【缺藥訊息】 公告日期：2024/02/23 缺藥品項：Tritace 錠劑 2.5mg 缺藥原因：因藥委會刪除，且廠商即將停產 配套措施：剩餘量保留慢性處方箋回院調劑。 【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，不建議用於昏厥或 CKD >stage3 之老年人。

高血壓 (ACEI)、心衰竭 Hypertension; Reduce cardiovascular event in high risk patients; Congestive heart failure, Myocardial infarction

 

Ramipril, an angiotensin-converting enzyme (ACE) inhibitor, is metabolized to a more potent ramiprilat (active drug). Both prevent the conversion of angiotensin I to angiotensin II, a vasoconstrictor agent, which decreases vasopressor activity and aldosterone secretion.

Absorption:
Ramipril (prodrug), Bioavailability, Oral: 28%; ramiprilat (active drug), 44%.
Distribution:
Ramipril (prodrug), Protein binding: about 73%.
Ramiprilat (active drug), Protein binding: about 56%.
Metabolism:
Ramipril (prodrug), Hepatic: almost complete metabolism to active drug, ramiprilat.
Active metabolite: ramiprilat (active drug).
Excretion:
Ramipril (prodrug), Renal: about 60%, less than 2% unchanged.
Renal, impaired renal function: reduced.
Ramiprilat (active drug), Renal, congestive heart failure: 12%.
Ramipril, Dialyzable: unknown (hemodialysis).
Elimination Half Life:
Ramiprilat (active drug): 13 to 17 hours (effective half-life); greater than 50 hours (terminal elimination half-life).

Concomitant use with a neprilysin inhibitor or use within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.
Concomitant aliskiren use in patients with diabetes.
History of angioedema related to prior therapy with an ACE inhibitor.
Hypersensitivity to ramipril, any component of this product, or to any other ACE inhibitor.

D (FDA)

Infant risk cannot be ruled out.

Common:
Cardiovascular: Hypotension (11%).
Neurologic: Asthenia, Dizziness (2.2% to 4%), Headache (5.4%).
Respiratory: Cough (8% to 12%).
Other: Fatigue.
Serious:
Dermatologic: Stevens-Johnson syndrome.
Gastrointestinal: Intestinal angioedema, Pancreatitis.
Hepatic: Hepatic necrosis, Hepatotoxicity.
Immunologic: Anaphylactoid reaction.
Other: Angioedema, Head and Neck.

Cardiovascular event risk, Reduction in High Cardiovascular Risk Patients:
initial, 2.5 mg ORALLY once daily for 1 week followed by 5 mg orally once daily for 3 weeks.
maintenance, 10 mg (if tolerated) ORALLY once daily or in 2 divided doses.
Congestive heart failure - Myocardial infarction:
initial, 2.5 mg ORALLY twice daily for 1 week; decrease to 1.25 mg ORALLY twice daily if patient becomes hypotensive.
maintenance, 5 mg (if tolerated) ORALLY twice daily; dose titration at 3-week intervals.
Hypertension:
(in patients not receiving a diuretic) initial, 2.5 mg ORALLY once daily; maintenance, 2.5 to 20 mg ORALLY once daily or in 2 divided doses.
Myocardial infarction:
initial, 2.5 mg ORALLY twice daily; titrate up to 5 mg ORALLY twice daily as tolerated.

CrCl 40 mL/min or less: 25% of normal dose recommended.
renal impairment in hypertensive patients: starting dose, 1.25 mg ORALLY once daily, titrate to effect, MAX 5 mg daily.
renal impairment in heart failure patients: starting dose, 1.25 mg ORALLY once daily; increase to 1.25 mg twice daily; titrate to effect, MAX 2.5 mg twice daily.