Myotan-CN

About

Azilsartan Medoxomil and Cilnidipine Tablets is a fixed dose combination drug containing Azilsartan Medoxomil Tablet and Cilnidipine Tablets and is used in the treatment of hypertension. It is Manufactured and Sold in India as Zilarbi CN and Myotan CN.

Azilsartan inhibits the pressor effects of an angiotensin II infusion in a dose-related manner. Azilsartan blocks the vasoconstrictor and aldosterone secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, independent of the pathway for angiotensin II synthesis.

Azilsartan medoxomil is rapidly hydrolyzed to azilsartan, the active metabolite, in the gastrointestinal tract during absorption.

Cilnidipine is a third 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.

In human studies, cilnidipine had weak inotropic effects and suppressed cardiac sympathetic overactivity. Therefore it may decrease the risk and mortality from long term cardiovascular complications. Once-daily cilnidipine was associated with less reflex tachycardia and had fewer effect on the autonomic nervous system in hypertensive patients.

Indications

Indicated for the treatment of hypertension, to lower blood pressure.

Dose and Method of Administration

Recommended Dose

Starting dose is 40/5 mg once daily

• The recommended adult oral dosage of Cilnidipine is 5-10 mg once daily.

• Dose may be increased to 40/10 mg after 2 to 4 weeks as needed to achieve blood pressure goals.

• Maximal dose is 40/10 mg.

• May be administered with other antihypertensive agents.

Contraindications

Azilsartan: Do not coadminister aliskiren-containing products with Azilsartan in patients with diabetes.

Cilnidipine: Cilnidipine is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Cilnidipine or any other component of this product.

Warning and Precautions

Azilsartan should not be used in following cases or should be used carefully in following cases

• Fetal Toxicity (Pregnancy)

• Hypotension in Volume- or Salt-Depleted Patients

• Impaired Renal Function

Cilnidipine is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Cilnidipine or any other component of this product.

Drug Interactions

Azilsartan may have drug interactions with the following drugs

• Non-steroidal Anti-Inflammatory Agents, including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

• Dual Blockade of the Renin-Angiotensin System (RAS)

• Lithium

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

Undesirable Side effects/ Overdose

Studies show that treatment with Azilsartan is well-tolerated with an overall incidence of adverse reactions similar to placebo. The most common adverse event leading to discontinuation was hypotension/orthostatic hypotension. Some other side effects may include Gastrointestinal Disorders: nausea, Diarrhea, General Disorders and Administration Site Conditions: asthenia, fatigue , Musculoskeletal and Connective Tissue Disorders: muscle spasm .

Nervous System Disorders: dizziness, dizziness postural, Respiratory, Thoracic, and Mediastinal Disorders: cough.

Check with your doctor immediately if any of the following side effects occur:

• Feeling like you might pass out

• Uinating less than usual or not at all

• drowsiness, confusion, mood changes, increased thirst, loss of appetite

• Swelling, weight gain, feeling short of breath; or

• electrolyte imbalance (dry mouth, extreme thirst, drowsiness, restless feeling, confusion, increased or decreased urination, constipation, muscle pain or weakness, fast heart rate, or seizure (convulsions)).

Other common side effects may include

• mild skin rash

• diarrhea, nausea, upset stomach;

• cough

• mild dizziness; or

• Weakness, tired feeling.