Medication info
Amlodipine Tablet (Amlodipine Besylate)

Amlodipine Tablet (Amlodipine Besylate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
(주)알피바이오
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201601145 · Approved 2016.02.29 · Insurance code 661604620

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina), reduction of hospitalization and risk of vascular intervention.
Who takes it
Adults
Adult dose
Adults: 5 mg of amlodipine is administered orally once daily, and may be increased up to a maximum of 10 mg daily based on patient response. Adjust dosage appropriately based on age and symptoms.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina), reduction of hospitalization and risk of vascular intervention.

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

This medication is used in the treatment of myocardial ischemia caused by insufficient blood supply to the heart muscle, such as in hypertension and stable or unstable angina. Additionally, it helps reduce the risk of hospitalization due to angina in patients with confirmed coronary artery disease who do not have heart failure and have a cardiac output of over 40%. It also contributes to lowering the risks associated with coronary artery interventions. Through this, it improves cardiovascular health.

How to take

Adult dose

Adults: 5 mg of amlodipine is administered orally once daily, and may be increased up to a maximum of 10 mg daily based on patient response. Adjust dosage appropriately based on age and symptoms.

Precautions

This medication is a dihydropyridine calcium channel blocker that lowers blood pressure and reduces cardiac burden. It should not be used in patients with hypersensitivity, in breastfeeding individuals, those with severe liver dysfunction, patients with aortic stenosis, or those in shock. Patients with severe hypotension, those requiring dialysis due to renal failure, elderly patients, and pregnant or potentially pregnant women should use this medication with caution. Common side effects include flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, various side effects such as weakness, hypotension, vasculitis, neurological symptoms, erectile dysfunction, dry mouth, hyperglycemia, joint pain, blood disorders, insomnia, skin rashes, etc., may occur. In patients with heart failure or impaired liver function, the effects and side effects of this drug should be carefully monitored. Even if stopped, the blood pressure-lowering effect fades gradually; hence dosage and intervals should be monitored if used in conjunction with other antihypertensive medications. This medication may not be suitable for situations requiring rapid blood pressure reduction in emergencies. It is known not to significantly affect driving or machinery operation abilities. Interactions may occur when taken with certain medications, especially with grapefruit juice, specific antibiotics, antihypertensive drugs, and immunosuppressants, hence caution is necessary. During pregnancy, due to safety not established, it should be used only in special cases, and breastfeeding should be discontinued while taking this drug. For pediatric patients, it should only be used in those aged 6 years and older, as safety and efficacy are not established for those under 6 years. Elderly patients generally tolerate the standard doses well, but careful observation is required. In case of overdose, severe hypotension and reflex tachycardia may occur, requiring immediate medical assistance, and gastric lavage or administration of activated charcoal may be helpful if necessary. This drug is not removed by hemodialysis, so proactive cardiovascular support treatment is necessary in case of overdose.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, erythema multiforme → severe allergic reaction.
  • Toxic epidermal necrolysis, skin peeling → severe skin reaction.
  • Difficulty breathing, respiratory difficulties → respiratory problems.
  • Jaundice, yellowing of skin or eyes → liver abnormalities (jaundice).

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 26 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • agitation
  • sensory reduction/alteration
  • peripheral neuropathy
  • syncope
  • taste alteration
  • tremor
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • 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 sealed container to prevent exposure to air or moisture, maintaining a storage temperature between 1°C and 30°C at room temperature. Proper storage will help to preserve the drug's effectiveness.

Appearance and packaging

Appearance

White octagonal tablet

Package unit

30 tablets/bottle, 500 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.