Amlodipine Besilate + Losartan Potassium (Duoden) 5mg/50mg Film Coated Tablet 30's

Certainly! Below is the detailed information for Amlodipine Besilate + Losartan Potassium (Duoden) 5mg/50mg Film Coated Tablet 30's:

Product Description:

Amlodipine Besilate + Losartan Potassium (Duoden) is a combination medication that combines two active ingredients: Amlodipine (a calcium channel blocker) and Losartan Potassium (an angiotensin II receptor blocker, or ARB). This combination is used primarily to treat high blood pressure (hypertension) and to improve cardiovascular outcomes. The tablet contains 5mg of Amlodipine and 50mg of Losartan, which work together to help relax blood vessels, reduce blood pressure, and improve blood flow, thereby decreasing the workload on the heart.

Each pack of Duoden contains 30 film-coated tablets.

Indications:

Amlodipine Besilate + Losartan Potassium (Duoden) is indicated for the following conditions:

1. Hypertension (High Blood Pressure):

   • Duoden is used to treat essential hypertension (high blood pressure) in adults when a combination of Amlodipine and Losartan is needed to effectively control blood pressure.

   • It can also be used in patients who require additional blood pressure control when Amlodipine and Losartan alone are not sufficient.

2. Chronic Kidney Disease (in patients with hypertension and type 2 diabetes):

   • Duoden is used in patients with hypertension and chronic kidney disease (especially those with type 2 diabetes) to reduce the progression of kidney damage.

   • Losartan helps reduce proteinuria (the presence of excess protein in the urine), which is often a sign of kidney damage.

3. Reduction of the Risk of Stroke and Heart Failure:

   • In patients with left ventricular hypertrophy (enlarged heart) following a stroke, Duoden may help in the prevention of stroke by reducing blood pressure and improving heart function.

Dosage:

The dosing of Amlodipine Besilate + Losartan Potassium (Duoden) will depend on the patient's individual needs and blood pressure response. Here are typical dosing guidelines:

• Initial Dose:

  • 1 tablet daily, containing 5mg of Amlodipine and 50mg of Losartan.

• Maintenance Dose:

  • The dose may be increased based on the individual patient's response to treatment. The maximum recommended dose is 1 tablet daily containing 10mg of Amlodipine and 100mg of Losartan.

  • Dosage adjustments may be made after several weeks of treatment to achieve optimal blood pressure control.

• Special Populations:

  • For patients with kidney disease or mild-to-moderate liver impairment, Duoden should be used with caution. Lower doses may be considered, and kidney function should be monitored regularly.

• Elderly:

  • Elderly patients may be more sensitive to the blood pressure-lowering effects of Duoden, and it may be advisable to start at a lower dose (5mg/50mg) and monitor the patient carefully.

Side Effects:

Like all medications, Amlodipine Besilate + Losartan Potassium (Duoden) may cause side effects, although not everyone experiences them. Common and serious side effects include:

Common Side Effects:

• Dizziness or lightheadedness, particularly when standing up quickly (orthostatic hypotension).

• Swelling (edema) of the ankles, feet, or legs (more commonly with Amlodipine).

• Headache.

• Fatigue or tiredness.

• Flushing or feeling warm.

• Nausea or stomach discomfort.

• Cough (more likely with Losartan in rare cases).

Serious Side Effects:

• Severe allergic reactions: Symptoms include rash, swelling of the face, difficulty breathing, or tightness in the chest.

• Severe dizziness, fainting, or confusion: May indicate low blood pressure.

• High potassium levels (hyperkalemia): Symptoms may include muscle weakness, fatigue, or irregular heartbeat.

• Liver problems: Symptoms of liver dysfunction include yellowing of the skin or eyes (jaundice), dark urine, or persistent abdominal pain.

• Kidney dysfunction: Symptoms may include changes in urine output, swelling, or fatigue.

• Angioedema (swelling of the deeper layers of the skin): This can be a serious side effect, particularly with Losartan. If swelling of the lips, face, or throat occurs, immediate medical attention should be sought.

• Fainting or bradycardia (slow heart rate).

If any of these serious side effects occur, immediate medical attention should be sought.

Contraindications:

Amlodipine Besilate + Losartan Potassium (Duoden) is contraindicated in the following conditions:

• Hypersensitivity to Amlodipine, Losartan, or any of the components of the tablet: If you are allergic to Amlodipine, Losartan, or any of the other ingredients in this medication, you should not take it.

• Severe hypotension (low blood pressure): Duoden should not be used in patients with significantly low blood pressure.

• Severe hepatic impairment: Duoden is contraindicated in patients with severe liver disease.

• Bilateral renal artery stenosis (narrowing of both kidneys' arteries): Using Duoden may further impair kidney function in these patients.

• Pregnancy (Category D): Duoden is contraindicated during pregnancy because it can harm the unborn baby, particularly during the second and third trimesters. If pregnancy is detected, treatment should be discontinued immediately.

• Breastfeeding: Duoden should be avoided during breastfeeding as it may pass into breast milk and affect the baby.

• Angioedema: Patients with a history of angioedema related to previous ACE inhibitors or ARBs (like Losartan) should not take this medication.

Precautions:

• Caution in patients with kidney disease: For patients with mild to moderate kidney impairment, the dose of Duoden may need to be adjusted. Kidney function should be monitored regularly.

• Caution in patients with liver disease: Liver function should be checked regularly in patients with mild liver impairment. For severe liver disease, Duoden is contraindicated.

• Caution in elderly patients: Elderly patients may be more sensitive to the effects of Duoden, especially regarding blood pressure reduction and the risk of orthostatic hypotension. It is important to monitor blood pressure regularly in elderly patients.

• Potassium monitoring: Patients taking Duoden should have their serum potassium levels monitored, as Losartan may increase the risk of hyperkalemia.

• Pregnancy and breastfeeding: Duoden should not be used during pregnancy or breastfeeding. Alternative medications should be considered.

Drug Interactions:

Amlodipine Besilate + Losartan Potassium (Duoden) can interact with several medications, including:

• Other antihypertensive medications: When used with other blood pressure-lowering drugs, there is an increased risk of hypotension (low blood pressure).

• Lithium: Lithium levels may increase in the blood when taken with Losartan, leading to potential toxicity.

• Potassium-sparing diuretics or potassium supplements: Taking potassium-sparing diuretics or potassium supplements alongside Losartan may increase the risk of hyperkalemia (high potassium levels).

• Non-steroidal anti-inflammatory drugs (NSAIDs): NSAIDs (e.g., ibuprofen, naproxen) may reduce the effectiveness of Losartan and may worsen kidney function.

• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): These may increase the plasma concentration of Amlodipine, increasing the risk of side effects such as swelling or dizziness.

• Diuretics: Patients using diuretics (e.g., furosemide) may be at increased risk of dehydration and electrolyte imbalance when taking Duoden.

Summary:

Amlodipine Besilate + Losartan Potassium (Duoden) is a combination of a calcium channel blocker (Amlodipine) and an angiotensin II receptor blocker (Losartan) used to treat hypertension, chronic kidney disease, and to reduce cardiovascular risks in patients with heart disease. The initial dose is typically 5mg of Amlodipine and 50mg of Losartan once daily, with a maximum dose of 10mg/100mg daily.

Common side effects include dizziness, swelling, and headache, while serious effects include angioedema, high potassium levels, and kidney dysfunction. Duoden is contraindicated in patients with severe hypotension, severe liver or kidney disease, and pregnancy.

Always follow the prescribed dosage, monitor for side effects, and consult with a healthcare provider before starting or stopping this medication.