Medication info
Rivaroxaban High Tablet 4/80/5 mg (Pitavastatin Calcium Hydrate, Valsartan, Amlodipine Besylate)

Rivaroxaban High Tablet 4/80/5 mg (Pitavastatin Calcium Hydrate, Valsartan, Amlodipine Besylate)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tabletPitavastatin Calcium Hydrate›4.409mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Dark pink round film-coated tablets
Packaging
30 tablets/PVC [6 tablets/PVC x 5]
Approval status
Active

MFDS item code 202502535 · Approved 2025.09.24 · Insurance code 644915450

Summary

Main use
(Hypertension, Dyslipidemia) Effects on blood pressure control and cholesterol improvement
Who takes it
Adults
Adult dose
This medication is taken once daily with water. It is recommended to take it at the same time each day, if possible (e.g., before breakfast). Amlodipine/Valsartan combination: - 5/80 milligrams: Administered to patients whose blood pressure is not adequately controlled by either amlodipine 5 milligrams or valsartan 80 milligrams alone. - 5/160 milligrams: Administered to patients whose blood pressure is not adequately controlled by either amlodipine 5 milligrams or valsartan 160 milligrams alone.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

(Hypertension, Dyslipidemia) Effects on blood pressure control and cholesterol improvement

  • Essential hypertension
  • primary hypercholesterolemia
  • dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo-B protein
  • elevated triglyceride levels
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled by taking amlodipine and valsartan together, and who also need to take pitavastatin. Amlodipine and valsartan help lower blood pressure, while pitavastatin is effective in controlling cholesterol levels by improving hypercholesterolemia and dyslipidemia. This medication is used to improve cardiovascular health by managing blood pressure and blood lipids simultaneously.

How to take

Adult dose

This medication is taken once daily with water. It is recommended to take it at the same time each day, if possible (e.g., before breakfast). Amlodipine/Valsartan combination: - 5/80 milligrams: Administered to patients whose blood pressure is not adequately controlled by either amlodipine 5 milligrams or valsartan 80 milligrams alone. - 5/160 milligrams: Administered to patients whose blood pressure is not adequately controlled by either amlodipine 5 milligrams or valsartan 160 milligrams alone.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so women who are pregnant or may become pregnant should not use this medication. Additionally, individuals who are allergic to any of the components or similar medications, those with severe liver impairment, severe kidney impairment, or active liver disease should avoid taking this medication. Patients with sodium or fluid deficiency should stabilize their condition before starting this medication and monitor blood pressure and symptoms closely during treatment. If there is hyperkalemia or if other medications that can elevate potassium levels are being taken, potassium levels should be checked frequently. Patients with compromised kidney function or renal artery stenosis require careful monitoring due to the risk of worsening kidney function. Patients with heart failure or after a myocardial infarction should closely monitor changes in kidney function and blood pressure when taking this medication, especially if heart failure is severe. This medication can lower blood pressure, so caution is needed in patients with hypotension or severe aortic stenosis. Some components of this medication are metabolized in the liver, so patients with reduced liver function may require dose adjustments and should undergo regular liver function tests. Muscle pain, weakness, or in severe cases muscle damage known as rhabdomyolysis may occur, so if these symptoms appear, patients should consult with a doctor immediately. During the use of this medication, side effects such as headache, dizziness, edema, and dyspepsia may occur, so if symptoms are severe or persistent, patients should inform healthcare providers. Caution is necessary when driving or operating machinery as dizziness or fatigue may occur. This medication may interact with other drugs, so it is important to inform healthcare providers about any other medications being taken. Women who are pregnant or breastfeeding should not take this medication, and if pregnancy is confirmed while taking it, treatment should be stopped immediately. Elderly patients may be more sensitive to this medication, so starting with a lower dose and careful monitoring of their condition is advised. In case of an overdose, severe blood pressure drop or shock may occur, so adherence to the prescribed dosage is crucial, and immediate emergency treatment is needed if unusual symptoms arise. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or deterioration in quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, vesicular dermatitis, skin peeling, mouth/eye mucosal pain, severe skin adverse reactions, shortness of breath or breathing difficulties, asthma attack, respiratory issues accompanied by cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver failure, etc.

Mild side effects

  • Headache
  • itching
  • abdominal pain
  • fatigue
  • numbness
  • alopecia
  • purpura
  • skin discoloration
  • phototoxic reactions
  • myalgia
Show 28 more
  • urinary disorders
  • nocturia
  • insomnia
  • emotional changes
  • tremors
  • sensory loss
  • taste abnormalities
  • arrhythmia
  • bradycardia
  • atrial fibrillation
  • ventricular tachycardia
  • myocardial infarction
  • vasculitis
  • rhinitis
  • vomiting
  • dyspepsia
  • pancreatitis
  • gastritis
  • gingival hyperplasia
  • palpitations
  • skin pain
  • burning sensation
  • arthralgia
  • edema
  • blurred vision
  • photopsia
  • hearing loss
  • etc.

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

Storage

This medication should be stored at room temperature between 1 and 30 degrees Celsius, and it is important to keep it in a well-closed container to prevent air exposure. This helps to maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Dark pink round film-coated tablets

Package unit

30 tablets/PVC [6 tablets/PVC x 5]

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.