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

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

Product Description:

Inozar is a combination tablet containing two active ingredients: Amlodipine Besilate (5 mg) and Losartan Potassium (50 mg). This combination is used primarily to treat high blood pressure (hypertension) and to manage other conditions related to cardiovascular health.

• Amlodipine is a calcium channel blocker that helps to relax and widen blood vessels, making it easier for the heart to pump blood. It also reduces the workload on the heart and helps lower blood pressure.

• Losartan is an angiotensin II receptor antagonist (ARB) that helps relax blood vessels by blocking the action of a hormone called angiotensin II, which normally causes blood vessels to tighten. This helps to reduce blood pressure and improve blood flow.

The combination of these two medications helps to lower blood pressure more effectively than either drug alone.

Each Inozar tablet contains:

• Amlodipine Besilate: 5 mg

• Losartan Potassium: 50 mg

The tablets come in a pack of 30 film-coated tablets.

Indications:

Inozar is indicated for the following conditions:

1. Hypertension (High Blood Pressure):

   • To treat essential hypertension (high blood pressure) in adult patients, either as initial therapy or for patients not adequately controlled on amlodipine or losartan alone.

2. Chronic Kidney Disease (CKD) in Hypertensive Patients:

   • To manage hypertension in patients with chronic kidney disease and type 2 diabetes. The combination helps protect the kidneys from damage due to high blood pressure.

3. Heart Failure (in combination with other therapies):

   • Used as part of the treatment for heart failure when other therapies are not sufficient.

Dosages:

The dosage of Inozar will depend on the severity of the condition being treated and the patient's response to treatment. The typical dosages are as follows:

• Adults with Hypertension:

  • Initial dose: One tablet of Inozar 5 mg/50 mg once daily.

  • Maintenance dose: One tablet daily, with adjustments based on the patient's blood pressure response. The dose may be increased if needed, but the usual range is between 5 mg/50 mg to 10 mg/100 mg once daily.

• Patients with Renal Impairment:

  • Dosage adjustments may be required for patients with mild to moderate renal impairment. It is generally not recommended for those with severe renal impairment.

• Patients with Heart Failure:

  • The dose should be tailored to the individual patient's needs and should be adjusted based on clinical response.

Note: This medication should be taken as directed by a healthcare provider. It can be taken with or without food.

Side Effects:

Like all medications, Inozar can cause side effects, although not everyone experiences them. Some of the common and serious side effects include:

1. Common Side Effects:

   • Dizziness or lightheadedness, particularly when standing up quickly (common during the initial stages of treatment).

   • Headache.

   • Fatigue or tiredness.

   • Swelling (edema) of the hands, feet, or ankles.

   • Flushing or redness of the skin.

   • Nausea or indigestion.

2. Serious Side Effects:

   • Low blood pressure (hypotension): Especially in patients who are salt-depleted or volume-depleted, such as those on diuretics.

   • Kidney problems: Reduced urine output, swelling in the legs, or abnormal kidney function tests.

   • Hyperkalemia (high potassium levels): Symptoms may include weakness, fatigue, or irregular heartbeat.

   • Angioedema: Swelling of the face, lips, tongue, or throat, which may cause difficulty breathing and requires immediate medical attention.

   • Liver dysfunction: Jaundice (yellowing of the skin or eyes), dark urine, or upper abdominal pain.

   • Chest pain, heart palpitations, or shortness of breath.

3. Rare but Serious Side Effects:

   • Acute kidney failure or worsening of pre-existing kidney disease.

   • Severe allergic reactions: Rash, hives, itching, or difficulty breathing.

   • Elevated blood potassium levels: May lead to serious heart problems.

   • Hypoglycemia (low blood sugar): Though rare, it may occur especially in patients with diabetes or who are on certain diabetic medications.

Contraindications:

Inozar should not be used in certain conditions or populations due to safety concerns:

1. Hypersensitivity:

   • Contraindicated in patients who are allergic to Amlodipine, Losartan, or any other components of the product.

2. Pregnancy:

   • Second and third trimesters: Losartan (and thus Inozar) should be avoided during pregnancy, as it can harm the developing fetus and lead to serious complications such as fetal renal dysfunction or death.

   • First trimester: Losartan should only be used in pregnancy if absolutely necessary and prescribed by a healthcare provider.

3. Breastfeeding:

   • It is not recommended during breastfeeding because both amlodipine and losartan pass into breast milk and may harm a nursing infant.

4. Severe Liver Disease:

   • Contraindicated in patients with severe hepatic impairment or cholestasis.

5. Severe Renal Impairment:

   • Contraindicated in patients with severe renal impairment or a history of renal artery stenosis (narrowing of the arteries supplying the kidneys).

6. Bilateral Renal Artery Stenosis:

   • Contraindicated in patients with bilateral renal artery stenosis or stenosis of the artery to a single kidney due to the increased risk of renal failure.

7. Hyperkalemia:

   • Should not be used in patients with hyperkalemia (high potassium levels) due to the potential for worsening this condition.

8. Severe Hypotension:

   • Contraindicated in patients with severe hypotension or those who are volume-depleted (e.g., from diuretic use or fluid loss).

Warnings and Precautions:

1. Electrolyte Imbalance:

   • Periodic monitoring of renal function and electrolytes (especially potassium) is recommended during treatment. Hyperkalemia (high potassium levels) can occur, particularly in patients with kidney problems.

2. Kidney Function:

   • Inozar can affect kidney function, especially in patients with pre-existing kidney disease or those using other medications that impact kidney function (e.g., NSAIDs, diuretics).

   • Renal function should be regularly monitored during therapy, and the medication should be discontinued if there are signs of kidney dysfunction.

3. Hypotension:

   • In patients with volume depletion (e.g., from diuretic therapy), Inozar can cause a significant drop in blood pressure. In such cases, careful monitoring and dose adjustment are necessary.

4. Liver Disease:

   • Caution is required in patients with mild to moderate liver disease, as losartan is metabolized in the liver. Close monitoring may be required.

5. Pregnancy and Contraception:

   • Women of childbearing age should avoid pregnancy while using Inozar. If pregnancy is suspected, therapy should be discontinued immediately, and alternative medications should be considered.

6. Symptomatic Hypotension:

   • Inozar may cause hypotension, especially when therapy is initiated. Patients should be monitored for signs of low blood pressure, particularly in the elderly or those on other antihypertensive medications.

Storage:

• Store Inozar at room temperature, away from moisture and direct light.

• Keep out of reach of children.

Important Note: Always take Inozar exactly as prescribed by your healthcare provider. Do not stop taking this medication suddenly or adjust your dose without consulting your doctor, as this can affect your blood pressure and overall health. Regular follow-up visits may be necessary to monitor for side effects or complications, especially related to kidney function and electrolytes.