Medication info
Amloduel Tablet 5/20 mg (Amlodipine, Atorvastatin)

Amloduel Tablet 5/20 mg (Amlodipine, Atorvastatin)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.935mg / 1 tabletAtorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
White oval film-coated tablets
Packaging
100 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 201402069 · Approved 2014.04.30 · Insurance code 670606910

Summary

Main use
Reduction of hypertension and cardiovascular risk and improvement of dyslipidemia
Who takes it
Adults
Adult dose
This medication is administered only to adults, and the dosage should be individualized based on the efficacy and tolerability of each component, Amlodipine and Atorvastatin. Amlodipine (S-Amlodipine): Administer orally once daily in doses of 5 (2.5) mg, and it may be increased to a maximum of 10 (5) mg daily based on the patient's response. Adjust as appropriate based on symptoms. Atorvastatin: The recommended initial dose is 1 time daily 1

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Reduction of hypertension and cardiovascular risk and improvement of dyslipidemia

  • Hypertension
  • fixed occlusion of the coronary artery
  • coronary vasospasm
  • vascular constriction
  • myocardial ischemia
  • angina pectoris
  • multiple risk factors for coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
View approved original text

This medication is used for patients who need to take both Amlodipine (S-Amlodipine) and Atorvastatin simultaneously. Amlodipine treats hypertension and angina pectoris, specifically myocardial ischemia due to coronary artery spasm or constriction. It helps reduce the risk of hospitalization due to angina and the risk of coronary artery revascularization. Atorvastatin is effective in lowering the risks of myocardial infarction, stroke, risk after vascular revascularization, hospitalization due to angina, and congestive heart failure. Additionally, it is used as an adjunctive therapy to improve blood lipid levels in patients with hypercholesterolemia and dyslipidemia. This medication helps treat and prevent various risk factors associated with cardiovascular diseases, thereby improving health status.

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, Amlodipine and Atorvastatin. Amlodipine (S-Amlodipine): Administer orally once daily in doses of 5 (2.5) mg, and it may be increased to a maximum of 10 (5) mg daily based on the patient's response. Adjust as appropriate based on symptoms. Atorvastatin: The recommended initial dose is 1 time daily 1

Precautions

This medication should not be used in certain patients. For example, it should not be administered to those with allergies to this medication or similar drugs, severe liver dysfunction, pregnant or breastfeeding women, and patients with muscle disorders. Furthermore, patients with severely impaired kidney function, elderly individuals, alcoholics, and those with a history of liver disease should be particularly cautious when using this medication. Patients at risk for muscle-related diseases should undergo muscle enzyme testing before administration. This medication is used to treat hypertension and hyperlipidemia and is generally well-tolerated, but occasionally side effects such as fatigue, edema, dizziness, headache, indigestion, and myalgia may occur. Rarely, symptoms such as skin rash or liver dysfunction can arise, so patients should notify healthcare professionals immediately if any abnormal symptoms occur. Pregnant women should avoid this medication due to potential risks to the fetus and must ensure contraceptive measures are taken; if pregnancy is confirmed, administration should be stopped immediately. Nursing mothers are also advised to refrain from nursing while taking this medication. This medication may interact with other drugs, so if you are taking any other medications, it is essential to inform your healthcare provider, especially if using drugs that affect liver metabolism or muscle function. In case of overdose, severe hypotension, shock, or cardiac problems may occur, necessitating immediate emergency treatment; this medication is not removed by hemodialysis, so specific treatment may be required. The safety for children and the elderly has not been adequately verified, thus caution is required during use, and it should be stored out of reach of children, avoiding transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), toxic epidermal necrolysis, severe allergic reactions, severe rash accompanied by fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues associated with cough and fever, jaundice, systemic lethargy, liver abnormalities (jaundice), sudden severe headache, thunderclap headache

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 rigidity
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • syncope
  • dysgeusia
  • tremor
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • 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 exposure to air and moisture. It is also important to store it away from direct sunlight in a cool place, between 15 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablets

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.

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.