Medication info
Novaropin Tablet (Amlodipine Maleate)

Novaropin Tablet (Amlodipine Maleate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Maleate›6.42mg / 1 tablet
Manufacturer / importer
제이더블유신약(주)
Appearance
White or yellowish octagonal tablet
Packaging
30 tablets (10 tablets/PTP packaging x 3)
Approval status
Active

MFDS item code 200600054 · Notified 2006.04.07 · Insurance code 644102180

Summary

Main use
Improvement of myocardial ischemia due to hypertension and coronary artery disease (stable angina, variant angina)
Who takes it
Adults
Adult dose
5 mg of amlodipine is administered orally once daily, and if symptoms do not improve within 2 to 4 weeks, the dose may be increased to a maximum of 10 mg per day. Dosage adjustments should be made appropriately based on symptoms.

Ingredients

Manufacturer
제이더블유신약(주)

Efficacy & effects

Improvement of myocardial ischemia due to hypertension and coronary artery disease (stable angina, variant angina)

  • Hypertension
  • fixed obstruction of the coronary artery
  • vasospasm of the coronary circulation
  • myocardial ischemia
View approved original text

This medication is used to control hypertension and treat myocardial ischemia caused by stable angina and variant angina resulting from fixed obstruction or vasospasm of the coronary arteries.

How to take

Adult dose

5 mg of amlodipine is administered orally once daily, and if symptoms do not improve within 2 to 4 weeks, the dose may be increased to a maximum of 10 mg per day. Dosage adjustments should be made appropriately based on symptoms.

Precautions

This medication should not be used in certain patients. Patients who are allergic to this drug or its ingredients, pregnant or potentially pregnant women, breastfeeding women, patients with cardiogenic shock, patients with severe aortic stenosis, patients with unstable angina, patients who have had a recent myocardial infarction, patients with severe liver dysfunction, and patients with severe hypotension should not receive this medication. Additionally, caution is advised when using it in patients with very poor kidney function, elderly patients, patients with acute heart failure, patients in hypertensive crisis, patients with mild to moderate liver impairment, patients with limited left ventricular function, patients with weakened heart function, and diabetic patients. When taking this medication, symptoms such as warmth and facial flushing, fatigue, edema, palpitations, dizziness, headache, dyspepsia, drowsiness, and ankle swelling may occur. Rarely, various side effects such as dry mouth, increased sweating, hypotension, vasculitis, insomnia, depression, skin rash, and liver function abnormalities may occur, so consult a doctor immediately if you notice any unusual symptoms. Abruptly stopping this medication may worsen symptoms, so the dosage should be gradually reduced according to the doctor's instructions, and care should be taken not to stop taking it arbitrarily. Patients with reduced liver function or the elderly may have higher blood concentrations of this medication, so it should be started at a low dosage and taken with careful monitoring. Taking this medication with grapefruit juice may lead to excessive blood pressure-lowering effects, so it is advisable not to consume them together. Moreover, when taken with other antihypertensive medications or multiple drugs, there may be interactions, so it is essential to inform the doctor or pharmacist and proceed with caution. Pregnant or breastfeeding women are advised against using this medication due to the lack of established safety, and consultation with a specialist is recommended if necessary. The safety and efficacy of this medication have not been established in children, so it should not be used in this population. In case of overdose, serious hypotension, arrhythmias, and shock may occur, requiring immediate emergency treatment and appropriate care as per the doctor's instructions. Lastly, this medication should be kept out of reach of children and care should be taken not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/conjunctival mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, markedly reduced urine output

Mild side effects

  • Flushing accompanied by warmth
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • migraine
  • weakness
  • abdominal pain
  • nausea
Show 27 more
  • dyspepsia
  • drowsiness
  • dry mouth
  • increased sweating
  • weakness
  • lethargy
  • pain
  • weight change
  • chills
  • hypotension
  • orthostatic hypotension
  • positional dizziness
  • peripheral ischemia
  • vasculitis
  • syncope
  • tachycardia
  • peripheral edema
  • tension increase
  • sensory loss
  • sensory disturbance
  • peripheral neuropathy
  • taste disturbance
  • tremors
  • paralysis
  • erectile dysfunction
  • gynecomastia
  • abnormal bowel movements

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, and kept at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White or yellowish octagonal tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)

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.