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Tensinel

Tensinel

ramipril

Manufacturer:

Konimex
Concise Prescribing Info
Contents
Ramipril
Indications/Uses
HTN, can be used alone or in combination w/ thiazide diuretics. CHF following acute MI. Reduces the risk of MI, stroke, CV death, & the need for revascularization procedures in patients at high risk of CV disease. Nondiabetic glomerular nephropathy (CrCl 20-70 mL/min) & proteinuria >3 g/24 hr. Incipient nephropathy in patients w/ normotensive type 2 DM.
Dosage/Direction for Use
HTN Initial dose: 2.5 mg once daily w/o diuretic. Adjust dose according to BP response. Maintenance dose: Adult 2.5-20 mg as a single dose or in 2 divided doses. If BP response is reduced w/ once-daily dosing interval, may increase or divide dose into 2 times daily. Consider combination w/ diuretic if BP is not adequately controlled w/ ramipril alone. Post MI in adult patient w/ clinical signs of heart failure Initially 2.5 mg twice daily, started 2 days following MI. In case of hypotension, reduce the dose to 1.25 mg twice daily. Titrate the dose based on patient's tolerance, target dose: 5 mg twice daily. Glomerular nephropathy Initially 1.25 mg once daily. May increase dose 2-times fold at 2-3 wk interval depending on BP response & patient's tolerance, max: 10 mg daily. Renal impairment CrCl 20-50 mL/min 1.25-5 mg daily; <20 mL/min 1.25 mg every other day or 2.5 mg daily. Hypertensive patient w/ kidney disorders Initially 1.25 mg once daily. May be increased to a max total dose of 5 mg daily. Heart failure patient w/ kidney disorders Initially 1.25 mg once daily. May be increased to 1.25 mg twice daily to a max dose of 2.5 mg twice daily, depending on clinical response & patient's tolerance. Patient w/ liver disorders Max daily dose: 2.5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to ramipril or other ACE inhibitors. Patients w/ history of angioedema associated w/ previous treatment w/ ACE inhibitor. Concomitant use w/ sacubithil/valsartan therapy. Not to be administered earlier than 36 hr after the last dose. Concomitant use w/ aliskiren-containing products & AIIA in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Not to be used in patients w/ hypotension or hemodynamic instability. Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney. Concomitant administration w/ extracorporeal therapy leading to blood contact w/ -vely charged surfaces. 2nd & 3rd trimester of pregnancy.
Special Precautions
Patients w/ history of angioedema unrelated to ACE inhibitor use. Anaphylactoid reactions in patients on dialysis w/ high-flux membranes & concomitant treatment w/ ACE inhibitors. May cause symptomatic hypotension; syndrome preceded by cholestatic jaundice, fulminant hepatic necrosis, & occasionally death; agranulocytosis & bone marrow depression, more common in patients w/ collagen vascular diseases (eg, SLE or scleroderma) & kidney disorders; progressive oliguria &/or azotemia & rarely acute renal failure &/or death in patients w/ severe CHF w/ renal function dependent on the renin-angiotensin-aldosterone system activity. Non-productive cough. Increased blood levels in patients w/ impaired liver function. Pregnancy & lactation. Childn.
Adverse Reactions
Anaphylactoid reactions; hypotension, syncope, angina pectoris, arrhythmia, chest pain, palpitations, MI, cerebrovascular accidents; angioneurotic edema; itchy, dry, persistent, non-productive cough; pancreatitis, abdominal pain, anorexia, constipation, diarrhea, dry mouth, dyspepsia, dysphagia, gastroenteritis, hepatitis, nausea, increased salivation, taste disturbances, & vomiting; hypersensitivity reactions (eg, urticaria, pruritus, or rash w/o fever), erythema, pemphigus, photosensitivity & purpura); anxiety, amnesia, convulsions, depression, hearing loss, insomnia, nervousness, neuralgia, neuropathy, paresthesia, somnolence, tinnitus, tremor, vertigo, & visual disturbances; +ve ANA, increased ESR, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, photosensitivity, rash, & dermatologic manifestations; eosinophilic pneumonitis.
Drug Interactions
Concomitant use w/ sacubitril/valsartan, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) or dipeptidyl peptidase IV inhibitors (eg, linagliptin, saxagliptin, vildagliptin), antidiabetic agents (eg, insulin & sulfonylurea derivatives), NSAIDs, heparin or cyclosporin, vasopressor sympathomimetics & other substances (eg, isoproterenol, dobutamine, dopamine, epinephrine), diuretics (eg, thiazide, spironolactone, triamterene, or amiloride), K supplements or salt substitutes containing K, trimethoprim & co-trimoxazole (trimethoprim/sulfamethoxazole, amiloride, lithium).
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors
ATC Classification
C09AA05 - ramipril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Tensinel tab 5 mg
Packing/Price
3 × 10's
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