ASACOR TABLETS 20MG 康脂錠 20毫克

許可證字號 衛署藥製字第039601號
有效日期 2015-12-06
發證日期 1995-12-06
許可證種類 製劑
通關簽審文件編號 DHY00103960100
中文品名 康脂錠２０毫克
英文品名 ASACOR TABLETS 20MG
適應症 高膽固醇血症、高三酸甘油酯血症。
劑型 錠劑
包裝 塑膠罐裝;;PTP 鋁箔盒裝
藥品類別 須由醫師處方使用
主成分略述 LOVASTATIN
申請商名稱 新益貿易股份有限公司
申請商地址 台中市北區進化路５６５號３樓
申請商統一編號 23677790
製造商名稱 衛達化學製藥股份有限公司
製造廠廠址 台中市南屯區文山里工業區２３路２１號
製造廠國別 TAIWAN
異動日期 2013-07-18
包裝與國際條碼 塑膠罐裝;;PTP 鋁箔盒裝

LOVASTATIN
洛伐他汀
 <<商品名>>
台灣健保藥品 - Asacor 康脂錠, Delipic 舒脂錠, Leslipid 特拿脂錠, Lovast 法拉利錠, Lovasta 樂脂清錠, Lovatin 樂伏脂錠, Lozutin 路脂定錠, Mevacor 美乏脂錠, Sancos 杏剋脂錠.
美國-  Altoprev; Mevacor
加拿大 -  Apo-Lovastatin; CO Lovastatin; Dom-Lovastatin; Gen-Lovastatin; Mevacor; Mylan-Lovastatin; Novo-Lovastatin
Ellanco (香港,馬來西亞); Medostatin (阿拉伯, 以色列, 馬來西亞, 新加坡); Mevacor (奧地利, 巴西, 丹麥, 芬蘭, 希臘, 香港, 墨西哥, 荷蘭, 秘魯, 巴基斯坦, 波蘭)

<<藥物作用>>
    此藥為一種稱為「Statin類」「降低膽固醇」的藥物。如果身體有太多的膽固醇或脂肪積聚於血管中，將會使血管阻塞，導致血液不能順暢地在血管中流通。由於血液不流通，將使血管內的壓力增加，因而導致高血壓，甚至造成腦血管破裂而導致中風。由於血液不流通，也會使血液運送氧氣的能力降低，由於心臟氧氣的缺乏，最終可能會導致心臟病或心絞痛的發生。
     Lovastatin 的藥理作用在於抑制膽固醇生化合成過程中極重要稱為「HMG-CoA 還原酶」的催化作用﹑此一重要的催化作用受阻後﹑膽固醇不能順利產生﹑在體內的產量自然降低﹑而最終達到降低膽固醇的目的。

<<用法>>
    此藥通常是一天服用一至兩次。由於膽固醇在晚上到清晨5點的時候分泌最多，因此如果一天服藥一次，最好能安排於晚飯時服用。如果一天服藥兩次，則於早餐及晚餐時，各服用一次。如有必要時，此藥的藥片可以壓碎與食物或水混合服用。

<<注意事項>>
     禁忌症：對Lovastatin藥物過敏者。孕婦﹑乳哺婦女﹑以及患有嚴重肝臟疾病﹑肝功能指數不明原因持續過高的病患不該使用此藥。
     如果懷孕，用母乳哺乳嬰兒，對藥物過敏，經常飲用大量的酒，或者有肝臟疾病﹑低血壓﹑癲癇症等，醫師需要針對這些情況謹慎用藥，因此在使用此藥前，應該先通知醫師。
     美國藥管局(FDA)將此藥歸類為X級：X級表示動物或人類實驗已證實藥物會導致胎兒先天性缺陷且用藥的風險明顯大於其益處﹑服用此類藥物對孕婦是絕對禁忌。由於此藥對胎兒的損害相當大，因此在服藥期間，應該使用極安全有效的方式避孕或與醫師討論適當的避孕方法。萬一在服藥期間發現已懷孕時，就應該立即通知醫師。
    此藥只能用來控制膽固醇過高，並不能根治此一病症。為了更有效降低膽固醇，除了定期服藥外，仍舊需要遵循醫師指示，食用低脂肪的食物﹑做適當的運動及減輕體重等，才能達到穩定膽固醇的效果。
    服用此藥一陣子後，除了得到醫師許可外，不可突然停止服藥。突然停藥，有可能會造成膽固醇突然升高。
    膽固醇過高﹑高血壓﹑糖尿病﹑身體過度的肥胖﹑吸煙等，都是造成血管硬化﹑導致中風及心臟病發作的主要因素。因此應該遵循醫師的指示，戒煙酒﹑食用低鹽量低脂肪的食物及使用適當的藥物以控制高血壓﹑糖尿病，及膽固醇過高等等。
  此藥最值得關注的副作用，就是可能對肝臟的影響。醫師可能會在服藥前﹑以及服藥後的六個禮拜及十二個禮拜要求驗血以測量肝功能是否正常﹑並且測量膽固醇的含量以適當調整所服用的劑量。患者應該依照醫師的指示，定期到醫院或診所做血液的檢驗。由於飲用大量的酒精可能會加重藥物對肝臟的損傷，服用此藥期間，應該盡量減少飲酒。
  此藥為一種稱為Statin類的「降膽固醇」藥物﹑這一類藥物較嚴重及值得關切的副作用為肌肉細胞發炎而產生溶解的現像﹑雖然發生此一副作用的機率相當低﹑但發生此一副作用後，將有可能造成腎臟方面的傷害。單純的肌肉細胞溶解﹑並不會造成多大的損害﹑但是未完全溶解的肌肉細胞組織﹑經過血液的循環﹑經由尿液到達腎臟後﹑如果阻塞住腎管的流通﹑有造成腎臟衰竭的可能。在服藥的期間﹑如果您突然有與運動無關或者不名原因引起的肌肉疼痛﹑觸痛及肌肉疲乏無力﹑尤其此肌肉酸痛伴隨著發燒及全身不舒服現像﹑就應該盡快通知醫師。
     以上所敘述肝功能及橫紋肌副作用雖嚴重，但其發生的機率相當微小，發怖此訊息的目的在於提供民眾正確藥物訊息及處理方式。美國藥管局(FDA)曾發出多次聲明強調「Statin類」藥物對防止心血管病變的重要性及必要性, 病患不可勿視此藥物可能提供的優點，更不該突然停止使用此藥物。

<<副作用>>
      Lovastatin 最常見的副作用為為：腹痛（高達 2.5％），便秘（高達 3.5％）。其它可能副作用包括：失眠﹑皮膚發紅﹑腹瀉﹑胸口灼熱或胃痛﹑排氣增加﹑噁心﹑頭暈﹑頭痛等，這些副作用，通常在服用藥物一陣子後，身體漸漸習慣了此藥物的作用，應該會漸漸地消失;不過，如果達到困擾你的程度，或者經過一段時間後，這些症狀還不能完全消除，就應該通知醫師。
     此藥較嚴重的副作用為:視覺模糊或視覺改變﹑發燒﹑肌肉痛﹑肌肉抽筋﹑極度的疲倦或虛弱等等，通常這些副作用發生的機率較低，但是如果發生時，應該盡快通知醫師。

<<懷孕及哺乳>>
     美國藥管局(FDA)將此藥歸類為X級：X級表示動物或人類實驗已證實藥物會導致胎兒先天性缺陷且用藥的風險明顯大於其益處﹑服用此類藥物對孕婦是絕對禁忌。
  孕婦不該服用此藥，此藥會影響胎兒骨骼正常的發育及成長，同時也可能會降低胎兒體內所需要的膽固醇，間接地影響到胎兒腦部及神經的發展。如果在服藥期間發現已經懷孕，就應該立即停止服藥，並且通知醫師。
     Micromedex公司哺乳評級結論﹕ 對嬰兒的風險性還無法排除。
(由於現有資料不足或專家結論不同情況下﹑無法充分證明哺乳期間使用藥物是否會增加嬰兒的風險。婦女若考慮使用母奶哺乳嬰兒﹑應該權衡藥物的優點或藥物對嬰兒潛在的風險性。)
    目前为止，尚不知此药是否会经由母乳到达婴儿体内，但與此藥同類型的另一藥物已被證實會分泌入母乳。为了避免造成新生儿发生严重副作用，餵奶的母亲应该使用其它乳制品以取代母乳。

<<忘記用藥>>
   為了有效地降低膽固醇，必須定期服用藥物。如果忘記服藥，應該在記得時，立即服用;但是，如果距離下次服藥的時間太近，就應該捨棄所遺忘的藥物，恢復到正常服藥的時間，千萬不可一次服用雙倍的劑量。

Alert Medications

藥        名                                  作   用     副  作  用   其  他
Aleviatin  100mg/tab〈Dilantin〉 抗癲癇   血糖↓ 運動不能   禁牛奶鎂鋁劑藥物同服
Dilantin                                      抗癲癇   血糖↓ 運動不能   禁牛奶鎂鋁劑藥物同服

Apo-Divalproex tab安保癲安腸溶錠®

成份 Divalproex Na
適應症 Treatment of the manic episodes associated with bipolar disorder. Treatment of simple or complex absence seizures including petit mal, primary generalized seizures with tonic-clonic manifestations. Prophylaxis of migraine.


用量 Epilepsy Adult Initially 10-15 mg/kg/day, increasing at 1-week interval by 5-10 mg/kg/day until seizures are controlled or side effects preclude further increases. Max: 60 mg/kg/day.Acute mania 250 mg tid. Dose should be increased to achieve the lowest therapeutic dose. Max: 60 mg/kg/day. Prophylaxis of migraine 250 mg bid. Some patients may benefit from doses up to 1 g/day.
用法 Should be taken with food
美國食品藥物管理局之懷孕等級 Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
禁忌 Hepatic disease or severe hepatic dysfunction.
注意事項 Perform liver function tests prior to therapy & at frequent intervals thereafter especially during the first 6 months. Children <3 years. Renal impairment. SLE. Pregnancy, lactation. May impair ability to drive or operate machinery.
不良反應 GI disturbances, weight increase, alopecia, hepatitis. (to view ADR Monitoring Form)


交互作用 Increased clearance by phenytoin, carbamazepine, phenobarb. May alter serum concentration of aspirin, carbamazepine, dicumarol, warfarin, tolbutamide & phenytoin. Aspirin, felbamate, rifampin, Selective Serotonin Reuptake Inhibitors (SSRIs), antipsychotics, MAOIs & tricyclic antidepressants. Alcohol, ethosuximide, lamotrigine,zidovudine. (for more Interaction Checks)


MIMS 藥理分類 抗癲癇藥 (Anticonvulsants) / 偏頭痛用藥 (Antimigraine Preparations)


ATC 分類 N03AG01 - Valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic. Used in the management of epilepsy.
產品類別 Rx (處方用藥)
本商品之市售規格
劑型                               包裝/價格
Apo-Divalproex 腸溶錠       Apo-Divalproex 250 mg x 100's
                                              Apo-Divalproex 500 mg x 100's


用途：
具抗痙攣及改善精神的情緒穩定劑。
用藥前應注意事項：
1. 肝功能障礙者，應避免使用本品。
2. 已懷孕或計劃要懷孕，或者正在哺乳的婦女。
服藥中應注意事項：
      1.       接受任何手術或牙科治療前，應小心使用，因本品會使出血時間延長或導致出血。
      2.       糖尿病人驗尿時，須將服用本品列入考慮，以免驗尿結果發生誤差。
      3. 會出現嗜睡現象，所以應避免駕車及從事危險性工作。
飲食須知：
1. 請與大量開水併服，若有胃腸不適現象，請於飯後服用。
2. 服用期間應避免酒類之攝取。
3. 請整粒吞服，勿咬碎或咀嚼之，若不慎咬碎，併服大量開水可降低苦味及刺激性。
4. 切勿與含碳酸氣之飲料併服。
貯存：
    本品引濕性強，非服用時切勿撕開鋁箔或打開瓶蓋。

DILANTIN

DILANTIN (Dī lan' tĭn)
(Phenytoin and Phenytoin sodium)
Oral Suspension, Tablets, Extended Oral Capsules
Read this Medication Guide before you start taking DILANTIN and each time you get a
refill. There may be new information.  This information does not take the place of
talking to your healthcare provider about your medical condition or treatment.  If you
have any questions about DILANTIN, ask your healthcare provider or pharmacist.  
What is the most important information I should know about DILANTIN?
Do not stop taking DILANTIN without first talking to your healthcare provider.  
Stopping DILANTIN suddenly can cause serious problems.  
DILANTIN can cause serious side effects including:
1.  Like other antiepileptic drugs, DILANTIN may cause suicidal thoughts or
actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms,
especially if they are new, worse, or worry you:
•  thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase activity and talking (mania)
• other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•  Pay attention to any changes, especially sudden changes, in mood, behaviors,
thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried
about symptoms.  
Reference ID: 2888819  10  

Do not stop taking DILANTIN without first talking to a healthcare provider.
•  Stopping DILANTIN suddenly can cause serious problems.  Stopping a seizure
medicine suddenly in a patient who has epilepsy can cause seizures that will not
stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines.  If you have
suicidal thoughts or actions, your healthcare provider may check for other causes.
2.  Dilantin may harm your unborn baby.
•  If you take DILANTIN during pregnancy, your baby is at risk for serious birth
defects.
• Birth defects may occur even in children born to women who are not taking
any medicines and do not have other risk factors  
• If you take DILANTIN during pregnancy, your baby is also at risk for
bleeding problems right after birth.  Your healthcare provider may give you
and your baby medicine to prevent this.  
• All women of child-bearing age should talk to their healthcare provider about
using other possible treatments instead of DILANTIN.  If the decision is made
to use DILANTIN, you should use effective birth control (contraception)
unless you are planning to become pregnant.
• Tell your healthcare provider right away if you become pregnant while taking
DILANTIN. You and your healthcare provider should decide if you will take
DILANTIN while you are pregnant.
• Pregnancy Registry: If you become pregnant while taking DILANTIN, talk to
your healthcare provider about registering with the North American
Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by
calling 1-888-233-2334. The purpose of this registry is to collect information
about the safety of antiepileptic drugs during pregnancy.
3. Swollen glands (lymph nodes)  
4.  Allergic reactions or serious problems which may affect organs and other
parts of your body like the liver or blood cells.  You may or may not have a rash
with these types of reactions. Symptoms include:
•  swelling of your face, eyes, lips, or tongue
• trouble swallowing or breathing
• a skin rash
• hives
• fever, swollen glands, or sore throat that do not go away or come and go
• painful sores in the mouth or around your eyes
• yellowing of your skin or eyes
Reference ID: 2888819  11 •  unusual bruising or bleeding
• severe fatigue or weakness
• severe muscle pain
• frequent infections or an infection that does not go away
Call your healthcare provider right away if you have any of the symptoms listed
above.
What is DILANTIN?
DILANTIN is a prescription medicine used to treat tonic-clonic (grand mal), complex
partial (psychomotor or temporal lobe) seizures, and to prevent and treat seizures that
happen during or after brain surgery.
Who should not take DILANTIN?
Do not take DILANTIN if you:
•  are allergic to phenytoin or any of the ingredients in DILANTIN. See the end
of this leaflet for a complete list of ingredients in DILANTIN.
• have had an allergic reaction to CEREBYX (fosphenytoin), PEGANONE
(ethotoin), or MESANTOIN (mephenytoin).
What should I tell my healthcare provider before taking DILANTIN?
Before you take DILANTIN, tell your healthcare provider if you:
• Have or had liver disease
• Have or had porphyria
• Have or had diabetes
• Have or have had depression, mood problems, or suicidal thoughts or behavior
• Are pregnant or plan to become pregnant.
o  If you become pregnant while taking DILANTIN, the level of
DILANTIN in your blood may decrease, causing your seizures to
become worse.  Your healthcare provider may change your dose of
DILANTIN.
• Are breast feeding or plan to breastfeed. DILANTIN can pass into breast milk.
You and your healthcare provider should decide if you will take DILANTIN or
breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including
prescription and non-prescription medicines, vitamins, and herbal supplements.  
Taking DILANTIN with certain other medicines can cause side effects or affect how
well they work. Do not start or stop other medicines without talking to your
healthcare provider.
Reference ID: 2888819  12 Know the medicines you take.  Keep a list of them and show it to your healthcare
provider and pharmacist when you get a new medicine.  
How should I take DILANTIN?
•  Take DILANTIN exactly as prescribed. Your healthcare provider will tell you
how much DILANTIN to take.
• Your healthcare provider may change your dose.  Do not change your dose of
DILANTIN without talking to your healthcare provider.
• DILANTIN can cause overgrowth of your gums.  Brushing and flossing your
teeth and seeing a dentist regularly while taking DILANTIN can help prevent
this.
• If you take too much DILANTIN, call your healthcare provider or local Poison
Control Center right away.
• Do not stop taking DILANTIN without first talking to your healthcare provider.
Stopping DILANTIN suddenly can cause serious problems.  
What should I avoid while taking DILANTIN?
Do not drink alcohol while you take DILANTIN without first talking to your healthcare
provider. Drinking alcohol while taking DILANTIN may change your blood levels of
DILANTIN which can cause serious problems.
Do not drive, operate heavy machinery, or do other dangerous activities until you know
how DILANTIN affects you. DILANTIN can slow your thinking and motor skills.
What are the possible side effects of DILANTIN?
See “What is the most important information I should know about DILANTIN?”
DILANTIN may cause other serious side effects including:
• Softening of your bones (osteomalacia).  This can cause broken bones.
Call your healthcare provider right away, if you have any of the symptoms listed
above.
The most common side effects of DILANTIN include:
•  problems with walking and coordination
• slurred speech
• confusion
• dizziness
• trouble sleeping
• nervousness
• tremor
• headache
• nausea
Reference ID: 2888819  13 •  vomiting
• constipation
• rash
These are not all the possible side effects of DILANTIN. For more information, ask your
healthcare provider or pharmacist.  
Tell your healthcare provider if you have any side effect that bothers you or that does not
go away.
Call your doctor for medical advice about side effects.  You may report side
effects to FDA at 1-800-FDA-1088.
How should I store DILANTIN?
•  Store DILANTIN-125 Suspension at room temperature between 68°F to 77°F
(20°C to 25°C). Protect from light.  Do not freeze.
• Store DILANTIN INFATABS at room temperature between 59°F to 86°F (15°C
to 30°C).
• Store DILANTIN Capsules at room temperature between 68°F to 77°F (20°C to
25°C) in tight, light-resistant containers. Protect from moisture.
Keep DILANTIN and all medicines out of the reach of children.
General information about DILANTIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication
Guide. Do not use DILANTIN for a condition for which it was not prescribed. Do not
give DILANTIN to other people, even if they have the same symptoms that you have.  It
may harm them.
This Medication Guide summarizes the most important information about DILANTIN.  If
you would like more information, talk with your healthcare provider.  You can ask your
healthcare provider or pharmacist for information about DILANTIN that was written for
healthcare professionals.
For more information about DILANTIN, visit http://www.pfizer.com or call
1-800-438-1985.
What are the ingredients in DILANTIN?
Oral Suspension
Active ingredient: phenytoin
Inactive ingredients: USP; alcohol, USP (maximum content not greater than 0.6 percent);
banana flavor; carboxymethylcellulose sodium, USP; citric acid, anhydrous, USP;
glycerin, USP; magnesium aluminum silicate, NF; orange oil concentrate; polysorbate
40, NF; purified water, USP; sodium benzoate, NF; sucrose, NF; vanillin, NF; and FD&C
yellow No. 6.
Reference ID: 2888819  14  
Tablet


Each tablet is a yellow triangular scored chewable tablet.
Active ingredient: 50 mg phenytoin
Inactive ingredients: D & C yellow No. 10, A1 lake, FD&C yellow No. 6, flavor,
saccharin sodium, sucrose, talc, and other ingredients.  
Extended Oral Capsule
Dilantin 100mg: Each capsule contains a white powder.  The medium orange cap has
“PD” imprinted in black ink and the white, opaque body has “DILANTIN” over
“100 mg” printed in black ink.
Active ingredient: 100 mg phenytoin sodium
Inactive ingredients: lactose monohydrate, confectioner’s sugar, talc, and magnesium
stearate. The capsule body contains titanium dioxide and gelatin.  The capsule cap
contains FD&C red No. 28, FD&C yellow No. 6, and gelatin.
Dilantin 30mg: Each capsule contains a white powder.  The small pale pink opaque cap
has “PD” imprinted in black ink and the white, opaque body has “Dilantin 30 mg”
printed in black ink.
Active ingredient: 30 mg phenytoin sodium


Inactive ingredients: lactose monohydrate, confectioner’s sugar, talc, and magnesium


stearate. The capsule shell cap and body contain Titanium Dioxide (cap and body);
gelatin (cap and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap).
This Medication Guide has been approved by the U.S. Food and Drug Administration.  
LAB-0398-1.0
Revised November 2010
Reference ID: 2888819  15