IKOTAB

What it is

IKOTAB contains nicorandil, available as tablets of either 10 mg or 20 mg. Nicorandil is a potassium channel opener with nitrate moiety, an antianginal agent with a dual mechanism of action. It opens ATP-dependent potassium channels in vascular smooth muscle, causing hyperpolarisation and arterial dilation with afterload reduction. Due to its nitrate moiety, nicorandil also relaxes vascular smooth muscle via an increase in intracellular cyclic GMP, resulting in pooling in capacitance vessels and a decrease in preload.

Approved indications

— Chronic stable angina pectoris

Dosing overview

The recommended therapeutic dose for nicorandil is 10 to 20 mg twice daily. The usual starting dose is 10 mg twice daily, preferably in the morning and in the evening. A lower starting dose of 5 mg twice daily may be used in patients who are prone to headache or other adverse reactions. Dosage should be titrated to the minimum effective dose. There are no dosage adjustments required for elderly patients; however, the lowest effective dose should be used.

Key safety warnings

Gastrointestinal, skin, mucosal, corneal and conjunctival ulcerations have been reported with nicorandil, with ulceration potentially occurring at different locations in the same patient. Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has also been reported, with onset varying from shortly after initiation to several years after starting treatment. Occurrence of persisting ulcers should lead to drug discontinuation because the ulcers may be refractory to treatment while taking nicorandil. Patients with diverticular disease may be at particular risk of fistula formation or bowel perforation during nicorandil treatment. Gastrointestinal perforations in the context of concomitant use of nicorandil and corticosteroids have been reported, and caution is advised when concomitant use is considered. Gastrointestinal ulcerations and haemorrhage in the context of concomitant use of acetylsalicylic acid or non-steroidal anti-inflammatory drugs with nicorandil have also been reported, and caution is advised when concomitant use is considered. Nicorandil may lower the blood pressure of hypertensive patients and therefore should be used with care when prescribed with antihypertensive drugs. Nicorandil should be used with care in combination with other medical products that may increase potassium levels because hyperkalaemia has been reported. Headache is the most commonly reported adverse event, occurring in up to 36.4% of patients, is dose-related, usually occurs during the first week of treatment and tends to diminish with time, although occasionally it may be severe and prolonged, with 5.3% of patients discontinuing treatment due to headache. Careful dose titration using a low starting dose (5 mg twice daily) for even two days has significantly reduced the incidence of headache and number of patients discontinuing treatment.

Contraindications

IKOTAB is contraindicated in patients with known or idiosyncratic hypersensitivity to nicorandil, nicotinamide, nicotinic acid or any of the excipients, in cardiogenic shock, in hypotension, and in patients with severe hypotension or with a risk of developing severe hypotension including acute myocardial infarction with acute left ventricular failure and low filling pressures and hypovolaemia. It is also contraindicated in patients receiving any soluble guanylate cyclase stimulators. Due to the risk of severe hypotension, concomitant use of nicorandil and phosphodiesterase 5 inhibitors (such as sildenafil, tadalafil and vardenafil) is contraindicated.

PBS listing

IKOTAB 20 mg tablets are listed on the PBS in pack size 60, with 2 PBS items under both restricted and unrestricted restriction categories, at an ex-manufacturer price of A$11.24. IKOTAB 10 mg tablets are listed on the PBS in pack size 60, with 2 PBS items under both restricted and unrestricted restriction categories, at an ex-manufacturer price of A$8.07.

Regulatory history

IKOTAB nicorandil 20 mg tablets were first listed on the ARTG on 14 November 2014 (ARTG 218689), with nicorandil 10 mg tablets listed on the same date (ARTG 218690).