Primace
Generic Name
Ramipril
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| primace 25 mg capsule | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Primace (Ramipril) is an ACE inhibitor used to treat high blood pressure, congestive heart failure, and to reduce the risk of cardiovascular events such as heart attack and stroke. It also helps protect the kidneys in patients with diabetes or kidney disease.
Uses & Indications
Dosage
Adults
The usual initial dose for hypertension is 2.5 mg once daily, adjusted based on response up to 10 mg daily. For heart failure, initial dose is typically 1.25-2.5 mg once daily, titrated up to 10 mg daily. For cardiovascular risk reduction, initial dose is 2.5 mg once daily, titrated to 10 mg daily. A 25 mg dose is exceptionally high for Ramipril and would only be considered in very specific, severe cases under strict medical supervision, exceeding typical maximum recommended doses (usually 10-20 mg).
Elderly
Similar to adults, but may require lower initial doses (e.g., 1.25 mg) and careful titration due to potential renal impairment and increased sensitivity.
Renal_impairment
Dosage adjustment is required. If creatinine clearance is < 30 mL/min, the initial dose should be 1.25 mg once daily, and the maximum dose is usually limited to 5 mg daily. Close monitoring of renal function and potassium levels is essential.
How to Take
Primace capsules should be swallowed whole with water. They can be taken with or without food, usually once daily, preferably at the same time each day.
Mechanism of Action
Ramipril inhibits the angiotensin-converting enzyme (ACE), which is responsible for converting angiotensin I to angiotensin II. Angiotensin II is a potent vasoconstrictor and stimulates aldosterone secretion. By inhibiting ACE, Ramipril leads to vasodilation, reduced aldosterone secretion, and decreased blood pressure. It also reduces cardiac workload and slows kidney damage.
Pharmacokinetics
Onset
Antihypertensive effect typically begins 1-2 hours after administration.
Excretion
Primarily excreted renally (60%) as metabolites and unchanged drug, with some biliary/fecal excretion (40%).
Half life
The active metabolite, ramiprilat, has an effective half-life of 13-17 hours, allowing for once-daily dosing.
Absorption
Well absorbed from the gastrointestinal tract; approximately 50-60% bioavailability of the active metabolite, ramiprilat.
Metabolism
Prodrug, ramipril, is extensively hydrolyzed in the liver to its active metabolite, ramiprilat, and other inactive metabolites.
Side Effects
Contraindications
- History of angioedema (swelling of the face, lips, tongue, or throat) related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Pregnancy (especially during the 2nd and 3rd trimesters)
- Bilateral renal artery stenosis or unilateral renal artery stenosis in a single functioning kidney
- Concomitant use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (CrCl < 60 mL/min)
Drug Interactions
Lithium
Increased serum lithium concentrations and lithium toxicity.
Aliskiren
Increased risk of hypotension, hyperkalemia, and renal impairment (contraindicated in diabetic patients or those with moderate to severe renal impairment).
Diuretics
Increased risk of symptomatic hypotension (low blood pressure), especially after initiating Primace.
Other antihypertensives
Additive hypotensive effects.
Non-Steroidal Anti-inflammatory Drugs (NSAIDs)
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in elderly or dehydrated patients.
mTOR inhibitors (e.g., everolimus, sirolimus, temsirolimus)
Increased risk of angioedema.
Hypoglycemic agents (e.g., insulin, oral hypoglycemic drugs)
Enhanced blood-glucose-lowering effect, potentially leading to hypoglycemia.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
Increased risk of hyperkalemia (high potassium levels).
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension, shock, bradycardia, electrolyte disturbances (especially hyperkalemia), and acute renal failure. Management involves supportive care, including intravenous fluid administration to correct hypotension, and vasopressors if needed. Hemodialysis can effectively remove the active metabolite, ramiprilat, from the circulation.
Pregnancy & Lactation
Primace is contraindicated in the 2nd and 3rd trimesters of pregnancy due to significant risk of fetal injury and death. Use in the 1st trimester should be avoided. Not recommended during lactation as it is excreted in breast milk and may affect the nursing infant.
Side Effects
Contraindications
- History of angioedema (swelling of the face, lips, tongue, or throat) related to previous ACE inhibitor treatment
- Hereditary or idiopathic angioedema
- Pregnancy (especially during the 2nd and 3rd trimesters)
- Bilateral renal artery stenosis or unilateral renal artery stenosis in a single functioning kidney
- Concomitant use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (CrCl < 60 mL/min)
Drug Interactions
Lithium
Increased serum lithium concentrations and lithium toxicity.
Aliskiren
Increased risk of hypotension, hyperkalemia, and renal impairment (contraindicated in diabetic patients or those with moderate to severe renal impairment).
Diuretics
Increased risk of symptomatic hypotension (low blood pressure), especially after initiating Primace.
Other antihypertensives
Additive hypotensive effects.
Non-Steroidal Anti-inflammatory Drugs (NSAIDs)
May reduce the antihypertensive effect and increase the risk of renal impairment, especially in elderly or dehydrated patients.
mTOR inhibitors (e.g., everolimus, sirolimus, temsirolimus)
Increased risk of angioedema.
Hypoglycemic agents (e.g., insulin, oral hypoglycemic drugs)
Enhanced blood-glucose-lowering effect, potentially leading to hypoglycemia.
Potassium-sparing diuretics/Potassium supplements/Salt substitutes containing potassium
Increased risk of hyperkalemia (high potassium levels).
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe hypotension, shock, bradycardia, electrolyte disturbances (especially hyperkalemia), and acute renal failure. Management involves supportive care, including intravenous fluid administration to correct hypotension, and vasopressors if needed. Hemodialysis can effectively remove the active metabolite, ramiprilat, from the circulation.
Pregnancy & Lactation
Primace is contraindicated in the 2nd and 3rd trimesters of pregnancy due to significant risk of fetal injury and death. Use in the 1st trimester should be avoided. Not recommended during lactation as it is excreted in breast milk and may affect the nursing infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, depending on manufacturer specifications.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Ramipril has been extensively studied in large-scale clinical trials, such as the HOPE (Heart Outcomes Prevention Evaluation) study, which demonstrated its significant benefits in reducing cardiovascular morbidity and mortality in high-risk patients.
Lab Monitoring
- Serum creatinine and blood urea nitrogen (BUN) levels (at baseline and periodically)
- Serum potassium levels (at baseline and periodically)
- Blood pressure (regularly)
- Complete blood count (CBC) with differential (if signs of infection or unexplained fever develop)
Doctor Notes
- Regularly monitor blood pressure, renal function (creatinine, BUN), and serum potassium levels, especially upon initiation and dose titration.
- Educate patients about the signs and symptoms of angioedema and advise immediate medical attention if it occurs.
- Counsel patients on potential drug interactions, particularly with potassium-sparing diuretics, NSAIDs, and lithium.
- Emphasize that Primace is contraindicated in pregnancy and should be discontinued if pregnancy is detected.
Patient Guidelines
- Take Primace exactly as prescribed by your doctor, usually at the same time each day.
- Do not stop taking the medicine suddenly without consulting your doctor, even if you feel better.
- Report any signs of swelling of your face, lips, tongue, or throat (angioedema) immediately to your doctor or seek emergency medical help.
- Avoid potassium-containing salt substitutes and discuss other potassium supplements or high-potassium foods with your doctor.
- Be aware of potential dizziness, especially during the first few days of treatment, and avoid driving or operating heavy machinery until you know how the medicine affects you.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Primace may cause dizziness, lightheadedness, or fatigue, especially when starting treatment or increasing the dose. Patients should exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Adopt a heart-healthy diet low in sodium and saturated fats, rich in fruits, vegetables, and whole grains.
- Engage in regular physical activity as advised by your doctor.
- Limit or avoid alcohol consumption and quit smoking to improve cardiovascular health.
- Maintain a healthy weight.
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