Losartan Potassium + Hydrochlorothiazide (Presartan H 50) 50mg/12.5mg Film Coated Tablet 100's

Product Description:

Losartan Potassium + Hydrochlorothiazide (Presartan H 50) is a combination medication that includes 50 mg of Losartan Potassium (an angiotensin II receptor antagonist) and 12.5 mg of Hydrochlorothiazide (a thiazide diuretic). This film-coated tablet is primarily used to treat high blood pressure (hypertension) and reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy. The two active ingredients work synergistically to lower blood pressure. Losartan works by blocking the effects of angiotensin II (a substance that narrows blood vessels), while Hydrochlorothiazide helps the body eliminate excess salt and water, which also lowers blood pressure. The product is available in 100-tablet packs.

Indications:

Losartan Potassium + Hydrochlorothiazide (Presartan H 50) is indicated for the treatment of the following conditions:

1. Hypertension (High Blood Pressure):

   • Used as an adjunct therapy in the management of high blood pressure in patients who require two agents to adequately control their condition. The combination helps to reduce overall blood pressure by both reducing blood vessel constriction (Losartan) and decreasing fluid volume (Hydrochlorothiazide).

2. Hypertension with Left Ventricular Hypertrophy:

   • Indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (a thickening of the heart’s left ventricle).

3. Chronic Heart Failure (Off-label use):

   • Although not a primary indication, the combination may sometimes be used off-label to assist with the management of chronic heart failure, especially in combination with other heart failure treatments.

Dosage:

The dosage of Losartan Potassium + Hydrochlorothiazide (Presartan H 50) is based on the individual patient's needs and the severity of their condition.

For Hypertension:

• Initial Dose: Typically, one tablet (50 mg of Losartan and 12.5 mg of Hydrochlorothiazide) once daily.

• Maintenance Dose: The dose may be increased to one tablet of 100 mg/25 mg once daily if necessary, based on the patient’s blood pressure response.

• Maximum Dose: 100 mg of Losartan/25 mg of Hydrochlorothiazide per day.

For Patients with Left Ventricular Hypertrophy and Hypertension:

• The typical starting dose is 50 mg of Losartan/12.5 mg of Hydrochlorothiazide once daily, which may be increased to 100 mg of Losartan/25 mg of Hydrochlorothiazide once daily based on clinical response.

Adjustment in Renal Impairment:

• Dose adjustments may be necessary in patients with renal impairment. A lower starting dose is often recommended in such cases.

Side Effects:

Losartan Potassium + Hydrochlorothiazide (Presartan H 50) may cause various side effects, some of which may require medical attention:

Common Side Effects:

• Dizziness or lightheadedness, especially when standing up quickly (due to low blood pressure).

• Headache.

• Fatigue or tiredness.

• Nausea or stomach discomfort.

• Cough (although less common than with ACE inhibitors).

Serious Side Effects (Less common but more severe):

• Hyperkalemia (elevated potassium levels), which can lead to muscle weakness, fatigue, and irregular heartbeats.

• Hypotension (low blood pressure), which can cause dizziness, fainting, and shock in severe cases.

• Dehydration or electrolyte imbalances (low sodium, low potassium, etc.), particularly with Hydrochlorothiazide.

• Severe allergic reactions, such as rash, itching, swelling of the face or throat, and difficulty breathing.

• Kidney dysfunction: Symptoms may include changes in urine output or swelling in the feet and ankles.

• Jaundice (yellowing of the skin or eyes), which may indicate liver issues.

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

Contraindications:

Losartan Potassium + Hydrochlorothiazide (Presartan H 50) should not be used in the following conditions:

1. Hypersensitivity:

   • Allergy to Losartan, Hydrochlorothiazide, or any other component of the tablet.

2. Severe Renal Impairment:

   • Contraindicated in patients with severe kidney problems (e.g., anuria, or the inability to produce urine).

3. Hyperkalemia:

   • Contraindicated in patients with high potassium levels (e.g., serum potassium > 5.5 mEq/L), as Losartan and Hydrochlorothiazide can both elevate potassium levels.

4. Severe Hepatic Impairment:

   • Should be avoided in patients with severe liver disease or biliary obstructive disorders, as the medication can worsen liver function.

5. Pregnancy:

   • Contraindicated during pregnancy (especially in the second and third trimesters) due to the risk of fetal harm and adverse pregnancy outcomes. Losartan can cause fetal renal failure, oligohydramnios (low amniotic fluid), and death in the fetus.

6. Breastfeeding:

   • Losartan and Hydrochlorothiazide can be excreted in breast milk and may not be recommended during breastfeeding. Consult a healthcare provider before use if breastfeeding.

Precautions:

• Pregnancy and Breastfeeding: As mentioned, Losartan is contraindicated during pregnancy, particularly after the first trimester. Hydrochlorothiazide should also be avoided in breastfeeding women.

• Kidney and Liver Function: Close monitoring is required in patients with pre-existing renal or hepatic disease. Adjustments in dosing may be necessary.

• Electrolyte Imbalances: Patients using Presartan H 50 should be monitored for electrolyte imbalances, including low sodium (hyponatremia), low potassium (hypokalemia), and high potassium (hyperkalemia). Regular blood tests are recommended.

• Use in Elderly: Older adults may be more susceptible to the side effects, especially hypotension and electrolyte disturbances. They should be closely monitored.

• Cough: Though Presartan H 50 is not associated with the cough seen with ACE inhibitors, some patients may still experience throat irritation or mild respiratory issues.

Drug Interactions:

Losartan Potassium + Hydrochlorothiazide (Presartan H 50) can interact with several other medications, including:

1. Potassium-Sparing Diuretics: Spironolactone, amiloride, or triamterene should not be used concomitantly with this combination due to the risk of hyperkalemia.

2. Lithium: The combination may increase lithium levels in the blood, leading to lithium toxicity. Monitoring of lithium levels is necessary.

3. NSAIDs (Nonsteroidal Anti-Inflammatory Drugs): NSAIDs, such as ibuprofen, can reduce the antihypertensive effect of Presartan H 50 and may also increase the risk of kidney problems.

4. Angiotensin-Converting Enzyme Inhibitors (ACE Inhibitors): Using Losartan with ACE inhibitors or aldosterone antagonists may increase the risk of hyperkalemia and kidney dysfunction.

5. Other Antihypertensive Drugs: Combining Presartan H 50 with other antihypertensive medications may lead to excessive blood pressure lowering (hypotension).

Conclusion:

Losartan Potassium + Hydrochlorothiazide (Presartan H 50) is a combination medication that effectively treats hypertension and reduces the risk of stroke in patients with high blood pressure and left ventricular hypertrophy. While generally well-tolerated, it can cause side effects such as dizziness, fatigue, and electrolyte imbalances. It should be used with caution in patients with renal or hepatic problems and pregnant women should avoid this medication. Regular monitoring of blood pressure, electrolyte levels, and kidney function is recommended. Always follow the prescribed dosage and consult your healthcare provider if you experience any concerning side effects.