Medication info
Daewoong Bio Amlodipine Tablets 5mg (Amlodipine Besylate)

Daewoong Bio Amlodipine Tablets 5mg (Amlodipine Besylate)

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

MFDS item code 201504178 · Approved 2015.06.29 · Insurance code 694000870

Summary

Main use
Effectively treats myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina) and reduces the risk of hospitalization and vascular revascularization.
Who takes it
Adults
Adult dose
For amlodipine, take 5 mg orally once a day, and the dosage may be increased up to a maximum of 10 mg per day based on patient response. Adjust as appropriate according to age and symptoms.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Effectively treats myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina) and reduces the risk of hospitalization and vascular revascularization.

  • Hypertension
  • fixed closure of coronary arteries
  • coronary artery spasms
  • vascular constriction
  • myocardial ischemia
  • angina
View approved original text

This medication is used for hypertension as well as myocardial ischemia caused by stable angina and variant angina. It also lowers the risk of hospitalization due to angina in patients with confirmed coronary artery disease who do not have heart failure or whose cardiac output is within the normal range, and reduces the risks related to coronary vascular revascularization. Therefore, this drug helps improve heart diseases and vascular problems.

How to take

Adult dose

For amlodipine, take 5 mg orally once a day, and the dosage may be increased up to a maximum of 10 mg per day based on patient response. Adjust as appropriate according to age and symptoms.

Precautions

This drug should not be used in certain patients. First, it is not to be administered to patients who have had allergic reactions to this drug or similar types of medications, nursing mothers, patients with severe liver dysfunction, patients with severe aortic stenosis, and those in shock. Moreover, it should be used with caution in patients with severe hypotension, those requiring renal dialysis, elderly patients, and pregnant or potentially pregnant women. This medication generally has good tolerability, but side effects such as flushing, fatigue, swelling of hands and feet, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea may occur. Rarely, cases of hypotension, neurological abnormalities, gastrointestinal issues, skin rashes, liver function abnormalities, and cardiovascular adverse reactions such as arrhythmias or chest pain have been reported. Particular care should be taken in patients with heart failure or impaired liver function, and since the effects of the drug appear slowly, it is not suitable for urgent treatment. This medication may interact with other drugs, so caution is needed, especially when taken with certain antibiotics, antihypertensives, hypoglycemics, and grapefruit juice. The effect of the drug may become excessively strong when taken with grapefruit juice, so it is not recommended. The safety of this drug has not been established for pregnant or nursing women; it should be used during pregnancy only in special cases and lactation should be discontinued while taking the drug. In children, efficacy has been confirmed in those aged 6 and older, but safety and efficacy have not been established in children under 6 years old. In case of overdose, blood pressure may drop excessively, and heart rate may increase, requiring immediate emergency treatment, and appropriate measures should be taken as directed by a physician. Finally, this medication is known not to significantly impair driving or operating machinery, but caution is needed as this may vary by individual.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • yellowing of the skin or eyes (jaundice)
  • extreme lethargy
  • severe allergic reactions
  • liver abnormalities (jaundice).

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension
  • sensory loss/sensory abnormalities
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia (gastritis)
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • weakness.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, to maintain the drug's efficacy, it is important to store it at room temperature, specifically between 1 and 30 degrees Celsius.

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.