Medication info

Rosuvastatin and Valsartan Film-Coated Tablets 10/160 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tabletValsartan›160mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202003913 · Approved 2020.05.27 · Insurance code 649104900

Summary

Main use
(Hypertension, Heart Failure) improvement and (Hypercholesterolemia) treatment
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, Valsartan/Rosuvastatin, for each patient. ◆ Valsartan 1. Essential Hypertension - Take it with water during or between meals, and preferably at the same time every day (e.g., in the morning). - Adults: The recommended dose is 80 mg orally once daily. - If blood pressure is not well controlled, the dose can be increased to 160 mg once daily.
Child dose
Safety and efficacy have not been established in pediatric patients and adolescents under 18, thus it is not provided.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

(Hypertension, Heart Failure) improvement and (Hypercholesterolemia) treatment

  • Essential hypertension
  • heart failure
  • left ventricular dysfunction
  • left ventricular systolic dysfunction
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed type hyperlipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • hypercholesterolemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
View approved original text

This medication is used for patients who need to take both Valsartan and Rosuvastatin. Valsartan is effective for patients with essential hypertension and heart failure who do not respond to ACE inhibitors, and it helps reduce the risk of mortality following myocardial infarction. Rosuvastatin is used for patients with hypercholesterolemia and various types of dyslipidemia, reducing the risk of cardiovascular disease and slowing the progression of atherosclerosis. By combining these two medications, they help control blood pressure and cholesterol simultaneously, improving the patient's cardiovascular health.

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, Valsartan/Rosuvastatin, for each patient. ◆ Valsartan 1. Essential Hypertension - Take it with water during or between meals, and preferably at the same time every day (e.g., in the morning). - Adults: The recommended dose is 80 mg orally once daily. - If blood pressure is not well controlled, the dose can be increased to 160 mg once daily.

Child dose

Safety and efficacy have not been established in pediatric patients and adolescents under 18, thus it is not provided.

Precautions

This medication can cause serious harm to the fetus when taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. It should not be taken if there is an allergy to any components of this medication or to the medication itself. Women who are pregnant or may become pregnant, as well as breastfeeding women should not take this medication, and women of childbearing age should use appropriate contraceptive methods. Patients with severely impaired liver function or specific liver diseases, patients with severely decreased kidney function, and patients with muscle disorders should not take this medication. Elderly patients, patients with high potassium levels, patients with slightly impaired liver function, and patients with heart disease should take special caution when using this medication. This medication may cause muscle-related side effects such as myalgia, muscle weakness, and rarely rhabdomyolysis, so if muscle pain or weakness, accompanied by fever occurs, immediate consultation with a doctor is recommended. Liver function abnormalities may occur, so it is advised to conduct liver function tests before and during treatment with this medication. This medication lowers blood pressure and may cause symptoms of hypotension (dizziness, fainting) at initiation of treatment, and if such symptoms occur, immediate notification to healthcare professionals is required. Drug interactions may occur when taken with specific medications, so current medications must be disclosed to healthcare professionals. This medication has not been proven safe and effective in children and adolescents (under 18 years old). In case of overdose, as there is no specific antidote, immediate medical attention is required for proper treatment, and hypotension or decreased consciousness may occur. During storage, keep it away from children's reach and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, chest tightness, dyspnea, cold sweat, pallor, severe rash with high fever, blistering, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty with breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output.

Mild side effects

Dyspepsia, nausea, dizziness, headache, conjunctival hemorrhage, constipation, asthenia, nasopharyngitis, urinary tract infection, contusion, increased serum hepatic transaminases (AST, ALT), increased serum creatine phosphokinase, increased serum potassium, elevated gamma-glutamyl transferase, musculoskeletal stiffness, limb pain, sensory loss, anxiety, upper respiratory tract infection, oral bleeding, vomiting, headache, dizziness, constipation, abdominal pain, itching,

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 allow light to enter. Additionally, it is important to store it at room temperature between 1°C to 30°C to maintain its efficacy.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.

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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.