Medication info
Baratan Tablet 160 mg (Valsartan)

Baratan Tablet 160 mg (Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›160mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Oval film-coated tablet with an orange hue
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201304289 · Approved 2013.02.07 · Insurance code 657805040

Summary

Main use
Treatment of essential hypertension and heart failure (including intolerance to ACE inhibitors), reduction of risk of mortality after myocardial infarction
Who takes it
Adults · Children
Adult dose
1. Essential Hypertension Take with water during or between meals. It is recommended to take it at the same time each day (e.g., in the morning). For all genders and ethnicities, a dose of 80 mg of valsartan orally once daily is recommended. Patients who do not achieve adequate blood pressure control may increase the dose to 160 mg daily or may combine with a diuretic. If additional blood pressure lowering is needed, the dose may be increased to a maximum of 320 mg per day. 2. Heart Failure Adults: The initial dose is recommended to be taken orally as 40 mg twice daily, which may be increased to 80 mg or 160 mg per dose. When combined with diuretics, consider reducing the diuretic dose. The maximum daily dose is 320 mg, divided into two doses. Triple combination therapy with ACE inhibitors and beta-blockers is not recommended. 3. Reducing the risk of mortality after Myocardial Infarction Adults: Treatment can be initiated within 12 hours after the onset of myocardial infarction. The starting dose is recommended to be 20 mg twice daily, and over the following weeks, the dose can be increased to 40 mg, 80 mg, or 160 mg twice a day, considering the patient’s tolerance. If hypotension or renal failure occurs, consider dose reduction. This medication can be given to patients undergoing treatment with other therapies (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statins) after myocardial infarction. However, combination with ACE inhibitors is not recommended. 4. Renal Impairment: If creatinine clearance is above 10 mL/min, no dose adjustment is necessary; however, this medication should not be used in patients with creatinine clearance below 10 mL/min or in dialysis patients as there is no experience available. 5. Liver Impairment: It is preferable for the daily dosing of this medication in patients with mild or moderate liver impairment to not exceed 80 mg per day. If the dose exceeds 80 mg, weigh the benefits against the risks of the treatment. This medication should not be used in patients with severe liver impairment, liver cirrhosis, or cholestasis. 6. Pediatrics: Safety and efficacy in pediatric patients under 18 years of age have not been established.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment of essential hypertension and heart failure (including intolerance to ACE inhibitors), reduction of risk of mortality after myocardial infarction

  • Essential hypertension
  • heart failure
  • left ventricular dysfunction
  • left ventricular systolic dysfunction
View approved original text

This medication is used to treat essential hypertension, helping to control blood pressure and maintain cardiovascular health. It can also be safely used in heart failure patients who are intolerant to ACE inhibitors, particularly those classified as NYHA stages II to IV. After a myocardial infarction, it is effective in reducing the risk of mortality in patients with left ventricular dysfunction, leading to improved survival rates. Thus, this medication plays an important role in managing hypertension and heart failure and in reducing the risk of mortality after a myocardial infarction.

How to take

Adult dose

1. Essential Hypertension Take with water during or between meals. It is recommended to take it at the same time each day (e.g., in the morning). For all genders and ethnicities, a dose of 80 mg of valsartan orally once daily is recommended. Patients who do not achieve adequate blood pressure control may increase the dose to 160 mg daily or may combine with a diuretic. If additional blood pressure lowering is needed, the dose may be increased to a maximum of 320 mg per day. 2. Heart Failure Adults: The initial dose is recommended to be taken orally as 40 mg twice daily, which may be increased to 80 mg or 160 mg per dose. When combined with diuretics, consider reducing the diuretic dose. The maximum daily dose is 320 mg, divided into two doses. Triple combination therapy with ACE inhibitors and beta-blockers is not recommended. 3. Reducing the risk of mortality after Myocardial Infarction Adults: Treatment can be initiated within 12 hours after the onset of myocardial infarction. The starting dose is recommended to be 20 mg twice daily, and over the following weeks, the dose can be increased to 40 mg, 80 mg, or 160 mg twice a day, considering the patient’s tolerance. If hypotension or renal failure occurs, consider dose reduction. This medication can be given to patients undergoing treatment with other therapies (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statins) after myocardial infarction. However, combination with ACE inhibitors is not recommended. 4. Renal Impairment: If creatinine clearance is above 10 mL/min, no dose adjustment is necessary; however, this medication should not be used in patients with creatinine clearance below 10 mL/min or in dialysis patients as there is no experience available. 5. Liver Impairment: It is preferable for the daily dosing of this medication in patients with mild or moderate liver impairment to not exceed 80 mg per day. If the dose exceeds 80 mg, weigh the benefits against the risks of the treatment. This medication should not be used in patients with severe liver impairment, liver cirrhosis, or cholestasis. 6. Pediatrics: Safety and efficacy in pediatric patients under 18 years of age have not been established.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established.

Precautions

This medication, especially when taken in the second and third trimesters of pregnancy, can cause serious harm to the fetus, so it should be discontinued immediately if pregnancy is confirmed. This medication should not be administered to patients with certain conditions. For example, individuals allergic to this medication or its components, pregnant or breastfeeding women, patients with severe liver impairment, patients with hereditary angioedema or a history of angioedema, patients with severe kidney dysfunction, patients with primary hyperaldosteronism, and patients with diabetes or severe kidney impairment should not use it. Elderly patients, those with hyperkalemia, patients with slightly impaired liver function, patients with certain heart conditions, and patients with fluid depletion should exercise special caution when using this medication, as hypotension may appear at the beginning of treatment. Common side effects during the use of this medication may include dizziness, headache, fatigue, cough, and diarrhea, while rare but serious adverse reactions may include angioedema, hepatitis, worsening kidney function, hypoglycemia, and muscle disorders, so any unusual symptoms should be discussed with a healthcare provider immediately. This medication can interact with other drugs, so blood pressure, kidney function, and electrolyte levels should be monitored periodically, especially when used with potassium-sparing diuretics, potassium supplements, non-steroidal anti-inflammatory drugs, and lithium preparations. Pregnant or breastfeeding women are advised not to take this medication, and if it must be used, breastfeeding should be discontinued. Safety and efficacy in pediatric patients under 18 years of age have not been established, so it is advisable not to use this medication in this population. In case of overdose, severe hypotension, consciousness impairment, or shock may occur, and immediate emergency treatment is required, so keep this medication out of reach of children. Finally, this medication has a blood pressure-lowering effect, so caution is needed as dizziness may occur when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough+fever, jaundice (yellowing of skin or eyes), profound malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • viral infection
  • upper respiratory tract infection
  • cough
  • diarrhea
  • fatigue
  • rhinitis
  • sinusitis
  • back pain
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  • abdominal pain
  • nausea
  • pharyngitis
  • joint pain
  • hypotension
  • orthostatic dizziness
  • orthostatic hypotension
  • vomiting
  • constipation
  • thirst
  • appetite loss
  • malaise
  • flushing
  • itching
  • serum sickness
  • vasculitis
  • drowsiness
  • fainting
  • loss of consciousness
  • rhabdomyolysis
  • weakness
  • anemia
  • tinnitus
  • hypertonia
  • decreased motor function
  • confusion
  • chest pain
  • rash

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a cool place below 30 degrees to maintain its efficacy.

Appearance and packaging

Appearance

Oval film-coated tablet with an orange hue

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.