Medication info
Sandoz Amlodipine Tablets 5 mg (Amlodipine Besylate)

Sandoz Amlodipine Tablets 5 mg (Amlodipine Besylate)

Prescription medicationApproval withdrawn
Ingredient · strength
Amlodipine Besylate›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
White octagonal tablet with a score line on one side
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200711536 · Notified 2007.10.23

This product's status changed to Approval withdrawn on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of myocardial ischemia caused by hypertension and coronary artery disease (stable and variant angina), and reduction of the risk of hospitalization due to angina and vascular intervention.
Who uses it
Adults
Adult dosage
Administer 5 mg orally once daily as amlodipine, and may increase to a maximum of 10 mg daily based on patient response. Adjust as appropriate according to age and symptoms.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

Treatment of myocardial ischemia caused by hypertension and coronary artery disease (stable and variant angina), and reduction of the risk of hospitalization due to angina and vascular intervention.

  • Hypertension
  • fixed closure of coronary arteries
  • vasospasm of coronary circulation
  • vascular constriction
  • myocardial ischemia
  • angina.
View approved original text

This medication is used for treating myocardial ischemia caused by hypertension and stable angina, as well as variant angina due to vasospasm. Additionally, it helps reduce the risk of hospitalization for angina in patients identified with coronary artery disease through recent angiography who do not have heart failure or have a cardiac output above 40%, and decreases the risks associated with coronary revascularization. Therefore, this drug is effective in improving cardiovascular health and preventing cardiovascular-related complications.

Dosage and Administration

Adult dosage

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

Precautions

This medication should not be used by certain patients. For example, individuals who have had allergic reactions to this drug or similar classes of medications should avoid it. Women who are pregnant, potentially pregnant, or breastfeeding should not take this drug. Patients with very poor liver function, severe aortic stenosis, and those in shock should also avoid using this drug. Additionally, patients with severe hypotension, those requiring dialysis due to renal failure, and elderly patients should exercise extra caution when taking this medication. This drug generally has good tolerability, but some patients may experience side effects such as flushing, fatigue, edema, palpitations, dizziness, headaches, drowsiness, abdominal pain, and nausea. Rarely, adverse reactions such as excessively low blood pressure, vasculitis, neurological disorders, erectile dysfunction, gastrointestinal issues, and skin rashes have been reported. It is important to consult healthcare professionals immediately if any abnormal symptoms occur while taking this medication. Patients with heart failure or impaired liver function should be especially cautious when administering this drug, and its effects may appear gradually, thus it is not suitable for emergency situations like acute angina. This drug may interact with other medications, so if you are taking other drugs, make sure to inform your healthcare provider. Particularly, taking it with grapefruit juice can increase blood pressure-lowering effects, so it is advisable to avoid this combination. Women who are pregnant or breastfeeding should be aware that the safety of this drug is not firmly established, and it is recommended to substitute with other safe medications or discontinue breastfeeding if possible. Safety in children has not yet been established, and for the elderly, routine dosing is generally appropriate. In cases of overdose, severe hypotension and cardiac problems may occur, necessitating immediate emergency treatment, and blood dialysis will not eliminate this drug, requiring specialized care. Lastly, this medication is not known to pose carcinogenic or mutagenic risks, and is considered safe when taken in appropriate doses in healthy adults.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • erythema multiforme
  • toxic epidermal necrolysis
  • dyspnea
  • difficulty breathing
  • jaundice
  • hepatitis
  • sudden and severe headaches
  • seizures
Show 4 more
  • confusion
  • visual disturbances
  • paralysis
  • generalized swelling.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 27 more
  • lethargy
  • pain
  • weight changes
  • hypotension
  • vasculitis
  • increased tension
  • sensory loss
  • dysesthesia
  • 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 should be stored in a tightly sealed container to prevent exposure to air or humidity. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White octagonal tablet with a score line on one side

Package unit

30 tablets/bottle, 100 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.