Medication info
Amlodipine Tablets (Amlodipine Besylate)

Amlodipine Tablets (Amlodipine Besylate)

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

MFDS item code 201406093 · Approved 2014.12.29 · Insurance code 641503090

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of the risk of hospitalization for angina and the risk of vascular reconstruction.
Who takes it
Adults
Adult dose
Administer 5 mg orally once a day as amlodipine, and the dosage may be increased to a maximum of 10 mg per day based on the patient's response. Adjust according to age and symptoms.

Ingredients

Manufacturer
맥널티제약(주)

Efficacy & effects

Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of the risk of hospitalization for angina and the risk of vascular reconstruction.

  • Hypertension
  • fixed obstruction of the coronary artery
  • vascular spasm
  • vasoconstriction
  • myocardial ischemia
  • angina.
View approved original text

This medication is effective in treating myocardial ischemia caused by hypertension, stable angina, and variant angina. It helps lower the risk of hospitalization for patients with coronary artery disease who do not have heart failure and have a left ventricular ejection fraction of 40% or more, and it reduces the risks associated with coronary artery revascularization. Therefore, it is used to prevent cardiovascular diseases and improve symptoms.

How to take

Adult dose

Administer 5 mg orally once a day as amlodipine, and the dosage may be increased to a maximum of 10 mg per day based on the patient's response. Adjust according to age and symptoms.

Precautions

This medication should not be used in certain patients. It is contraindicated for individuals with allergies to this medication or similar types of drugs, breastfeeding women, patients with severe liver dysfunction, patients with severe aortic stenosis, and patients in shock. Additionally, it should be administered with caution to patients with severe hypotension, those requiring dialysis due to kidney failure, the elderly, and women who are pregnant or may become pregnant. While taking this medication, side effects such as facial flushing, fatigue, swelling, palpitations, dizziness, headaches, drowsiness, abdominal pain, and nausea may occur. Rarely, various adverse reactions including hypotension, vascular inflammation, neurological abnormalities, dyspepsia, liver dysfunction, and skin rashes have been reported. Patients with heart failure or impaired liver function may be more sensitive to the effects and side effects of this medication. Any abrupt cessation of the medication may lead to gradual changes in blood pressure, so dosage adjustments should be made under a doctor's supervision. This medication is not expected to be effective quickly during emergencies, and it is reported to have little impact on the ability to drive or operate machines. There may be interactions when taken with other medications, so caution is advised especially when taken with certain antibiotics, antihypertensives, analgesics, grapefruit juice, etc. Some medications may increase the plasma concentration of this drug, raising the risk of side effects. For women who are pregnant or breastfeeding, the safety of this medication has not been established, so it should be administered with caution when necessary, and breastfeeding should be discontinued. In children, effectiveness has only been confirmed for those aged 6 and older, and it should not be used in children under 6. In case of overdose, severe hypotension and cardiac issues can occur, necessitating immediate emergency treatment, and this medication cannot be removed by dialysis, so specialized treatment is required. There is no evidence that long-term use of this medication increases the risk of cancer or genetic abnormalities, and it can generally be used safely.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • jaundice
  • toxic epidermal necrolysis
  • angioedema
  • erythema multiforme.

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headaches
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension disorders
  • sensory loss/paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbances
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myalgia
  • leukopenia

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 or light. Additionally, it is recommended to keep it at room temperature between 1°C and 30°C. This will help maintain the effectiveness of the medication 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.