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Overview

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This medicine contains an important and useful components, as it consists of
Palovaroteneis available in the market in concentration

Name

Aliskiren

Precaution

Aliskiren requires careful consideration and monitoring due to several important precautions: - **Angioedema Risk**: Patients who have experienced angioedema (swelling beneath the skin) with previous treatments should avoid aliskiren. If symptoms of angioedema develop, treatment must be stopped immediately, and medical advice sought. - **Renal Function**: Regular monitoring of renal function is crucial, especially for patients with diabetes, pre-existing renal dysfunction, or heart failure. Aliskiren can affect kidney function, leading to potential impairment. - **Pregnancy**: Aliskiren is contraindicated during pregnancy, particularly in the second and third trimesters, due to the risk of fetal injury or death. Pregnant women should discontinue use immediately. - **Drug Interactions**: Aliskiren interacts with various medications, including ACE inhibitors, ARBs, and potassium supplements. Combining these can increase the risk of hyperkalemia (high potassium levels) and hypotension (low blood pressure). - **Hypersensitivity**: Patients with known hypersensitivity to aliskiren or its components should avoid this medication to prevent allergic reactions. - **Electrolyte Imbalance**: Monitoring serum potassium levels is essential, as aliskiren can cause hyperkalemia, which may lead to serious cardiac issues. - **Concomitant Medications**: Avoid using aliskiren with cyclosporine, as this combination can significantly increase blood levels of aliskiren, leading to toxicity. - **General Monitoring**: Regular blood pressure checks and overall health assessments are necessary to ensure the safe and effective use of aliskiren.

Indication

Aliskiren is primarily indicated for the treatment of hypertension (high blood pressure) in adults and children aged 6 years and older. Its specific uses and considerations include: - **Monotherapy or Combination Therapy**: Aliskiren can be used alone or in combination with other antihypertensive medications to manage high blood pressure effectively. - **Essential Hypertension**: It is particularly useful for treating essential hypertension, which is high blood pressure without an identifiable cause. Aliskiren helps relax blood vessels, allowing the heart to pump blood more efficiently. - **Blood Pressure Control**: The medication is designed to lower blood pressure, reducing the workload on the heart and arteries, and decreasing the risk of cardiovascular events such as heart attacks and strokes. - **Renin Inhibition**: Aliskiren works by inhibiting renin, an enzyme involved in the renin-angiotensin-aldosterone system (RAAS), which regulates blood pressure. By blocking renin, it reduces the production of angiotensin II, a hormone that causes blood vessels to narrow. - **Clinical Efficacy**: Clinical trials have shown that aliskiren begins to lower blood pressure within two weeks of starting treatment, making it a reliable option for managing hypertension. - **Off-Label Use**: While primarily approved for hypertension, aliskiren has been studied for other conditions, such as heart failure, but it is not currently indicated for these uses due to insufficient outcome data demonstrating cardiovascular disease risk reduction.

Contra indication

Aliskiren has several important contraindications that must be considered to ensure safe use: - **Pregnancy**: Aliskiren is strictly contraindicated during pregnancy, especially in the second and third trimesters, due to the risk of fetal injury or death. Women who become pregnant while taking aliskiren should stop the medication immediately. - **Angioedema History**: Patients with a history of angioedema (swelling beneath the skin) related to previous treatments with aliskiren or other similar medications should not use aliskiren. - **Concomitant Use with ACE Inhibitors or ARBs in Diabetes**: Aliskiren should not be used in combination with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in patients with diabetes due to the increased risk of kidney impairment, low blood pressure, and high potassium levels. - **Hypersensitivity**: Patients with known hypersensitivity to aliskiren or any of its components should avoid this medication to prevent allergic reactions. - **Severe Renal Impairment**: Aliskiren is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) due to the risk of further kidney damage. - **Concomitant Use with Cyclosporine**: The combination of aliskiren with cyclosporine is contraindicated because cyclosporine significantly increases the blood levels of aliskiren, leading to potential toxicity. - **Pediatric Use**: The safety and efficacy of aliskiren have not been established in children under 6 years of age or weighing less than 50 kg (110 lbs), so it should not be used in this population. - **Breastfeeding**: Due to the potential for adverse effects on nursing infants, aliskiren is not recommended for use during breastfeeding.

Side Effect

Aliskiren, like other medications, can cause various side effects, ranging from mild to severe. Some of the most common and significant side effects include: - **Gastrointestinal Issues**: Diarrhea is one of the most frequently reported side effects, affecting about 2.3% of patients. Other gastrointestinal issues may include abdominal pain and dyspepsia (indigestion). - **Respiratory Problems**: Cough and nasopharyngitis (inflammation of the throat and nasal passages) are common, occurring in about 2.2% and 2.0% of patients, respectively. - **Fatigue**: Feelings of tiredness or weakness are reported by some patients taking aliskiren. - **Dizziness**: This side effect can occur due to the blood pressure-lowering effects of the medication, especially when standing up suddenly. - **Headache**: Some patients may experience headaches as a side effect of aliskiren. - **Hyperkalemia**: Elevated potassium levels in the blood can occur, which may lead to serious heart problems if not monitored and managed properly. - **Hypotension**: Low blood pressure is a potential side effect, particularly when aliskiren is used in combination with other antihypertensive medications. - **Renal Impairment**: Aliskiren can affect kidney function, leading to increased blood urea nitrogen (BUN) or serum creatinine levels in some patients. - **Angioedema**: Swelling beneath the skin, typically around the eyes, lips, or throat, is a rare but serious side effect that requires immediate medical attention. - **Anemia**: Minor decreases in hemoglobin and hematocrit levels have been observed, which can slightly increase the risk of anemia. - **Peripheral Edema**: Swelling in the extremities, such as the hands, feet, or ankles, can occur as a side effect of aliskiren. - **Rash and Pruritus**: Skin rashes and itching are less common side effects but can occur in some patients. - **Musculoskeletal Pain**: Some patients may experience pain in the muscles or joints.

Pregnancy Category ID

4

Mode of Action

Aliskiren is a direct renin inhibitor, which means it works by blocking the action of renin, an enzyme crucial in the renin-angiotensin-aldosterone system (RAAS). This system plays a central role in regulating blood pressure and fluid balance in the body. Here’s how aliskiren exerts its effects: - **Renin Inhibition**: Renin is the first enzyme in the RAAS cascade. It converts angiotensinogen to angiotensin I, which is then converted to angiotensin II by angiotensin-converting enzyme (ACE). - **Reduced Angiotensin II Production**: By inhibiting renin, aliskiren reduces the production of angiotensin I and, consequently, angiotensin II. Angiotensin II is a potent vasoconstrictor that narrows blood vessels and stimulates the release of aldosterone, a hormone that promotes sodium reabsorption and potassium excretion in the kidneys. - **Vasodilation**: With less angiotensin II available, blood vessels dilate (widen), which reduces peripheral resistance and lowers blood pressure. - **Decreased Aldosterone Secretion**: Lower levels of angiotensin II lead to reduced aldosterone secretion from the adrenal glands. This results in decreased sodium reabsorption and increased potassium retention in the kidneys, further contributing to blood pressure reduction. - **Reduced Plasma Volume**: The combined effects of vasodilation and decreased sodium reabsorption lead to a reduction in plasma volume, which helps lower blood pressure. - **Direct Binding to Renin**: Aliskiren binds to the S3bp binding site of renin, which is essential for its activity. This direct inhibition is highly specific and effective in blocking the RAAS at its initial step. - **Blood Pressure Control**: By interrupting the RAAS at the level of renin, aliskiren provides a sustained and effective reduction in blood pressure, making it a valuable option for managing hypertension. - **Cardiovascular Protection**: Although aliskiren primarily targets blood pressure, its effects on the RAAS may also provide cardiovascular protection by reducing the workload on the heart and arteries.

Interaction

Aliskiren interacts with several medications and substances, requiring careful management to avoid adverse effects: - **ACE Inhibitors and ARBs**: Combining aliskiren with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) can increase the risk of hyperkalemia (high potassium levels), hypotension (low blood pressure), and kidney impairment, especially in patients with diabetes. - **Potassium Supplements**: Concomitant use of aliskiren with potassium supplements or potassium-sparing diuretics can lead to hyperkalemia, which may cause serious heart problems. - **NSAIDs**: Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen can reduce the antihypertensive effect of aliskiren and increase the risk of kidney problems. - **Cyclosporine**: Cyclosporine significantly increases the blood levels of aliskiren, leading to potential toxicity. This combination should be avoided. - **Diuretics**: When used with diuretics, aliskiren may cause excessive blood pressure lowering, leading to symptoms such as dizziness or fainting. - **Lithium**: Aliskiren can increase the blood levels of lithium, potentially leading to lithium toxicity. Close monitoring of lithium levels is required if these drugs are used together. - **High-Fat Meals**: High-fat meals can significantly decrease the absorption of aliskiren, reducing its effectiveness. It is recommended to take aliskiren consistently with or without food, but not with high-fat meals. - **Other Antihypertensives**: When aliskiren is used with other antihypertensive medications, there is an increased risk of hypotension. Dosage adjustments and close monitoring may be necessary. - **Alcohol**: Consuming alcohol while taking aliskiren can enhance the blood pressure-lowering effects, leading to dizziness or fainting. It is advisable to limit alcohol intake.

Pregnancy Category Note

C (1st trimester), D (2nd & 3rd trimesters)

Adult Dose

The dosing of aliskiren for adults is carefully tailored to ensure effective blood pressure control while minimizing side effects. Here are the key points regarding adult dosing: - **Starting Dose**: The typical starting dose for aliskiren is 150 mg once daily. This dose is generally well-tolerated and effective for most patients with hypertension. - **Dose Titration**: If the initial dose does not achieve the desired blood pressure reduction, it can be increased to 300 mg once daily after 2 weeks. This titration allows for a gradual adjustment to the medication and helps minimize potential side effects. - **Maximum Dose**: The maximum recommended dose of aliskiren is 300 mg once daily. Higher doses do not provide additional benefits and may increase the risk of adverse effects. - **Consistent Timing**: Aliskiren should be taken at the same time each day to maintain consistent blood levels and optimal blood pressure control. Patients should establish a routine pattern for taking the medication, either with or without food, but not with high-fat meals, which can decrease absorption. - **Combination Therapy**: Aliskiren can be used alone or in combination with other antihypertensive medications, such as diuretics, calcium channel blockers, or beta-blockers, to achieve better blood pressure control. When used in combination, dosage adjustments may be necessary to avoid excessive blood pressure lowering. - **Special Populations**: In patients with moderate to severe renal impairment (creatinine clearance less than 60 mL/min), the starting dose should be 150 mg once daily, with careful monitoring of renal function and electrolytes. Dose adjustments should be made cautiously in these patients. - **Elderly Patients**: Elderly patients may be more sensitive to the effects of aliskiren and may require lower doses. The starting dose of 150 mg once daily is usually appropriate, with careful monitoring for side effects such as dizziness or hypotension. - **Monitoring**: Regular monitoring of blood pressure, renal function, and serum potassium levels is essential during aliskiren therapy. This helps ensure the medication is working effectively and allows for early detection of any potential adverse effects.

Child Dose

The dosing of aliskiren for children is carefully considered to ensure safe and effective treatment of hypertension. Here are the key points regarding pediatric dosing: - **Approved Age Range**: Aliskiren is approved for use in children aged 6 years and older who weigh at least 20 kg (44 lbs). - **Starting Dose**: The typical starting dose for children is based on weight. For children weighing 20 to 50 kg (44 to 110 lbs), the recommended starting dose is 75 mg once daily. For children weighing more than 50 kg, the starting dose is 150 mg once daily. - **Dose Titration**: If the initial dose does not achieve the desired blood pressure reduction, it can be increased after 2 weeks. For children weighing 20 to 50 kg, the dose can be increased to 150 mg once daily. For children weighing more than 50 kg, the dose can be increased to 300 mg once daily. - **Maximum Dose**: The maximum recommended dose for children is 300 mg once daily, regardless of weight. Higher doses do not provide additional benefits and may increase the risk of adverse effects. - **Consistent Timing**: Aliskiren should be taken at the same time each day to maintain consistent blood levels and optimal blood pressure control. Children should establish a routine pattern for taking the medication, either with or without food, but not with high-fat meals, which can decrease absorption. - **Combination Therapy**: Aliskiren can be used alone or in combination with other antihypertensive medications to achieve better blood pressure control in children. When used in combination, dosage adjustments may be necessary to avoid excessive blood pressure lowering. - **Monitoring**: Regular monitoring of blood pressure, renal function, and serum potassium levels is essential during aliskiren therapy in children. This helps ensure the medication is working effectively and allows for early detection of any potential adverse effects. - **Special Considerations**: Children with renal impairment or those taking other medications that affect the renin-angiotensin-aldosterone system (RAAS) may require closer monitoring and potential dose adjustments. The use of aliskiren in children with severe renal impairment is not recommended. - **Safety and Efficacy**: The safety and efficacy of aliskiren in children under 6 years of age or weighing less than 20 kg have not been established. Therefore, aliskiren should not be used in this population. - **Adverse Effects**: Children taking aliskiren should be monitored for adverse effects such as dizziness, hyperkalemia, and hypotension. Parents and caregivers should be educated about the signs of these adverse effects and when to seek medical attention.

Renal Dose

Adjusting the dose of aliskiren for patients with renal impairment is crucial to ensure safe and effective treatment. Here are the key considerations for renal dosing: - **Mild Renal Impairment**: For patients with mild renal impairment (creatinine clearance 60-89 mL/min), no dose adjustment is typically required. However, these patients should be monitored closely for any signs of worsening renal function or electrolyte imbalances. - **Moderate Renal Impairment**: In patients with moderate renal impairment (creatinine clearance 30-59 mL/min), the starting dose of aliskiren should be 150 mg once daily. Dose titration to 300 mg once daily can be considered with careful monitoring of renal function and serum potassium levels. - **Severe Renal Impairment**: Aliskiren is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) due to the increased risk of further kidney damage and hyperkalemia. Alternative antihypertensive medications should be considered for these patients. - **Dialysis**: There is limited information on the use of aliskiren in patients undergoing dialysis. Given the potential risks, aliskiren is generally not recommended for these patients. Alternative treatments should be explored. - **Monitoring**: Regular monitoring of renal function and serum potassium levels is essential for all patients with renal impairment taking aliskiren. This includes periodic measurements of blood urea nitrogen (BUN), serum creatinine, and electrolytes to detect any adverse effects early. - **Concomitant Medications**: Patients with renal impairment who are taking other medications that affect the renin-angiotensin-aldosterone system (RAAS), such as ACE inhibitors or ARBs, should avoid aliskiren due to the increased risk of hyperkalemia and further renal impairment. - **Fluid Balance**: Maintaining proper fluid balance is crucial for patients with renal impairment. Dehydration can exacerbate the effects of aliskiren on renal function, so adequate hydration is essential. - **Dose Adjustments**: If a patient with renal impairment experiences adverse effects such as hyperkalemia or worsening renal function, the dose of aliskiren may need to be reduced or discontinued. Close collaboration with a healthcare provider is necessary to manage these situations effectively.

Administration

Information not available