Medication info
Amoratarnal Tablet 5/80/5 mg

Amoratarnal Tablet 5/80/5 mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.94mg / 1 tabletValsartan›80mg / 1 tabletRosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pale pink oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202108065 · Approved 2021.12.21 · Insurance code 648604390

Summary

Main use
(Hypertension) Blood pressure control and (hyperlipidemia) cholesterol improvement effect
Who takes it
Adults
Adult dose
This medication should be taken once daily as one tablet with water. It is recommended to take it at the same time every day (e.g., before breakfast). For the amlodipine/valsartan combination, the appropriate dosages of 5/80 mg, 5/160 mg, or 10/160 mg should be administered to patients whose blood pressure is not adequately controlled with monotherapy. For rosuvastatin, the initial dose is 5 mg once daily.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

(Hypertension) Blood pressure control and (hyperlipidemia) cholesterol improvement effect

  • Essential hypertension
  • primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • primary dysbetalipoproteinemia
  • hypertension
  • low HDL cholesterol levels
View approved original text

This medication is used in patients requiring simultaneous treatment with an amlodipine/valsartan combination and rosuvastatin. The amlodipine/valsartan combination effectively controls blood pressure when hypertension is not adequately managed with monotherapy. Rosuvastatin aids in the treatment of various types of hyperlipidemia and dyslipidemia that cannot be controlled with diet and exercise, and it delays the progression of atherosclerosis. Additionally, it is used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in patients at high risk for cardiovascular disease. Therefore, this medication is used to manage blood pressure and cholesterol levels and improve cardiovascular health.

How to take

Adult dose

This medication should be taken once daily as one tablet with water. It is recommended to take it at the same time every day (e.g., before breakfast). For the amlodipine/valsartan combination, the appropriate dosages of 5/80 mg, 5/160 mg, or 10/160 mg should be administered to patients whose blood pressure is not adequately controlled with monotherapy. For rosuvastatin, the initial dose is 5 mg once daily.

Precautions

This medication may cause serious harm to the fetus and newborn, especially during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. It should not be used in patients with allergies to this medication’s ingredients or similar drugs, in pregnant or nursing women, or in patients with severe liver or kidney disease. Patients with a deficiency of sodium or fluids may experience hypotension; therefore, their condition should be assessed and monitored carefully before administration. Patients with high potassium levels or those taking other medications that may increase potassium should have their potassium levels checked frequently. Caution is advised in patients with impaired kidney function, kidney transplant recipients, and those with a history of angioedema; treatment should be stopped immediately if symptoms appear. Patients with heart-related diseases, such as heart failure or following myocardial infarction, or those with aortic stenosis should also exercise caution. Dizziness or fatigue may occur during treatment; care should be taken when driving or operating machinery. Additionally, liver function or muscle-related adverse reactions may occur, so regular testing is needed, and any symptoms of muscle pain or weakness should be reported to a healthcare professional immediately. There may be interactions with other medications, so inform your healthcare provider of any other medications being taken, especially when used with certain antibiotics, antifungals, and immunosuppressants. It is recommended to start elderly patients on a lower dose and increase it slowly while closely monitoring their physical condition. Women who are pregnant or nursing should not take this medication; if pregnancy is confirmed during treatment, it should be discontinued immediately and discussed with a healthcare professional. The safety of this medication in children and adolescents has not been established and is not recommended. In cases of overdose, severe hypotension or cardiac function abnormalities may occur, requiring immediate emergency treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning-like headache, seizure, confusion, vision changes, paralysis, urination

Mild side effects

  • Peripheral edema
  • warmth
  • increased ALT
  • increased AST
  • increased blood creatinine
  • flank pain
  • throat pain
  • dizziness
  • sensory loss
  • nasopharyngitis
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  • rash
  • nasopharyngitis
  • influenza
  • anxiety
  • drowsiness
  • orthostatic dizziness
  • headache
  • dizziness
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat 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 may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pale 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.