Medication info
Olmesartan Medoxomil and Amlodipine Tablets 5/20 mg

Olmesartan Medoxomil and Amlodipine Tablets 5/20 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
White round film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP×2]
Approval status
Active

MFDS item code 202000345 · Approved 2020.01.21 · Insurance code 647304460

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosage is as follows: - 5/20 mg: for patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Olmesartan Medoxomil 20 mg. - 10/20 mg: for patients on monotherapy with Olmesartan Medoxomil 20 mg.
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years of age.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medicine is used to effectively control blood pressure in patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy using either Amlodipine or Olmesartan Medoxomil.

How to take

Adult dose

This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosage is as follows: - 5/20 mg: for patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Olmesartan Medoxomil 20 mg. - 10/20 mg: for patients on monotherapy with Olmesartan Medoxomil 20 mg.

Child dose

Safety and efficacy have not been established in 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, so it must be discontinued immediately once pregnancy is confirmed. It should not be used in patients with allergies to any of the ingredients, those who are pregnant or nursing, severe liver disease, aortic stenosis, biliary obstruction, patients on kidney dialysis, in shock, or certain diabetic patients. In patients with fluid or salt depletion, hypotension can occur, so careful monitoring is required at the start of treatment. As vasodilation may lead to hypotension, patients with heart valve disease should be particularly cautious. Patients with heart failure or coronary artery disease may also experience worsening of their condition while taking this medication, so it should be used cautiously. Patients with impaired kidney function are at a higher risk of worsening kidney function, thus regular monitoring of kidney condition is necessary. Patients with reduced liver function should also be cautious while taking this medication. While taking this medication, various side effects may occur, including dizziness, headache, hypotension, edema, dyspepsia, rash, etc., and consultation with a doctor or pharmacist is advised if any abnormal symptoms develop. Regular blood tests and blood pressure measurements are required, especially due to the risks of hyperkalemia, changes in kidney function, and blood pressure drop. During pregnancy, this medication can have serious effects on the fetus, so those planning to become pregnant or who are pregnant should definitely consult their healthcare provider. If breastfeeding, it is advised to discontinue either breastfeeding or the medication due to the possibility of the drug being passed through breast milk. Its safety and efficacy have not been established in children under 18 years of age, so it is not recommended. In the elderly, due to possible impairment of kidney and liver function, treatment should start at a lower dose and be carefully monitored. In case of overdose, severe hypotension, vascular dilation, arrhythmias may occur, and immediate medical attention is required. This medication should be stored in a tightly closed container to protect from moisture and heat and kept out of reach of children, and it is best not to transfer the medication to another container. This medication may interact with other antihypertensive drugs or specific medications, so it is crucial to inform healthcare providers about any concomitant medications. In particular, taking this medication with grapefruit juice may enhance its effects, so it is advisable not to consume them together.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, markedly reduced urine output.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • decreased libido
  • palpitations
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
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  • dry mouth
  • upper abdominal pain
  • rash
  • urticaria
  • muscle tension
  • limb pain
  • back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pit edema
  • fatigue
  • weakness
  • facial swelling
  • decreased potassium levels
  • increased blood creatinine
  • increased blood uric acid
  • elevated gamma-glutamyltransferase
  • decreased hemoglobin and hematocrit
  • orthostatic hypotension.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. This way of storage helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

28 tablets/box [14 tablets/PTP×2]

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.