Ramipril


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO HTN Initial: 2.5 mg once daily. Maintenance: 2.5-5 mg/day as a single dose, up to 10 mg/day as needed. Heart failure Initial: 1.25 mg once daily. Max: 10 mg/day. Post MI Start treatment: 3-10 days after infarction. Initial: 2.5 mg bid, may increase to 5 mg bid after 2 days. Maintenance: 2.5-5 mg bid. Prophylaxis of CV events in high-risk patients Initial: 2.5 mg once daily, may increase to 5 mg once daily after 1 wk if tolerated. Maintenance: 10 mg once daily after a further 3 wk.
Dosage Details
Oral
Hypertension
Adult: Initially, 2.5 mg once daily, 1st dose preferably given at bedtime. Maintenance: 2.5-5 mg daily as a single dose, up to 10 mg/day as needed.

Oral
Heart failure
Adult: Initially, 1.25 mg once daily. Max: 10 mg/day. Doses ≥2.5 mg may be given in single or 2 divided doses.

Oral
Post-myocardial infarction
Adult: Initially, 2.5 mg bid, may increase to 5 mg bid after 2 days. Start treatment: 3-10 days after infarction. Maintenance: 2.5-5 mg bid.

Oral
Prophylaxis of cardiovascular events in high-risk patients
Adult: Initially, 2.5 mg once daily, may increase to 5 mg once daily after 1 wk if tolerated. Maintenance: 10 mg once daily after a further 3 wk.
Renal Impairment
CrCl Dosage
10-30 Initially, 1.25 mg/day. Max: 5 mg/day.
30-60 Not necessary to adjust the initial dose. Max: 5 mg/day.
Hepatic Impairment
Max: 2.5 mg/day.
Administration
May be taken with or without food.
Contraindications
History of angioedema (hereditary, idiopathic or due to previous angioedema w/ ACE inhibitors. Concomitant use w/ aliskiren in patients w/ diabetes or renal impairment. Pregnancy and lactation.
Special Precautions
Patients w/ bilateral renal artery stenosis or a single kidney w/ unilateral renal artery stenosis; at risk for hypotension (e.g. patients w/ volume or salt depletion); aortic or mitral valve stenosis. Renal and hepatic impairment.
Adverse Reactions
Laryngeal stridor, angioedema of the face and tongue, glottis; intestinal angioedema. Cholestatic jaundice. Asthenia/fatigue, headache, dizziness, hypotension, persistent and non-productive cough, syncope, nausea, vomiting, vertigo, abnormal kidney function, and diarrhoea. Hyperkalemia. Anaemia, neutropenia/agranulocytosis, pancytopenia, leukopenia, thrombocytopenia. Increased BUN and serum creatinine levels.
Potentially Fatal: Severe anaphylactic reactions and angioedema. Rarely, hepatic necrosis.
Patient Counseling Information
Inform patients to refrain from activities involving mental alertness and physical coordination after drug intake.
MonitoringParameters
Correct volume and/or salt depletion prior to treatment. Monitor BP, serum creatinine and K levels. Monitor renal function during the 1st few wk of treatment and periodically thereafter.
Overdosage
Symptoms: Marked hypotension, shock, bradycardia, electrolyte disturbances and renal failure. Management: Perform gastric lavage, administer adsorbent. May consider admin of α-1 adrenergic agonists or angiotensin II to restore haemodynamic stability. Symptomatic and supportive treatment.
Drug Interactions
May enhance hypotensive effect w/ diuretics and other antihypertensives. May increase risk of renal function deterioration w/ NSAIDs. May increase serum levels and toxicity of lithum. May increase hyperkalaemic effect w/ K-sparing diuretics and supplements.
Potentially Fatal: Concomitant use w/ aliskiren may increase the risk of hyperkalaemia, hypotension and nephrotoxicity in patients w/ diabetes or renal impairment.
Action
Description: Ramipril, a prodrug of ramiprilat, competitively inhibits ACE from converting angiotensin I to angiotensin II (a potent vasoconstrictor) resulting in increased plasma renin activity and reduced aldosterone (a hormone that causes water and Na retention) secretion. This promotes vasodilation thus producing a hypotensive effect and a beneficial effect in CHF.
Onset: 1-2 hr.
Duration: 24 hr.
Pharmacokinetics:
Absorption: Well absorbed from the GI tract (50-60%). Bioavailability: 28% (ramipril); 44% (ramiprilat). Time to peak plasma concentration: 2-4 hr (ramiprilat).
Distribution: Plasma protein binding: Approx 56% (ramiprilat); 73% (ramipril).
Metabolism: Undergoes enzymatic saponification by esterases to form ramiprilat (active metabolite).
Excretion: Mainly via urine (60%, as ramiprilat); faeces (approx 40%). Elimination half-life: 13-17 hr (ramiprilat).
Storage
Store between 15-30°C.
References
Altace Capsules. U.S. FDA. https://www.fda.gov/. Accessed 20/11/2013.

Anon. Ramipril. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 20/11/2013.

Buckingham R (ed). Ramipril. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/11/2013.

Joint Formulary Committee. Ramipril. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/11/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Ramipril. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 20/11/2013.

Disclaimer: This information is independently developed by MIMS based on Ramipril from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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