Medication info

Dubika Tablet 10/40mg

Prescription medicationTablet경구Expired
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›13.888mg / 1 tablet
Manufacturer / importer
삼아제약(주)
Appearance
Brownish-red round film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP x 2], 30 tablets/bottle
Approval status
Expired

MFDS item code 201500290 · Approved 2015.01.20

This product's status changed to Expired on 2025.01.20. 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 with one tablet, regardless of meals, preferably at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Prescribed for patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Prescribed for patients not adequately controlled with olmesartan medoxomil 20 mg.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Amlodipine or Olmesartan Medoxomil is used in patients with essential hypertension when blood pressure control is difficult with monotherapy. These medications effectively lower blood pressure, reduce the risk of cardiovascular diseases, and help improve patients' health. Therefore, they are used for the treatment of essential hypertension.

How to take

Adult dose

This medication is administered once daily with one tablet, regardless of meals, preferably at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20 mg: Prescribed for patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or olmesartan medoxomil 20 mg. - 10/20 mg: Prescribed for patients not adequately controlled with olmesartan medoxomil 20 mg.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second or third trimester of pregnancy, so it must be discontinued immediately upon confirmation of pregnancy. This drug should never be taken if there is an allergy to its main ingredients or similar substances, or if the person is pregnant or breastfeeding. Patients with severely impaired liver or kidney function, certain heart diseases or biliary obstruction, and specific genetic metabolic disorders should also avoid using this drug. In patients with insufficient body fluids or salts, hypotension may occur, so it is essential to closely monitor their condition during initial administration, and take appropriate action immediately if hypotension occurs. Due to its vasodilating effect, caution is required in patients with severe aortic stenosis, coronary artery disease, or congestive heart failure. Patients with impaired kidney function may have a risk of worsening kidney function, so regular monitoring is needed during the use of this drug. This medication may cause side effects such as dizziness, headache, hypotension, edema, and gastrointestinal disorders, so if any unusual symptoms arise, patients should consult a healthcare provider. This medication may interact with other drugs, so patients should inform their healthcare provider of any other medications they are taking, particularly when combined with blood pressure medications, diuretics, or potassium-sparing agents. Women who are pregnant or planning to become pregnant are recommended to use other blood pressure medications that have demonstrated safety instead of this one. Breastfeeding women should consider discontinuing breastfeeding or stopping the use of this medication due to its potential to be transferred through breast milk. It is advisable not to use this medication in pediatric patients under 18 years of age as safety and efficacy have not been established. In elderly patients, lower doses should be started considering reduced kidney and liver function, and their condition should be closely monitored. In case of overdose, severe hypotension and vascular dilation may occur, so immediate medical attention is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • decreased libido
  • orthostatic hypotension
  • decreased blood potassium
  • increased blood creatinine
  • increased blood uric acid
  • increased gamma-glutamyl transferase
  • decreased hemoglobin
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  • thrombocytopenia
  • nausea
  • vomiting
  • dyspepsia
  • diarrhea
  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • increased urination
  • erectile dysfunction
  • peripheral edema
  • swelling
  • pitting edema
  • fatigue
  • weakness
  • facial swelling
  • angioedema
  • hair loss

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is essential to maintain the storage temperature between 1 to 30 degrees Celsius to ensure the effectiveness of the medication is retained and it can be used safely.

Appearance and packaging

Appearance

Brownish-red round film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2], 30 tablets/bottle

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.