Medication info
New Bicaplus Tablet 5/40/12.5 mg

New Bicaplus Tablet 5/40/12.5 mg

Prescription medicationTablet경구
Ingredient · strength
Olmesartan Medoxomil›40mg / 1 tabletAmlodipine Besylate›6.944mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Pale yellow round film-coated tablet
Packaging
30 tablets/PTP [10 tablets/Alu-Alu × 3]
Approval status
Active

MFDS item code 201805261 · Approved 2018.12.26 · Insurance code 669907340

Summary

Main use
Improvement in blood pressure control for essential hypertension
Who takes it
Adults · Children
Adult dose
This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20/12.5mg: Administered to patients whose blood pressure is inadequately controlled on the combination treatment of Amlodipine/Olmesartan Medoxomil 5/20mg. - 5/40/12.5mg: Administered to patients whose blood pressure is inadequately controlled on the combination treatment of Amlodipine/Olmesartan Medoxomil 5/40mg.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 have not been established, so its administration is not recommended.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

Essential hypertension generally refers to a condition where blood pressure is persistently high. The combination therapy of amlodipine and olmesartan medoxomil is used in cases of hypertension where blood pressure is not well controlled among these patients. These medications help lower blood pressure by dilating blood vessels and reducing the burden on the cardiovascular system. Through combination therapy, blood pressure can be managed more effectively, contributing to a reduction in the risk of complications such as heart attacks or strokes. Therefore, it plays an important role in controlling blood pressure in patients with essential hypertension and is used for maintaining healthy blood pressure.

How to take

Adult dose

This medication should be taken once daily with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20/12.5mg: Administered to patients whose blood pressure is inadequately controlled on the combination treatment of Amlodipine/Olmesartan Medoxomil 5/20mg. - 5/40/12.5mg: Administered to patients whose blood pressure is inadequately controlled on the combination treatment of Amlodipine/Olmesartan Medoxomil 5/40mg.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 have not been established, so its administration is not recommended.

Precautions

This medication can cause serious harm to the fetus or newborn if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. This medication should not be used in patients with allergies to it or its components, or in those who have specific heart, kidney, or liver diseases. Patients with excessively low blood pressure, acute heart disease, severe kidney or liver dysfunction may also face risks from taking this medication. This medication lowers blood pressure, so caution is needed in patients with reduced blood volume or dehydration as hypotension may occur. Patients with impaired renal function or those who have undergone kidney transplantation should have their kidney function and electrolyte levels monitored regularly while on this medication. Use of this medication is not recommended for patients with decreased liver function, as serious side effects such as hepatic coma may occur. Because this medication has a strong blood pressure-lowering effect, caution should be taken when used in conjunction with other antihypertensive drugs, alcohol, tranquilizers, etc., as symptoms of hypotension may worsen. During treatment with this medication, dizziness or drowsiness may occur, so it is advisable to avoid driving or operating machinery or engaging in dangerous activities. This medication can cause imbalances in blood electrolytes, so regular blood tests to check sodium, potassium levels, etc., are necessary. Due to the hydrochlorothiazide component, photosensitivity may occur, so it is necessary to be mindful of UV protection during use. The safety and efficacy of this medication in pediatric patients have not been established, so it is advised that children under 18 avoid using it. The elderly may have reduced kidney and liver function, so it is recommended to start at a low dose and use it carefully. In case of overdose, severe hypotension, palpitations, electrolyte abnormalities may occur, and immediate medical treatment should be sought. This medication should be stored in a place away from moisture, heat, and direct sunlight, out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling of the skin, pain of mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, skin or eyes turning yellow (jaundice), extreme fatigue, sudden and very severe headache, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination changes

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory infections
  • nasopharyngitis
  • urinary tract infections
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
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  • neutropenia
  • agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity reactions
  • hyperkalemia
  • hypokalemia
  • loss of appetite
  • diabetes
  • hypercalcemia
  • hyperglycemia
  • hypomagnesemia
  • hyponatremia
  • hypochloremia
  • hypertriglyceridemia
  • hypercholesterolemia
  • hyperuricemia
  • hypochloremic metabolic alkalosis

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This way, the effectiveness and safety of the medication can be preserved for a longer period.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/PTP [10 tablets/Alu-Alu × 3]

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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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.