Medication info
Olmesartan Medoxomil/Amlo-dipine 5/40 mg Tablets

Olmesartan Medoxomil/Amlo-dipine 5/40 mg Tablets

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

MFDS item code 202000346 · Approved 2020.01.21 · Insurance code 647304450

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, one tablet with water, regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). The recommended dosage is as follows: - 5/20 mg: Given to patients whose blood pressure is not adequately controlled with Amlodipine 5 mg or Olmesartan Medoxomil 20 mg monotherapy. - 10/20 mg: Administered to patients whose blood pressure is not adequately controlled with Olmesartan Medoxomil 20 mg monotherapy.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

This medication is used in patients with essential hypertension who find it difficult to control blood pressure with either amlodipine or olmesartan medoxomil alone. It effectively lowers blood pressure and helps reduce the risk of cardiovascular diseases.

How to take

Adult dose

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

Child dose

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

Precautions

This medication can cause serious damage to the fetus and newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. It should not be taken if there is hypersensitivity to any of its components, or if the patient is pregnant or breastfeeding, has severe liver disease, aortic stenosis, bile duct obstruction, is undergoing kidney dialysis, is in a state of shock, or has certain types of diabetes. In patients who are volume or salt-depleted, hypotension may occur, so their condition should be closely monitored at the start of treatment, and appropriate measures should be taken if symptoms of hypotension arise. Acute hypotension may rarely occur due to its vasodilatory effects, so particular caution is needed in patients with aortic stenosis. In patients with severe heart disease, congestive heart failure, reduced kidney function, or impaired liver function, this medication should be used with caution. Side effects such as dizziness, headache, hypotension, orthostatic hypotension, edema, gastrointestinal disturbances, and rash may occur; if any unusual symptoms appear, consultation with a physician is advised. It is advisable for pregnant or breastfeeding women to avoid this medication, and if breastfeeding, they should either stop breastfeeding or discontinue the medication. Safety and efficacy have not been established in children under the age of 18, thus it is not recommended for this age group. Elderly patients may be more sensitive to this medication due to reduced liver, kidney, or heart function, hence starting with a low dose and careful monitoring is recommended. In case of overdose, hypotension and decreased cardiac function may occur, so immediate medical treatment should be sought. Taking this medication with grapefruit juice may excessively enhance the blood pressure-lowering effect, so it is advisable not to take them together. When combined with other medications, the potential for interactions exists, thus it is crucial to consult with a physician or pharmacist, especially with potassium-sparing diuretics, lithium, and non-steroidal anti-inflammatory drugs. Keep the medication out of the reach of children and store it in a tightly sealed container, avoiding direct sunlight and moisture.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, and urine retention.

Mild side effects

  • Dizziness
  • headache
  • reduced libido
  • drowsiness
  • sensory abnormalities
  • decreased sensation
  • nausea
  • vomiting
  • indigestion
  • diarrhea
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  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • frequent urination
  • erectile dysfunction
  • fatigue
  • weakness
  • facial edema
  • decreased potassium in the blood
  • increased serum creatinine
  • increased uric acid levels
  • increased gamma-glutamyl transferase
  • reduced hemoglobin and hematocrit
  • flushing
  • palpitations
  • vasodilation
  • vertigo
  • and fatigue.

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. To maintain the efficacy of the medication, it is best to store it at room temperature, specifically between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow 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.