Medication info
Amlodipine/Valsartan Tablet 5/160 mg

Amlodipine/Valsartan Tablet 5/160 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.935mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Dark yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201308304 · Approved 2013.07.19 · Insurance code 648507000

Summary

Main use
Improvement of essential hypertension control through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose of this drug is 1 tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). Dosage adjustment is not necessary for patients with mild to moderate renal impairment, but patients with severe renal impairment or those on dialysis should not take this medication. Patients with liver impairment should not exceed a daily dose of 80 mg of valsartan, and this drug should not be given to patients with severe liver impairment.
Child dose
The safety and efficacy for pediatric patients under 18 years have not been established, so the use of this drug is not recommended.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of essential hypertension control through the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of amlodipine or valsartan. It helps in stably controlling blood pressure in difficult cases.

How to take

Adult dose

The recommended dose of this drug is 1 tablet once daily, to be taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). Dosage adjustment is not necessary for patients with mild to moderate renal impairment, but patients with severe renal impairment or those on dialysis should not take this medication. Patients with liver impairment should not exceed a daily dose of 80 mg of valsartan, and this drug should not be given to patients with severe liver impairment.

Child dose

The safety and efficacy for pediatric patients under 18 years have not been established, so the use of this drug is not recommended.

Precautions

This drug can severely damage the fetus and newborn when taken during the second and third trimester of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. People who are allergic to the main ingredients of this drug or similar medications, pregnant or breastfeeding women, patients with severe kidney or liver dysfunction, and patients with certain heart diseases should not take this medication. Patients with low sodium or body fluids need to correct their condition before taking this drug and should carefully monitor their blood pressure and physical condition during use. Patients with high potassium levels or those taking medications that contain a lot of potassium should frequently check their potassium levels. Patients with renal vascular problems or those who've undergone kidney transplant should be cautious as this medication can affect kidney function. If symptoms of angioedema such as facial swelling, lip swelling, or tongue swelling appear while taking this medication, treatment must be stopped immediately, and it should not be taken again. Patients with heart failure or those who have had a myocardial infarction should take this medication while periodically evaluating changes in renal function, and acute myocardial infarction patients should be cautious about the possibility of worsening symptoms. Dose adjustments are needed for patients with liver dysfunction, and it is preferable not to use this medication for patients with liver or bile duct problems. Dizziness or fatigue may occur while driving or operating machinery, so caution is required. This medication may interact with other antihypertensive drugs or specific medications, so patients must notify their doctor or pharmacist if they are taking other medications. Women who are pregnant or planning to become pregnant should not use this medication, and breastfeeding women are also advised to avoid it. Safety and efficacy have not been fully established for pediatric patients under 18 years old, so it is not recommended for this age group. In case of overdose, severe hypotension or cardiac arrhythmias may occur, so if symptoms arise, medical attention should be sought immediately. While taking this medication, regular checks for blood pressure, kidney function, and electrolyte levels should be conducted, and immediate consultation with a doctor is required if any abnormal symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, vasculitis, syncope, hypotension, increased liver function tests (including serum bilirubin), hepatitis, jaundice, Stevens-Johnson syndrome, intestinal vascular edema, renal failure and kidney damage, elevated serum creatinine, acute renal failure, changes in kidney function, worsening heart failure, pulmonary edema, myocardial infarction, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), severe neurological symptoms

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
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  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • frequency of urination
  • polyuria
  • erectile dysfunction
  • edema
  • angioedema
  • facial swelling

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is also recommended to store the medication in a room temperature between 1°C to 30°C, away from extreme heat or cold.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.