Medication info

Olmesartan Medoxomil and Amlodipine Tablets 5/40 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
Pale yellow round film-coated tablets
Packaging
30 tablets/PTP[((10 tablets/PTP) X3)]
Approval status
Expired

MFDS item code 202000604 · Approved 2020.02.04

This product's status changed to Expired on 2025.02.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of essential hypertension blood pressure control
Who takes it
Adults · Children
Adult dose
This medication is taken once daily, with or without food, and it is recommended to take it at the same time each day (e.g., morning). The recommended dosages are as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: For patients on olmesartan medoxomil 20 mg monotherapy whose blood pressure is not adequately controlled.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Improvement of essential hypertension blood pressure control

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with amlodipine or olmesartan medoxomil. This medicine effectively lowers blood pressure and helps reduce the risk of cardiovascular disease. When patients have difficulty controlling their blood pressure, taking this medication will contribute to improving their condition. It aids in maintaining a healthy lifestyle through stable blood pressure management. This medication is used in the treatment of essential hypertension.

How to take

Adult dose

This medication is taken once daily, with or without food, and it is recommended to take it at the same time each day (e.g., morning). The recommended dosages are as follows: - 5/20 mg: For patients whose blood pressure is not adequately controlled by monotherapy with amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: For patients on olmesartan medoxomil 20 mg monotherapy whose blood pressure is not adequately controlled.

Child dose

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

Precautions

This medication can cause serious harm or even death to the fetus and newborn when taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. This medication should not be administered to certain patients, such as those with allergies to the active ingredients or similar substances, pregnant or breastfeeding women, patients with severe liver or heart problems, and patients undergoing kidney dialysis, as it may pose risks. Patients with a deficiency of fluids or salts may develop low blood pressure, and their condition must be carefully monitored during the initial administration; patients with acute hypotension due to vascular dilation or those with heart diseases also require caution. This medication may cause various adverse reactions, including dizziness, headache, hypotension, gastrointestinal issues, skin rashes, myalgia, and other symptoms, so caution should be exercised. Particularly, patients with impaired kidney function or heart failure may experience worsening kidney function or electrolyte imbalance, necessitating regular check-ups. This medication can interact with other drugs, so if taking other medications, patients must inform their doctor or pharmacist, and it is advisable to avoid taking it with grapefruit juice. During pregnancy, the use of this medication may pose risks to the fetus; therefore, individuals planning to become pregnant or who are pregnant must consult with healthcare professionals. Breastfeeding women should consult with healthcare professionals regarding whether to continue breastfeeding or discontinue the medication, as it may pass into breast milk. This medication has not been established for safety and efficacy in children under 18 years of age and is not recommended for them. In elderly patients, decreased kidney and liver function may alter the drug's effects and side effects; therefore, caution during administration is needed, and starting with a lower dose is usually recommended. In case of overdose, symptoms such as hypotension and arrhythmia may occur; if symptoms present, medical attention should be sought immediately, and blood pressure and heart function need to be closely monitored. This medication should be stored in a tightly sealed container, protected from moisture and heat, and kept out of reach of children; it is advisable not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, severe allergic reactions, severe skin abnormal reactions (severe rash, blisters, skin peeling, oral/eye mucosal pain), breathlessness or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), sudden and very severe headache, seizures, confusion, vision abnormalities, paralysis, markedly reduced urine output, generalized severe swelling

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • decreased libido
  • palpitations
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
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  • constipation
  • dry mouth
  • abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • frequent urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • dependent edema
  • fatigue
  • weakness
  • facial swelling
  • decreased serum potassium
  • increased serum creatinine
  • increased serum uric acid
  • increased gamma-glutamyl transferase
  • decreased hemoglobin and hematocrit
  • flushing
  • abdominal pain

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is best kept at room temperature between 1 and 30 degrees Celsius. This storage method preserves the effectiveness of the medication safely.

Appearance and packaging

Appearance

Pale yellow round film-coated tablets

Package unit

30 tablets/PTP[((10 tablets/PTP) X3)]

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.