Medication info
Novas Tablets (Amlodipine Besylate)

Novas Tablets (Amlodipine Besylate)

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

MFDS item code 201906225 · Approved 2019.09.02 · Insurance code 057700390

Summary

Main use
Effectiveness in treating myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reducing the risk of hospitalization for angina and vascular interventional procedures.
Who takes it
Adults
Adult dose
Adults: 5 mg of amlodipine is administered once daily orally, and can be increased to a maximum of 10 mg per day based on the patient's response. Adjustments should be made according to age and symptoms.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Effectiveness in treating myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reducing the risk of hospitalization for angina and vascular interventional procedures.

  • Hypertension
  • fixed obstruction of the coronary artery
  • coronary vasospasm
  • vascular contraction
  • myocardial ischemia
  • angina.
View approved original text

This medication is used for myocardial ischemia caused by fixed obstruction of the coronary arteries or vasospasm (variant angina) such as hypertension or stable angina. Additionally, it helps reduce the risks of hospitalization for angina and coronary interventions in patients recently diagnosed with coronary heart disease via angiography, provided they do not have heart failure or reduced cardiac output. Therefore, this medication is effectively used to manage cardiovascular diseases and improve symptoms.

How to take

Adult dose

Adults: 5 mg of amlodipine is administered once daily orally, and can be increased to a maximum of 10 mg per day based on the patient's response. Adjustments should be made according to age and symptoms.

Precautions

This medication should not be administered to certain patients. For instance, it should not be used in patients with allergies to this medication or similar drugs, nursing mothers, patients with severe liver dysfunction, patients with severe aortic stenosis, and patients in shock. Additionally, it should be used with caution in patients with severe hypotension, those requiring dialysis for renal failure, the elderly, pregnant women, or women who may become pregnant. Especially in case of pregnancy, careful consideration is necessary, with use recommended only when no safe alternative medication is available. Various side effects can occur while taking this medication. The most common side effects include facial flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, symptoms such as decreased blood pressure, neurological problems, gastrointestinal issues, skin rashes, and liver dysfunction have been reported, so immediate consultation with a physician is required if any abnormal symptoms appear. Patients with heart failure should exercise caution as this drug may cause pulmonary edema, and patients with impaired liver function may require dose adjustments as its effects may last longer. This drug has a slow onset of action, hence it is not suitable for the treatment of acute angina. It is known to have little effect on driving or machine operation abilities, but individual responses may vary, thus caution should be exercised. This drug can interact with several other medications, so if any other drugs are being taken, the healthcare provider must be informed. Particular caution is required when used in conjunction with certain antibiotics, antihypertensives, statins, and immunosuppressants. Safety during pregnancy or lactation has not been established, so its use should be avoided whenever possible or discussed with a healthcare provider beforehand. It is recommended to discontinue breastfeeding while taking this medication. Use in children is recommended only for those aged 6 years or older, as safety and efficacy have not been established below this age. Older adults can be given the standard dosage, but caution should be taken according to their physical condition. In case of overdose, severe hypotension and cardiac problems may occur, necessitating immediate emergency treatment. This medication is not removed by hemodialysis, so professional treatment is essential.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, polymorphic erythema → severe allergic reactions; hepatitis, jaundice → liver dysfunction (jaundice); dyspnea → respiratory issues; toxic epidermal necrolysis → severe skin reactions.

Mild side effects

  • Facial flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 26 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory impairment/abnormal sensation
  • peripheral neuropathy
  • fainting
  • taste disturbance
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myalgia
  • leukopenia.

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

Storage

This medication can be sensitive to air or moisture, thus it should be stored in a tightly closed container. It is important to maintain a storage temperature of 1 to 30 degrees Celsius to preserve its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

White octagonal tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 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.