Cilacar-T

Cilnidipine + Telmisartan

Cilnidipine, a 4th generation DHP calcium channel blocker and Telmisartan, an angiotensin receptor blocker. It is used for the treatment of hypertension.

Cilnidipine is a 4th generation dihydropyridine calcium antagonist with a slow onset and long duration of action. Calcium antagonists inhibit influx of extracellular calcium ions into the cells, resulting in decreased vascular smooth muscle tone and vasodilation, leading to a reduction in blood pressure

Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist that displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II. In humans, an 80 mg dose of Telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase and the inhibitory effect is maintained over 24 hours and still measurable up to 48 hours

Indications

• Treatment of essential hypertension in adults. Clinidipine and telmisartan are indicated in adults whose Blood Pressure (BP) is not adequately controlled on Cilnidipine or Telmisartan monotherapy

Dose and Method of Administration

The recommended adult oral dosage of Cilinidipine and Telmisartan is one tablet per day.

Contraindications

FDC of Cilnidipine and Telmisartan is contraindicated in:

• Hypersensitivity to the active substance, other calcium channel antagonist or to any of the excipients listed

• Advanced Aortic stenosis

• Second and third trimesters of pregnancy

• Biliary obstructive disorders

• Severe hepatic impairment The concomitant use of Telmisartan and Cilnidipine with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2 )

Warnings and Precautions

• Telmisartan

• Pregnancy: Angiotensin II receptor antagonists should not be initiated during pregnancy. antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.

• Hepatic impairment: Telmisartan is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment, since Telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for Telmisartan. Telmisartan should be used only with caution in patients with mild to moderate hepatic impairment.

• Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the reninangiotensin- aldosterone system.

• Renal impairment and kidney transplantation: When Telmisartan is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.

• Intravascular hypovolaemia: Symptomatic hypotension, especially after the first dose of Telmisartan, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting. Such conditions should be corrected before the administration of Telmisartan. Volume and/or sodium depletion should be corrected prior to administration of Telmisartan.

• Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended

• Other conditions with stimulation of the renin-angiotensin-aldosterone system: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as Telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure.

• Primary aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. Therefore, the use of Telmisartan is not recommended.

• Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Diabetic patients treated with insulin or antidiabetics: In these patients hypoglycaemia may occur under Telmisartan treatment. Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.

• Hyperkalaemia The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.

• Ethnic differences: As observed for angiotensin converting enzyme inhibitors, Telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

• Other: As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

• Cilnidipine : Cilnidipine should be used carefully in patients with Angina, Chronic renal insufficiency, Congestive heart failure, Hypotension, Liver dysfunction, or elevated liver enzymes and Peripheral edema (confounding physical findings in congestive failure)

Drug Interactions

• 1. Digoxin

• 2. Potassium sparing diuretics or potassium supplements

• 3. Lithium

• 4. Non-steroidal anti-inflammatory medicinal products

• 5. Diuretics (thiazide or loop diuretics)

• 6. Other antihypertensive agents

• 7. Corticosteroids (systemic route)

Cilnidipine can interact with aldesleukin, quinidine, phenytoin, rifampicin, erythromycin, other anti-hypertensive drugs and anti-psychotic drug