藥品新增 新藥介紹. <28D045>Desmopressin (Minirin Melt) (60ug) 凍晶口溶錠.

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1 <28D045>Desmopressin (Minirin Melt) (60ug) 凍晶口溶錠. <28D045>Desmopressin (Minirin Melt) (60ug) 凍晶口溶錠. 藥理作用 / 不良反應 Synthetic analogue of the antidiuretic hormone arginine vasopressin. In a dose dependent manner, desmopressin increases cyclic adenosine monophosphate (camp) in renal tubular cells which increases water permeability resulting in decreased urine volume and increased urine osmolality; increases plasma levels of von Willebrand factor, factor VIII, and t-pa contributing to a shortened activated partial thromboplastin time (aptt) and bleeding time. Indication& Dosage: Sublingual Adult: Diabetes insipidus: Initial: 60 mcg 3 times daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis. Usual maintenance: 120 to 720 mcg equally divided 2 or 3 times daily. Fluid restriction should be observed. Pediatric: Diabetes insipidus: Children: Initial: 60 mcg 3 times daily; total daily dose should be increased or decreased as needed to obtain adequate antidiuresis. Usual maintenance: 120 to 720 mcg equally divided 2 to 3 times daily; divide daily doses so that the evening dose is 2 times higher than the morning or afternoon dose to ensure adequate antidiuresis during the night. Fluid restriction should be observed. Adolescents: Refer to adult dosing. Nocturnal enuresis: Children 5 years and Adolescents: Initial: 120 mcg administered 1 hour before bedtime; dose may be titrated up to a maximum of 360 mcg to achieve desired response. Fluid intake should be limited 1 hour prior to dose until the next morning, or at least 8 hours after administration. Known hypersensitivity to desmopressin acetate or any component of the formulations; hyponatremia or a history of hyponatremia; moderate-to-severe renal impairment (CrCl <50 ml/minute). Frequency may not be defined. Central nervous system: Headache (2% to 5%), dizziness. Dermatologic: Skin rash. Endocrine & metabolic: Hyponatremia, water intoxication.

2 懷孕用藥分級 (FDA) 健保規範其他藥品圖檔 Gastrointestinal: abdominal cramps, sore throat. Hepatic: Increased serum transaminases. Respiratory: Rhinitis, epistaxis, cough, nasal congestion, upper respiratory tract infection. <1%: Abnormality in thinking, agitation, anaphylaxis (rare), balanitis, chest pain, coma, diarrhea, drowsiness, dyspepsia, edema, eye pruritus, hypersensitivity reaction (rare), insomnia, localized warm feeling, pain, palpitations, photophobia, seizure, tachycardia, vomiting, vulvar pain. B NA 取代 28D011 Desmopressin(Minirin) 0.1mg tab

3 < 10T139> Tocilizumab (Actemra) (80mg/4ml) 針. 注意注意 < 10T139> Tocilizumab (Actemra) (80mg/4ml) 針. 注意注意 藥理作用 / Antagonist of the interleukin-6 (IL-6) receptor. Endogenous IL-6 is induced by inflammatory stimuli and mediates a variety of immunological responses. Inhibition of IL-6 receptors by tocilizumab leads to a reduction in cytokine and acute phase reactant production. Indication& Dosage: I.V. Adult: Rheumatoid arthritis: Note: Methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) may be continued for the treatment of rheumatoid arthritis. Tocilizumab should not be used in combination with biologic DMARDs. IV: Initial: 4 mg/kg every 4 weeks; may be increased to 8 mg/kg based on clinical response (maximum dose: 800 mg). Systemic juvenile idiopathic arthritis (SJIA): Children 2 years: IV: Note: Dose adjustment should not be made based solely on a single-visit body weight measurement due to fluctuations in body weight. May be used as monotherapy or in combination with methotrexate. <30 kg: 12 mg/kg every 2 weeks 30 kg: 8 mg/kg every 2 weeks Hypersensitivity to tocilizumab or any component of the formulation. 不良反應 M: Increased serum cholesterol, Increased serum ALT, increased serum AST, Infusion-related reaction. L: Hypertension, peripheral edema, Headache, dizziness, Skin rash, dermatological reaction, Increased LDL cholesterol, hypothyroidism, diarrhea, abdominal pain, oral mucosa ulcer, gastric ulcer, stomatitis, weight gain, gastritis,neutropenia, thrombocytopenia, leukopenia increased serum bilirubin, antibody development, herpes simplex infection, injection site reaction, conjunctivitis, nephrolithiasis, upper respiratory tract infection, nasopharyngitis, bronchitis, cough, dyspnea. R: Anaphylaxis, anaphylactoid reaction, angioedema, aspergillosis,

4 懷孕用藥分級 (FDA) 健保規範其他藥品圖檔 candidiasis, cellulitis, chronic inflammatory demyelinating polyneuropathy, cryptococcosis, diverticulitis, gastroenteritis, gastrointestinal perforation, herpes zoster, hypersensitivity, hypersensitivity pneumonitis, hypertriglyceridemia, hypotension, increased HDL cholesterol, malignant neoplasm (including breast and colon cancer), multiple sclerosis, otitis media, pneumonia, pneumocystosis, reactivation of latent Epstein-Barr virus, septic arthritis, sepsis, Stevens-Johnson syndrome, tuberculosis, urinary tract infection, varicella. C 需事前審查核准後使用 ; 使用本類藥品之醫事機構應注意監測病患用藥後之不良反應及可能發生的重大安全事件 ( 如肺結核及病毒性肝炎 )(103/9/1) 限專科醫師使用, 其它詳見健保規定 和健保規定 ) 限使用於 2 歲 ( 含 ) 以上的活動性多關節幼年型慢性關節炎患者 2) 成人類風濕關節炎 Do not initiate if ANC is <2000/mm 3, platelets are <100,000/mm 3 or if ALT or AST are >1.5 times ULN.

5 < 10T121> Tocilizumab (Actemra) (200mg/10ml) 針. < 10T121> Tocilizumab (Actemra) (200mg/10ml) 針. 藥理作用 / Antagonist of the interleukin-6 (IL-6) receptor. Endogenous IL-6 is induced by inflammatory stimuli and mediates a variety of immunological responses. Inhibition of IL-6 receptors by tocilizumab leads to a reduction in cytokine and acute phase reactant production. Indication& Dosage: I.V. Adult: Rheumatoid arthritis: Note: Methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) may be continued for the treatment of rheumatoid arthritis. Tocilizumab should not be used in combination with biologic DMARDs. IV: Initial: 4 mg/kg every 4 weeks; may be increased to 8 mg/kg based on clinical response (maximum dose: 800 mg). Systemic juvenile idiopathic arthritis (SJIA): Children 2 years: IV: Note: Dose adjustment should not be made based solely on a single-visit body weight measurement due to fluctuations in body weight. May be used as monotherapy or in combination with methotrexate. <30 kg: 12 mg/kg every 2 weeks 30 kg: 8 mg/kg every 2 weeks Hypersensitivity to tocilizumab or any component of the formulation. 不良反應 M: Increased serum cholesterol, Increased serum ALT, increased serum AST, Infusion-related reaction. L: Hypertension, peripheral edema, Headache, dizziness, Skin rash, dermatological reaction, Increased LDL cholesterol, hypothyroidism, diarrhea, abdominal pain, oral mucosa ulcer, gastric ulcer, stomatitis, weight gain, gastritis,neutropenia, thrombocytopenia, leukopenia increased serum bilirubin, antibody development, herpes simplex infection, injection site reaction, conjunctivitis, nephrolithiasis, upper respiratory tract infection, nasopharyngitis, bronchitis, cough, dyspnea. R: Anaphylaxis, anaphylactoid reaction, angioedema, aspergillosis,

6 懷孕用藥分級 (FDA) 健保規範其他藥品圖檔 candidiasis, cellulitis, chronic inflammatory demyelinating polyneuropathy, cryptococcosis, diverticulitis, gastroenteritis, gastrointestinal perforation, herpes zoster, hypersensitivity, hypersensitivity pneumonitis, hypertriglyceridemia, hypotension, increased HDL cholesterol, malignant neoplasm (including breast and colon cancer), multiple sclerosis, otitis media, pneumonia, pneumocystosis, reactivation of latent Epstein-Barr virus, septic arthritis, sepsis, Stevens-Johnson syndrome, tuberculosis, urinary tract infection, varicella. C 需事前審查核准後使用 ; 使用本類藥品之醫事機構應注意監測病患用藥後之不良反應及可能發生的重大安全事件 ( 如肺結核及病毒性肝炎 )(103/9/1) 限專科醫師使用, 其它詳見健保規定 和健保規定 ) 限使用於 2 歲 ( 含 ) 以上的活動性多關節幼年型慢性關節炎患者 2) 成人類風濕關節炎 Do not initiate if ANC is <2000/mm 3, platelets are <100,000/mm 3 or if ALT or AST are >1.5 times ULN.

7 <23K002>Ketoprofen (Kepinton) 200mg/S.R capsule <23K002>Ketoprofen (Kepinton) 200mg/S.R capsule 藥理作用 / Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties.other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels. Indication& Dosage: PO Adult: Rheumatoid arthritis or osteoarthritis: : (Extended-release): Initial, 200 mg ORALLY once a day; MAX 200 mg/day. Pediatric: Safety and efficacy not established in pediatric patients. Hypersensitivity to ketoprofen, aspirin, other NSAIDs, or any component of the formulation. 不良反應 M: Dyspepsia, liver function test abnormal. L: Peripheral edema, headache, depression, dizziness, dreams, insomnia, malaise, nervousness, somnolence, rash, abdominal pain, constipation, diarrhea, flatulence, nausea, gastrointestinal bleeding, peptic ulcer, anorexia, stomatitis, vomiting, urinary tract, irritation, visual disturbances, tinnitus, renal dysfunction. R: Agranulocytosis, allergic reaction, allergic rhinitis, alopecia, anaphylaxis, anemia, angioedema, arrhythmia, aseptic meningitis, blurred vision, bone marrow suppression, bronchospasm, buccal necrosis, bullous rash, chills, cholestatic hepatitis, confusion, CHF, conjunctivitis, cystitis, diabetes mellitus, drowsiness, dysphoria, dyspnea, eczema, edema, epistaxis, erythema multiforme, exfoliative dermatitis, facial edema, fecal occult blood, fluid retention, gastritis, gastrointestinal perforation, GI ulceration, gynecomastia,

8 懷孕用藥分級 (FDA) 健保規範其他藥品圖檔 hallucinations, hearing decreased, hematemesis, hematuria, hemolytic anemia, hemoptysis, hepatic dysfunction, hepatitis, hepatotoxicity, hot flashes, hypertension, hyponatremia, impotence, infection, interstitial nephritis, intestinal ulceration, jaundice, laryngeal edema, leukopenia, libido disturbance, melena, microvesicular steatosis, migraine, myocardial infarction, nephrotic syndrome, onycholysis, palpitation, pancreatitis, peptic ulcer, peripheral neuropathy, peripheral vascular disease, photosensitivity, polydipsia, polyuria, pruritus, purpura, purpuric rash, renal failure, renal papillary necrosis, retinal hemorrhage, septicemia, shock, Stevens-Johnson syndrome, tachycardia, thrombocytopenia, toxic amblyopia, toxic epidermal necrolysis, tubulopathy, ulcerative colitis, urticaria, vasodilation, xerostomia. C NA Do not crush or break extended release capsules.

9 < 39S182> Sertaconazole (Zalain) 500mg/Vaginal tablet < 39S182> Sertaconazole (Zalain) 500mg/ Vaginal tablet 藥理作用 / Alters fungal cell wall membrane permeability; inhibits the CYP450-dependent synthesis of ergosterol. 不良反應 懷孕用藥分級 (FDA) 健保規範 其他 藥品圖檔 1)Indication& Dosage: Vaginal preparations Adult & adolescence: Vulvovaginal Candidiasis: Adult: 1# HS for one day. A second dose may be administered 1-2weeks later. Children (>12yrs): 1# HS for one day (Refer to adult dosing). Sensitivity to sertaconazole nitrate or other imidazoles. The adverse effects of this medicament are, in general, slight and transient. Occasionally it can produce genitourinary alterations(feeling of urethral burning), vaginalpruritus,vaginitis, urinary continence, cystitis and rarely allergic/dermatologic alterations can appear(erythema, exanthematous eruptions, contact dermatitis). NA NA The administration is preferable at the moment of going to bed, in order to favour the local action and vaginal absorption.it is recommended to protect the underclothes, owing to possibility that a vaginal drainage takes place.

10 < 32L018> Lidocaine (Lidopat Patch) 5%,3 片 / 包 < 32L018> Lidocaine (Lidopat Patch) 5%,3 片 / 包 藥理作用 / 不良反應 懷孕用藥分級 (FDA) Lidocaine blocks both initiation and conduction of nerve impulses by decreasing ionic flux through the neuronal membrane, which results in local anesthesia after topical application. The penetration of lidocaine through intact skin will produce an analgesic effect but is not sufficient to produce complete sensory block. 1)Indication& Dosage: Topical use Adult : Postherpetic neuralgia: Apply up to 3 patches (MAX) TOPICALLY only once, for up to 12 hours within a 24-hour period. Hypersensitivity to lidocaine or any component of the formulation Frequency not always defined. Cardiovascular: Edema, bradycardia. Central nervous system: Apprehension, confusion, dizziness, drowsiness, paresthesia. Dermatologic: Erythema, petechia, pruritus, dermatitis, exacerbation of pain, skin depigmentation, skin edema, skin rash, urticaria. Gastrointestinal: Nausea, vomiting. Hematologic and oncologic: Bruise, methemoglobinemia. Hypersensitivity: Anaphylactoid reaction, angioedema, hypersensitivity reaction. Local: Local irritation. Neuromuscular & skeletal: Weakness. B 健保規範限使用於帶狀疱疹皮膚病灶後神經痛, 並符合下列條件 : 1. 使用其他止痛劑或非類固醇抗發炎劑 (NSAIDs) 藥品治療後仍 其他 無法控制疼痛或有嚴重副作用者 (97/12/1 98/4/1) 2.Lidocaine 貼片劑 ( 限使用 Lidopat Patch):(98/9/1) (1) 限每日最大為 3 片, 且日超過 2 片時, 需於病歷記 載理由 臨床症狀改善, 應逐步調低 限使用 Lidopat Patch (98/9/1) (2)Lidopat 貼片劑不得與 gabapentin 或 pregabalin 成分口服 製劑併用 (101/2/1) 小額採購

11 藥品圖檔

12 <24O008>Olmesartan (Olmetec) 20mg/Tablet <24O008>Olmesartan (Olmetec) 20mg/Tablet 藥理作用 / As a selective and competitive, nonpeptide angiotensin II receptor antagonist, olmesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II; olmesartan interacts reversibly at the AT1 and AT2 receptors of many tissues and has slow dissociation kinetics; its affinity for the AT1 receptor is 12,500 times greater than the AT2 receptor. Angiotensin II receptor antagonists may induce a more complete inhibition of the renin-angiotensin system than ACE inhibitors, they do not affect the response to bradykinin, and are less likely to be associated with nonrenin-angiotensin effects (eg, cough and angioedema). Olmesartan increases urinary flow rate and, in addition to being natriuretic and kaliuretic, increases excretion of chloride, magnesium, uric acid, calcium, and phosphate. Indication& Dosage: PO Adult: Hypertension: Initial: 20 mg once daily; if initial response is inadequate, may be increased to 40 mg once daily after 2 weeks. Usual dosage rang: 20 to 40 mg daily. May administer with other antihypertensive agents if blood pressure inadequately controlled with olmesartan. Pediatric: Hypertension: Children 6 to 16 years: 20 kg to <35 kg: Initial: 10 mg once daily; if initial response inadequate after 2 weeks, dose may be increased (maximum: 20 mg once daily). 35 kg: Initial: 20 mg once daily; if initial response inadequate after 2 weeks, dose may be increased (maximum: 40 mg once daily) 1) Concomitant use with aliskiren in patients with diabetes mellitus 2) Hypersensitivity to olmesartan or any component of the formulation; concomitant use with aliskiren in patients with moderate to severe renal impairment (GFR <60 ml/minute/1.73 m 2 ). 不良反應 L: Dizziness, headache, Hyperglycemia, hypertriglyceridemia, diarrhea, back pain, CPK increased, hematuria, bronchitis, pharyngitis, rhinitis, sinusitis, Flu-like syndrome. R:

13 懷孕用藥分級 (FDA) 健保規範其他藥品圖檔 Acute renal failure, alopecia, anaphylaxis, angioedema, arthritis, gastroenteritis, hypercholesterolemia, hyperkalemia, hyperlipidemia, hyperuricemia, liver enzymes increased, peripheral edema, rhabdomyolysis, serum creatinine increased, sprue-like symptoms, tachycardia. D NA

Name Brufen Flu Tablets & Suspension Description For the relief of the symptoms of colds and flu. Active Ingredients:

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