Norpace (new) 100 Mg Capsule (10 Cap)

NORPACE (NEW) 100 MG CAPSULE by RPG LIFE SCIENCES LIMITED

• Name

  • Brand Name: NORPACE (NEW) 100 MG CAPSULE
  • Common Name: Disopyramide

• Composition

  • Each capsule contains Disopyramide Phosphate 100 mg.

• Uses NORPACE (NEW) 100 MG CAPSULE is an anti-arrhythmic medicine used to treat irregular heartbeats (arrhythmia). It is primarily indicated for documented ventricular arrhythmias, such as sustained ventricular tachycardia, that are considered life-threatening. The medication works by blocking abnormal electrical signals in the heart to restore and maintain a normal, steady heart rhythm. It is also indicated for obstructive hypertrophic cardiomyopathy.

• Dosage and Administration

  • The dosage of Norpace must be individualized based on patient response and tolerance.
  • The usual adult dosage of immediate-release Norpace is 400 to 800 mg per day given in divided doses.
  • For most adults, the recommended dosage is 600 mg/day, typically administered as 150 mg every 6 hours.
  • For patients weighing less than 50 kg (110 pounds), the recommended dosage is 400 mg/day, given as 100 mg every 6 hours.
  • For patients with cardiomyopathy or possible cardiac decompensation, a loading dose should not be given, and the initial dosage should be limited to 100 mg every 6 to 8 hours.
  • NORPACE (NEW) 100 MG CAPSULE should be taken regularly as advised by the doctor, preferably at a fixed time, and can be taken with or without food.
  • Capsules should be swallowed whole; do not crush, chew, or break them.
  • Do not stop taking this medicine abruptly without consulting your doctor, as this can worsen your condition.

• Side Effects

  • Common Side Effects: Dry mouth, constipation, blurred vision, urinary hesitancy or retention, dizziness, fainting, unusual tiredness, nausea, stomach pain, bloating, headache, muscle pain or weakness, dry eyes, dry nose, dry throat, rash, and itching.
  • Serious Side Effects: Worsening of irregular heartbeat, shortness of breath, chest pain, dangerously fast or slow heartbeat, lightheadedness, low blood pressure (hypotension), low blood sugar (hypoglycemia), swelling in the legs or rapid weight gain (signs of heart failure), yellowing of the skin or eyes, and allergic reactions (hives, difficulty breathing, swelling of the face, lips, tongue, or throat).

• Precautions

  • Contraindications: Do not use if you have a known allergy to disopyramide, cardiogenic shock, second- or third-degree heart block (unless a pacemaker is present), congenital QT syndrome, or sick sinus syndrome.
  • Cardiac Conditions: Use with extreme caution in patients with heart disease affecting blood-pumping capacity, a history of heart failure, or existing low blood pressure. Regular monitoring of cardiac function, including ECGs, is essential.
  • Organ Impairment: Use with caution in patients with kidney or liver impairment, as dose adjustments and regular monitoring of organ function tests may be necessary due to an increased risk of severe adverse effects.
  • Metabolic Conditions: Caution is advised for patients with electrolyte imbalances or diabetes, as this medicine may cause hypoglycemia (low blood sugar levels). Regular monitoring of blood sugar is recommended.
  • Anticholinergic Effects: Patients with glaucoma, enlarged prostate, or other urinary problems should use this medicine with caution due to its anticholinergic properties that can worsen these conditions.
  • Driving and Machinery: This medicine may cause dizziness, fainting, or blurred vision. Patients should avoid driving or operating machinery if they experience these symptoms.
  • Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding; consult a doctor.
  • Interactions: Avoid consumption of grapefruit juice or grapefruit. Caution is advised with alcohol due to increased risk of drowsiness. Concomitant use with other antiarrhythmic agents should be reserved for life-threatening arrhythmias unresponsive to single-agent therapy, as it may lead to serious negative inotropic effects or excessively prolong conduction.

• Storage

  • Store at room temperature, ideally at 25°C (77°F); however, excursions between 15°C to 30°C (59°F to 86°F) are permitted.
  • Keep out of the sight and reach of children.

NORPACE (Disopyramide) 100 MG CAPSULE (10 CAP) by RPG LIFE SCIENCES LIMITED: Frequently Asked Questions

What is Norpace used for?

Norpace (disopyramide) is an antiarrhythmic medication primarily used to treat life-threatening heart rhythm problems, specifically ventricular arrhythmias, including sustained ventricular tachycardia. It helps to restore and maintain a normal, steady heartbeat.

How does Norpace work?

Norpace works by affecting the electrical signals in your heart. It belongs to a class of medications that block certain sodium channels, which slows down overactive electrical impulses in the heart. This action helps to stabilize your heart rhythm and prevent it from beating too fast or irregularly.

What is the usual dosage of Norpace?

The dosage of Norpace is highly individualized and determined by your doctor based on your response and tolerance. For most adults, the usual total daily dosage is between 400 to 800 milligrams (mg) given in divided doses. A common recommended dosage is 600 mg per day, which might be given as 150 mg every 6 hours for immediate-release capsules, or 300 mg every 12 hours for extended-release forms. For adults weighing less than 50 kg, the recommended dosage is typically 400 mg per day, given in divided doses (e.g., 100 mg every 6 hours for immediate-release). Your doctor may adjust your dose based on your kidney or liver function and overall health.

What are the possible side effects of Norpace?

Common side effects can include dry mouth, dry nose, dry eyes, constipation, blurred vision, difficulty or hesitancy in urinating, nausea, stomach pain or bloating, headache, dizziness, tiredness, and muscle weakness.

More serious side effects requiring immediate medical attention include:

• Worsening or new onset of heart failure (symptoms like shortness of breath, swelling of ankles, feet, or hands, rapid weight gain).
• Low blood pressure (hypotension), causing dizziness or feeling faint.
• Serious heart rhythm changes (e.g., a very fast, pounding, or uneven heartbeat, severe irregular heartbeat, fainting, chest pain, or trouble breathing).
• Low blood sugar (hypoglycemia), especially in people with diabetes (symptoms include headache, hunger, weakness, sweating, confusion, irritability, dizziness, or feeling jittery).
• Signs of an allergic reaction (hives, difficulty breathing, swelling of your face, lips, tongue, or throat).

Is Norpace safe during pregnancy or breastfeeding?

Pregnancy: Norpace is generally not recommended during pregnancy unless the potential benefits clearly outweigh the potential risks. It is categorized as Pregnancy Category C, meaning animal studies have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant humans. There have been case reports of uterine contractions. Consult your doctor if you are pregnant or planning to become pregnant.

Breastfeeding: Norpace passes into breast milk, and its main metabolite (N-monodesalkyldisopyramide or MND) can concentrate in breast milk. While some experts consider it compatible with breastfeeding, it should be used with caution, and the infant should be monitored for any anticholinergic symptoms. You should discuss with your doctor whether to stop breastfeeding or stop taking the medication, considering the importance of the drug for your health.

Can Norpace be taken with other medications?

Norpace can interact with a wide range of other medications, potentially leading to serious side effects or altered drug effectiveness. It's crucial to inform your doctor about all prescription, over-the-counter medications, vitamins, nutritional supplements, and herbal products you are taking.

Significant interactions can occur with:

• Other antiarrhythmic drugs (e.g., quinidine, procainamide, flecainide, amiodarone, sotalol) due to an increased risk of QT interval prolongation and serious arrhythmias.
• Beta-blockers (e.g., metoprolol, propranolol) and calcium channel blockers (e.g., verapamil, diltiazem) due to increased risk of heart failure, low blood pressure, or very slow heartbeat.
• Certain antibiotics (e.g., clarithromycin, erythromycin, pentamidine) and antifungals (e.g., ketoconazole) which can increase disopyramide levels.
• Phenytoin (an anti-seizure medication) which can lower disopyramide plasma levels.
• Medications that prolong the QT interval, certain antidepressants, antipsychotics, and antimalarial drugs.
• Anticholinergic agents as Norpace itself has anticholinergic properties.

What precautions should be taken while taking Norpace?

It is very important for your doctor to monitor your progress regularly, including blood tests to check blood sugar levels, kidney function, liver function, and electrolyte levels (like potassium). Do not stop taking Norpace suddenly, as this can worsen your heart condition. Be cautious when driving or operating machinery until you know how Norpace affects you, as it can cause dizziness and blurred vision. Avoid alcohol consumption, as it may increase certain side effects. Inform your doctor about any pre-existing conditions such as heart failure, kidney or liver disease, diabetes, glaucoma, enlarged prostate, myasthenia gravis, or electrolyte imbalances.

What happens if a dose of Norpace 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, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose or extra doses to make up for a missed one.

How should Norpace be stored?

Norpace capsules should be stored in a closed container at room temperature, typically between 20°C to 25°C (68°F to 77°F). It should be kept away from excessive heat, moisture, and direct light. Do not freeze the medication. Always keep Norpace, and all medicines, out of the reach of children.