Nictoris10 mg

Nictoris is indicated for the prevention and long-term treatment of chronic stable angina pectoris.

• Established/guideline-supported use: Nictoris is used as an anti-anginal agent in patients with chronic stable angina, particularly where first-line therapies (beta-blockers, calcium channel blockers, or nitrates) are inadequately effective, not tolerated, or contraindicated.
• Adjunct use: Nictoris may be added to existing anti-anginal therapy (such as a beta-blocker or calcium channel blocker) when symptom control is insufficient on monotherapy.

Nictoris is not indicated for the treatment of acute myocardial infarction or unstable angina.

Nictoris is an oral anti-anginal medicine that belongs to a unique class of drugs combining potassium-channel-opening activity with a nitrate-like (nicotinamide nitrate ester) action. This dual mechanism produces both arterial and venous vasodilation, helping to reduce the workload of the heart and improve blood flow to the heart muscle in patients with angina.

Potassium channel activator (with nitrate-like vasodilating properties); anti-anginal agent.

Nicorandil has a dual mechanism of action:

• Potassium channel activation: Nicorandil opens ATP-sensitive potassium (K-ATP) channels in vascular smooth muscle, causing hyperpolarization of the cell membrane and relaxation of arterial smooth muscle, which reduces afterload (arteriolar dilation, including coronary arterioles).
• Nitrate-like action: The nicotinamide nitrate moiety of Nicorandil stimulates guanylate cyclase, increasing cyclic GMP, which produces venodilation and reduces preload, similar to organic nitrates.

Together, these actions reduce myocardial oxygen demand while improving coronary blood flow, without causing significant tolerance (tachyphylaxis) with continued use, unlike conventional nitrates.

Nictoris tablets are taken orally, twice daily (morning and evening), swallowed whole with water, generally without regard to meals. Doses should be taken at consistent times each day to maintain steady blood levels.

Nictoris has clinically significant interactions with the following:

• Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil): Contraindicated in combination. Concurrent use markedly potentiates the hypotensive effect of Nictoris, which can result in severe, potentially fatal hypotension.
• Soluble guanylate cyclase stimulators (e.g., riociguat): Contraindicated; risk of severe hypotension due to additive vasodilatory effects.
• Other nitrates and vasodilators: Additive hypotensive effects; concurrent use requires caution and dose adjustment.
• Antihypertensive agents, tricyclic antidepressants, and alcohol: May potentiate the blood-pressure-lowering effect of Nictoris.
• Corticosteroids and NSAIDs: Concurrent use may increase the risk of gastrointestinal ulceration and perforation associated with Nictoris (see Precautions and Warnings).

No clinically significant interactions have been established with beta-blockers, calcium channel blockers, digoxin, warfarin, rifampicin, or cimetidine.

Common side effects of Nictoris include:

• Headache - very common, especially at the start of treatment or after dose increases; often improves with continued use or dose reduction.
• Flushing
• Dizziness
• Nausea and vomiting
• Palpitations and tachycardia
• Weakness

Important safety concern - ulceration: Nictoris is associated with a recognized risk of ulceration, including gastrointestinal (mouth, anal, and intestinal), skin, and mucosal (including ocular/corneal) ulceration. These ulcers can be serious, may be associated with complications such as perforation, fistula, abscess, or bleeding, and may not resolve until Nictoris is discontinued. Any unexplained ulceration occurring during treatment should prompt discontinuation and medical evaluation (see Precautions and Warnings).

Less common effects include hypotension, syncope, myalgia, and, rarely, angioedema or hepatic dysfunction.

Pregnancy: There is limited human data on the use of Nictoris during pregnancy. Animal studies have not shown clear evidence of teratogenicity, but embryotoxic effects have been observed at high doses. Nictoris should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use.

Lactation: It is not known whether Nictoris is excreted in human breast milk. Because of the potential for adverse effects in the nursing infant, breastfeeding is generally not recommended during treatment with Nictoris unless advised by a physician.

Ulceration (important safety concern): Nictoris use is associated with gastrointestinal, anal, skin, and mucosal ulceration, which can be serious and may lead to complications such as perforation, fistula, or abscess. If unexplained ulceration (including mouth ulceration or stomatitis) develops at any site during treatment, Nictoris should be discontinued promptly and the patient evaluated medically, as these ulcers may not resolve while treatment continues.

Hypotension risk: Use with caution in patients with hypovolemia or low systolic blood pressure, as Nictoris can cause significant blood pressure reduction.

Pulmonary edema: Use with relative caution in patients with acute pulmonary edema.

Gastrointestinal disease: Use with caution in patients with diverticular disease or those taking corticosteroids or NSAIDs concurrently, due to increased risk of gastrointestinal ulceration/perforation.

Glaucoma: Use with caution due to potential effects on intraocular pressure.

Driving and operating machinery: Nictoris may cause dizziness, particularly when treatment is initiated; patients should be cautious until they know how the medicine affects them.

Abrupt discontinuation: Avoid sudden withdrawal; dose should be tapered gradually if discontinuation is required, to avoid rebound angina.

Overdose with Nictoris is expected to cause pronounced peripheral vasodilation, resulting in marked hypotension and reflex tachycardia, and possibly headache.

If overdose is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. Management is supportive and may include cardiac monitoring, keeping the patient supine with legs elevated, intravenous fluid replacement, and use of vasopressor agents in cases of severe or life-threatening hypotension. There is no specific antidote.

Store at room temperature (below 30°C), in a cool and dry place, protected from light and moisture. Keep out of reach of children.

Elderly: Use the lowest effective starting dose with careful monitoring, as elderly patients may be more sensitive to the hypotensive effects of Nictoris.

Renal impairment: No specific dose adjustment is established; use with caution and monitor blood pressure and renal function.

Hepatic impairment: Dose reduction may be necessary, especially in severe impairment; use with caution.

Pediatric patients: Not recommended; safety and efficacy have not been established in children.

Pregnant and breastfeeding women: See Pregnancy and Lactation section.

Nictoris is generally used as a long-term, maintenance therapy for chronic stable angina, continued for as long as clinically indicated to control symptoms, under regular physician review. Treatment should not be stopped abruptly; if discontinuation is needed, the dose should be tapered gradually under medical supervision.

Potassium channel activators; anti-anginal agents.

Nicorandil dilates blood vessels through a dual mechanism: activation of ATP-sensitive potassium channels causes arterial (including coronary) vasodilation, reducing afterload, while its nitrate-like component stimulates guanylate cyclase to increase cyclic GMP, producing venodilation and reducing preload. This combined action decreases the heart's oxygen demand while improving coronary blood flow, relieving angina symptoms.

The use of Nictoris in children and adolescents is not recommended, as safety and efficacy have not been established in this population. Nictoris should only be used in adults for the approved indication of angina pectoris.