Coveram 4 mg+5 mg

Description

Indications
Coveram is prescribed as a substitution therapy for patients with hypertension and/or stable coronary heart disease who are already stabilized on separate doses of perindopril and amlodipine taken together at the same dosage level. It is important to note that treatment should not be initiated with Coveram.

Use this medication only as directed by a registered physician.

Pharmacology
Perindopril is a pro-drug that undergoes hydrolysis to form perindoprilat, which acts as an angiotensin-converting enzyme (ACE) inhibitor in both humans and animals. ACE plays a crucial role in converting angiotensin I, an inactive decapeptide, into angiotensin II, a potent vasoconstrictor that also stimulates aldosterone secretion from the adrenal cortex and provides negative feedback on renin production. By inhibiting ACE, perindopril reduces plasma levels of angiotensin II, leading to decreased vasoconstriction, an increase in plasma renin activity, and reduced aldosterone secretion. These effects contribute to natriuresis and diuresis, potentially leading to increased serum potassium levels.

Amlodipine, a dihydropyridine calcium channel blocker, prevents the influx of calcium ions into vascular smooth muscle and cardiac muscle cells. Research suggests that amlodipine interacts with both dihydropyridine and non-dihydropyridine binding sites. The contraction of cardiac and vascular smooth muscles relies on extracellular calcium ion movement through specific channels. Amlodipine selectively inhibits this influx, exerting a greater effect on vascular smooth muscle cells compared to cardiac muscle. Although negative inotropic effects have been observed in vitro, these effects are not evident in intact animals at therapeutic doses.

Dosage & Administration
Coveram (perindopril arginine and amlodipine) is intended for patients already stabilized on corresponding doses of the individual components. It is not recommended to initiate treatment with this combination.

Food intake may affect the hepatic metabolism of perindopril, reducing its conversion to perindoprilat. The standard dosage is one tablet per day, taken as a single dose, preferably in the morning before a meal. Since perindopril and amlodipine may be used for different medical conditions, dose adjustments should be based on clinical judgment and individual patient needs.

Dose modifications may be required by adjusting the dosage of perindopril and/or amlodipine separately until clinical stability is achieved. Reference should be made to the product information of the individual perindopril and amlodipine formulations when making adjustments.

If a dosage reduction is necessary, the use of separate products containing amlodipine 2.5 mg or perindopril equivalent to perindopril arginine 2.5 mg should be considered to maintain clinical stability.

Use this medication only as directed by a registered physician.

Drug Interactions

• Baclofen may enhance the antihypertensive effects of Coveram. Blood pressure and renal function should be closely monitored, and dose adjustments may be necessary.
• The combination of Coveram with nitroglycerine, other nitrates, or vasodilators may lead to a further reduction in blood pressure and should be used with caution.

Contraindications
Coveram is contraindicated in the following cases:

• Patients with a known hypersensitivity to perindopril, amlodipine, ACE inhibitors, dihydropyridines, or any excipients in the formulation.
• Use during pregnancy and breastfeeding.

Side Effects
The most commonly reported side effects associated with perindopril and amlodipine (administered separately) include:

• Oedema, dizziness, drowsiness, headache (particularly at the beginning of treatment), altered taste sensation, paraesthesia, vision disturbances (including double vision), tinnitus, vertigo, palpitations, flushing, and low blood pressure.
• Respiratory effects such as dyspnea and cough.
• Gastrointestinal symptoms including abdominal pain, nausea, vomiting, dyspepsia, changes in bowel habits, diarrhea, and constipation.
• Skin reactions such as pruritus, rash, and exanthema.
• Musculoskeletal effects including ankle swelling, joint swelling, and muscle spasms.
• Fatigue and weakness (asthenia).

Pregnancy & Lactation
Coveram should not be used during pregnancy or breastfeeding. Patients who are planning to conceive should be switched to an alternative antihypertensive medication with a well-established safety profile for use in pregnancy. If pregnancy is detected during treatment, Coveram should be discontinued immediately, and an appropriate alternative should be initiated.

Precautions & Warnings

• Coveram contains lactose monohydrate; therefore, it should not be used by individuals with rare hereditary conditions such as galactose intolerance, glucose-galactose malabsorption, or total lactase deficiency.
• Since ACE inhibitors reduce the formation of angiotensin II and subsequently decrease aldosterone production, some patients may experience an increase in serum potassium levels. Periodic monitoring of serum electrolytes (including sodium, potassium, and urea) is recommended, especially when Coveram is used in combination with diuretics.

Use in Special Populations

• Paediatric use: The safety and efficacy of Coveram in children have not been established; therefore, its use in pediatric patients is not recommended.

Therapeutic Class
Combination antihypertensive medications.

Storage Conditions
Store in a dry place at temperatures below 25°C. Keep the container tightly sealed and protect from light.