Medication info

Rocab 60/10 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Fimasartan Potassium Trihydrate Granules›150mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
Orange, convex, octagonal film-coated tablets
Packaging
30 tablets (10 tablets/PTP package X 3), 100 tablets (10 tablets/PTP package X 10)
Approval status
Active

MFDS item code 201700491 · Approved 2017.01.25

Summary

Main use
Treatment of hypertension and hypercholesterolemia (reducing the risk of atherosclerosis)
Who takes it
Adults
Adult dose
Pimasartan: Take 30-60 mg once daily regardless of meals; if blood pressure is not adequately controlled, the dose may be increased to 120 mg once daily. Rosuvastatin: The initial dose is 5 mg once daily, and may be maintained at 10 mg once daily if necessary. Dosage adjustments should be made at intervals of at least 4 weeks, and not exceeding a maximum of 20 mg once daily.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Treatment of hypertension and hypercholesterolemia (reducing the risk of atherosclerosis)

  • Essential hypertension
  • primary hypercholesterolemia
  • familial hypercholesterolemia (heterozygous)
  • combined hyperlipidemia
  • familial hypercholesterolemia (homozygous)
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is used for patients who need to take both Pimasartan and Rosuvastatin simultaneously. Pimasartan is primarily used to treat essential hypertension and helps control blood pressure. Rosuvastatin is mainly used to improve hypercholesterolemia and various types of dyslipidemia, and is used as an adjunct if dietary changes and exercise are insufficient. It also helps reduce the risk of cardiovascular diseases, thereby lowering the risk of stroke, myocardial infarction, and arterial revascularization. This medication is effectively used to improve the health of patients with both hypertension and dyslipidemia.

How to take

Adult dose

Pimasartan: Take 30-60 mg once daily regardless of meals; if blood pressure is not adequately controlled, the dose may be increased to 120 mg once daily. Rosuvastatin: The initial dose is 5 mg once daily, and may be maintained at 10 mg once daily if necessary. Dosage adjustments should be made at intervals of at least 4 weeks, and not exceeding a maximum of 20 mg once daily.

Precautions

This medication may cause serious harm to the fetus and newborn if taken during pregnancy, especially during the second and third trimesters, so it should be stopped immediately upon confirmation of pregnancy. It is contraindicated for women who are allergic to this medication, pregnant or breastfeeding women, patients with severe liver disease, and patients with significantly impaired kidney function. Patients with very low blood pressure, weak kidney function, specific heart conditions, or muscle disease should use this medication with caution and be closely monitored. Since this medication can affect the liver and muscles, any symptoms of muscle pain, muscle weakness, or abnormal liver function during treatment should be reported to medical personnel immediately. As this is an antihypertensive medication, low blood pressure symptoms may occur shortly after starting treatment, particularly in patients who are dehydrated or taking diuretics. This medication may interact with other drugs, so anyone taking other medications should inform their healthcare provider, particularly in the case of potassium-sparing diuretics or certain antibiotics and antifungals. Regular monitoring of liver function, serum potassium levels, and muscle enzyme levels is recommended during treatment. Women of childbearing potential should use appropriate contraception while taking this medication and should not take it if planning to become pregnant or during pregnancy. Elderly patients may react sensitively to this medication, thus careful dosage adjustment and monitoring of their condition are necessary. The safety and efficacy of this medication have not been established for children and adolescents under 18 years of age. Dizziness or drowsiness may occur after taking this medication, so caution should be exercised when driving or operating dangerous machinery. When storing this medication, keep it out of reach of children, and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), difficulty breathing, severe allergic reactions, hepatitis, jaundice, acute hepatitis, acute liver failure, serious neurological symptoms, severe muscle weakness, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), acute renal failure, thrombocytopenia, death, acute pancreatitis, intestinal obstruction, hemorrhagic duodenal ulcer, hemorrhoids, abdominal pain, intracranial hemorrhage, transient ischemic attack, atherosclerosis

Mild side effects

  • Headache
  • dizziness
  • dyspepsia
  • nausea
  • fever
  • muscle pain
  • itching
  • localized hives
  • upper abdominal pain
  • esophagitis
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  • gastritis
  • nasopharyngitis
  • tonsillitis
  • upper respiratory infection
  • ALT elevation
  • γ-GTP elevation
  • liver enzyme elevation
  • increased white blood cell count
  • urinary disturbances
  • increased urination
  • cough
  • weakness
  • decrease in platelet count
  • muscle cramps
  • musculoskeletal stiffness
  • flushing
  • redness
  • erectile dysfunction
  • constipation
  • vomiting
  • thrombocytopenia
  • diarrhea

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature to maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

Orange, convex, octagonal film-coated tablets

Package unit

30 tablets (10 tablets/PTP package X 3), 100 tablets (10 tablets/PTP package X 10)

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.