Medication info

Hyden 160 mg Tablet (Valsartan)

Prescription medicationTablet경구Expired
Ingredient · strength
Valsartan›160mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Oval film-coated tablets with an orange color and gray tint.
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 202000761 · Approved 2020.02.10

This product's status changed to Expired on 2025.02.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), reduction of risk of mortality post-myocardial infarction.
Who takes it
Adults
Adult dose
1. Essential hypertension - Adults: It is recommended to take 80 mg orally once daily as valsartan. - If blood pressure is not well controlled, the dose can be increased to 160 mg daily or combined with a diuretic, with a maximum of 320 mg daily. - Elderly patients (75 years and older): Start with 40 mg once daily. - Patients with renal impairment, fluid deficit, or hepatic impairment should adjust the dose accordingly. 2. Heart failure Adults: The initial dose is recommended to be 40 mg orally twice daily, with the possibility to increase to 80 mg or 160 mg per dose. When combined with a diuretic, the dosage reduction of the diuretic should be considered. The maximum total daily dose is split to 320 mg. The triple combination of this medication with ACE inhibitors and beta-blockers is not recommended. 3. Reduction of mortality risk post-myocardial infarction Adults: Treatment may begin within 12 hours after presentation of myocardial infarction. The initial dose is recommended to be 20 mg orally twice daily, with subsequent increase to 40 mg, 80 mg, or 160 mg based on patient tolerance over several weeks. Consider dose reduction in case of hypotension or renal impairment. This medication can also be given to patients undergoing treatment with other therapies (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statins). However, combination with ACE inhibitors is not recommended. 4. Renal impairment: No dose adjustment is necessary for patients with a creatinine clearance of 10 mL/min or higher; however, there is no experience with patients with a creatinine clearance below 10 mL/min or dialysis patients, so this medication should not be used. 5. Hepatic impairment: For patients with mild to moderate hepatic impairment, it is preferable not to exceed a daily dose of 80 mg. Care should be taken when increasing doses exceeding 80 mg to weigh the therapeutic benefits against risks. This medication should not be used in cases of severe hepatic impairment, liver cirrhosis, or cholestasis. 6. Pediatric: Safety and efficacy in children and adolescents under 18 years have not been established.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Treatment of essential hypertension and heart failure (intolerance to ACE inhibitors), reduction of risk of mortality post-myocardial infarction.

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

This medication is used to control essential hypertension. It is also suitable for heart failure patients who cannot use ACE inhibitors and is helpful for those classified as NYHA Class II to IV. Additionally, it is effective in reducing the risk of mortality in stable patients with left ventricular dysfunction or impaired contractility after myocardial infarction. In summary, this medication is used for the treatment of hypertension, certain heart failure patients, and reducing mortality risk post-myocardial infarction.

How to take

Adult dose

1. Essential hypertension - Adults: It is recommended to take 80 mg orally once daily as valsartan. - If blood pressure is not well controlled, the dose can be increased to 160 mg daily or combined with a diuretic, with a maximum of 320 mg daily. - Elderly patients (75 years and older): Start with 40 mg once daily. - Patients with renal impairment, fluid deficit, or hepatic impairment should adjust the dose accordingly. 2. Heart failure Adults: The initial dose is recommended to be 40 mg orally twice daily, with the possibility to increase to 80 mg or 160 mg per dose. When combined with a diuretic, the dosage reduction of the diuretic should be considered. The maximum total daily dose is split to 320 mg. The triple combination of this medication with ACE inhibitors and beta-blockers is not recommended. 3. Reduction of mortality risk post-myocardial infarction Adults: Treatment may begin within 12 hours after presentation of myocardial infarction. The initial dose is recommended to be 20 mg orally twice daily, with subsequent increase to 40 mg, 80 mg, or 160 mg based on patient tolerance over several weeks. Consider dose reduction in case of hypotension or renal impairment. This medication can also be given to patients undergoing treatment with other therapies (e.g., thrombolytics, acetylsalicylic acid, beta-blockers, and statins). However, combination with ACE inhibitors is not recommended. 4. Renal impairment: No dose adjustment is necessary for patients with a creatinine clearance of 10 mL/min or higher; however, there is no experience with patients with a creatinine clearance below 10 mL/min or dialysis patients, so this medication should not be used. 5. Hepatic impairment: For patients with mild to moderate hepatic impairment, it is preferable not to exceed a daily dose of 80 mg. Care should be taken when increasing doses exceeding 80 mg to weigh the therapeutic benefits against risks. This medication should not be used in cases of severe hepatic impairment, liver cirrhosis, or cholestasis. 6. Pediatric: Safety and efficacy in children and adolescents under 18 years have not been established.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Women who are allergic to this medication or its ingredients, pregnant, or breastfeeding, as well as patients with severe liver or kidney disease, should not take this medication. Elderly patients or those with hyperkalemia, liver dysfunction, or cardiovascular diseases should be particularly cautious when taking this medication, especially since blood pressure can drop rapidly; thus, it is advised to start with a low dose and monitor closely. This medication lowers blood pressure and may cause symptoms such as dizziness or fainting, so caution is advised when driving or operating machinery. Using potassium-sparing diuretics or potassium supplements simultaneously may dangerously increase serum potassium levels, so consultation with a physician is necessary. When taken with other antihypertensive medications or non-steroidal anti-inflammatory drugs, blood pressure-lowering effects may be reduced or kidney function may be affected, necessitating regular check-ups. This medication is not recommended during breastfeeding; if it must be taken, discontinuation of breastfeeding is recommended. Safety and efficacy in children and adolescents have not been established, so use is not advised. In case of overdose, symptoms such as hypotension, decreased consciousness, and shock may occur, requiring immediate medical attention and appropriate treatment. This medication should be kept out of reach of children, and transferring it to another container may adversely affect its quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), angioedema (swelling of the face, lips, throat, or tongue), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions.
  • Severe rash with high fever, blisters, skin peeling, mucous membrane pain in the mouth/eyes, severe skin reactions.
  • Breathing difficulty, asthma attacks, respiratory distress accompanied by cough and fever.
  • Jaundice, severe malaise.
  • Sudden and severe reactions.

Mild side effects

Headache, dizziness, viral infection, upper respiratory tract infection, cough, diarrhea, fatigue, rhinitis, sinusitis, back pain, abdominal pain, nausea, pharyngitis, arthralgia, weakness, insomnia, flushing, decreased libido, drowsiness, atrial fibrillation, vomiting, constipation, dry mouth, loss of appetite, malaise, rash, myalgia, indigestion, anemia, tinnitus, hypertension, reduction in exercise capacity, confusion, chest pain, hypotension in patients undergoing dialysis when given in low doses.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is also important to store it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Oval film-coated tablets with an orange color and gray tint.

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.