Medication info
New Amlodipine Tablets 5 mg (Amlodipine Besylate)

New Amlodipine Tablets 5 mg (Amlodipine Besylate)

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

MFDS item code 201603334 · Approved 2016.06.10 · Insurance code 053600290

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina), reduction of risks for hospitalization due to angina and revascularization procedures.
Who takes it
Adults
Adult dose
For amlodipine, 5 mg is taken orally once daily, and the dose may be increased up to a maximum of 10 mg per day according to the patient's response. Adjustments should be made appropriately based on age and symptoms.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina), reduction of risks for hospitalization due to angina and revascularization procedures.

  • Hypertension
  • fixed occlusion of the coronary arteries
  • vasospasm of the coronary vasculature
  • vasoconstriction
  • myocardial ischemia
  • angina.
View approved original text

This medication is used to treat myocardial ischemia in patients with hypertension and stable or unstable angina. Additionally, in patients whose coronary artery disease has been confirmed by recent angiography and who do not have heart failure or have a cardiac output of over 40%, it helps reduce the risk of hospitalization due to angina and the risks associated with revascularization procedures. This drug enhances heart function and improves the stability of cardiovascular diseases, effectively managing the patient's health condition.

How to take

Adult dose

For amlodipine, 5 mg is taken orally once daily, and the dose may be increased up to a maximum of 10 mg per day according to the patient's response. Adjustments should be made appropriately based on age and symptoms.

Precautions

This medication should not be used in certain patients. It should not be administered to patients who have had allergic reactions to this drug or similar medications, nursing women, patients with severe liver dysfunction, patients with severe aortic stenosis, and patients in shock. Additionally, caution should be exercised when using this drug in certain cases. Patients with severe hypotension, those requiring dialysis for kidney dysfunction, elderly individuals, and pregnant or potentially pregnant women should be particularly careful when using this medication. Various side effects may occur when taking this medication. Common side effects include facial flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, symptoms may include excessively low blood pressure or conditions such as vasculitis, neurological symptoms, erectile dysfunction, gynecomastia, dry mouth, dyspepsia, weight changes, insomnia, skin rashes, etc., so if any unusual symptoms occur, consult a doctor immediately. Patients with heart failure or impaired liver function should use this medication with special caution, and since the effects of this medication appear slowly, it is not suitable for acute situations like severe angina. This drug may interact with other medications; therefore, if you are currently taking any other drugs, you must inform your healthcare provider. In particular, taking this medication with grapefruit juice may enhance its blood pressure-lowering effects and is not recommended. Pregnant or nursing women should avoid using this medication since its safety has not been established. It is advisable to consider alternative medications and to stop breastfeeding while taking this drug. In children, this medication is recommended only for those over 6 years of age, as its effects in children under 6 are not known. In case of overdose, severe hypotension and cardiac dysfunction may occur, necessitating immediate emergency treatment. This drug is not removed by blood dialysis. This medication is known not to significantly affect driving or machinery operation, but dizziness or other symptoms may occur in some individuals, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • toxic epidermal necrolysis
  • jaundice
  • hepatitis
  • difficulty breathing
  • dyspnea
  • severe edema
  • pulmonary edema.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight increase/decrease
  • hypotension
  • vasculitis
  • hypertonicity
  • sensory loss/abnormal sensation
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremor
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myalgia

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 exposure to air or moisture and kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained for a long time.

Appearance and packaging

Appearance

White octagonal tablets

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.