Medication info
Shinovafin Tablet (Amlodipine Besylate)

Shinovafin Tablet (Amlodipine Besylate)

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

MFDS item code 200707752 · Notified 2007.07.05 · Insurance code 653800900

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 due to angina and vascular interventions.
Who takes it
Adults
Adult dose
Administer 5 mg orally once daily as amlodipine, and the dosage can be increased to a maximum of 10 mg per day depending on the patient's response. Adjust according to age and symptoms.

Ingredients

Manufacturer
신일제약(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 due to angina and vascular interventions.

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

This medication is used in the treatment of myocardial ischemia caused by hypertension and stable angina due to fixed occlusion of the coronary artery, as well as variant angina due to vasospasm. It also helps reduce the risk of hospitalization due to angina in patients with confirmed coronary artery disease who have no heart failure and whose left ventricular ejection fraction is over 40%, as well as the risks associated with coronary vascular interventions. This drug is effective in managing cardiovascular diseases, improving patient symptoms, and protecting heart health.

How to take

Adult dose

Administer 5 mg orally once daily as amlodipine, and the dosage can be increased to a maximum of 10 mg per day depending on the patient's response. Adjust according to age and symptoms.

Precautions

This medication should not be used in certain patients. Patients who are allergic to this medication or similar class drugs, those with severe liver dysfunction, severe aortic stenosis, and patients in a severe shock state should not receive this treatment. Furthermore, it is advisable that breastfeeding women avoid the use of this drug. Patients with severe hypotension or those needing dialysis for renal failure, elderly patients, and pregnant women or women who may become pregnant should use this medication with caution. This drug has a blood pressure-lowering effect, and side effects such as flushing of the face, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea may occur upon use. Rarely, hypotension, vasculitis, neurological issues, gastrointestinal problems, skin rash, and liver dysfunction have been reported, so if abnormal symptoms occur, consult a doctor immediately. This medicine may remain in the system longer in patients with poor liver function, increasing the risk of side effects, and should be used with caution. The effects of this medication appear gradually and are not suitable for cases requiring rapid blood pressure reduction. It does not significantly impact driving or machinery operation ability but caution is needed as dizziness may occur. This drug can interact with several other medications, so if taking other drugs, it is essential to inform your physician or pharmacist. In particular, taking it with grapefruit juice may excessively increase the blood pressure-lowering effect, so it is advisable to avoid this combination. Pregnant or nursing women must consult medical personnel before using this medication, and it is recommended to stop breastfeeding if nursing. Use is limited to children aged 6 and older, and safety and efficacy have not been established in those under 6 years old. Overdose may lead to severe hypotension or shock, and if suspected, immediate emergency treatment should be sought; this drug is not removed by hemodialysis. While taking this medication, if any abnormal symptoms occur, immediately notify healthcare personnel, and it is important to monitor liver function and blood pressure regularly.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • hepatitis
  • jaundice
  • toxic epidermal necrolysis
  • difficulty breathing.

Mild side effects

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

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is best to maintain a storage temperature between 1 to 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.