Medication info

Amlomin Tablet 5 mg (Amlodipine Besilate)

Prescription medicationExpired
Ingredient · strength
Amlodipine Besylate›Strength being verified
Manufacturer / importer
(주)테라젠이텍스
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201801212 · Approved 2018.03.20

This product's status changed to Expired on 2023.03.20. 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), reduction in risk of hospitalization due to angina and risk from coronary revascularization.
Who uses it
Adults
Adult dosage
Administer 5 mg orally once a day as amlodipine, and the dose may be increased to a maximum of 10 mg per day based on patient response. Adjust according to age and symptoms.

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Treatment of myocardial ischemia caused by hypertension and coronary artery disease (stable and variant angina), reduction in risk of hospitalization due to angina and risk from coronary revascularization.

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

This medication is used to improve myocardial ischemia caused by stable angina due to fixed occlusion of coronary arteries, as well as myocardial ischemia due to variant angina caused by vasospasm and vascular contraction. Additionally, it helps reduce the risk of hospitalization due to angina in patients confirmed to have coronary artery disease through angiography who do not have heart failure or have a cardiac output of less than 40%, and reduces the risks associated with coronary artery revascularization. Therefore, this medication is effective in managing cardiovascular diseases and improving patient heart health.

Dosage and Administration

Adult dosage

Administer 5 mg orally once a day as amlodipine, and the dose may be increased to a maximum of 10 mg per day based on patient response. Adjust according to age and symptoms.

Precautions

This medication should not be administered to certain patients. For instance, it is not to be used in individuals with allergies to this medication or similar types of drugs, women who are pregnant or may become pregnant, women who are breastfeeding, patients with severe liver dysfunction, patients with severe aortic stenosis, and those in shock. In addition, this medication must be used with caution. Special attention is required in patients with severe hypotension, those who require dialysis due to renal failure, and in elderly individuals. Various side effects may occur while taking this medication. The most common side effects include flushing or symptoms of vasodilation, fatigue, swelling, palpitations, dizziness, headache, drowsiness, abdominal pain, and nausea. Rarely, severe hypotension, vasculitis, neurological symptoms, erectile dysfunction, gynecomastia, dyspepsia, weight changes, skin rashes, hair loss, liver function abnormalities have been reported, and in severe cases, allergic reactions or cardiac issues may occur. Patients with heart failure or impaired liver function should use this medication with greater caution, and if blood pressure drops too low, the effects may continue even after discontinuation of the medication; thus, careful monitoring of doses and administration intervals when used with other antihypertensives is necessary. This medication is not suitable for emergency treatment as its effects may take time to manifest in acute unstable angina. It is reported that this medication does not significantly affect the ability to drive or operate machinery. This medication may interact with other drugs; therefore, it is essential to inform healthcare professionals of any medications being taken simultaneously. In particular, concomitant use with grapefruit juice should be avoided as it may increase blood pressure-lowering effects. The safety of this medication has not been established in pregnant or breastfeeding women; thus, it is advisable to avoid use in special cases, and breastfeeding should be discontinued during its use. Safety and efficacy in children have not been adequately confirmed. In the elderly, it is recommended to use the standard dosage, as tolerance is similar to that of younger patients. In cases of overdose, severe hypotension and tachycardia may occur, necessitating close monitoring of cardiac and respiratory functions and appropriate emergency measures. Hemodialysis may not be effective, therefore other treatments should be utilized. No reports of carcinogenicity or mutagenicity have been associated with prolonged use of this medication.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • skin peeling
  • pain in oral/ocular mucosa
  • difficulty breathing
  • asthma attacks
  • visual disturbances
  • jaundice
  • generalized malaise
  • sudden and severe headache
Show 12 more
  • thunderclap headache
  • seizures
  • altered consciousness
  • paralysis
  • markedly reduced urine output
  • generalized severe edema
  • increased blood pressure
  • severe allergic reactions
  • severe skin reactions
  • respiratory problems
  • liver abnormalities (jaundice)
  • severe neurological symptoms.

Mild side effects

  • Flushing
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • drowsiness
  • abdominal pain
  • nausea
  • weakness
Show 26 more
  • lethargy
  • pain
  • weight gain/loss
  • hypotension
  • vasculitis
  • hypertonia
  • sensory loss/parethesia
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • 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
  • leucopenia.

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

Storage

This medication should be stored in a tightly closed container that blocks light, at a temperature between 1 degree and 30 degrees Celsius. Storing it this way can help maintain its effectiveness and prevent degradation.

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.