藥品異動通知2024.01.11

藥理作用/作用機轉

適應症/

劑量

PO

【Adult】

　●Rheumatoid arthritis; Osteoarthritis; pain; primary dysmenorrhea: 100 to 150 mg/day in divided doses as needed or scheduled; may administer 100 mg as an initial loading dose followed by a maintenance dose; maximum dose (after day 1): 150 mg/day.

【Pediatric】Safety and efficacy not established.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

CrCl ≤30 mL/minute: Avoid use due to increased risk of acute kidney injury

『Hepatic Impairment: Adult』

No dosage adjustment necessary

使用禁忌

Hypersensitivity to diclofenac or bovine protein (Zipsor only) or any component of the formulation; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; use in the setting of coronary artery bypass graft surgery.

警告/預防

Anaphylactoid reactions, Cardiovascular events, CNS effects, Drug reaction with eosinophilia and systemic symptoms, GI events, Hematologic effects, Hepatic effects, Hyperkalemia, Renal effects, Skin reactions/hypersensitivity

不良反應

【>10%】Edema, nausea

【1% to 10%】 Hypertension, diaphoresis, pruritus, skin rash, abdominal pain, constipation, diarrhea, duodenal ulcer, dyspepsia, flatulence, gastric ulcer, gastrointestinal hemorrhage, gastrointestinal perforation, heartburn, vomiting, anemia, prolonged bleeding time, increased liver enzymes, increased serum ALT/AST, dizziness, drowsiness, headache, musculoskeletal pain, tinnitus, renal function abnormality, sinusitis

【<1%】AMI, arrhythmia, HF, flushing, hypotension, palpitations, syncope, tachycardia, vasculitis, Alopecia, ecchymoses, erythema multiforme, exfoliative dermatitis, skin photosensitivity, SJS/TEN, urticaria, hyperglycemia, weight changes, change in appetite, colitis, eructation, esophagitis, gastritis, glossitis, hematemesis, melena, pancreatitis, peptic ulcer, stomatitis, xerostomia, cystitis, dysuria, hematuria, oliguria, proteinuria, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia, purpuric disease, rectal hemorrhage, thrombocytopenia, fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis, jaundice, anaphylaxis, angioedema, infection, sepsis, abnormal dreams, anxiety, coma, confusion, depression, hallucination, insomnia, malaise, meningitis, nervousness, paresthesia, seizure, vertigo, asthenia, tremor, blurred vision, conjunctivitis, auditory impairment, interstitial nephritis, polyuria, renal failure syndrome, asthma, dyspnea, pneumonia, respiratory depression, fever

【Frequency not defined】SEE UPTODATE.

懷孕用藥分級(FDA)

C /避免使用，除非有治療必要, use in the third trimester is not recommended

健保規範

• 藥品說明：

• 藥品理由：

其他

NSAIDs can be continued during the first 2 trimesters of pregnancy in patients with rheumatic and musculoskeletal diseases; use in the third trimester is not recommended.

建議懷孕20週左右或以上之孕婦避免使用非類固醇消炎藥品(NSAIDs)，因為可能會導致羊水量低下，影響胎兒發育