Medication info
Sinobafin Tablet 10 mg (Amlodipine Besylate)

Sinobafin Tablet 10 mg (Amlodipine Besylate)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.889mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
White octagonal tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201001950 · Notified 2010.03.08 · Insurance code 653804440

Summary

Main use
Effective in treating myocardial ischemia due to hypertension and stable/variant angina, and reducing the risk of hospitalization for angina and the risk of coronary artery revascularization.
Who takes it
Adults
Adult dose
Administer 5 mg orally once daily as amlodipine, with the possibility to increase to a maximum of 10 mg daily based on patient response. Adjust according to age and symptoms.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Effective in treating myocardial ischemia due to hypertension and stable/variant angina, and reducing the risk of hospitalization for angina and the risk of coronary artery revascularization.

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

This medication is used to treat hypertension or angina pectoris caused by coronary artery obstruction and vascular spasm. Additionally, it helps reduce the risk of hospitalization for angina and the risk following coronary artery revascularization in patients with coronary artery disease confirmed by recent angiography who do not have heart failure or have a cardiac output of over 40%. Therefore, this medication is used to improve cardiovascular health and effectively manage angina symptoms.

How to take

Adult dose

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

Precautions

This medication should not be used by certain patients. It may be dangerous for individuals allergic to this drug or similar drugs, those who are breastfeeding, individuals with severely impaired liver function, those with severely narrowed heart valves, and those in a state of shock. Patients with severe hypotension, those requiring renal dialysis, elderly patients, pregnant women or women of childbearing age should use this medication with caution. Common side effects may include flushing, fatigue, edema, palpitations, dizziness, headache, drowsiness, abdominal pain, nausea. Rarely, varied adverse reactions such as lethargy, decreased blood pressure, sensory disturbances, erectile dysfunction, dry mouth, hyperglycemia, joint pain, skin rashes may occur, necessitating consultation with a physician upon occurrence of unusual symptoms. Heart failure patients may exhibit symptoms of pulmonary edema with long-term use of this medication, so caution is required. Patients with liver dysfunction may experience prolonged drug effects, requiring dosage adjustments and careful monitoring. This drug lowers blood pressure gradually and is not suitable for situations where rapid blood pressure reduction is needed. While it has minimal impact on driving or operating machinery, care should be taken if dizziness occurs. This drug may interact with several other medications; particularly, the combination with grapefruit juice may enhance blood pressure lowering effects, so it is advisable to avoid concurrent use. The risk of hypotension may increase when combined with certain drugs, so patients should inform healthcare professionals of all medications they are taking. Safety during pregnancy has not been established, so it should only be used during pregnancy when truly necessary, and it is recommended to stop breastfeeding when taking this medication. Effectiveness has been confirmed in children aged 6 and older, but it is not to be used in children under 6 years of age. Overdose can cause severe hypotension and cardiac problems, requiring immediate emergency treatment, and this medication is not removed by dialysis, so prompt medical action is crucial.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • toxic epidermal necrolysis
  • jaundice
  • hepatitis
  • severe edema
  • severe allergic reactions
  • liver dysfunction
  • severe skin reactions.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • lethargy
Show 26 more
  • malaise
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory decrease
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremor
  • extrapyramidal disorder
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • dyspepsia
  • gingival hyperplasia
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • low back pain
  • muscle cramps
  • myalgia.

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 storage at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White octagonal tablet

Package unit

30 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.