LOPACE H

Each film coated tablets contains:

(Losartan Potassium IP 50 mg & Hydrochlorothiazide USP 12.5 mg)

Tablet for Oral Use

Losartan potassium is an angiotensin receptor blocker (ARB) that blocks the binding of Angiotensin II to its receptor that ultimately leads to decrease in blood pressure.

Hydrochlorothiazide is a diuretic that decreases blood pressure by preventing the reabsorption of water and sodium in the kidney.

Absorption: Losartan Potassium is approximately 33% orally bioavailable. Losartan has a T_max of 1 hour and the active metabolite has a T_max of 3-4 hours. Taking losartan with food decreases the C_max but does only results in a 10% decrease in the AUC of losartan and its active metabolite.

An oral dose of Hydrochlorothiazide is 65-75% bioavailable, with a T_max of 1-5 hours, and a C_max of 70-490ng/mL following doses of 12.5-100mg. When taken with a meal, bioavailability is 10% lower, C_max is 20% lower, and T_max increases from 1.6 to 2.9 hours.

Protein Binding: Protein binding of Losartan Potassium is 99% and Hydrochlorothiazide is 40-68%.

Distribution: The volume of distribution of Losartan Potassium is 34.4±17.9L and 10.3±1.1L for the active metabolite. The volume of distribution of Hydrochlorothiazide varies widely from one study to another with values of 0.83-4.19L/kg.

Metabolism: Losartan Potassium undergoes extensive first pass hepatic metabolism, 14% is converted to an active metabolite, 4% excreted unchanged in urine, 6% excreted in urine as active metabolite. Hydrochlorothiazide is not metabolized.

• Mild to Moderate Hypertension
• Hypertension not controlled by monotherapy
• Diabetic Nephropathy
• To prevent recurrent stroke

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ADVERSE REACTION:

The most common side effects are: colds, (upper respiratory infection) ï dizziness ï stuffy nose ï back pain

May cause low blood pressure, a new onset or worsening of systemic lupus erythematous, sensitivity of skin to sun and skin cancer.

DOSAGE AND ADMINISTRATION:

The recommended initial dose is 1 tab/day; it may be increased up to 2 tab/day.

CONTRAINDICATIONS:

• Allergic to any of the components of Losartan Potassium or Hydrochlorothiazide
• Severely Impaired Liver Function

WARNINGS AND PRECAUTIONS:

• Is not recommended in early pregnancy & breast feeding
• Tell the doctor if you have had skin cancer or if you develop an unexpected skin lesion during the treatment
• Tell doctor if you have Gout as it may increase the level of uric acid
• Do not take alcohol while using Losartan Potassium & Hydrochlorothiazide

Drug Interaction:

Avoid taking Losartan Potassium/Hydrochlorothiazide with:

• Lithium (used to treat depression),

• Potassium supplements, potassium-sparing diuretics (spironolactone, triamterene, amiloride), Potassium salts, or other medicines that may increase serum Potassium (e.g. Trimethoprim-containing medicines)