Medication info

All-Duo Tablet 5/20 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Olmesartan Medoxomil›20mg / 1 tabletAmlodipine Maleate›6.42mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
White, round film-coated tablet
Packaging
28 tablets/((14 tablets/Alu-Alu)x2)
Approval status
Approval withdrawn

MFDS item code 201405460 · Approved 2014.11.24

This product's status changed to Approval withdrawn on 2024.03.29. 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
The medication is administered once daily, 1 tablet with or without food. 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 amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: administered to patients with olmesartan medoxomil 20 mg alone.
Child dose
Safety and efficacy for pediatric patients under 18 years of age have not been established.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled with amlodipine or olmesartan medoxomil monotherapy. It effectively lowers blood pressure to reduce the risk of cardiovascular disease and aids in stable blood pressure management. It contributes to improving health by adjusting appropriately to the patient's blood pressure condition.

How to take

Adult dose

The medication is administered once daily, 1 tablet with or without food. 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 amlodipine 5 mg or olmesartan medoxomil 20 mg monotherapy. - 10/20 mg: administered to patients with olmesartan medoxomil 20 mg alone.

Child dose

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

Precautions

This drug can cause serious harm or death to the fetus or newborn if taken during the second or third trimester of pregnancy; therefore, it must be discontinued immediately if pregnancy is confirmed. Do not take this medication if you are allergic to the active ingredients or similar drugs, are pregnant or breastfeeding, have severe liver impairment, or have certain heart diseases. Patients who are depleted of fluid or salt should be monitored closely as this medication can cause significant drops in blood pressure initially. Rare instances of rapid vascular expansion leading to severe drops in blood pressure have been reported, particularly caution is advised for patients with specific heart diseases. Patients with heart failure or impaired kidney function may experience changes in kidney function when taking this medication, so caution is required. Side effects such as dizziness, headache, hypotension, edema, and indigestion may occur during treatment; if you experience any unusual symptoms, consult your physician. The amlodipine component may increase blood pressure-lowering effects when taken with grapefruit juice, so it is advisable to avoid grapefruit juice. If you are pregnant, using this medication may pose a risk to the fetus; therefore, it is necessary to consult a doctor if you are planning to become pregnant or are already pregnant. Breastfeeding mothers should consult their doctor about the possibility of this drug passing into breast milk, considering stopping breastfeeding or discontinuing the drug. The drug is not recommended for children under 18 years of age as safety and efficacy have not been established. Elderly patients should use caution as reduced kidney and liver function may lead to increased serum concentrations of the drug; starting at a low dose is advisable. In cases of overdose, severe hypotension and vascular expansion may occur, requiring immediate medical assistance, and continuous monitoring of heart and respiratory function is necessary. Store this medication in a sealed container away from direct sunlight and moisture, and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, severe allergic reactions, angioedema, cholelithiasis, exacerbation of cerebral infarction, gum bleeding, serious skin adverse reactions, hair loss, jaundice, liver abnormalities, elevated liver enzymes, leukopenia, thrombocytopenia, toxic epidermal necrolysis, acute renal failure, kidney abnormalities, severe edema, serious neurological symptoms (dizziness, fainting, exacerbation of cerebral infarction), dyspnea, asthma attacks, hyperkalemia

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • sensory disturbances
  • hypotension due to vasodilation
  • orthostatic hypotension
  • nausea
  • vomiting
  • indigestion
  • diarrhea
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  • constipation
  • dry mouth
  • upper abdominal pain
  • rash
  • muscle tension
  • limb pain
  • low back pain
  • polyuria
  • erectile dysfunction
  • fatigue
  • weakness
  • facial edema
  • decreased serum potassium
  • increased serum creatinine
  • increased serum uric acid
  • elevated gamma-glutamyl transferase
  • decreased hemoglobin and hematocrit
  • flushing
  • palpitations

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. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White, round film-coated tablet

Package unit

28 tablets/((14 tablets/Alu-Alu)x2)

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.