Isonorm 10

ISONORM 10 by LUPIN LTD

Name

• Brand Name: Isonorm 10 Tablet
• Common Name (Active Ingredient): Isosorbide Mononitrate

Composition

Each tablet contains Isosorbide Mononitrate 10 mg.

Uses

ISONORM 10 is primarily prescribed for the management and prevention of angina pectoris, a type of chest pain caused by reduced blood flow to the heart due to coronary artery disease. It is also used for the long-term management of stable angina and in cases of heart failure. This medicine works by relaxing and widening blood vessels, thereby increasing blood and oxygen supply to the heart and reducing its workload. It is not intended for the treatment of acute angina attacks.

Dosage and Administration

The dosage of ISONORM 10 should be as instructed by a healthcare professional. It can be taken with or without food. Tablets should be swallowed whole with water and not crushed or chewed. It is typically recommended to take a single daily dose in the morning, or if twice daily, with a 7-hour gap to minimize the risk of developing tolerance. Do not stop taking the medicine suddenly without consulting your doctor, as this may worsen angina symptoms.

Side Effects

Common side effects may include headache, dizziness, lightheadedness, nausea, vomiting, flushing (redness of the face and neck), low blood pressure (hypotension), and rapid heartbeat (tachycardia). Consult your doctor if these side effects persist or worsen. Serious but rare side effects can include severe dizziness or fainting, irregular heartbeat, and blurred vision.

Precautions

• Contraindications: ISONORM 10 is contraindicated in patients with a known allergy to Isosorbide Mononitrate or other nitrates. It should not be used in individuals with severe hypotension, anemia, obstructive heart disease, head trauma, or increased intracranial pressure. Concomitant use with phosphodiesterase type 5 inhibitors (e.g., sildenafil, tadalafil), commonly used for erectile dysfunction, is contraindicated due to the risk of severe blood pressure reduction.
• Warnings: Exercise caution in pregnant or breastfeeding women; a doctor's consultation is essential. Patients with liver or kidney issues, or glaucoma, should also consult their doctor. Alcohol consumption should be avoided as it can increase dizziness and lead to a disulfiram-like reaction. This medicine may cause dizziness or sleepiness; therefore, avoid driving or operating heavy machinery until you know how it affects you.

Storage

Store ISONORM 10 below 30°C in a dry place, protected from light and moisture. Keep out of the reach of children. Always check the expiry date before use.

ISONORM 10, manufactured by LUPIN LTD, contains the active ingredient Isosorbide Mononitrate 10mg. This medication is a nitrate vasodilator primarily used for heart-related conditions.

What is ISONORM 10 used for?

ISONORM 10 is used to prevent and manage angina pectoris, which is chest pain caused by coronary artery disease (narrowed or blocked heart arteries). It helps in the long-term management of this condition and is also used in some cases of heart failure and esophageal spasms. It is not intended to treat an acute angina attack that has already started.

How does ISONORM 10 work?

ISONORM 10 belongs to a group of medicines called nitrates. Its primary action is to relax the smooth muscles in blood vessels, leading to their widening (vasodilation). This effect is mainly mediated by the release of nitric oxide. By dilating veins, it reduces the amount of blood returning to the heart (preload), and by dilating arteries, it reduces the resistance the heart pumps against (afterload). This combined action decreases the heart's workload and improves the blood and oxygen supply to the heart muscle, thereby preventing angina attacks.

What is the usual dosage for ISONORM 10?

For immediate-release forms of Isosorbide Mononitrate 10mg, the typical starting dose is 5-10 mg orally twice daily, with doses usually given about 7 hours apart. This schedule allows for a "nitrate-free" period to prevent the body from developing tolerance to the medication. The dose may be increased to 10-20 mg twice daily or 20 mg every 12 hours as needed. For extended-release formulations, doses typically range from 30-60 mg once daily, which can be increased up to 120 mg or, in rare cases, up to 240 mg once daily. It's crucial to follow your doctor's specific instructions, as dosages can vary based on individual needs and the type of tablet (standard or slow-release).

What are the possible side effects of ISONORM 10?

Common side effects include headache, which often indicates the medicine is working, dizziness (especially when standing up), and flushing (warmth or redness). These usually improve as your body adjusts to the medication. Less common but serious side effects can include severe allergic reactions (rash, hives, swelling of the face/lips/tongue, difficulty breathing), severe eye pain, blurred vision, unusually fast or slow heartbeat, worsening chest pain, or symptoms of methemoglobinemia (unusual weakness, shortness of breath, blue skin or lips, nausea, vomiting, rapid heartbeat). Seek medical attention if you experience serious side effects.

Is ISONORM 10 safe during pregnancy or breastfeeding?

Pregnancy: ISONORM 10 is generally not recommended during pregnancy unless the potential benefits clearly outweigh the potential risks. There are limited controlled studies in human pregnancy, though animal studies have not shown evidence of harm to the fetus. If you are pregnant or planning to become pregnant, it is important to discuss this with your doctor, who may recommend a review by a heart specialist and an obstetrician. Breastfeeding: Use ISONORM 10 with caution while breastfeeding. It is not definitively known how much of the medication passes into breast milk, but levels are likely to be low, and serious side effects in the infant are unlikely. It is best to consult your doctor or pharmacist to weigh the benefits against any potential risks to your baby.

Can ISONORM 10 be taken with other medications?

ISONORM 10 can interact with several medications. It is contraindicated and should absolutely not be taken with:

• Medicines for erectile dysfunction (ED) or pulmonary hypertension, such as sildenafil (Viagra), tadalafil (Cialis), avanafil, or vardenafil (Levitra), as this combination can cause a sudden and severe drop in blood pressure, leading to collapse or even be fatal.
• Riociguat, a soluble guanylate cyclase stimulator used for pulmonary hypertension, due to the risk of severe hypotension.

Other medications that require caution or may interact include:

• Alcohol, which can increase side effects like dizziness and lightheadedness.
• Other blood pressure-lowering medications, as their combined effect can lower blood pressure too much.
• Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, which may worsen angina or heart failure.
• Certain migraine medications containing ergotamine.

Always inform your doctor or pharmacist about all prescription, over-the-counter, and herbal supplements you are taking.

What precautions should be taken while taking ISONORM 10?

• Do not stop taking ISONORM 10 suddenly without consulting your doctor, as this can lead to a severe angina attack.
• Allow for a "nitrate-free" period each day, as directed by your doctor, to prevent tolerance to the medication from developing.
• Limit alcohol consumption while on this medication, as it can worsen dizziness and lightheadedness.
• Stand up slowly from a sitting or lying position to reduce the risk of dizziness or fainting due to a drop in blood pressure.
• Inform your doctor about any pre-existing medical conditions, especially recent heart attack, heart failure, low blood pressure, hypertrophic cardiomyopathy, glaucoma, severe anemia, or liver/kidney disease.
• If you experience persistent or worsening headaches, discuss them with your doctor, who may recommend an over-the-counter pain reliever.

What happens if a dose of ISONORM 10 is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose (e.g., within 12 hours for a twice-daily medication), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should ISONORM 10 be stored?

Store ISONORM 10 tablets in a closed container at room temperature, typically between 20° - 30°C (68° - 86°F), away from heat, moisture, and direct light. Keep the bottle tightly closed when not in use and ensure it is out of the reach of children. Do not freeze the medicine.