Medication info

New Amlos Tablet 5mg (Esamolodipine Besylate Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
S-Amlodipine Besylate Dihydrate›7.38mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
White octagonal tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201905834 · Approved 2019.08.19

This product's status changed to Expired on 2024.08.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of myocardial ischemia due to hypertension and coronary artery disease (angina) and reduction of hospitalization risk due to angina.
Who takes it
Adults
Adult dose
This medication should be taken with sufficient quantities of water. Administer orally as 2.5 mg of Esamolodipine once daily, which can be increased to a maximum of 5 mg per day depending on the patient's response. Adjust dosage appropriately based on symptoms.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Improvement of myocardial ischemia due to hypertension and coronary artery disease (angina) and reduction of hospitalization risk due to angina.

  • Hypertension
  • fixed occlusion of coronary arteries
  • coronary vasospasm
  • myocardial ischemia
  • angina.
View approved original text

This medication is used to treat hypertension and myocardial ischemia resulting from decreased blood supply to the heart, particularly symptoms caused by stable angina or variant angina. It also helps to reduce the risk of hospitalization due to angina in patients recently diagnosed with coronary heart disease by angiography who do not have heart failure or reduced cardiac output. Additionally, it supports safe treatment by reducing risks related to coronary vascular interventions. This drug is effectively used to improve cardiovascular health and prevent complications due to angina and myocardial ischemia.

How to take

Adult dose

This medication should be taken with sufficient quantities of water. Administer orally as 2.5 mg of Esamolodipine once daily, which can be increased to a maximum of 5 mg per day depending on the patient's response. Adjust dosage appropriately based on symptoms.

Precautions

It is very important that this medication is not used in specific patients. For example, it should not be administered to women who are allergic to this drug or similar components, who are pregnant or breastfeeding, patients in shock or with serious heart problems, and those with severe liver or blood pressure issues. Additionally, patients with genetic issues like lactose intolerance should avoid using this drug. Caution is necessary when using this medication in patients with severe renal impairment, elderly individuals, acute heart failure patients, and patients with slightly impaired liver function. The drug is generally well tolerated but may cause symptoms such as warmth and facial flushing, fatigue, edema, palpitations, dizziness, headache, indigestion, drowsiness, and ankle swelling. Rarely, side effects like dry mouth, increased sweating, hypotension, insomnia, skin rash, and liver function abnormalities have been reported. Discontinuing the medication suddenly may worsen symptoms, so it must be tapered off slowly according to a doctor's instructions. Patients with reduced liver function should be cautious as this drug may have an extended duration of action in their bodies. It is advisable to take this medication with sufficient water, and patients should be careful when driving or operating dangerous machinery due to the risk of dizziness from lowered blood pressure. Furthermore, this medication can interact with several other drugs, so patients taking other medications should inform their healthcare provider. Particularly, it is advisable to avoid taking it with grapefruit juice as it may enhance the drug's efficacy. Its safety during pregnancy or breastfeeding is not established, so use should be avoided, and breastfeeding is recommended to be discontinued. For children, it is recommended only for those over 6 years of age, and in the elderly, it should start at a lower dose with careful observation of their condition. In case of overdose, serious hypotension and heart problems may occur, requiring immediate medical attention, and this drug is not removed by dialysis. Finally, this medication should be kept out of reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, toxic epidermal necrolysis, chest tightness, difficulty breathing, cold sweat, pallor, severe swelling, severe rash with high fever, blistering, skin peeling, pain in mouth/eyes, difficulty in breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice, generalized severe lethargy, sudden and extreme headache, thunderclap headache, seizures, altered consciousness.

Mild side effects

  • Flushing accompanied with warmth
  • fatigue
  • edema
  • palpitations
  • dizziness
  • headache
  • migraine
  • weakness
  • abdominal pain
  • nausea
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  • indigestion
  • drowsiness
  • dry mouth
  • increased sweating
  • weakness
  • lethargy
  • pain
  • weight gain and loss
  • chills
  • hypotension
  • orthostatic hypotension
  • postural dizziness
  • peripheral ischemia
  • vasculitis
  • syncope
  • tachycardia
  • peripheral edema
  • tension increase
  • sensory reduction
  • sensory abnormalities
  • peripheral neuropathy
  • dysgeusia
  • tremors
  • paralysis
  • extrapyramidal disorders
  • erectile dysfunction.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature within the range of 1 to 30 degrees Celsius. This way, the drug's efficacy and safety can be well preserved.

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.