Medication info
Novatec Tablet (Amlodipine Maleate)

Novatec Tablet (Amlodipine Maleate)

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

MFDS item code 200501811 · Notified 2005.04.18 · Insurance code 654300210

Summary

Main use
Improvement of hypertension and myocardial ischemic conditions (stable angina, variant angina)
Who takes it
Adults
Adult dose
5 mg orally once daily as amlodipine. If symptoms do not improve within 2 to 4 weeks, the dose may be increased up to 10 mg daily depending on the patient's response. Adjust as appropriate according to symptoms.

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

Improvement of hypertension and myocardial ischemic conditions (stable angina, variant angina)

  • Hypertension
  • fixed coronary obstruction
  • coronary vasospasm
  • myocardial ischemia
View approved original text

This medication is used to control hypertension and improve myocardial ischemic conditions such as stable angina due to fixed coronary obstruction and variant angina caused by coronary vasospasm.

How to take

Adult dose

5 mg orally once daily as amlodipine. If symptoms do not improve within 2 to 4 weeks, the dose may be increased up to 10 mg daily depending on the patient's response. Adjust as appropriate according to symptoms.

Precautions

This medication should not be used in certain patients. Patients with an allergy or hypersensitivity to this medication or its components should not take it. Women who are pregnant, may become pregnant, or who are breastfeeding should avoid this medication for safety. Patients in shock, including cardiogenic shock, those with severe aortic stenosis, unstable angina patients, and those who have had a recent myocardial infarction within the last month should not use this medication. Patients with severe liver dysfunction or severe hypotension are also prohibited from taking this medication. Additionally, patients with significantly reduced kidney function, the elderly, those with acute heart failure, patients in hypertensive crisis, patients with mild to moderate liver dysfunction, those with limited left ventricular function, patients with low cardiac reserve, and those with diabetes should take this medication with caution, under close medical supervision. This medication generally has good tolerability; however, it may cause facial flushing, warmth, fatigue, edema, palpitations, dizziness, headache, dyspepsia, drowsiness, and ankle swelling as side effects. Rarely, symptoms like dry mouth, increased sweating, hypotension, syncope, myalgia, skin rash, liver dysfunction, and allergic reactions have been reported, so consult a healthcare professional immediately if any abnormal symptoms occur. This medication should not be suddenly discontinued, as this can worsen symptoms. Patients with heart failure or liver dysfunction need to be particularly careful regarding dosage adjustment and supervision. Take this medication with plenty of water, and be cautious with hazardous tasks such as operating dangerous machinery or driving, as it may cause dizziness or fatigue due to its blood pressure-lowering effects. This medication may interact when used with other antihypertensives, diuretics, beta-blockers, ACE inhibitors, etc., so if you are taking other medications, be sure to inform your doctor or pharmacist. Particularly, using it with grapefruit juice may intensify the blood pressure-lowering effect, so it is advisable to avoid this combination. During pregnancy or breastfeeding, the safety of this medication has not been established, so it is recommended to avoid it. Its safety in children has also not been confirmed. In elderly patients, drug metabolism may be slower, so it is important to start with a low dose and administer it with caution. In case of overdose, severe hypotension, tachycardia, and shock may occur, so it is essential to visit a hospital immediately for appropriate treatment. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • toxic epidermal necrolysis
  • jaundice
  • hepatitis
  • severe allergic reactions
  • severe skin abnormal reactions
  • liver abnormalities
  • severe liver dysfunction
  • worsening of heart failure
Show 17 more
  • severe edema
  • difficulty breathing
  • respiratory problems
  • severe headache
  • thunderclap headache
  • seizures
  • confusion
  • vision abnormalities
  • paralysis
  • serious neurological symptoms
  • markedly reduced urine output
  • elevated blood pressure
  • severe edema
  • shock
  • loss of consciousness
  • coma
  • pulmonary edema

Mild side effects

  • Flushing accompanied by warmth
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • migraine
  • weakness
  • nausea
  • dyspepsia
Show 26 more
  • drowsiness
  • ankle swelling
  • dry mouth
  • increased sweating
  • fatigue
  • malaise
  • pain
  • weight change
  • chills
  • hypotension
  • orthostatic hypotension
  • positional dizziness
  • peripheral ischemia
  • vasculitis
  • syncope
  • tachycardia
  • peripheral edema
  • nervous tension
  • sensory loss/sensation abnormality
  • peripheral neuropathy
  • taste disturbance
  • tremors
  • paralysis
  • erectile dysfunction
  • gynecomastia
  • bowel movement

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 special container that does not allow light to enter. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius. This way of storage helps maintain the medication'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.