Medication info

Amrovan Plus Tablet 5/160/5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›160mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pale yellow-pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202106220 · Approved 2021.08.27

Summary

Main use
Improvement of hypertension and dyslipidemia, reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This medication should be taken once daily, 1 tablet at a time, with water. It is recommended that it be taken at the same time each day (e.g., before breakfast) whenever possible. The doses of amlodipine/valsartan combination and rosuvastatin should be individualized based on effectiveness and tolerability. Examples of amlodipine/valsartan combination dosing: - 5/80 mg: for patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of hypertension and dyslipidemia, reduction of cardiovascular disease risk

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • complex dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • risk factors for coronary heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is used to control blood pressure in patients with essential hypertension using a combination of amlodipine and valsartan, and to improve hypercholesterolemia and dyslipidemia with the addition of rosuvastatin. Amlodipine and valsartan are effective for hypertensive patients whose blood pressure is not adequately controlled. Rosuvastatin helps to lower lipid levels in patients with hypercholesterolemia and familial hypercholesterolemia that are not managed by diet. Furthermore, rosuvastatin delays the progression of atherosclerosis, reduces the risk of cardiovascular diseases, and decreases the likelihood of stroke and myocardial infarction. This medication is used to improve cardiovascular health and to reduce overall cardiovascular risk by controlling both blood pressure and lipid levels.

How to take

Adult dose

This medication should be taken once daily, 1 tablet at a time, with water. It is recommended that it be taken at the same time each day (e.g., before breakfast) whenever possible. The doses of amlodipine/valsartan combination and rosuvastatin should be individualized based on effectiveness and tolerability. Examples of amlodipine/valsartan combination dosing: - 5/80 mg: for patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnant. People with allergies to any ingredients in this medication or similar medications, as well as pregnant or nursing women, and patients with severe liver or kidney impairment should not use this medication. Patients with low sodium or fluid levels in the body should improve their condition before taking this medication, and if symptoms of low blood pressure occur during treatment, they should lie down immediately and seek medical attention if necessary. Patients with high potassium levels or who are taking medications that may increase potassium levels should frequently monitor their potassium levels and exercise caution. Patients with issues in kidney blood vessels or those who have received a kidney transplant, as well as those with a history of angioedema, require special observation when using this medication. Patients who have experienced heart failure or myocardial infarction should carefully monitor their condition, including kidney function, while on this medication. Acute myocardial infarction patients should be cautious as symptoms may worsen with this medication. Some ingredients in this medication can cause muscle-related side effects, such as myalgia or myopathy, and rarely rhabdomyolysis, so any abnormal muscle symptoms should be reported to healthcare providers immediately. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. This medication may affect liver and kidney functions, so regular liver and kidney function tests are recommended. There may be interactions with other medications, so if any other medications are being taken, it is essential to inform healthcare providers, especially when taken with specific antifungal agents, antibiotics, immunosuppressants, or fibrates. This medication should not be used during pregnancy or while nursing, and women planning to become pregnant should use appropriate contraception. Safety and efficacy have not been established in children under 18 years of age, so it is not recommended. Elderly patients may be more sensitive to the medication, so it is advised to start at a lower dose and monitor their condition during administration. Overdose can lead to severe hypotension or shock, so immediate hospital attention is required for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities associated with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, mental confusion, visual disturbances, paralysis, urinary changes.

Mild side effects

  • Peripheral edema
  • warmth sensation
  • flank pain
  • sore throat
  • dizziness
  • numbness
  • nasopharyngitis
  • rash
  • rhinitis
  • influenza
Show 26 more
  • visual disturbances
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • sensory abnormalities
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • orthostatic hypotension
  • hypotension
  • cough
  • oropharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • erythema
  • sweating
  • itching
  • joint swelling
  • low back pain
  • arthritis
  • muscle cramps
  • weakness

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

Storage

This medication should be stored in a tightly sealed container as it may be sensitive to air or moisture. Additionally, it should be kept at room temperature between 1 to 30 degrees Celsius, avoiding extremely hot or cold environments.

Appearance and packaging

Appearance

Pale yellow-pink oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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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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.