Medication info
Amloduret Tablet 10/20mg

Amloduret Tablet 10/20mg

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.87mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Blue oval film-coated tablet
Packaging
100 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 201402067 · Approved 2014.04.30

Summary

Main use
(Hypertension, Angina) Improvement of myocardial ischemia and reduction of the risk of myocardial infarction and stroke in cardiovascular risk factors
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosage should be individualized for each patient based on the effectiveness and tolerability of amlodipine/atorvastatin. Amlodipine (Es-Amlodipine): Administer orally once daily at 5 (2.5) mg, which may be increased to a maximum of 10 (5) mg daily depending on the patient's response. Adjust dosage appropriately according to symptoms. Atorvastatin: - Primary hypercholesterolemia and mixed dyslipidemia patients (Fredrickson Types IIa and IIb)

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

(Hypertension, Angina) Improvement of myocardial ischemia and reduction of the risk of myocardial infarction and stroke in cardiovascular risk factors

  • Hypertension
  • myocardial ischemia due to stable angina
  • variant angina
  • multiple risk factors for coronary artery disease
  • myocardial infarction and stroke in patients with type 2 diabetes
  • revascularization
  • chronic stable angina
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
  • primary hypercholesterolemia
  • mixed dyslipidemia
View approved original text

This medication is used for patients who need to take two drugs, amlodipine and atorvastatin, together. Amlodipine treats hypertension and myocardial ischemia caused by coronary artery disease, such as stable and variant angina, and reduces the risk of hospitalization and coronary revascularization due to angina. Atorvastatin reduces the risk of myocardial infarction, stroke, revascularization, and angina, and also lowers the risk of hospitalization due to congestive heart failure. Additionally, it improves blood lipid levels in patients with hypercholesterolemia and dyslipidemia and is used as an adjunct in the treatment of various types of dyslipidemia. This medication is effective in reducing the risk of cardiovascular disease and improving vascular health.

How to take

Adult dose

This medication is administered only to adults, and the dosage should be individualized for each patient based on the effectiveness and tolerability of amlodipine/atorvastatin. Amlodipine (Es-Amlodipine): Administer orally once daily at 5 (2.5) mg, which may be increased to a maximum of 10 (5) mg daily depending on the patient's response. Adjust dosage appropriately according to symptoms. Atorvastatin: - Primary hypercholesterolemia and mixed dyslipidemia patients (Fredrickson Types IIa and IIb)

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this drug or similar medications, those with severe liver dysfunction, pregnant or breastfeeding women, patients with muscle disease, severe aortic stenosis, patients in shock, patients within one month post-myocardial infarction, patients with unstable angina, and those taking certain hepatitis treatments should not take this medication. Additionally, patients with severely impaired kidney function, the elderly, alcoholics, those with a history of liver disease, and patients at high risk for muscle damage should use this drug cautiously. In such cases, muscle damage indicators should be examined before starting treatment, and the patient's condition should be closely monitored during administration. This medication is generally well-tolerated, but symptoms such as flushing, fatigue, edema, palpitations, dizziness, headache, nausea, weakness, lethargy, pain, weight gain/loss, hypotension, vasculitis, muscle tension, sensory loss/abnormal sensations, peripheral neuropathy, fainting, altered taste, tremors, extrapyramidal disorders, erectile dysfunction, gynecomastia, changes in bowel habits, dry mouth, indigestion, gingival hypertrophy, gum hyperplasia, pancreatitis, vomiting, high blood sugar, joint pain, low back pain, and muscle cramps may occur. Rarely, muscle pain, liver function abnormalities, allergic reactions, skin rashes, and blood abnormalities have been reported, so if these symptoms occur, consult a doctor immediately. Regular liver function tests should be conducted if there are any liver function abnormalities or signs of hepatitis, and if liver function worsens, the use of this medication should be discontinued. Additionally, if symptoms such as muscle pain or weakness occur, they should be reported immediately, as severe cases may require discontinuation of the medication. This medication can interact with other drugs, so caution is necessary, especially when taken with certain antibiotics, antifungals, immunosuppressants, some antivirals, and grapefruit juice. If there are co-administered drugs, medical personnel must be informed, and dosage adjustments or monitoring may be necessary. Women who are pregnant or may become pregnant should not take this medication, and if pregnancy is confirmed during use, it should be stopped immediately and a doctor should be consulted. Breastfeeding women should also not take this medication, and breastfeeding should be stopped if taking this medication. Safety for children and the elderly has not been adequately established, so use with caution is necessary. In case of overdose, serious symptoms such as low blood pressure, heart rhythm disturbances, and shock may occur, so immediate emergency treatment is required, and medical personnel should closely monitor cardiovascular function and provide appropriate 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 mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with coughing and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and urination.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • muscle tension
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • fainting
  • altered taste
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • indigestion
  • gingival hypertrophy
  • gum hyperplasia
  • pancreatitis
  • vomiting
  • high blood sugar
  • joint pain
  • low back pain
  • muscle cramps

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is advisable to keep the storage temperature between 15 to 30 degrees Celsius.

Appearance and packaging

Appearance

Blue oval film-coated tablet

Package unit

100 tablets/bottle, 30 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.

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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.