Medication info
Newadin Tablet (Amlodipine Besilate)

Newadin Tablet (Amlodipine Besilate)

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

MFDS item code 201903636 · Approved 2019.05.31 · Insurance code 693202110

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina) and reduction of the risk of hospitalization for angina and vascular intervention.
Who takes it
Adults
Adult dose
Adults: Take 5 mg of amlodipine orally once daily, which may be increased to a maximum of 10 mg daily according to the patient's response. Adjustment should be appropriately made according to age and symptoms.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

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

  • Hypertension
  • fixed obstruction of coronary arteries
  • vascular spasm
  • vascular contraction
  • myocardial ischemia
  • angina
View approved original text

This medication is used for the treatment of myocardial ischemia due to hypertension and stable or variant angina. It is also effective in reducing the risk of hospitalization due to angina and risk of coronary artery intervention in patients with confirmed coronary heart disease through angiography, in cases where there is no heart failure or the ejection fraction is not below 40%. This drug aids in the treatment and prevention of cardiovascular disease and improves health status.

How to take

Adult dose

Adults: Take 5 mg of amlodipine orally once daily, which may be increased to a maximum of 10 mg daily according to the patient's response. Adjustment should be appropriately made according to age and symptoms.

Precautions

This drug should not be used in certain patients. For example, it is contraindicated in individuals who have had an allergic reaction to this drug or similar medications, in breastfeeding women, patients with severe liver dysfunction, those with severe aortic stenosis, and patients in a state of shock. Furthermore, it should be administered with caution to patients with severe hypotension, those with renal failure needing dialysis, elderly patients, and women who are pregnant or may become pregnant. While taking this medication, various side effects may occur. The most common side effects include flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, lethargy, decreased blood pressure, neurological abnormalities, erectile dysfunction, digestive issues, skin rashes, liver function abnormalities have been reported, and severe allergic reactions may also occur, so caution is advised. Patients with heart failure or liver function impairment should be particularly careful when using this medication, and blood pressure may slowly decrease even after discontinuation, thus caution is necessary when using other antihypertensive drugs together. This drug is known not to significantly affect the ability to drive or operate machinery, but it may vary by individual, so caution is warranted. There may be interactions when taken with other medications. In particular, concurrent use with grapefruit juice may intensify the blood pressure-lowering effect, so it is advisable to avoid it. Additionally, when used with certain antibiotics or antihypertensive medications or immunosuppressants, the risk of side effects may increase, so it is important to follow the physician's guidance. The safety of this medication in pregnant or breastfeeding women is not clearly established, so it should be avoided unless there are exceptional circumstances or consultation with a physician is warranted. For children, it can be administered from 6 years old, but its efficacy and safety have not been established for those under 6 years old. In cases of overdose, extremely low blood pressure and heart problems may occur, so immediate medical attention is required for appropriate treatment. This drug is not known to cause carcinogenic or genetic abnormalities even with long-term use; however, it should always be taken according to the prescription and guidance of a healthcare professional.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • jaundice
  • severe allergic reactions
  • severe skin reactions
  • liver abnormalities (jaundice)
  • severe edema or urinary abnormalities
  • pulmonary edema
  • angioedema
Show 1 more
  • toxic epidermal necrolysis

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • lethargy
Show 25 more
  • malaise
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory decrease/abnormalities
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • indigestion
  • gingival hypertrophy
  • 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 may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to keep the storage temperature between 1 and 30 degrees Celsius. This will help to maintain the efficacy and safety 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.