Medication info
New Amlodipine 10 mg (Amlodipine Besylate)

New Amlodipine 10 mg (Amlodipine Besylate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.889mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201603335 · Approved 2016.06.10 · Insurance code 053600380

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of risks associated with angina hospitalization and vascular intervention.
Who takes it
Adults
Adult dose
Adults are to take 5 mg orally once daily as Amlodipine, and the dose may be increased up to a maximum of 10 mg once daily depending on the patient's response. Adjust doses 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 variant angina), and reduction of risks associated with angina hospitalization and vascular intervention.

  • Hypertension
  • fixed obstruction of coronary arteries
  • coronary artery vasospasm
  • vasoconstriction
  • myocardial ischemia
View approved original text

This medication is used for hypertension, stable angina (myocardial ischemia due to fixed obstruction of coronary arteries), and variant angina (myocardial ischemia due to vasospasm and vasoconstriction of coronary blood vessels). Additionally, it is helpful in reducing the risk of hospitalization due to angina and lowering the risks associated with coronary vascular intervention in patients where coronary artery disease is confirmed by recent angiography but there is no heart failure or reduced cardiac output. Therefore, it is effective in maintaining cardiovascular health and preventing complications related to angina.

How to take

Adult dose

Adults are to take 5 mg orally once daily as Amlodipine, and the dose may be increased up to a maximum of 10 mg once daily depending on the patient's response. Adjust doses appropriately based on age and symptoms.

Precautions

This medication should not be used in certain patients. Patients who have had allergic reactions to this medication or similar drugs in the past should not take this medicine. Women who are breastfeeding are also advised not to take this medication. Patients with severe liver dysfunction, severe aortic stenosis, and those in shock should not use this medication. It should be used with caution in some patients. Patients with very low blood pressure, those requiring dialysis due to renal failure, the elderly, and women who are pregnant or may become pregnant should be careful when using this medication. Common side effects include flushing, fatigue, and swelling. Patients may also experience rapid heartbeat, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, excessively low blood pressure, vasculitis, neurological symptoms, erectile dysfunction, gynecomastia, dyspepsia, liver dysfunction have been reported. Allergic reactions such as skin rashes or itching may occur, so if any abnormal symptoms arise, consult a physician immediately. Patients with heart failure or liver dysfunction should use this medication with greater caution, and since the blood pressure-lowering effect may gradually persist after discontinuation, adjustments may be necessary when taken in combination with other antihypertensive drugs. This medication is known not to significantly affect the ability to drive or operate machinery; however, dizziness may occur in some individuals, so caution is advised. Drug interactions may occur when this medication is taken with other drugs. In particular, taking it with grapefruit juice may excessively enhance the blood pressure-lowering effect, so concurrent use should be avoided. Additionally, caution is needed when taken with certain antibiotics, immunosuppressants, and statins, and dosage adjustments may be necessary for co-administered drugs. Women who are pregnant or breastfeeding should not use this medication unless absolutely necessary, as its safety has not been established. Particularly during breastfeeding, it is advisable to discontinue breastfeeding while taking this medication. Use in children is recommended only for those aged 6 and above, as safety and efficacy have not been established in younger children. In cases of overdose, excessively low blood pressure and irregular heartbeats may occur, requiring immediate medical attention and appropriate emergency care. This medication has not been reported to cause carcinogenic or genotoxic potential after long-term use and is considered safe.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, erythema multiforme, toxic epidermal necrolysis, jaundice, hepatitis, abdominal discomfort, myocardial infarction, arrhythmia, chest pain, edema accompanied by increased blood pressure, pulmonary edema, shock due to hypotension, non-cardiogenic pulmonary edema.

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • weight gain/loss
  • hypotension
  • vasculitis
  • hypertonia
  • sensory loss/abnormal sensations
  • peripheral neuropathy
  • syncope
  • taste disturbances
  • tremors
  • extrapyramidal symptoms
  • 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

Store this medication in a tightly closed container to prevent exposure to air or moisture, and keep it at room temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy of the medication.

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.