Medication info
Amlovan Plus Tablet 5/80/10 mg

Amlovan Plus Tablet 5/80/10 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tabletRosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202106219 · Approved 2021.08.27 · Insurance code 651205780

Summary

Main use
(Improvement of hypertension, dyslipidemia) and reduction of cardiovascular disease risk
Who takes it
Adults
Adult dose
This medication is taken once daily, with one tablet alongside water. It is recommended to take it at the same time each day (e.g., before breakfast). The dosing of the amlodipine/valsartan combination and rosuvastatin should be individualized for each patient. Amlodipine/valsartan combination regimen: - 5/80 mg: administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

(Improvement of hypertension, dyslipidemia) and reduction of cardiovascular disease risk

  • Primary hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary artery disease
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication effectively helps control blood pressure in primary hypertension patients who have difficulty regulating their blood pressure with monotherapy, using a combination of amlodipine and valsartan. Additionally, rosuvastatin aids in lowering blood cholesterol levels, assisting dietary management in patients with primary hypercholesterolemia and dyslipidemia, and particularly plays a role in delaying the progression of atherosclerosis. This medication is also used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in patients at high risk for cardiovascular diseases. Therefore, this medication is beneficial in managing both hypertension and dyslipidemia simultaneously to improve cardiovascular health.

How to take

Adult dose

This medication is taken once daily, with one tablet alongside water. It is recommended to take it at the same time each day (e.g., before breakfast). The dosing of the amlodipine/valsartan combination and rosuvastatin should be individualized for each patient. Amlodipine/valsartan combination regimen: - 5/80 mg: administered to patients whose blood pressure is not adequately 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 upon confirmation of pregnancy. Patients with hypersensitivity to any of the ingredients, pregnant or breastfeeding women, patients with severe liver or kidney disease, and those with specific vascular or muscular disorders should not take this medication. Patients with sodium or fluid depletion, high potassium levels, and those with renal vascular issues should exercise caution while taking this medication and require close monitoring by a physician. Patients with a history of heart failure or after a myocardial infarction, acute myocardial infarction patients, aortic stenosis patients, and those with severe myasthenia should be cautious while taking this medication. As this medication lowers blood pressure, if symptoms of hypotension occur during treatment, the patient should lie down immediately and seek appropriate treatment if necessary. While taking this medication, side effects such as muscle pain, muscle weakness, dizziness, headache, digestive issues, and skin rashes may occur, so patients should consult a doctor if any unusual symptoms arise. This medication can interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. Pregnant or breastfeeding women should not take this medication, and women planning to become pregnant should use appropriate contraception. This medication is not recommended for children under 18 years of age, as its safety and efficacy have not been established. Older adults may be more sensitive to this medication; therefore, dosage adjustments and caution are needed during use. Overdose of this medication can lead to severe hypotension, shock, heart problems, etc. Thus, the prescribed dosage must be strictly followed, and if an overdose occurs, patients should go to the hospital immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin shedding, pain in oral/ocular mucosa, Stevens-Johnson syndrome, breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances

Mild side effects

  • Peripheral edema
  • flushing
  • increased ALT
  • increased AST
  • elevated serum creatinine
  • flank pain
  • sore throat
  • dizziness
  • paresthesia
  • rhinopharyngitis
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  • rash
  • nasopharyngitis
  • influenza
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • erythema
  • sweating
  • itching

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, with a storage temperature maintained between 1 degree and 30 degrees Celsius. By storing it this way, the medication's effectiveness can be securely maintained.

Appearance and packaging

Appearance

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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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.