Medication info
AmloDigen Tablet (Amlodipine Besilate)

AmloDigen Tablet (Amlodipine Besilate)

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

MFDS item code 201905733 · Approved 2019.08.14 · Insurance code 057600140

Summary

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

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

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

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

This medication is used to treat myocardial ischemia due to hypertension, stable angina and variant angina. Furthermore, in patients with confirmed coronary heart disease undergoing recent angiography but without severe heart failure, this drug reduces the risk of hospitalization due to angina and decreases the risk associated with coronary artery revascularization. Thus, it helps improve symptoms of cardiovascular diseases and reduce risks.

How to take

Adult dose

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

Precautions

This medication should not be used in certain patients. For example, individuals with a history of allergy to this drug or similar class of drugs, nursing women, patients with severe liver dysfunction, severe aortic stenosis, and those in a state of shock should not take this medication. Additionally, this medication should be administered with caution in some cases. Patients with severe hypotension, those requiring dialysis due to kidney failure, elderly individuals, and women who are pregnant or may become pregnant need special attention. Various side effects may occur while taking this medication. The most common side effects include flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, excessively low blood pressure, allergic reactions, skin rashes, hair loss, muscle pain, digestive issues, etc., have also been reported. For patients with heart failure, this medication can cause pulmonary edema, so caution is necessary. In patients with liver impairment, the half-life of the drug may be prolonged, necessitating dosage adjustments. Blood pressure may gradually decrease even after discontinuing the medication, so caution is advised when used with other antihypertensive drugs. This medication is not expected to provide rapid effect in emergency situations and is not known to significantly affect driving or operating machinery. There may be interactions when taken with other medications, so it is advisable to avoid combining with grapefruit juice. When taken with certain antibiotics, antihypertensives, immunosuppressants, etc., blood pressure changes or increased risk of side effects may occur, and physician's guidance should be followed. The safety of this medication during pregnancy is not confirmed, therefore it is recommended to use other safe medications when possible, and if taking this medication while breastfeeding, it is advisable to discontinue nursing. In children, use is only recommended for those aged 6 years and older, as safety and efficacy have not been established in those under 6 years of age. In the case of overdose, a sharp drop in blood pressure and irregular heartbeat may occur, and immediate access to medical facilities is required. Treatment should be done while closely monitoring blood pressure and heart function for appropriate measures.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • toxic epidermal necrolysis
  • difficulty breathing
  • shortness of breath
  • jaundice
  • hepatitis
  • elevated liver enzymes
  • severe swelling
  • confusion
Show 6 more
  • seizures
  • paralysis
  • visual disturbances
  • severe headache
  • hypertension
  • pulmonary edema.

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 26 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory loss/abnormal sensation
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremor
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramping
  • 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 that can block light, at room temperature between 1 and 30 degrees Celsius. Storing it this way preserves the drug's efficacy and safety.

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.