Medication info
Rivaroxaban 2/160 mg

Rivaroxaban 2/160 mg

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›2mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Pink rectangular film-coated tablet
Packaging
30 tablets (6 tablets/PTP x 5)
Approval status
Active

MFDS item code 201500966 · Approved 2015.02.25 · Insurance code 644913920

Summary

Main use
Improvement of hypercholesterolemia and hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered only to adults, and the dosage should be individualized based on the efficacy and tolerability of each component, pitavastatin calcium and valsartan. For pitavastatin calcium, take 1-2 mg once daily, and if necessary, the dosage can be increased to a maximum of 4 mg per day. For valsartan, during the treatment of essential hypertension, take 80 mg orally once daily. If blood pressure control is insufficient, the dosage can be increased to a maximum of 320 mg per day if additional blood pressure reduction is needed.
Child dose
Safety and efficacy have not been established for children and adolescents under 18 years of age, and therefore are not administered.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and hypertension

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated apo-B protein
  • elevated triglycerides
  • essential hypertension
  • heart failure
  • intolerance to heart failure
  • left ventricular failure
View approved original text

This medication is used for patients who require concurrent administration of two drugs, pitavastatin calcium and valsartan. Pitavastatin calcium primarily lowers total cholesterol, bad cholesterol (LDL), apo-B protein, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing good cholesterol (HDL) to assist with dietary therapy. Valsartan is used for the treatment of essential hypertension and is also effective in patients with heart failure and those intolerant to ACE inhibitors (NYHA class II-IV). Additionally, it helps reduce the risk of mortality in patients with impaired left ventricular function after myocardial infarction. Therefore, this medication is used to improve the treatment of patients with hypertension, heart failure, and concomitant dyslipidemia.

How to take

Adult dose

This medication is administered only to adults, and the dosage should be individualized based on the efficacy and tolerability of each component, pitavastatin calcium and valsartan. For pitavastatin calcium, take 1-2 mg once daily, and if necessary, the dosage can be increased to a maximum of 4 mg per day. For valsartan, during the treatment of essential hypertension, take 80 mg orally once daily. If blood pressure control is insufficient, the dosage can be increased to a maximum of 320 mg per day if additional blood pressure reduction is needed.

Child dose

Safety and efficacy have not been established for children and adolescents under 18 years of age, and therefore are not administered.

Precautions

This medication should not be used by pregnant women or women who may become pregnant. Taking this medication during pregnancy can cause serious harm to the fetus, so it should be discontinued immediately upon confirmation of pregnancy. Also, nursing mothers are advised not to take this medication, and if it is necessary to take it, breastfeeding should be discontinued. Patients with allergies to this medication, severe impairment of liver or kidney function, or certain genetic diseases should not use it. Elderly patients or those with compromised liver function should be particularly cautious when using this medication, and dosage should be adjusted if necessary. Blood pressure may drop sharply, so start with a low dose when first taking it, and closely monitor the patient's condition. If symptoms such as muscle pain, weakness, or darkening of urine occur, consult a doctor immediately and discontinue the medication if they occur. Regular liver function and blood tests are important as liver function abnormalities or abnormal blood test values may occur. When taking this medication with others, interactions may occur, so it is essential to inform your doctor or pharmacist of any other medications currently being taken, especially when combined with diuretics, potassium supplements, certain antibiotics, and immunosuppressants. This medication has not been established as safe for children and should not be used. In case of overdose, symptoms such as hypotension, decreased consciousness, and shock can occur, so immediate medical treatment should be sought. This medication should be stored out of the reach of children, and it is safe not to transfer the medication to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, shedding of skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue throughout the body, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dyspepsia
  • nausea
  • elevated serum AST
  • chest discomfort
  • increased sweating
  • dizziness
  • malaise
  • itching
  • rash
Show 26 more
  • thrombocytopenia
  • stiffness
  • drowsiness
  • insomnia
  • heaviness in the head
  • paralysis
  • thirst
  • abdominal pain
  • abdominal bloating
  • constipation
  • stomatitis
  • vomiting
  • decreased appetite
  • glossitis
  • gastric discomfort
  • diarrhea
  • thrombocytopenia
  • granulocytopenia
  • leukopenia
  • eosinophilia
  • leukocytosis
  • elevated globulin
  • anemia
  • increased frequency of urination
  • elevated BUN
  • elevated serum creatinine

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not let light in. It is also recommended to store the medication at a normal room temperature between 1 to 30 degrees Celsius, not in excessively hot or cold places.

Appearance and packaging

Appearance

Pink rectangular film-coated tablet

Package unit

30 tablets (6 tablets/PTP 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

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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.