Medication info
Medik roten tablet 5/160 mg (Amlodipine Besylate, Valsartan)

Medik roten tablet 5/160 mg (Amlodipine Besylate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Dark yellow oval film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP packaging x 2]
Approval status
Active

MFDS item code 201308479 · Approved 2013.07.30 · Insurance code 646003750

Summary

Main use
Improvement of blood pressure control in essential hypertension through the combination of Amlodipine and Valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning).
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration of this medication is not recommended.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement of blood pressure control in essential hypertension through the combination of Amlodipine and Valsartan

  • Essential hypertension
View approved original text

In the treatment of essential hypertension, when blood pressure control is difficult with monotherapy of either Amlodipine or Valsartan alone, this medication helps in effectively controlling blood pressure by using both drugs together. This contributes to stabilizing blood pressure and reducing the risk of cardiovascular complications.

How to take

Adult dose

The recommended dose of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning).

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, so administration of this medication is not recommended.

Precautions

This medication must be discontinued immediately if pregnancy is confirmed during the second or third trimester, due to the risk of serious harm to the fetus and newborn. Individuals with allergies to the main ingredients of this medication or similar drugs, pregnant or breastfeeding women, and those with severe kidney or liver diseases should not take this medication. Patients with low sodium or fluid levels should improve their condition before taking this medication, and blood pressure and status should be monitored closely during treatment. Patients with high potassium levels should frequently check potassium levels when taking this drug along with potassium supplements or potassium-sparing diuretics. Patients with renal artery stenosis or those who have recently undergone kidney transplant should closely monitor changes in kidney function while on this medication. If symptoms of angioedema such as swelling of the face, lips, or tongue occur during treatment, discontinue the medication immediately and do not take it again. Patients with heart failure or after myocardial infarction should always evaluate kidney function while on this medication, and some heart failure patients may require caution. Specific heart conditions such as acute myocardial infarction or aortic valve stenosis require careful attention while using this medication. This medication may increase the risk of hypotension, hyperkalemia, and worsening kidney function when taken with other angiotensin agents, so it must be administered with caution. Take care when driving or operating machinery, as dizziness or fatigue may occur. In case of overdose, severe hypotension, tachycardia, or shock may occur, necessitating immediate medical treatment. This medication is not recommended for children under 18 years of age, as its safety and efficacy have not been adequately established in this population. Older adults can be administered similar doses as younger adults but should be observed closely.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, breathing difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, altered consciousness, visual disturbances, paralysis,

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • sensory abnormalities
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • fainting
Show 27 more
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngitis and laryngitis
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • weakness
  • frequent urination
  • polyuria
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial edema
  • fatigue
  • flushing
  • asthenia

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

Storage

Store this medication in a tightly sealed container to protect it from air or moisture. Additionally, it is best to store the medication at room temperature between 1 °C and 30 °C.

Appearance and packaging

Appearance

Dark yellow oval film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP packaging x 2]

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.