Medication info

Olmesartan Medoxomil and Amlodipine Tablets 5/40 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tablet
Manufacturer / importer
(주)팜젠사이언스
Appearance
Pale yellow round film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP × 2]
Approval status
Expired

MFDS item code 202002849 · Approved 2020.04.22

This product's status changed to Expired on 2025.04.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Amlodipine and Olmesartan Medoxomil are used for patients with essential hypertension, which occurs without a known cause. Both medications effectively lower blood pressure, helping when blood pressure is not adequately controlled. These drugs reduce burden on the heart and blood vessels, contributing to the prevention of complications. If blood pressure cannot be controlled with monotherapy, other treatment methods may also be used in combination. These medications play a significant role in managing hypertension and contribute to improving health. Therefore, they are used for the treatment of essential hypertension.

How to take

Adult dose

This medication is administered once daily, taking one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20 mg: Given to patients whose blood pressure is not adequately controlled with monotherapy of Amlodipine 5 mg or Olmesartan Medoxomil 20 mg. - 10/20 mg: Given to patients whose blood pressure is not adequately controlled with monotherapy of Olmesartan Medoxomil 20 mg.

Child dose

Safety and efficacy in pediatric patients under 18 years have not been established.

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 upon confirmation of pregnancy. Individuals who are allergic to this medication's active ingredients or similar components, who are pregnant or breastfeeding, those with severe liver dysfunction, severe aortic valve stenosis, bile duct obstruction, patients undergoing dialysis, those in a state of shock, and specific diabetes patients should not take this medication. Patients with low blood pressure or those with conditions that cause blood vessels to dilate, patients with severe obstructive coronary artery disease, congestive heart failure, impaired kidney function, and those with liver dysfunction should use this medication cautiously and consult healthcare professionals immediately if symptoms of low blood pressure or other side effects occur. This medication can cause various side effects such as dizziness, headache, low blood pressure, orthostatic hypotension, heart palpitations, dyspepsia, nausea, skin rash, and edema, so any abnormal symptoms should be reported to healthcare providers. The use of this medication is prohibited during pregnancy due to the risk of fetal damage, and it should be replaced with safer alternatives if planning to conceive or if pregnancy is suspected. If breastfeeding, it is recommended to discontinue either breastfeeding or the medication, as this drug can be transmitted through breast milk and may affect the infant. It is advised not to use in children under 18 years, as safety and efficacy have not been established for this group. Elderly patients should start with a low dose due to the potential for increased drug concentrations in the body from decreased kidney and liver function and should adjust the dose cautiously. In case of overdose, symptoms of low blood pressure and reduced heart function may arise; appropriate treatment must be sought immediately. Avoid taking this medication with grapefruit juice, as it may excessively enhance the blood pressure-lowering effect, and consult healthcare providers regarding potential interactions when taking with other medications. Store this medication in a place out of reach of children, keeping it away from moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, severe allergic reactions, severe skin reactions, jaundice, liver dysfunction, severe edema, markedly decreased urine output, severe neurological symptoms (dizziness, fainting), acute renal failure, increased blood creatinine, angioedema, autoimmune hepatitis, hives, leukopenia, thrombocytopenia, toxic epidermal necrolysis, sudden cardiac death, exacerbation of cerebral infarction, gum bleeding, acute renal failure.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • decreased libido
  • heart palpitations
  • low blood pressure
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
Show 22 more
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle stiffness
  • limb pain
  • low back pain
  • frequency of urination
  • erectile dysfunction
  • peripheral edema
  • edema
  • dependent edema
  • fatigue
  • weakness
  • facial edema
  • decreased blood potassium
  • increased blood creatinine
  • increased blood uric acid
  • increased gamma-glutamyl transferase
  • hemoglobin and hematocrit changes.

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

Storage

This medication may be sensitive to air and moisture, and should be stored in a tightly closed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

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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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.