Cobaltan Tablet (Hypertension)

1) Efficacy, effect

1. Essential hypertension

2. Heart failure

Heart failure intolerant to ACE inhibitors (NYHA class II. ~ IV.)

3. Reduced risk of death after myocardial infarction

Reduced risk of death after myocardial infarction in clinically stable patients with signs, symptoms, or radiological evidence of left ventricular dysfunction and/or left ventricular systolic dysfunction.

2) Usage, dosage

1. Essential hypertension

Take with water during meals or between meals. If possible, it is recommended to take it at the same time every day (e.g., in the morning).

1) Adults: Regardless of gender or race, oral administration of 80 mg once daily as valsartan is recommended.

The blood pressure lowering effect appears gradually within 2 weeks and reaches its maximum effect after 4 weeks.

For patients with poor blood pressure control, the dose may be increased to 160 mg per day or diuretics may be administered together. If additional blood pressure lowering is needed, the dose can be increased up to 320 mg per day.

2) Elderly (age 75 or older): Start taking this drug at 40 mg once a day.

3) Patients with renal impairment:

(1) Creatinine clearance rate 20 to 50 mL/min: No dosage adjustment is necessary.

(2) Creatinine clearance rate 10 to 20 mL/min: Start administration of this drug at 40 mg once a day.

(3) Creatinine clearance less than 10 mL/min and dialysis patients: Do not administer this drug.

4) Patients with a lack of fluid in the blood: For patients with a lack of fluid in the blood (e.g., patients taking high doses of diuretics and unable to reduce the dose), start administration of this drug at 40 mg once a day.

5) Patients with hepatic impairment: For patients with mild to moderate hepatic impairment, start treatment with this drug at 40 mg once a day, and the dosage should not exceed 80 mg per day. This drug should not be administered to patients with severe hepatic impairment, cirrhosis, or cholestasis.

6) Children: Safety and effectiveness have not been established in children and adolescents under 18 years of age.

2. Heart failure

Adults: The recommended starting dose is 40 mg orally twice a day, and can be increased to 80 mg or 160 mg once. When coadministering diuretics, a reduction in the diuretic dose should be considered. The maximum daily dose is 320 mg, administered in divided doses. Triple coadministration of this drug with ACE inhibitors and beta blockers is not recommended.

3. Reduced risk of death after myocardial infarction

Adults: Administration can begin within 12 hours after the onset of myocardial infarction. It is recommended that the starting dose be 20 mg twice a day, and then administer 40 mg, 80 mg, and 160 mg twice a day over the next few weeks. Increase the dose considering tolerability.

If symptoms of low blood pressure or renal failure occur, consider reducing the dose.

This drug can also be administered to patients who are being treated with other administration methods (e.g., thrombolytic agents, acetylsalicylic acid, beta blockers, and statin drugs) after myocardial infarction. However, combined use with ACE inhibitors is not recommended.

4. Patients with renal impairment

: If the creatinine clearance rate is over 10 mL/min, dose adjustment is not necessary, but if the creatinine clearance rate is less than 10 mL/min and there is no experience with dialysis patients, do not administer this drug as there is no experience in using it.

5. Patients with liver failure

: It is recommended that the daily dose of this drug for patients with mild to moderate hepatic impairment do not exceed 80 mg per day. When administering more than 80 mg per day, it should be considered whether the benefits of treatment outweigh the risks when increasing the dose. This drug should not be administered to patients with severe liver impairment, cirrhosis, or cholestasis.

6. Pediatrics

: Safety and efficacy have not been established in children and adolescents under 18 years of age.

3) Packaging unit

30 tablets/bottle

4) Ingredients, content

Valsartan Valsartan 160mg

5) Period of use

36 months from date of manufacture

6) Storage method

Airtight container, store below 30°C, avoiding heat and moisture.