Medication info
Orotenion Tablet 5/20 mg (Amlodipine Besilate, Olmesartan Medoxomil)

Orotenion Tablet 5/20 mg (Amlodipine Besilate, Olmesartan Medoxomil)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›20mg / 1 tablet
Manufacturer / importer
고려제약(주)
Appearance
White round film-coated tablet
Packaging
28 tablets (14 tablets/PTP × 2)
Approval status
Active

MFDS item code 201505939 · Approved 2015.08.25 · Insurance code 642802790

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is administered once daily with water, irrespective of meals. It is recommended to take it at the same time each day (e.g., morning). The recommended doses are 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg. Dosage adjustments should be made at intervals of more than 2 weeks based on the blood pressure response of the patient. For patients with renal impairment, liver impairment, or elderly patients, caution is required when adjusting the dosage.
Child dose
Safety and efficacy for pediatric patients under 18 years have not been established.

Ingredients

Manufacturer
고려제약(주)

Efficacy & effects

Improvement in blood pressure control for 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 adequately controlled with either amlodipine or olmesartan medoxomil monotherapy.

How to take

Adult dose

This medication is administered once daily with water, irrespective of meals. It is recommended to take it at the same time each day (e.g., morning). The recommended doses are 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg. Dosage adjustments should be made at intervals of more than 2 weeks based on the blood pressure response of the patient. For patients with renal impairment, liver impairment, or elderly patients, caution is required when adjusting the dosage.

Child dose

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

Precautions

This medication can cause serious harm to the fetus, especially during the 2nd and 3rd trimesters of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. Those allergic to this medication or similar drugs, individuals who are pregnant or breastfeeding, people with severe liver or heart diseases, patients undergoing renal dialysis, those in shock, and patients with certain types of diabetes should not take this medication. Hypertensive patients who are deficient in fluids or sodium may experience excessively low blood pressure at the start of treatment, so they must be monitored carefully, and appropriate measures should be taken immediately if symptoms appear. Because rapid vasodilation can lead to hypotension, individuals with problems related to the heart or blood vessels should be particularly cautious. Patients with impaired kidney function may experience changes in renal function while taking this medication, so regular examinations are necessary. Patients with decreased liver function may experience delayed metabolism of this medication, so caution is advised during administration. Various side effects such as dizziness, headache, nausea, and edema can occur while taking this medication, and if symptoms worsen, consultation with a healthcare professional is recommended. Elderly patients may be more sensitive to this medication, so dosage adjustments and close monitoring of their condition are necessary. When taking this medication with other drugs, interactions may occur, so all medications currently being taken must be reported to the healthcare professional. Taking this medication during pregnancy may cause renal damage or other serious problems in the fetus, so individuals who are planning to become pregnant or who are pregnant must consult a doctor. In breastfeeding women, this medication may pass into breast milk and affect the baby, so it is recommended to discontinue breastfeeding or to stop taking this medication. Safety and efficacy for children under 18 years have not been established, therefore its use is not recommended. Overdosing on this medication can lead to severe hypotension and cardiac issues, so dosage should be adhered to strictly, and immediate medical attention should be sought in case of overdose. This medication should be kept out of reach of children and stored in a cool, dry place away from direct sunlight and moisture.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • hair loss
  • pruritus
  • acute renal failure
  • intestinal vascular edema
  • autoimmune hepatitis
  • rhabdomyolysis
  • hyperkalemia
  • cholelithiasis
Show 13 more
  • female breast neoplasm
  • worsened cerebral infarction
  • gum bleeding
  • difficulty breathing
  • respiratory distress
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in membranes of mouth/eyes
  • yellowing of skin or eyes (jaundice)
  • extreme lethargy
  • severe swelling
  • and urinary disorders.

Mild side effects

  • Dizziness
  • headache
  • decreased libido
  • drowsiness
  • sensory disturbances
  • somnolence
  • syncope
  • vertigo
  • palpitations
  • rapid heartbeat
Show 25 more
  • hypotension
  • orthostatic hypotension
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tightness
  • limb pain
  • low back pain
  • increased urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pitting edema
  • fatigue
  • weakness
  • facial swelling
  • decreased potassium levels in blood
  • increased creatinine levels in blood
  • increased uric acid in blood

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture, and should be kept at room temperature between 1 and 30 degrees Celsius. This way, the effectiveness of the medication can be well maintained.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

28 tablets (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.