Medication info
Novagen Tablets 5 mg (Amlodipine Besilate)

Novagen Tablets 5 mg (Amlodipine Besilate)

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

MFDS item code 201404016 · Approved 2014.08.28 · Insurance code 646203620

Summary

Main use
Effective in the treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina) and in reducing the risk of hospitalization and vascular revascularization.
Who takes it
Adults
Adult dose
5 mg once daily orally as amlodipine, with a maximum dose of 10 mg daily based on the patient's response. Adjust according to age and symptoms.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

Effective in the treatment of myocardial ischemia due to hypertension and coronary artery disease (stable and unstable angina) and in reducing the risk of hospitalization and vascular revascularization.

  • Hypertension
  • fixed obstruction of the coronary arteries
  • vascular spasm
  • vascular constriction
  • myocardial ischemia
  • angina.
View approved original text

This medication is used to treat hypertension and myocardial ischemia resulting from stable angina and unstable angina. Additionally, in patients with identified coronary artery disease without heart failure or with left ventricular ejection fraction greater than 40%, it helps reduce the risk of hospitalization due to angina and decreases the risks associated with coronary artery revascularization. Therefore, it is effectively used for managing cardiovascular diseases and preventing complications.

How to take

Adult dose

5 mg once daily orally as amlodipine, with a maximum dose of 10 mg daily based on the patient's response. Adjust according to age and symptoms.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to individuals who are allergic to this drug 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 severely hypotensive patients, patients requiring dialysis due to renal failure, the elderly, and women who are pregnant or may become pregnant. When taking this drug, side effects such as flushing, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea may occur. Rarely, various adverse reactions such as hypotension, vasculitis, neurological abnormalities, erectile dysfunction, gastrointestinal issues, liver function abnormalities, and skin rashes have been reported. Patients with heart failure or impaired liver function should exercise particular caution when using this drug, and while the drug is discontinued, blood pressure may gradually decrease, so care should be taken when combined with other antihypertensive medications. This drug is not suitable for treating unstable angina that requires emergency treatment. It is known to have little impact on driving or operating machinery. This drug may interact with several other medications, so particular caution is needed when used with specific antibiotics or antihypertensives or with grapefruit juice. Grapefruit juice can significantly enhance the effects of this drug, so it is preferable to avoid consuming them together. The safety of this drug has not been established in pregnant women, so it is best not to use it except in special cases, and nursing should be discontinued while using this drug. The efficacy of this drug has not been confirmed in children under 6 years of age, while it can be administered in standard doses to children over 6 years old and the elderly. In cases of overdose, severe hypotension and cardiac problems may occur, so immediate medical assistance should be sought, and treatment such as gastric lavage or medication may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, skin peeling, pain in mouth/eye mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory problems, yellowing of the skin or eyes (jaundice), liver abnormalities (jaundice), sudden and severe headaches, thunderclap headaches, seizures, confusion, vision abnormalities, paralysis, severe neurological symptoms, markedly reduced urine output, systemic severity

Mild side effects

  • Flushing
  • fatigue
  • swelling
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory loss/sensory disturbance
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremors
  • extrapyramidal symptoms
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • arthralgia
  • low back pain
  • muscle cramps
  • myalgia

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to keep the medication at room temperature between 1°C and 30°C. Proper storage helps maintain the drug's efficacy over time.

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.