Medication info
Rivaroxaban 2/80 mg Tablets

Rivaroxaban 2/80 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Pitavastatin Calcium Hydrate›2mg / 1 tabletValsartan›80mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (6 tablets/PTP x 5)
Approval status
Active

MFDS item code 201500967 · Approved 2015.02.25 · Insurance code 644913910

Summary

Main use
Treatment of hypercholesterolemia (dyslipidemia) and hypertension
Who takes it
Adults · Children
Adult dose
This medication is given to adults only, and the dosage is individualized based on the patient's response and tolerance. Administer once daily after breakfast. Pitavastatin Calcium: Initially, take 1–2 mg once daily, and may increase up to a maximum of 4 mg. Valsartan: 1) Essential Hypertension: A recommended oral dose of 80 mg once daily, which can be increased up to 320 mg if necessary. 2) Heart Failure
Child dose
Safety and efficacy have not been established in children and adolescents under 18 years; therefore, it is not administered.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Treatment of hypercholesterolemia (dyslipidemia) and hypertension

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • LDL cholesterol
  • apolipoprotein B
  • triglycerides
  • essential hypertension
  • heart failure
  • left ventricular dysfunction
  • left ventricular systolic dysfunction
View approved original text

This medication is only used for patients who require the combined administration of pitavastatin calcium and valsartan. Pitavastatin calcium helps to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels, and increase HDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, in conjunction with dietary therapy. Valsartan is used for the treatment of essential hypertension, and is effective in patients with heart failure who are intolerant to ACE inhibitors. Additionally, it reduces the risk of death after myocardial infarction in stable patients with heart left ventricle dysfunction. Therefore, this medication is used to improve the management of cardiovascular diseases such as hypertension, heart failure, and dyslipidemia.

How to take

Adult dose

This medication is given to adults only, and the dosage is individualized based on the patient's response and tolerance. Administer once daily after breakfast. Pitavastatin Calcium: Initially, take 1–2 mg once daily, and may increase up to a maximum of 4 mg. Valsartan: 1) Essential Hypertension: A recommended oral dose of 80 mg once daily, which can be increased up to 320 mg if necessary. 2) Heart Failure

Child dose

Safety and efficacy have not been established in children and adolescents under 18 years; therefore, it is not administered.

Precautions

This medication can cause serious harm to the fetus and newborn especially during pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used by individuals allergic to this drug or its components, pregnant or breastfeeding women, patients with severe liver impairment or liver disease, patients with a history of hereditary angioedema, or patients with severe kidney impairment. Elderly patients, patients with high potassium levels, liver impairment, heart disease, or kidney impairment should use this medication with special caution. This medication may cause muscle-related adverse reactions such as myalgia and muscle weakness, as well as liver dysfunction, blood abnormalities, and allergic reactions; therefore, if symptoms appear, consult a physician immediately. Since this medication lowers blood pressure, hypotension may occur, and there is also a risk of dizziness or fainting, so caution is needed when driving or operating machinery. Interactions may occur when this medication is combined with others, so it is essential to inform the healthcare provider of any medications being taken. Pregnant or breastfeeding women are advised not to take this medication, but if it is necessary, they should consult a specialist for a cautious decision. The safety and effectiveness in pediatric patients have not been established; therefore, it is generally recommended not to use it in this population. In cases of an overdose, severe hypotension, altered consciousness, shock, etc., emergency care should be sought immediately. This medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema (swelling of the face, lips, pharynx, tongue), liver dysfunction, jaundice, hyperkalemia, hepatitis, renal failure, rhabdomyolysis, thrombocytopenia, shock, fainting, loss of consciousness, angioedema, heart failure, hypotension, elevated creatinine levels, BUN elevation, vasculitis, agranulocytosis, leukopenia, bullous dermatitis, intestinal angioedema, severe neurological symptoms (severe headache, seizures, confusion, visual disturbances, paralysis)

Mild side effects

  • Headache
  • dyspepsia
  • nausea
  • chest discomfort
  • increased sweating
  • dizziness
  • skin tingling
  • drowsiness
  • insomnia
  • heavy feeling in the head
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  • paresthesia
  • lethargy
  • abdominal pain
  • bloating
  • constipation
  • stomatitis
  • vomiting
  • loss of appetite
  • glossitis
  • gastrointestinal discomfort
  • diarrhea
  • thrombocytopenia
  • granulocytopenia
  • leukopenia
  • eosinophilia
  • leukocytosis
  • globulin elevation
  • positive Coombs test
  • anemia
  • increased urine
  • decreased aldosterone
  • increased aldosterone
  • adrenocortical disorders

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

Storage

This medication must be stored in a tightly sealed container that prevents light exposure, and it is safe to store between temperatures of 1 to 30 degrees Celsius at room temperature. Therefore, it is important to avoid direct sunlight and not to place it in excessively hot or cold locations.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.