Nikoran 10 Mg Tablet (20 Tab)

NIKORAN 10 MG TABLET (20 TAB) by TORRENT PHARMACEUTICALS LTD.

Nikoran 10 mg Tablet is a medication prescribed for the management and prevention of angina pectoris, a type of chest pain resulting from reduced blood flow to the heart. It is often used in adult patients who are inadequately controlled by or have contraindications or intolerance to other first-line anti-anginal therapies, such as beta-blockers and/or calcium channel antagonists.

• Composition

  • Active Ingredient: Nicorandil 10 mg

• Uses Nikoran 10 mg Tablet is primarily used for:

  • Preventing and treating chronic stable angina pectoris (heart-related chest pain).
  • Improving blood flow and oxygen supply to the heart muscle, thereby reducing its workload.
  • Enhancing exercise tolerance and overall quality of life in patients with angina.

• Dosage and Administration

  • The usual starting dose for adults is 10 mg twice daily, preferably in the morning and evening.
  • Doses may be titrated upwards based on patient needs, response, and tolerance, up to a maximum of 40 mg twice daily. A lower starting dose of 5 mg twice daily may be considered for patients prone to headaches.
  • Tablets should be swallowed whole with water, with or without food, and should not be crushed or chewed.
  • It is crucial to take doses at the same times each day for consistent blood levels. Do not discontinue the medicine without consulting a doctor, as sudden withdrawal may worsen angina symptoms.

• Side Effects Common side effects may include:

  • Headache (especially in the initial days of treatment)
  • Dizziness, weakness, and flushing (reddening of the skin)
  • Nausea and vomiting
  • Fast or irregular heartbeats More serious, though less common, side effects can include:
  • Low blood pressure
  • Mouth, eye, or skin ulcers
  • Increased potassium levels (hyperkalaemia)
  • Visual disturbances

• Precautions

  • Allergy: Do not take if allergic to nicorandil or any excipients.
  • Drug Interactions:
    • Contraindicated with phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) and soluble guanylate cyclase stimulators (e.g., riociguat) due to the risk of a severe drop in blood pressure.
    • Caution with NSAIDs (including aspirin) and corticosteroids, as it may increase the risk of severe gastrointestinal ulceration, perforation, and hemorrhage.
    • May enhance the blood pressure-lowering effect of other antihypertensive agents, vasodilators, and alcohol.
  • Medical Conditions: Use with caution in patients with hypovolaemia, severe hypotension, heart failure (NYHA class III or IV), acute pulmonary oedema, and glucose-6-phosphate dehydrogenase deficiency.
  • Pregnancy and Breastfeeding: Not recommended during pregnancy or breastfeeding; consult a doctor.
  • Driving and Machinery: May cause dizziness or weakness; avoid driving or operating heavy machinery until you know how the medicine affects you.
  • Children: Not recommended for use in children as safety and efficacy have not been established.

• Storage

  • Store in a refrigerator, ideally between 2°C to 25°C.
  • Keep protected from light and moisture to maintain efficacy.
  • Keep out of reach of children and pets.
  • Do not use after the expiry date.

NIKORAN 10 MG TABLET FAQs

What is Nikoran 10 mg Tablet used for?

Nikoran 10 mg Tablet is primarily used for the symptomatic treatment and prevention of stable angina pectoris, a type of heart-related chest pain caused by reduced blood flow to the heart. It is typically prescribed to adults when other first-line anti-anginal therapies, such as beta-blockers or calcium channel antagonists, are not suitable or have not been effective. This medicine helps to improve blood flow to the heart and enhance exercise tolerance.

How does Nikoran 10 mg Tablet work?

Nikoran 10 mg Tablet contains Nicorandil, which works through a dual mechanism as a vasodilator. It acts as a potassium channel opener, which relaxes the smooth muscle cells in blood vessels, leading to their widening (dilation) and an increase in blood flow to the heart. Additionally, it acts as a nitric oxide (NO) donor, further relaxing vascular smooth muscles, particularly in the veins, which reduces the heart's workload. This combined action improves the oxygen supply to the heart muscle and reduces the frequency and severity of angina attacks.

What is the usual dosage of Nikoran 10 mg Tablet?

The usual starting dose for Nikoran 10 mg Tablet is 10 mg twice daily, typically taken once in the morning and once in the evening. Depending on the patient's needs, response, and tolerance, the dose may be increased by a doctor up to 20 mg twice daily, and in some cases, up to 40 mg twice daily. For patients who are particularly prone to headaches, a lower starting dose of 5 mg twice daily may be used for the first few days. The tablets can be taken with or without food and should be swallowed whole with water without crushing or chewing.

What are the possible side effects of Nikoran 10 mg Tablet?

Common side effects include headache (especially during the first few days of treatment, which often improves), dizziness, weakness, nausea, vomiting, and flushing (a sensation of warmth or redness in the face, ears, neck, and trunk). Less common but serious side effects can include severe low blood pressure, and ulcerations of the gastrointestinal tract (mouth, stomach, intestines, anal passage), skin, cornea, or conjunctiva. Other reported side effects include increased potassium levels and irregular heartbeat. If side effects are persistent or severe, it is important to consult your doctor.

Is Nikoran 10 mg Tablet safe during pregnancy or breastfeeding?

Nikoran 10 mg Tablet is generally not recommended during pregnancy unless specifically considered essential by a physician, as there is limited human data and animal studies have shown potential risks. Similarly, it is not recommended during breastfeeding because it is not known whether nicorandil passes into breast milk. Always consult your doctor for advice if you are pregnant, planning a pregnancy, or breastfeeding.

Can Nikoran 10 mg Tablet be taken with other medications?

It is crucial to inform your doctor about all other medications you are taking. Nikoran 10 mg Tablet is contraindicated with phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil, used for erectile dysfunction) and soluble guanylate cyclase stimulators (e.g., riociguat), as this combination can lead to a severe and dangerous drop in blood pressure.

Caution is advised when taken with:

• Alcohol: Can significantly increase the risk of dizziness and low blood pressure.
• Antihypertensive drugs or other vasodilators: May potentiate the blood pressure-lowering effect.
• Aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): May increase the risk of gastrointestinal ulceration, perforation, and bleeding.
• Corticosteroids: May increase the risk of gastrointestinal perforations.
• Medicines that may increase potassium levels: Use with care due to the rare risk of hyperkalaemia. However, no significant interactions have been observed with beta-blockers, calcium antagonists, digoxin, acenocoumarol, rifampicin, and cimetidine.

What precautions should be taken while taking Nikoran 10 mg Tablet?

Do not take Nikoran 10 mg Tablet if you are allergic to nicorandil or have severe low blood pressure (hypotension), cardiogenic shock, left ventricular failure with low filling pressure, hypovolaemia (low blood volume), or acute pulmonary oedema. Since Nikoran 10 mg Tablet can cause dizziness or weakness, avoid driving or operating heavy machinery until you know how the medicine affects you. It is important not to stop taking this medicine abruptly, as sudden withdrawal can cause your chest pain to return or worsen. Always consult your doctor before discontinuing treatment. Be vigilant for any signs of ulceration, such as blood in stools or vomit, and report them to your doctor immediately.

What happens if a dose of Nikoran 10 mg Tablet is missed?

If you miss a dose of Nikoran 10 mg Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

How should Nikoran 10 mg Tablet be stored?

Nikoran 10 mg Tablet should ideally be stored in a refrigerator, at a temperature between 2°C and 8°C. It is important not to freeze the tablets. Keep the medicine protected from light and moisture, and ensure it is stored out of the reach and sight of children and pets. Once opened, it is generally recommended to use the contents of the bottle pack within one month.