Medication info

Prodipin Tablet (Amlodipine Besylate)

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

MFDS item code 201403498 · Approved 2014.07.30

This product's status changed to Expired on 2024.07.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of ischemic heart disease caused by hypertension and coronary artery disease (stable and variant angina pectoris) and reduction of risks associated with angina hospitalization and vascular procedure.
Who takes it
Adults
Adult dose
Adults: The usual oral dose is 5 mg once a day as amlodipine, which may be increased to a maximum of 10 mg once a day depending on the patient's response. Adjustments should be made according to age and symptoms.

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

Treatment of ischemic heart disease caused by hypertension and coronary artery disease (stable and variant angina pectoris) and reduction of risks associated with angina hospitalization and vascular procedure.

  • Hypertension
  • fixed closure of coronary arteries
  • vasospasm
  • vascular contraction
  • myocardial ischemia
  • angina pectoris
View approved original text

This medication is used to treat symptoms of myocardial ischemia due to hypertension, stable angina pectoris from coronary artery narrowing or blockage, and variant angina pectoris due to sudden vascular spasms. It also helps reduce the risk of hospitalization due to angina for patients with confirmed coronary heart disease through angiography who do not have heart failure or have cardiac output of more than 40%, and reduces the risks associated with coronary vascular procedures. This medication is effectively used to improve the symptoms of these cardiovascular diseases and reduce risk.

How to take

Adult dose

Adults: The usual oral dose is 5 mg once a day as amlodipine, which may be increased to a maximum of 10 mg once a day depending on the patient's response. Adjustments should be made according to age and symptoms.

Precautions

This medication is a dihydropyridine calcium channel blocker that lowers blood pressure and reduces the burden on the heart. There may be instances where this medication should not be taken. Individuals who are allergic to this medication or similar medications, nursing women, those with severe liver dysfunction, patients with severe aortic stenosis, and patients in shock should not take this medication. Particularly, patients with very low blood pressure, those requiring renal dialysis, the elderly, and women who are pregnant or may become pregnant should use this medication with caution. When using this medication, side effects such as flushing, fatigue, edema, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea may occur. Rarely, various adverse reactions such as hypotension, vasculitis, neurological abnormalities, erectile dysfunction, gynecomastia, indigestion, weight changes, and skin rashes have been reported. In patients with heart failure, there may be an increased risk of pulmonary edema after taking this medication, so caution is needed. In patients with impaired liver function, drug metabolism may be slowed, necessitating dose adjustments. This medication lowers blood pressure gradually and is not suitable for the treatment of acute angina. Furthermore, taking it with grapefruit juice can excessively increase the drug's effect, so it should be avoided. When taking this medication with other drugs, interactions may occur; it is especially important to consult a doctor or pharmacist when taking it with certain antibiotics, blood pressure medications, immunosuppressants, and statins. Women who are pregnant or nursing have not established safety for this medication, so it should only be taken as prescribed by a doctor in necessary situations, and breastfeeding is recommended to be discontinued. In case of overdose, severe hypotension, tachycardia, and a shock state may occur, so immediate medical attention is required, and emergency treatment may be necessary. This medication is also available for use in children, but the efficacy and safety in children under 6 years of age have not been sufficiently established. The elderly can also take it at usual doses, but they should be cautious of potential side effects. Special precautions are not necessary when driving or operating machinery, but caution is advised if dizziness or drowsiness occurs.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, erythema multiforme, toxic epidermal necrolysis, skin peeling, severe rash with fever, pain in oral/ocular mucosa, difficulty breathing, respiratory distress, jaundice, hepatitis, sudden and severe headache, lightning-like headache, seizures, confusion, vision disturbances, paralysis, significantly decreased urine output, severe swelling throughout the body, and accompanied by increased blood pressure

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
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  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • tension increase
  • sensory loss/sensory abnormalities
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremors
  • extrapyramidal symptoms
  • erectile dysfunction
  • gynecomastia
  • changes in bowel habits
  • dry mouth
  • indigestion
  • gingival hypertrophy
  • pancreatitis
  • vomiting
  • hyperglycemia
  • joint pain
  • low back pain
  • muscle cramps
  • muscle pain
  • leukopenia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is best to store it at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness and ensure its safe use.

Appearance and packaging

Appearance

White octagonal tablet

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.