Tritace
Generic Name
Ramipril
Manufacturer
Sanofi
Country
France
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tritace 5 mg tablet | ৳ 14.04 | ৳ 196.56 |
Description
Overview of the medicine
Tritace (Ramipril) is an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure (hypertension), congestive heart failure, and to reduce the risk of cardiovascular events like heart attack and stroke in high-risk patients. It also helps in protecting the kidneys in diabetic patients with early kidney disease.
Uses & Indications
Dosage
Adults
Hypertension: Initial dose 2.5 mg once daily, adjusted to 5-10 mg daily depending on response. Maximum recommended daily dose is 10 mg. Congestive Heart Failure: Initial dose 1.25 mg once daily, titrated up to a maximum of 10 mg daily. Post-MI: Initial dose 2.5 mg twice daily, increased to 5 mg twice daily if tolerated. Diabetic Nephropathy/Cardiovascular Risk Reduction: Initial dose 2.5 mg once daily, increased to 5 mg once daily, then to 10 mg once daily if tolerated.
Elderly
Similar to adults, but initial dose should be lower (e.g., 1.25 mg) due to potential for greater blood pressure response and age-related renal impairment. Titrate cautiously.
Renal_impairment
Initial dose 1.25 mg once daily if Creatinine Clearance (CrCl) is less than 60 mL/min. Maximum dose 5 mg/day if CrCl is less than 30 mL/min. Ramiprilat is not significantly removed by hemodialysis.
How to Take
Tritace tablets should be swallowed whole with a sufficient amount of liquid (e.g., 1/2 glass of water) with or without food. It is recommended to take it at approximately the same time each day.
Mechanism of Action
Ramipril inhibits the angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I to angiotensin II. Angiotensin II is a potent vasoconstrictor and stimulates aldosterone secretion. By reducing angiotensin II levels, ramipril causes vasodilation (widening of blood vessels), decreases peripheral vascular resistance, reduces blood pressure, and lowers aldosterone levels, leading to less sodium and water retention. This overall effect reduces cardiac workload and improves heart function.
Pharmacokinetics
Onset
Antihypertensive effect starts within 1-2 hours after oral administration. The peak effect is observed in 3-6 hours.
Excretion
Approximately 60% of the dose is excreted renally (as ramiprilat and its metabolites), and the remaining 40% is excreted via feces (primarily as metabolites).
Half life
The effective elimination half-life of ramiprilat is 13-17 hours with multiple dosing, but can be prolonged in patients with renal impairment or severe heart failure.
Absorption
Ramipril is well absorbed orally (50-60%) and rapidly hydrolyzed in the liver to its active metabolite, ramiprilat. Bioavailability of ramiprilat is approximately 45%. Food does not significantly affect absorption.
Metabolism
Ramipril is a prodrug and is extensively metabolized in the liver by esterases to its active metabolite, ramiprilat, and other inactive metabolites.
Side Effects
Contraindications
- History of angioedema (swelling of face, lips, tongue, or throat) related to previous ACE inhibitor treatment or hereditary/idiopathic angioedema
- Concomitant use with sacubitril/valsartan
- Bilateral renal artery stenosis or severe unilateral renal artery stenosis in a single functioning kidney
- Pregnancy (especially 2nd and 3rd trimesters)
- Hypotension or hemodynamic instability
- Concomitant use of aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m²)
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity. Monitor lithium levels.
Aliskiren
Contraindicated in diabetic patients or those with renal impairment (GFR < 60 mL/min/1.73m²), as it increases the risk of hypotension, hyperkalemia, and renal impairment.
Diuretics
Increased risk of symptomatic hypotension, especially with initial ramipril dose. Reduce diuretic dose or discontinue prior to starting ramipril.
Sacubitril/Valsartan
Concomitant use is contraindicated due to increased risk of angioedema. Ramipril should not be initiated within 36 hours of the last dose of sacubitril/valsartan.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of ramipril and increase the risk of renal impairment, especially in elderly or volume-depleted patients.
Dual blockade of the Renin-Angiotensin System (RAS)
Dual blockade with ACE inhibitors, ARBs, or aliskiren is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Generally not recommended.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
Increased risk of hyperkalemia. Monitor serum potassium levels closely.
Storage
Store below 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension with bradycardia, electrolyte disturbances, and renal failure. Management involves symptomatic and supportive treatment, including intravenous fluids to correct hypotension. Hemodialysis is not effective in removing ramiprilat from the systemic circulation.
Pregnancy & Lactation
Pregnancy Category D (2nd and 3rd trimesters). ACE inhibitors can cause fetal harm including death. Discontinue as soon as pregnancy is detected. Not recommended during breastfeeding due to potential risks to the infant. An alternative treatment with a better established safety profile during breastfeeding should be preferred.
Side Effects
Contraindications
- History of angioedema (swelling of face, lips, tongue, or throat) related to previous ACE inhibitor treatment or hereditary/idiopathic angioedema
- Concomitant use with sacubitril/valsartan
- Bilateral renal artery stenosis or severe unilateral renal artery stenosis in a single functioning kidney
- Pregnancy (especially 2nd and 3rd trimesters)
- Hypotension or hemodynamic instability
- Concomitant use of aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m²)
Drug Interactions
Lithium
Increased serum lithium concentrations and toxicity. Monitor lithium levels.
Aliskiren
Contraindicated in diabetic patients or those with renal impairment (GFR < 60 mL/min/1.73m²), as it increases the risk of hypotension, hyperkalemia, and renal impairment.
Diuretics
Increased risk of symptomatic hypotension, especially with initial ramipril dose. Reduce diuretic dose or discontinue prior to starting ramipril.
Sacubitril/Valsartan
Concomitant use is contraindicated due to increased risk of angioedema. Ramipril should not be initiated within 36 hours of the last dose of sacubitril/valsartan.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the antihypertensive effect of ramipril and increase the risk of renal impairment, especially in elderly or volume-depleted patients.
Dual blockade of the Renin-Angiotensin System (RAS)
Dual blockade with ACE inhibitors, ARBs, or aliskiren is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Generally not recommended.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
Increased risk of hyperkalemia. Monitor serum potassium levels closely.
Storage
Store below 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension with bradycardia, electrolyte disturbances, and renal failure. Management involves symptomatic and supportive treatment, including intravenous fluids to correct hypotension. Hemodialysis is not effective in removing ramiprilat from the systemic circulation.
Pregnancy & Lactation
Pregnancy Category D (2nd and 3rd trimesters). ACE inhibitors can cause fetal harm including death. Discontinue as soon as pregnancy is detected. Not recommended during breastfeeding due to potential risks to the infant. An alternative treatment with a better established safety profile during breastfeeding should be preferred.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture, specific details on packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA and local regulatory bodies
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Ramipril has been extensively studied in major clinical trials such as the Heart Outcomes Prevention Evaluation (HOPE) study and the MICRO-HOPE substudy, demonstrating significant benefits in reducing cardiovascular events and improving renal outcomes in high-risk patients.
Lab Monitoring
- Serum potassium levels (especially at initiation, dose adjustments, and in patients with renal impairment)
- Renal function (serum creatinine, blood urea nitrogen - BUN)
- Blood pressure (regularly to ensure therapeutic effect and avoid hypotension)
- Complete blood count (CBC) with differential (periodically, especially in patients with collagen vascular disease or on immunosuppressants)
Doctor Notes
- Initiate ramipril therapy with a low dose and titrate slowly based on patient response and tolerability.
- Monitor blood pressure, renal function (creatinine, BUN), and serum potassium levels regularly, especially at initiation and dose escalation.
- Educate patients on the possibility of a dry cough and the importance of reporting any signs of angioedema immediately.
- Avoid concomitant use with aliskiren in diabetic or renally impaired patients and with sacubitril/valsartan due to increased risks.
Patient Guidelines
- Take Tritace exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor.
- Report any signs of angioedema (swelling of the face, lips, tongue, or throat) immediately to your doctor.
- Inform your doctor about all other medications, including over-the-counter drugs, supplements, and herbal products.
- Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Tritace may cause dizziness, lightheadedness, or fatigue, especially at the start of treatment or when the dose is increased. Patients should exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain a healthy diet low in sodium and high in fruits and vegetables.
- Engage in regular physical activity as advised by your doctor.
- Avoid smoking and limit alcohol consumption.
- Monitor your blood pressure regularly at home if recommended by your doctor.
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