Ivaprex Tablet

Ivaprex Tablet 5 mg Introduction and Uses

Ivaprex Tablet 5 mg is an antiarrhythmic drug used in the treatment of symptomatic stable angina, specifically in those patients having hypertension and a resting heart rate of 75 beats per minute or greater. It is a selective if inhibitor – acting on the If current in the sinoatrial node of the heart. Its primary effect is to reduce heart rate, and in doing so, reduce the oxygen demand on the myocardium by up to 10–15%.

Brand Name	Ivaprex
Type	Tablet
Weight	5 mg
Generic	Ivabradine
Manufacturer	Incepta Pharmaceuticals Ltd.
Available in	English বাংলা

Mechanism of Action

Ivaprex Tablet 5 mg acts by selectively inhibiting the I_f current within the sinoatrial node, a specialized group of cells in the heart responsible for setting the pace of the heartbeat. The I_f current determines the slow-inward diastolic depolarization of the cells, meaning it determines how often the cells depolarize. By inhibiting the I_f current, the heart rate is decreased which reduces the oxygen demand of the myocardium.

How Long Does It Take to Work?

The effects of ivabradine can be seen within two hours of ingestion and its effect on heart rate is usually seen within two days. It is recommended to take the medication on an empty stomach to achieve the fullest effect.

Absorption

Ivaprex Tablet 5 mg is rapidly absorbed from the gut but its rate of absorption is not affected by food intake. After maximal absorption, the concentration of ivabradine in the circulation increases slowly and reaches its peak concentration after four to six hours.

Route of Elimination

Ivaprex Tablet 5 mg is primarily eliminated through biliary excretion. Following a single dose of ivabradine, approximately 68% of the dose was eliminated in the bile. The remainder of the dose is excreted in the urine and feces.

Dosage

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Since ivabradine has been studied in a limited number of patients aged 75 years or more, a lower starting dose should be considered for these patients (2.5mg twice daily i.e. one half 5mg tablet twice daily) before up-titration if necessary.

Renal insufficiency: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15ml/min. No data are available in patients with creatinine clearance below 15ml/min. Ivabradine should therefore be used with precaution in this population.

Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment. Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency.

Children and adolescents: Ivabradine is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Ivaprex Tablet 5 mg is available as oral tablets with doses ranging from 2.5 mg to 15 mg. The usual recommended dose for the treatment of stable angina is 7.5 mg once daily taken on an empty stomach. The dose can be titrated up to a maximum of 15 mg once daily if necessary.

Administration

Ivaprex Tablet 5 mg should be taken with a full glass of water and should be taken on an empty stomach, i.e. at least two hours after eating or two hours before eating, for maximum effect. To reduce the risk of dizziness, it is important to take this medication exactly as prescribed.

Side Effects

The most common side effects of ivabradine include dizziness, headache, nausea, bradycardia, fatigue, diarrhea, abdominal pain and dyspepsia. Patients should seek medical attention if these side effects persist or become worse. Rarely, serious side effects such as swelling, breathing difficulty and palpitations may occur.

Toxicity

The toxicity of ivabradine has not been established. There have been no reported cases of overdose with this drug. In the event of an overdose, symptomatic treatment is recommended.

Precautions

Patients with certain medical conditions should not take ivabradine, including those with severe bradycardia, severe hypotension, moderate to severe renal impairment, or heart failure of NYHA class III or IV. In addition, patients taking certain medications such as calcium channel blockers, vasodilators, beta-blockers, and certain antibiotics should not take ivabradine.

Interaction

Ivaprex Tablet 5 mg can interact with certain drugs, including calcium channel blockers, vasodilators such as nitroglycerin, certain antibiotics, beta-blockers, and digoxin. The combination of these drugs could cause an excessive bradycardia and hypotension. Close medical monitoring is recommended for patients taking these medications.

Disease Interaction

Patients with certain diseases should not take ivabradine, including those with severe bradycardia, severe hypotension, moderate to severe renal impairment, or heart failure of NYHA class III or IV. Certain medications, such as calcium channel blockers, vasodilators, beta-blockers, and certain antibiotics, can also interact with ivabradine and should be avoided in these patients.

Drug Interaction

Certain drugs, including calcium channel blockers, vasodilators, beta-blockers, and certain antibiotics, can interact with ivabradine and should be avoided. Ivaprex Tablet 5 mg should not be used concomitantly with other If current inhibitors due to the risk of additive bradycardic effect.

Food Interactions

The rate of absorption of ivabradine is not affected by food intake, but it is recommended to take on an empty stomach for maximum effect.

Pregnancy Use

Ivaprex Tablet 5 mg has not been studied in pregnant women and its use is not recommended. Animal studies have shown some evidence of fetotoxicity but a risk to humans has not been established.

Lactation Use

Ivaprex Tablet 5 mg has not been studied in women who are breastfeeding and its use is not recommended.

Acute Overdose

There are no known reports of an overdose of ivabradine and its toxicity has not been established. Symptomatic treatment should be initiated if an overdose is suspected.

Contraindication

Ivaprex Tablet 5 mg is contraindicated in patients with severe bradycardia, severe hypotension, moderate to severe renal impairment, or heart failure of NYHA class III or IV, as well as in patients taking certain medications such as calcium channel blockers, vasodilators, beta-blockers, and certain antibiotics.

Use Direction

Ivaprex Tablet 5 mg should be taken with a full glass of water and should be taken on an empty stomach, i.e. at least two hours after eating or two hours before eating, for maximum effect. The dose should be reduced in patients with renal impairment. The dose should be gradually reduced and/or discontinued in patients with a reduction in heart rate or increase in blood pressure.