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

Product Description:

Amlodipine Besilate + Losartan Potassium (Amlosta) 5mg/50mg Film-Coated Tablets is a combination medication that combines two antihypertensive agents: Amlodipine Besilate (5mg) and Losartan Potassium (50mg). Amlodipine is a calcium channel blocker, while Losartan is an angiotensin II receptor antagonist (ARB). This combination helps to lower high blood pressure (hypertension) and reduce the risk of cardiovascular events. Amlodipine works by relaxing the blood vessels, making it easier for the heart to pump blood. Losartan works by blocking the effects of angiotensin II, which helps to lower blood pressure by relaxing blood vessels.

This combination is used to treat high blood pressure and is typically prescribed for patients who need dual therapy to control their blood pressure more effectively.

Indications:

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

1. Hypertension (High Blood Pressure):

   • To treat essential hypertension in adults, either as monotherapy or in combination with other antihypertensive medications when blood pressure control is insufficient with either drug alone.

2. Cardiovascular Risk Reduction:

   • Chronic kidney disease (CKD) in patients with hypertension and type 2 diabetes, to help reduce the risk of kidney damage.

   • Prevention of stroke in hypertensive patients with left ventricular hypertrophy (LVH) as part of a treatment plan.

Dosage and Administration:

The dosage should be individualized based on the patient's response to therapy and clinical condition. The usual starting dose for Amlodipine Besilate + Losartan Potassium (Amlosta) is:

• Initial dose: 1 tablet (5mg/50mg) taken once daily.

• Maintenance dose: Depending on the patient’s response to the medication, the dose can be increased, but the maximum recommended dose is 1 tablet (10mg/100mg) once daily.

For patients who are not well controlled on monotherapy (either Amlodipine or Losartan), a combination of both drugs can help achieve better blood pressure control.

Administration:

• Amlosta should be taken orally with or without food.

• It is recommended to take the tablet at the same time each day to help remember.

If a dose is missed, take it as soon as possible, but skip the missed dose if it is close to the time for the next dose. Do not take two doses at once to make up for a missed dose.

Side Effects:

Common side effects may include:

1. Amlodipine (Calcium Channel Blocker) Related Side Effects:

   • Swelling (edema), particularly in the legs and ankles.

   • Dizziness or lightheadedness, especially when standing up quickly.

   • Flushing or feeling warm.

   • Palpitations (rapid heart rate).

   • Headache.

   • Fatigue or tiredness.

2. Losartan (Angiotensin II Receptor Blocker) Related Side Effects:

   • Dizziness or lightheadedness, especially when standing up.

   • Elevated blood potassium levels (hyperkalemia).

   • Fatigue.

   • Cough (though much less common than with ACE inhibitors).

   • Back pain.

   • Nausea.

Serious side effects (require immediate medical attention):

1. Angioedema (swelling of the face, lips, tongue, or throat, which could cause difficulty breathing).

2. Severe hypotension (very low blood pressure).

3. Kidney problems, as evidenced by reduced urine output, swelling, or weight gain.

4. Elevated potassium levels, which can cause irregular heartbeats or muscle weakness.

5. Liver problems, such as jaundice (yellowing of the skin or eyes), dark urine, or severe stomach pain.

6. Chest pain, which could indicate a heart issue.

7. Signs of dehydration (thirst, dry mouth, reduced urine output).

Contraindications:

Amlodipine Besilate + Losartan Potassium (Amlosta) should not be used in the following conditions:

1. Hypersensitivity:

   • Known allergy to Amlodipine, Losartan, or any of the excipients in the tablet.

2. Severe Liver Dysfunction:

   • Amlodipine and Losartan should be avoided in patients with severe hepatic impairment or biliary obstructive disorders.

3. Renal Artery Stenosis:

   • Use of this combination is contraindicated in patients with bilateral renal artery stenosis or unilateral renal artery stenosis if the other kidney is also compromised.

4. Pregnancy:

   • Amlodipine Besilate + Losartan Potassium (Amlosta) is contraindicated during pregnancy, particularly during the second and third trimesters, as Losartan may cause harm to the fetus (e.g., renal dysfunction, fetal death).

5. Severe Renal Impairment:

   • This combination medication is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease without appropriate dose adjustments.

6. Hyperkalemia:

   • Contraindicated in patients with high potassium levels (hyperkalemia) due to the potential for potassium levels to rise further with Losartan use.

7. Concomitant Use with Aliskiren:

   • This combination is contraindicated in diabetic patients who are using Aliskiren (another blood pressure medication) due to the increased risk of adverse effects such as kidney dysfunction, hyperkalemia, and low blood pressure.

Precautions:

• Renal Impairment: Amlodipine Besilate + Losartan Potassium should be used with caution in patients with mild to moderate renal impairment. Kidney function should be monitored regularly, and dose adjustments may be necessary.

• Electrolyte Imbalance: This medication can cause hyperkalemia (high potassium levels), especially in patients with renal impairment or in those taking potassium supplements, potassium-sparing diuretics, or other medications that increase potassium.

• Liver Disease: Losartan is metabolized by the liver. In patients with mild to moderate liver impairment, the use of Amlost should be monitored closely. Amlodipine is less likely to be affected by liver disease but should still be used cautiously in these patients.

• Hypotension: This combination may cause significant lowering of blood pressure, especially in patients who are volume-depleted (e.g., those on diuretics). In these cases, blood pressure should be monitored, and appropriate adjustment in therapy should be made.

• Pregnancy and Breastfeeding: Amlodipine Besilate + Losartan Potassium should not be used during pregnancy and breastfeeding, as it can harm the fetus or newborn.

Drug Interactions:

1. Potassium Supplements or Potassium-Sparing Diuretics: Increased risk of hyperkalemia.

2. Lithium: The combination may increase lithium toxicity. Careful monitoring of lithium levels is required.

3. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): Concurrent use with NSAIDs may reduce the antihypertensive effect of Amlosta and may also increase the risk of kidney impairment.

4. ACE Inhibitors or ARBs: Caution should be used when combining Amlosta with ACE inhibitors or other ARBs due to the increased risk of hyperkalemia and kidney issues.

5. Cyclosporine: Increased risk of kidney dysfunction when used with Cyclosporine.

Summary:

Amlodipine Besilate + Losartan Potassium (Amlosta) 5mg/50mg is a combination medication used for the treatment of high blood pressure (hypertension). It helps lower blood pressure by combining a calcium channel blocker (Amlodipine) and an angiotensin II receptor antagonist (Losartan). The medication should be used with caution in patients with renal impairment, those who are pregnant or breastfeeding, and those taking other medications that affect potassium levels. Side effects may include dizziness, swelling, and elevated potassium levels. Always consult with a healthcare provider before starting this medication to ensure it is appropriate for your condition.