel walls.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
40 mg/5 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white to off-white and the other layer blue, marked with the company logo and "A1" contains 40 mg telmisartan and 5 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminium Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).
40 mg/10 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white to off-white and the other layer blue, marked with the company logo and "A2" contains 40 mg telmisartan and 10 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminium Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).
80 mg/5mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white to off-white and the other layer blue, marked with the company logo and "A3" contains 80 mg telmisartan and 5 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminium Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).
80 mg/10 mg
Each oval-shaped, biconvex, uncoated, bilayer tablet with one layer white to off-white and the other layer blue, marked with the company logo and "A4" contains 80 mg telmisartan and 10 mg amlodipine. Nonmedicinal ingredients: colloidal anhydrous silica, FD&C Blue No. 1 Aluminium Lake (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch, sodium hydroxide, and sorbitol (E420).
How should I use this medication?
The usual dose of this medication depends on the dose of amlodipine and telmisartan taken separately before starting this medication. The dose is taken once daily, the same time of day, preferably in the morning.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
Amlodipine - telmisartan may be taken with or without food.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in the original package, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
are allergic to amlodipine, telmisartan, or any ingredients of the medication
are allergic to similar medications (e.g., calcium channel blockers, ARBs)
are breast-feeding
are pregnant
have a rare hereditary condition of fructose intolerance (this medication contains sorbitol)
have biliary obstruction (problems with the draining of bile from the liver and gall bladder)
have severe liver problems
have low heart output because of a serious heart problem
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
back pain
difficulty sleeping
headache
muscle aches
unusual tiredness or weakness
upper respiratory tract infection (such as colds or sinus infections)
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
abnormal heartbeat (e.g., pounding heartbeat, slow heartbeat, fast heartbeat)
dizziness
easy bruising or bleeding
low blood pressure (e.g., dizziness, fainting, dizziness when standing up)
skin rash
swelling of ankles or feet
symptoms of depression (e.g., feeling sad, weight changes, sleep changes, hopelessness, guilt, loss of interest in activities)
symptoms of kidney problesm (e.g., difficulty urinating, producing little or no urine)
symptoms of liver problems (e.g., nausea, abdominal pain, tiredness, loss of appetite, feeling unwell, yellowing of the skin or eyes)
tingling or prickling sensations in the hands and feet
vertigo (feeling of spinning)
vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
chest pain
symptoms of a heart attack (e.g., chest pain, pressure or heaviness; nausea; shortness of breath; cool, clammy skin; anxiety)
symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the mouth, tongue, face, or throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Dizziness, fainting, spinning sensations: This medication can cause dizziness, fainting, or spinning sensations.
Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.
Heart attack and stroke: If you have a history of heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you have heart disease, problems with blood supply to the brain, or have had a recent heart attack, there is a risk that this medication may cause a heart attack or a stroke.
If you develop symptoms of a heart attack (e.g., chest pain, pressure, or heaviness; nausea; shortness of breath; anxiety; cool, clammy skin) or a stroke (e.g., sudden dizziness, difficulty speaking, headache, difficulty walking, confusion, blurred vision), get immediate medical attention.
Kidney function: If you have a kidney problem (e.g., kidney disease, renal artery stenosis), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
People that have kidney problems and take this medication are more likely to experience increased levels of potassium in the blood. If you experience an irregular or slow heartbeat or nausea, contact your doctor as soon as possible.
Liver function: Amlodipine - telmisartan is removed from the body by the liver. People with reduced liver function are more likely to experience side effects related to this medication.
If you have mild to moderate liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have severe liver problems or have biliary obstruction, you should not use this medication.
Low blood pressure: This medication may cause low blood pressure. Low blood pressure is more likely to occur if you are dehydrated, are taking diuretics ("water pills"), are on a low-salt diet, or have diarrhea or vomiting. If you experience dizziness or lightheadedness, lie down until the symptoms go away and contact your doctor.
Potassium levels: This medication can increase potassium levels in the blood. Your doctor may monitor your potassium levels with blood tests. Do not use potassium supplements or salt substitutes with potassium unless recommended by your doctor.
Pregnancy: As with other medications related to telmisartan, this medication can cause serious harm or even death to the developing baby if taken during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if amlodipine or telmisartan pass into breast milk. If you are a breast-feeding mother and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for adolescents and children under the age of 18.
Seniors: Seniors may be more sensitive to the side effects of this medication. 

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