Medication info
Amodipine Tablets 5 mg (Amlodipine Besilate)

Amodipine Tablets 5 mg (Amlodipine Besilate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Camsylate›7.841mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
White hexagonal tablet
Packaging
30 tablets/box [10 tablets/PTP X 3], 300 tablets/bottle
Approval status
Active

MFDS item code 200402637 · Notified 2004.06.08 · Insurance code 643501600

Summary

Main use
Effect in the treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina) and reduction of the risk of hospitalization and vascular interventions.
Who takes it
Adults · Children
Adult dose
For amlodipine, take 5 mg orally once a day, and can be increased up to a maximum of 10 mg per day according to the patient's response. Adjustments may be made according to age and symptoms.
Child dose
The oral dosing for effective blood pressure reduction of amlodipine is once a day at 2.5 mg to 5 mg. Doses exceeding 5 mg per day have not been studied in pediatric patients.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Effect in the treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina) and reduction of the risk of hospitalization and vascular interventions.

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

This medication is used in the treatment of myocardial ischemia caused by hypertension and stable and unstable angina. Additionally, in patients recently confirmed to have coronary artery disease through angiography, with no heart failure or an ejection fraction greater than 40%, it helps reduce the risk of hospitalization due to angina and the risk of coronary interventions. Therefore, it is effectively used in the management and prevention of cardiovascular diseases.

How to take

Adult dose

For amlodipine, take 5 mg orally once a day, and can be increased up to a maximum of 10 mg per day according to the patient's response. Adjustments may be made according to age and symptoms.

Child dose

The oral dosing for effective blood pressure reduction of amlodipine is once a day at 2.5 mg to 5 mg. Doses exceeding 5 mg per day have not been studied in pediatric patients.

Precautions

This medication should not be used in certain patients. For instance, people allergic to this medication or similar types of drugs, nursing women, patients with severely impaired liver function, patients with severe aortic stenosis, and patients in shock should not be treated. Furthermore, caution is required for severely hypotensive patients, those requiring dialysis due to kidney failure, elderly patients, and women who are pregnant or may become pregnant. This medication generally has good tolerability, but side effects such as facial flushing due to vasodilation, fatigue, leg swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea may occur. More rarely, various adverse reactions such as hypotension, vasculitis, neurological symptoms, erectile dysfunction, gynecomastia, digestive disorders, weight changes, joint pain, muscle cramps, blood cell reduction, insomnia, cough, and skin rashes have been reported. Patients with heart failure may have an increased risk of pulmonary edema when using this medication, and patients with impaired liver function may require dosage adjustments due to increased drug concentrations. This medication takes effect gradually and is not suitable for the treatment of acute angina. It is known not to significantly affect driving or machine operation ability. This medication can interact with various other drugs, so if you are taking other medications, be sure to consult with your doctor or pharmacist. In particular, it is recommended to avoid concomitant use with grapefruit juice as it may enhance the antihypertensive effect. Pregnant or nursing women should only use this medication if there are no alternative medications available, and it is recommended to discontinue breastfeeding. It is recommended for children aged 6 years and older, as safety and efficacy have not been established for those younger. Overdose may result in severe hypotension and tachycardia, requiring immediate emergency treatment. This medication is not removed by blood dialysis, so appropriate measures such as gastric lavage or administration of adsorbents should be taken in the event of an overdose.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, erythema multiforme, toxic epidermal necrolysis, respiratory distress, difficulty breathing, respiratory abnormality accompanied by cough and fever, hepatitis, jaundice, liver abnormal symptoms, severe swelling, significantly reduced urine output

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 27 more
  • malaise
  • pain
  • weight changes
  • hypotension
  • vasculitis
  • tension increase
  • sensory loss
  • sensory abnormalities
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hypertrophy
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • 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 container that protects it from light and air and kept at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White hexagonal tablet

Package unit

30 tablets/box [10 tablets/PTP X 3], 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.