Medication info
Olmesartan Medoxomil/Amlodipine Tablet 5/40 mg

Olmesartan Medoxomil/Amlodipine Tablet 5/40 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Pale yellow, round film-coated tablet
Packaging
28 tablets/PTP
Approval status
Active

MFDS item code 201500379 · Approved 2015.01.26 · Insurance code 649508520

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is to be taken once daily as one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., morning) if possible. The recommended dosages are 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 olmesartan medoxomil 20 mg.
Child dose
Safety and efficacy for pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Patients with essential hypertension may use this medication if blood pressure is not adequately controlled by monotherapy with amlodipine or olmesartan medoxomil. This drug effectively manages hypertension to stabilize blood pressure and reduce cardiovascular burden. Consistent use contributes to improving hypertension and preventing complications. Therefore, this medication is used for treating essential hypertension.

How to take

Adult dose

This medication is to be taken once daily as one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., morning) if possible. The recommended dosages are 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 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 harm to the fetus and newborn during the second and third trimesters of pregnancy, so it must be promptly discontinued upon confirmation of pregnancy. Do not use this medication if you are allergic to any of its active ingredients or similar substances, are pregnant or breastfeeding, have serious liver or heart problems, or are undergoing kidney dialysis. Caution is required when administering this drug to patients who are dehydrated or depleted of electrolytes, as blood pressure may drop too low; appropriate measures should be taken if hypotension develops. Because this medication can cause vasodilation leading to a sudden drop in blood pressure, patients with heart valve issues should use it with caution. Use of this medication should be approached with caution in patients with weakened heart function, and those with impaired kidney function should be closely monitored for changes in renal function. Patients with impaired liver function should also use this medication cautiously, as it is metabolized by the liver and may affect liver function. While taking this medication, dizziness, headache, hypotension, edema, dyspepsia, skin rash, and other side effects may occur; any unusual symptoms should prompt immediate consultation with a physician. This medication may interact with many other drugs; if you are taking any other medications, be sure to inform your doctor or pharmacist. Avoid using this medication during pregnancy; if you are planning to become pregnant or are pregnant, discuss alternative treatment options. For breastfeeding women, it is recommended to discontinue breastfeeding or to stop the medication as it may be excreted in breast milk. Safety and efficacy have not been established for children under 18 years of age, and its use is not recommended. Elderly patients (65 years and older) may have increased sensitivity to this medication, so dosage adjustments and careful monitoring are necessary. In case of overdose, there may be a rapid drop in blood pressure and increased heart rate, necessitating immediate medical attention, along with continuous monitoring of blood pressure and heart function. This medication should be kept out of reach of children, stored in a tightly sealed container, and protected from direct sunlight and moisture. Avoid transferring to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • acute renal failure
  • increased serum creatinine
  • autoimmune hepatitis
  • toxic epidermal necrolysis
  • hair loss
  • hyperkalemia
  • acute renal failure
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  • leukopenia
  • thrombocytopenia
  • severe allergic reactions
  • severe skin reactions
  • liver abnormalities (jaundice)
  • serious neurological symptoms
  • severe edema or urinary abnormalities.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • altered sensation
  • diminished perception
  • decreased libido
  • lightheadedness
  • palpitations
  • rapid pulse
  • hypotension
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  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • epigastric pain
  • rash
  • muscle tension
  • limb pain
  • lower back pain
  • polyuria
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pitting edema
  • fatigue
  • weakness
  • facial edema
  • decreased serum potassium
  • increased serum creatinine
  • increased serum uric acid
  • gamma-glutamyltransferase elevation.

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale yellow, round film-coated tablet

Package unit

28 tablets/PTP

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.