Coveram Tablet

Introduction

Perindopril Arginine and Amlodipine are commonly used in combination to manage hypertension (high blood pressure) and prevent cardiovascular events such as strokes and heart attacks. Perindopril is an ACE inhibitor that helps relax blood vessels, while Amlodipine is a calcium channel blocker that lowers blood pressure by relaxing the muscles of the heart and arteries. This combination is often prescribed to patients who require dual therapy to control blood pressure effectively.

Uses

The Coveram Tablet 5 mg+10 mg combination is primarily used for:

Management of hypertension (high blood pressure)
Reducing the risk of stroke, myocardial infarction, and other cardiovascular events in high-risk patients
Treating patients with stable coronary artery disease (CAD) or stable angina
Treating heart failure in some cases

Brand Name	Coveram
Type	Tablet
Weight	5 mg+10 mg
Generic	Perindopril Arginine + Amlodipine
Manufacturer	Servier Bangladesh Operation
Available in	English বাংলা

Mechanism of Action

Perindopril works by inhibiting the angiotensin-converting enzyme (ACE), which reduces the production of angiotensin II, a potent vasoconstrictor. This leads to vasodilation, reduced blood pressure, and decreased workload on the heart. Amlodipine, on the other hand, blocks calcium channels in the vascular smooth muscles, leading to vasodilation, reduced peripheral resistance, and decreased blood pressure. Together, these medications complement each other, providing better blood pressure control and cardiovascular protection.

How Long Does It Take to Work?

The onset of action for Perindopril can be observed within a few hours of administration, with peak effects occurring after 4-6 hours. Amlodipine typically starts working within 24-48 hours, with peak effects seen after 6-12 hours. However, it may take several weeks for the full therapeutic effects to be realized.

Absorption

Perindopril Arginine is rapidly absorbed from the gastrointestinal tract and converted to its active metabolite, perindoprilat. Amlodipine is also well absorbed, with an absolute bioavailability of 64-90%. Food does not significantly affect the absorption of either drug.

Route of Elimination

Perindoprilat, the active form of Perindopril, is eliminated primarily by the kidneys, with a small amount excreted via feces. Amlodipine is extensively metabolized by the liver, with its inactive metabolites primarily excreted in urine.

Dosage

perindopril arginine & amlodipine is as substitution therapy for patients already controlled with separate doses of perindopril (5 or 10 mg) and amlodipine (5 or 10 mg), given concurrently at the dose level. Treatment should not be initiated with this combination.

Food intake may reduce hepatic biotransformation of perindopril to perindoprilat. Recommended treatment is one tablet per day as a single dose, preferably to be taken in the morning and before a meal. As perindopril and amlodipine may be used for different clinical indications, dose adjustments should be based on clinical judgment and the individual patient profile.

Adjustments can be made by decreasing or increasing the dose of either perindopril and/or amlodipine using separate perindopril and/or amlodipine products within the recommended dose range until clinical stability is re-established. Consult the Product Information of the individual perindopril and/or amlodipine products being used when adjusting the dose.

In the event that down-titration is required, adjustments using amlodipine 2.5 mg or a dose of perindopril equivalent to perindopril arginine 2.5 mg, as separate products should be considered until clinical stability is re-established.

The dosage of Coveram Tablet 5 mg+10 mg depends on the patient’s condition and response to treatment. Typical dosages are:

Perindopril Arginine: 5-10 mg once daily
Amlodipine: 5-10 mg once daily

The combination is usually available in fixed-dose tablets of 5/5 mg, 10/5 mg, or 10/10 mg of Perindopril and Amlodipine, respectively. Adjustments should be made based on the patient’s blood pressure response and tolerability.

Administration

This combination is administered orally, usually once daily. It is recommended to take the medication at the same time each day, with or without food. Consistency in administration is important to maintain stable blood pressure control.

Side Effects

Common side effects include:

Dizziness
Headache
Fatigue
Swelling of the ankles or feet (edema)
Cough (due to Perindopril)
Flushing
Nausea

In rare cases, serious side effects such as severe hypotension, angioedema, or allergic reactions may occur. If these symptoms develop, medical attention is required.

Toxicity

Toxicity from this combination is uncommon, but in cases of overdose, hypotension (low blood pressure) is the primary concern. Excessive doses may also lead to renal impairment, hyperkalemia (elevated potassium levels), and cardiovascular complications. Supportive care, including fluid management and monitoring of kidney function, is usually required in cases of overdose.

Precautions

Precautions should be taken for patients with the following conditions:

Severe renal impairment or kidney disease
Liver disease
Congestive heart failure
Patients with a history of angioedema
Low blood pressure
Electrolyte imbalances (e.g., hyperkalemia)

Regular monitoring of blood pressure, kidney function, and electrolytes is recommended during treatment.

Interaction

Both Perindopril and Amlodipine may interact with other medications. Key interactions include:

Diuretics: May increase the risk of hypotension and electrolyte imbalances
Potassium supplements and potassium-sparing diuretics: May increase the risk of hyperkalemia
NSAIDs: May reduce the antihypertensive effect and worsen kidney function
Other antihypertensive drugs: May potentiate the blood pressure-lowering effects

Disease Interaction

The combination should be used cautiously in patients with:

Kidney disease
Liver disease
Congestive heart failure
Aortic stenosis

Drug Interaction

Key drug interactions include:

ACE inhibitors/ARBs: May increase the risk of renal impairment and hyperkalemia
Beta-blockers: Can cause excessive hypotension and bradycardia
Cyclosporine: May increase the risk of nephrotoxicity
Grapefruit juice: Can increase the levels of Amlodipine, leading to increased effects or side effects

Food Interactions

Avoid grapefruit and grapefruit juice as they can increase the blood levels of Amlodipine, leading to enhanced effects or side effects such as dizziness or low blood pressure.

Pregnancy Use

This combination is not recommended during pregnancy, particularly in the second and third trimesters, due to the risk of fetal harm. ACE inhibitors like Perindopril can cause fetal toxicity, including kidney damage and developmental defects.

Lactation Use

It is not recommended to use Coveram Tablet 5 mg+10 mg while breastfeeding due to the potential for adverse effects on the nursing infant. Consultation with a healthcare provider is necessary to weigh the risks and benefits.

Acute Overdose

Acute overdose of this combination can lead to severe hypotension, dizziness, fainting, and kidney impairment. Treatment is supportive and includes intravenous fluids, monitoring of blood pressure and renal function, and in severe cases, vasopressors may be needed.

Contraindication

This combination is contraindicated in:

Patients with a history of hypersensitivity to Perindopril, Amlodipine, or any other ACE inhibitors
Pregnant women, especially in the second and third trimesters
Patients with a history of angioedema related to previous ACE inhibitor therapy
Severe hypotension
Patients with bilateral renal artery stenosis

Use Direction

Follow the prescribed dosage and administration schedule provided by the healthcare provider. The medication should be taken regularly to achieve optimal blood pressure control. It is essential not to discontinue the medication abruptly without consulting a healthcare provider.

Storage Conditions

Store the medication in a cool, dry place, away from moisture and heat. Keep out of reach of children. Do not use the medication beyond its expiration date.

Volume of Distribution

The volume of distribution for Amlodipine is approximately 21 L/kg, indicating widespread distribution in tissues. Perindopril has a lower volume of distribution and is predominantly distributed in the extracellular fluid.

Half-Life

The half-life of Amlodipine is about 30-50 hours, allowing for once-daily dosing. Perindoprilat, the active metabolite of Perindopril, has a half-life of 30-120 hours, depending on renal function.

Clearance

Amlodipine is metabolized extensively by the liver, and its clearance is approximately 7 mL/min/kg. Perindopril is cleared predominantly via the kidneys, and its clearance is reduced in patients with renal impairment.

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