Medication info
NovaTin Tablets (Amlodipine Besilate)

NovaTin Tablets (Amlodipine Besilate)

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

MFDS item code 200806021 · Notified 2008.05.30 · Insurance code 665001070

Summary

Main use
Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of hospitalization risk for angina and risks associated with vascular interventions.
Who takes it
Adults
Adult dose
Administer 5 mg orally once daily as amlodipine, with the maximum dose increased to 10 mg per day based on patient response. Adjust according to age and symptoms.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and variant angina), and reduction of hospitalization risk for angina and risks associated with vascular interventions.

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

This medication is used for the treatment of myocardial ischemia related to stable angina caused by hypertension and fixed obstruction of the coronary artery, as well as variant angina due to coronary vasospasm. It also helps to reduce the risk of hospitalization due to angina in patients with confirmed coronary artery disease by angiography, who do not have heart failure or have a cardiac output greater than 40%. Additionally, it aids in decreasing risks associated with coronary artery interventions, therefore it is effective in lowering cardiovascular disease risks and improving symptoms.

How to take

Adult dose

Administer 5 mg orally once daily as amlodipine, with the maximum dose increased to 10 mg per day based on patient response. Adjust according to age and symptoms.

Precautions

This medication should not be used in patients who are allergic to this drug or similar medications. Women who are breastfeeding should avoid using this medication. It should not be administered to patients with severely impaired liver function, severely narrowed aortic valves, or those in a state of shock. Patients with severe hypotension, patients requiring dialysis due to renal failure, elderly patients, pregnant women, or women who may become pregnant should use this medication with caution. This drug effectively lowers blood pressure and is generally well tolerated, but side effects such as flushing, fatigue, edema, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea may occur. Rarely, various adverse reactions like hypotension, vasculitis, neurological abnormalities, erectile dysfunction, gastrointestinal issues, elevated blood sugar, myalgia, hematological abnormalities, insomnia, and skin rashes have been reported. In heart failure patients, there may be an increase in pulmonary edema, requiring caution, and patients with liver dysfunction may need dosage adjustments due to prolonged drug half-life. The effects of this medication appear gradually, making it unsuitable for acute angina. It is known to have little effect on the ability to drive or operate machinery. This medication can interact with several other drugs, so caution is needed when taken with grapefruit juice, certain antibiotics, antihypertensives, immunosuppressants, etc. Women who are pregnant or breastfeeding are recommended to avoid this medication, with the use during pregnancy only considered when no safe alternatives are available. In children, efficacy is confirmed for those older than 6 years; safety and efficacy in children under 6 years are not known. Overdosage can lead to severe hypotension and shock, necessitating immediate medical attention to receive appropriate care. There is no evidence that this medication causes carcinogenicity or genetic abnormalities, making it safe for long-term use.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • hepatitis
  • jaundice
  • toxic epidermal necrolysis
  • difficulty breathing
  • respiratory distress
  • angioedema
  • allergic reactions
  • severe allergic reactions
Show 10 more
  • severe skin adverse reactions
  • severe edema or urinary abnormalities
  • profound lethargy
  • confusion
  • paralysis
  • severe headache
  • seizures
  • visual disturbances
  • elevated blood pressure
  • acute pulmonary edema

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 25 more
  • malaise
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension abnormalities
  • sensory loss/sensory abnormalities
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremors
  • extrapyramidal disorders
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia (gastritis)
  • gingival hypertrophy
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • muscle

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

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.