Medication info

Olmesartan/Amlodipine Tablets 5/20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›20mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
White round film-coated tablets
Packaging
30 tablets/PTP[((10 tablets/PTP) x 3)]
Approval status
Expired

MFDS item code 202000603 · Approved 2020.02.04

This product's status changed to Expired on 2025.02.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered once daily, 1 tablet, with or without food, preferably at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administered as monotherapy with olmesartan medoxomil 20 mg.
Child dose
Safety and efficacy for pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used for the treatment of patients with essential hypertension whose blood pressure is not adequately controlled by monotherapy with amlodipine or olmesartan medoxomil. It helps prevent cardiovascular complications by effectively lowering blood pressure.

How to take

Adult dose

This medication is administered once daily, 1 tablet, with or without food, preferably at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Administered to patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Administered as monotherapy with olmesartan medoxomil 20 mg.

Child dose

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

Precautions

This medication can cause serious damage or death to the fetus and newborn if taken during the second and third trimesters of pregnancy, so discontinuation is required immediately upon confirmation of pregnancy. It should not be used in individuals with allergies to the active ingredients or similar compounds, those who are pregnant or breastfeeding, individuals with severe liver disease, heart valve disease, biliary obstruction, patients undergoing kidney dialysis, patients in shock, and certain diabetic patients. Patients with deficient fluid or salt may experience hypotension, so they should be closely monitored when starting this medication, and care should be taken as rapid vasodilation may also lead to hypotension. Caution is advised when administering to patients with weakened cardiac or kidney function, obstructive coronary artery disease, congestive heart failure, and those with reduced liver function. Various side effects such as dizziness, headache, hypotension, palpitations, dyspepsia, rash, and edema may occur; any abnormal symptoms should prompt immediate consultation with a medical professional. This medication may lower blood pressure, so when used in conjunction with other antihypertensive medications, careful monitoring of blood pressure, kidney function, and electrolyte status is necessary, and interactions may occur with certain drugs, which should be disclosed. This medication should not be taken during pregnancy, and if breastfeeding, caution is required as it may be excreted in breast milk and affect the infant, thus breastfeeding should be discontinued or medication should be stopped. Safety and efficacy have not been established for children under 18 years of age, and it is not recommended for them. Elderly patients may have reduced kidney and liver function, so treatment should start with a low dose and be approached cautiously. In the case of overdose, hypotension and cardiac function abnormalities may occur, requiring immediate medical attention, and treatment to raise blood pressure may be necessary if hypotension is severe. This medication should be stored away from direct sunlight and moisture, out of reach of children, and it is advisable not to transfer it to a different container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, respiratory distress, angioedema, pain in mucous membranes of mouth/eyes, severe allergic reactions, severe skin reactions, liver abnormalities (jaundice), serious neurological symptoms (dizziness, fainting), severe edema or urination abnormalities (acute renal failure, markedly reduced urine output, elevated serum creatinine), angioedema, autoimmune hepatitis

Mild side effects

  • Dizziness
  • headache
  • orthostatic hypotension
  • drowsiness
  • paresthesia
  • decreased sensation
  • fainting
  • vertigo
  • palpitations
  • rapid heartbeat
Show 25 more
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pit edema
  • fatigue
  • weakness
  • facial swelling
  • decreased potassium in blood
  • increased creatinine in blood
  • increased uric acid in blood

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 recommended to store the medication at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/PTP[((10 tablets/PTP) x 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.