Medication info

Sabetec Tablet 5/20 Milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
White round film-coated tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Expired

MFDS item code 201405081 · Approved 2014.10.31

This product's status changed to Expired on 2024.10.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control of essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered as one tablet once daily, regardless of meals, and it is recommended to take it at the same time daily (e.g., in the morning). The recommended dosing is as follows: - 5/20 milligrams: Administered to patients whose blood pressure is not adequately controlled with amlodipine 5 milligrams or olmesartan medoxomil 20 milligrams monotherapy. - 10/20 milligrams: Administered to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 milligrams monotherapy.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Improvement in blood pressure control of essential hypertension

  • Essential hypertension
View approved original text

This medication is used to effectively lower blood pressure in patients with essential hypertension who are inadequately controlled with amlodipine or olmesartan medoxomil monotherapy. By doing so, it helps reduce the risk of cardiovascular complications and improves the overall health of patients.

How to take

Adult dose

This medication is administered as one tablet once daily, regardless of meals, and it is recommended to take it at the same time daily (e.g., in the morning). The recommended dosing is as follows: - 5/20 milligrams: Administered to patients whose blood pressure is not adequately controlled with amlodipine 5 milligrams or olmesartan medoxomil 20 milligrams monotherapy. - 10/20 milligrams: Administered to patients whose blood pressure is not adequately controlled with olmesartan medoxomil 20 milligrams monotherapy.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately if pregnancy is confirmed. It should not be taken in cases of allergy to the active ingredients or similar substances, during pregnancy or breastfeeding, severe liver impairment, aortic stenosis, biliary obstruction, in patients undergoing renal dialysis, patients in a state of shock, or in certain diabetic patients. Close monitoring is essential when starting treatment in patients with fluid or salt depletion, as hypotension may occur; if hypotension develops, appropriate measures should be taken. Rapid vasodilation may cause hypotension, so patients with aortic stenosis should be particularly cautious. Patients with severe obstructive coronary artery disease may have an increased risk of angina or myocardial infarction upon initial dosing or dosage increase. Patients with heart failure should use it cautiously, and patients with impaired kidney function may also experience changes in renal function, requiring caution. Patients with decreased liver function should be cautious as the medication may remain in the body for a prolonged period. Side effects such as dizziness, headache, hypotension, nausea, rash, swelling, etc., may occur during the course of treatment, and any unusual symptoms should be reported to healthcare professionals. Grapefruit juice should be avoided as it may excessively increase the effects of the medication. It is generally advised not to use this medication during pregnancy, and if planning pregnancy or if pregnancy is confirmed, consultation with healthcare professionals is mandatory. Breastfeeding mothers should discontinue either breastfeeding or the medication, as it can be transferred via breast milk. Safety and efficacy for children under 18 years of age have not been established, and it is best to avoid administering this medication to them. Elderly patients may have decreased renal and liver function, so starting at a lower dose and careful monitoring is advised. Overdose may result in hypotension and arrhythmias; immediate treatment at a hospital is required, and blood pressure-raising treatment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, severe allergic reactions, severe skin adverse reactions, yellowing of the skin or eyes (jaundice), liver abnormalities (jaundice), acute renal failure, angioedema, oliguria, severe edema accompanied by elevated blood pressure, serious neurological symptoms (severe headache, seizures, confusion, visual disturbances, paralysis), severe edema or urination abnormalities

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • altered sensation
  • reduced libido
  • palpitations
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
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  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pitting edema
  • fatigue
  • weakness
  • facial swelling
  • decreased serum potassium
  • elevated serum creatinine
  • increased serum uric acid
  • elevated gamma-glutamyltransferase
  • hemoglobin

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

Storage

This medication may be sensitive to air or moisture and should be stored in a sealed container. It is best kept at room temperature, neither too hot nor too cold, that is, between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/PTP × 3)

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.