Medication info
Amotenion 5 mg (Amlodipine Besylate)

Amotenion 5 mg (Amlodipine Besylate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
부광약품(주)
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201403176 · Approved 2014.07.16 · Insurance code 642203460

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of hospitalization risk from angina and the risk associated with revascularization procedures.
Who takes it
Adults
Adult dose
Administer orally 5 mg once daily as amlodipine, and may increase to a maximum of 10 mg daily based on patient response. Adjust according to age and symptoms.

Ingredients

Manufacturer
부광약품(주)

Efficacy & effects

Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of hospitalization risk from angina and the risk associated with revascularization procedures.

  • Hypertension
  • fixed coronary stenosis
  • vascular spasms of the coronary vessels
  • vasoconstriction
  • myocardial ischemia
View approved original text

This medication is used for myocardial ischemia caused by hypertension, stable angina, and variant angina due to vascular spasms. Additionally, it helps reduce the risk of hospitalization due to angina for patients recently diagnosed with coronary artery disease who do not have heart failure or decreased cardiac output, and it also helps decrease the risk associated with coronary revascularization procedures. Thus, it plays an important role in effectively managing cardiovascular diseases.

How to take

Adult dose

Administer orally 5 mg once daily as amlodipine, and may increase to a maximum of 10 mg daily based on patient response. Adjust according to age and symptoms.

Precautions

This medication is important to avoid in certain patients. For example, patients who have had an allergy to this medication or to drugs in the same class, nursing women, patients with severe liver dysfunction, patients with severe aortic stenosis, and patients in a state of shock should not take this medication. Moreover, there are patients who require caution when using this medication, such as patients with severe hypotension, patients with kidney failure who require dialysis, the elderly, and pregnant or potentially pregnant women should use this medication cautiously. Possible side effects while taking this medication include flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, symptoms such as hypotension, skin rash, allergic reactions, muscle pain, joint pain, dyspepsia, cough, and shortness of breath can occur, so if any abnormalities occur, consultation with a healthcare professional should be sought. Patients with heart failure or reduced liver function may experience different effects from this medication, so caution is warranted. Additionally, because this medication remains in the body for a long time, blood pressure may gradually decrease even after discontinuing it, so when taking other antihypertensive agents, adjustments in dosage and intervals are necessary. While this medication is not known to significantly impair the ability to drive or operate machinery, dizziness may occur in some individuals, so caution is warranted. There may be interactions with other medications, especially when taken with certain antibiotics, antihypertensive agents, anticoagulants, or grapefruit juice, so healthcare professionals should be informed and careful monitoring is required. There is a risk of hypotension when combined with some medications, thus caution is necessary. Women who are pregnant or breastfeeding should avoid this medication as its safety is not assured, and unless in special cases, it is not recommended during pregnancy, and breastfeeding should be suspended. It may also be used for children, but safety and efficacy have not been established in children under 6 years of age. In case of overdose, severe hypotension and increased heart rate may occur, necessitating an immediate visit to a medical facility, and gastric lavage or detoxification treatment may be needed if necessary. This medication is known to pose no risk of carcinogenicity or genetic abnormalities even with long-term use.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), toxic epidermal necrolysis
  • Chest tightness, difficulty breathing, respiratory distress, angioedema
  • Severe rash with fever, rash, blisters, skin peeling, oral/ocular mucosal pain
  • Dermatological adverse reactions (erythema multiforme)
  • Yellowing of the skin or eyes (jaundice), hepatitis, elevated liver enzymes
  • Cardiac and neurological abnormalities: Myocardial infarction, arrhythmias (including bradycardia, ventricular tachycardia, atrial fibrillation), seizures, altered consciousness

Mild side effects

  • Cardiovascular: Flushing, vasculitis, hypotension, palpitations, blood pressure lowering, sinoatrial block or atrioventricular block
  • General: Fatigue, swelling, weakness, lethargy, pain, weight increase/decrease, dizziness, headache, drowsiness, insomnia, mood changes, weakness, impaired glucose tolerance
  • Gastrointestinal: Abdominal pain, nausea, dry mouth, dyspepsia (gastritis), gingival hypertrophy, pancreatitis, vomiting, changes in bowel habits, diarrhea, loose stools, constipation, precordial pain
  • Nervous system: Tension, sensory impairment

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure and is best kept at room temperature between 1 and 30 degrees. By storing it this way, the efficacy of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

White octagonal tablet

Package unit

30 tablets/bottle, 300 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.