Composition:
active ingredients: valsartan and amlodipine besylate;
1 tablet contains amlodipine besylate (calculated as 100% anhydrous substance) - 6.94 mg, which is equivalent to amlodipine - 5 mg; valsartan (calculated as 100% anhydrous substance) - 80 mg or
amlodipine besylate (calculated as 100% anhydrous substance) – 6.94 mg, which is equivalent to amlodipine – 5 mg; valsartan (calculated as 100% anhydrous substance) – 160 mg, or
amlodipine besylate (calculated as 100% anhydrous substance) – 13.88 mg, which is equivalent to amlodipine – 10 mg; valsartan (calculated as 100% anhydrous substance) – 160 mg;
Dosage form.
Film-coated tablets.
Main physicochemical properties:
5 mg/80 mg tablets: round tablets with a biconvex surface, film-coated, yellow-brown in color;
5 mg/160 mg tablets: round tablets with a biconvex surface, film-coated, yellow-brown in color;
10 mg/160 mg tablets: round tablets with a biconvex surface, with a score on one side, film-coated, light yellow in color with a brown tint.
Pharmacological properties.
Pharmacodynamics.
Corsar ® AM contains two antihypertensive components with additional mechanisms of blood pressure control in patients with essential hypertension: amlodipine belongs to the class of calcium antagonists, and valsartan belongs to the class of angiotensin II antagonists. The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater extent than either component alone.
Indication.
Essential hypertension in adult patients whose blood pressure is not controlled with amlodipine or valsartan monotherapy.
Contraindication.
- Hypersensitivity to the active substance, dihydropyridine derivatives or to any of the excipients of the drug.
- Severe liver dysfunction, biliary cirrhosis or cholestasis.
- Concomitant use of angiotensin receptor antagonists (ARBs), including valsartan, or angiotensin-converting enzyme (ACE) inhibitors with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mg/min/1.73 m2 ).
- Pregnant women and women planning to become pregnant (see section "Use during pregnancy or breastfeeding").
- Severe hypotension.
- Shock (including cardiogenic shock).
- Left ventricular outflow tract obstruction (e.g. hypertrophic obstructive cardiomyopathy and severe aortic stenosis).
- Hemodynamically unstable heart failure after acute myocardial infarction.
Interaction with other drugs and other types of interactions.
Medicines that require caution when used concomitantly
Other antihypertensive drugs
Commonly used antihypertensive drugs (e.g. alpha-blockers, diuretics) and other drugs that may cause hypotensive adverse events (e.g. tricyclic antidepressants, alpha-blockers used to treat benign prostatic hyperplasia) may potentiate the hypotensive effect of the combination.
Interactions related to amlodipine
Concomitant use not recommended
The use of amlodipine with grapefruit juice or grapefruit is not recommended, as bioavailability may be increased in some patients, leading to increased hypotensive effect of the drug.
Medicines that require caution when used concomitantly
Interactions related to valsartan
Concomitant use not recommended
Lithium
When lithium is used concomitantly with ACE inhibitors or angiotensin II receptor antagonists, including valsartan, reversible increases in serum lithium concentrations and toxicity have been reported. Concomitant use of valsartan and lithium is not recommended. If the use of such a combination is necessary, serum lithium levels should be carefully monitored. The risk of lithium toxicity may be further increased by concomitant use of Corsar AM and diuretics.
Potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium levels
If drugs that affect potassium channels are prescribed in combination with valsartan, frequent monitoring of potassium plasma levels should be considered.
Application features.
The safety and efficacy of amlodipine in the treatment of hypertensive crisis have not been established.
If hypotension occurs during the use of Corsar® AM, the patient should be placed on his back and, if necessary, an intravenous infusion of saline should be administered. After stabilization of blood pressure, treatment can be continued.
Use during pregnancy or breastfeeding.
Because no information is available regarding the use of valsartan/amlodipine during breastfeeding, the drug is not recommended during breastfeeding; alternative treatments with better established safety profiles during breastfeeding are preferable, especially while breastfeeding a newborn or preterm infant.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Patients using Corsar® AM may experience dizziness or a feeling of weakness after taking the drug, so they should take this into account when driving vehicles and working with potentially dangerous mechanisms.
Amlodipine may have minor or moderate influence on the ability to drive or use machines. If patients experience dizziness, headache, fatigue or nausea while taking amlodipine, their reactions may be impaired.
Method of administration and doses.
Patients whose blood pressure is inadequately controlled with amlodipine or valsartan monotherapy may be switched to combination therapy with Corsar® AM. The recommended dose is 1 tablet per day. Corsar® AM tablets can be taken regardless of meals. It is recommended to take Corsar® AM with a small amount of water. The tablets cannot be divided.
Patients taking valsartan and amlodipine separately can be switched to Corsar® AM, which contains the same doses of the components.
Individual dose titration with the components (i.e. amlodipine and valsartan) is recommended before switching to a fixed-dose combination. If clinically indicated, direct conversion from monotherapy to a fixed-dose combination may be considered.
The maximum daily dose is 1 tablet of Corsar ® AM 5 mg/80 mg or 1 tablet of Corsar ® AM.
5 mg/160 mg, or 1 tablet of Corsar® AM 10 mg/160 mg (maximum permissible doses of the drug components are 10 mg of amlodipine content, 320 mg of valsartan content).
Studies of the treatment of children (under 18 years of age) with this drug have not been conducted. Therefore, until more complete information is available, Corsar® AM is not recommended for use in children.
Overdose.
There is no experience of overdose with the combination of valsartan/amlodipine. The main symptom of overdose with valsartan is likely to be marked hypotension with dizziness. Overdose with amlodipine may lead to increasing peripheral vasodilation and possibly reflex tachycardia. Significant and potentially prolonged systemic hypotension, up to shock and death, has been reported.
Treatment
If the drug has been taken recently, vomiting should be induced or the stomach should be lavaged. The absorption of amlodipine is significantly reduced by the use of activated charcoal immediately or within 2 hours after taking amlodipine.
Clinically significant arterial hypotension caused by overdose of Corsar ® AM requires active support of the cardiovascular system, including frequent monitoring of cardiac and respiratory function, elevation of extremities, attention to the volume of circulating fluid and urination. To restore vascular tone and blood pressure, a vasoconstrictor drug can be used in the absence of contraindications to its use. With a persistent decrease in blood pressure, which is a consequence of calcium channel blockade, intravenous administration of calcium gluconate may be appropriate.
Removal of valsartan and amlodipine by hemodialysis is unlikely.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Vacation category.
According to the recipe.
Producer.
JSC "Farmak".
