Medication info
Nudipine Tablets (Amlodipine Maleate)

Nudipine Tablets (Amlodipine Maleate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Maleate›6.42mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
White octagonal tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200501348 · Notified 2005.04.18 · Insurance code 657300150

Summary

Main use
Improvement of myocardial ischemia caused by hypertension and coronary artery disease (stable angina, variant angina)
Who takes it
Adults
Adult dose
Administer 5 mg orally once daily as Amlodipine, and if symptoms do not improve within 2 to 4 weeks, it may be increased to a maximum of 10 mg per day. Adjustments should be made according to the symptoms.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Improvement of myocardial ischemia caused by hypertension and coronary artery disease (stable angina, variant angina)

  • Hypertension
  • fixed closure of the coronary artery
  • spasm contraction of the coronary vessels
  • myocardial ischemia
View approved original text

This medication is used to treat hypertension and myocardial ischemia caused by stable angina and variant angina due to narrowing or temporary contraction of heart blood vessels.

How to take

Adult dose

Administer 5 mg orally once daily as Amlodipine, and if symptoms do not improve within 2 to 4 weeks, it may be increased to a maximum of 10 mg per day. Adjustments should be made according to the symptoms.

Precautions

This medication should not be administered to certain patients. For example, patients who have an allergy to this medication or its components or have experienced hypersensitivity reactions, pregnant women or those who could become pregnant, nursing women, patients with cardiogenic shock, severe aortic stenosis, unstable angina, patients who have recently suffered a myocardial infarction, severe liver dysfunction, and severe hypotension are at risk when taking this medication. Additionally, patients with severely impaired kidney function, elderly patients, acute heart failure patients, hypertensive crisis patients, patients with mild to moderate liver dysfunction, patients with limited left ventricular function, patients with low cardiac reserve, and diabetic patients should take this medication cautiously and monitor their condition closely in accordance with a physician's instructions. This medication is generally well-tolerated, but during the initial use, patients may experience flushing or a feeling of warmth, fatigue, or swelling. Symptoms such as rapid heartbeat, dizziness, headache, dyspepsia, drowsiness, and ankle edema may also occur. Rarely, side effects such as dry mouth, increased sweating, hypotension, syncope, muscle pain, skin rash, liver dysfunction, etc. may occur, so any unusual symptoms should be reported to a doctor immediately. This medication should not be suddenly discontinued as it may worsen symptoms. Therefore, if discontinuing the medication, it is necessary to gradually taper off under the guidance of a physician, and patients should be careful not to stop taking it without permission. It is advisable to take this medication with a sufficient amount of water, and as it may cause dizziness due to the blood pressure-lowering effect, caution should be exercised when driving or operating dangerous machinery. This medication may interact with other drugs. In particular, it is advisable to avoid taking it with grapefruit juice as it may excessively enhance the blood pressure-lowering effect. Furthermore, when used in conjunction with certain antibiotics, antidepressants, or antihypertensives, doctors or pharmacists should be informed and careful monitoring should be conducted. Pregnant or nursing women are advised to avoid this medication as its safety has not been established. The safety in children has not been sufficiently confirmed, and elderly individuals may experience higher drug concentrations, so starting with a lower dose and closely monitoring the condition is advised. In case of overdose, severe hypotension, cardiac abnormalities, or coma may occur, therefore appropriate treatment should be sought immediately at a medical facility. Lastly, this medication should be kept out of reach of children, and it is safe not to transfer it to another container. Special care should be taken to maintain the quality of the medication during storage.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), angioedema → severe allergic reaction
  • Severe rash, skin peeling, mucosal pain, toxic epidermal necrolysis, Stevens-Johnson syndrome → severe skin adverse reactions
  • Shortness of breath → respiratory issues
  • Jaundice → liver issues (jaundice)
  • Sudden and severe headache, seizures, consciousness confusion, paralysis → severe neurological symptoms
  • Severe swelling throughout the body → severe edema or urinary issues

Mild side effects

  • Fever
  • flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • migraine
  • weakness
  • nausea
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  • dyspepsia
  • drowsiness
  • dry mouth
  • increased sweating
  • weakness
  • lethargy
  • pain
  • weight change
  • chills
  • hypotension
  • postural hypotension
  • postural dizziness
  • peripheral ischemia
  • vasculitis
  • syncope
  • tachycardia
  • peripheral edema
  • tension increase
  • sensory loss
  • sensory abnormalities
  • peripheral neuropathy
  • taste disturbances
  • tremors
  • paralysis
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • gastritis

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to pass through. Additionally, it is important to store it at room temperature, between 1°C and 30°C, to maintain its efficacy.

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.