Medication info
Amrovica HCT Tablets 10/40/12.5 Milligrams

Amrovica HCT Tablets 10/40/12.5 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletOlmesartan Medoxomil›40mg / 1 tabletHydrochlorothiazide›12.5mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Grayish-red round film-coated tablet
Packaging
28 tablets (14 tablets/PTP *2)
Approval status
Active

MFDS item code 201805285 · Approved 2018.12.26 · Insurance code 653404260

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is taken once daily, one tablet, regardless of meals, preferably at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20/12.5mg: For patients not adequately controlled with combined therapy of Amlodipine/Olmesartan Medoxomil 5/20mg. - 5/40/12.5mg: For patients not adequately controlled with combined therapy of Amlodipine/Olmesartan Medoxomil 5/40mg.
Child dose
The safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Combination therapy of Amlodipine and Olmesartan Medoxomil is used when blood pressure is not adequately controlled in patients with essential hypertension. These medications work to dilate blood vessels and lower blood pressure, helping effectively manage hypertension. When blood pressure is uncontrolled, this combination therapy can reduce the risk of cardiovascular disease and maintain health.

How to take

Adult dose

This medication is taken once daily, one tablet, regardless of meals, preferably at the same time each day (e.g., in the morning). The recommended dosages are as follows: - 5/20/12.5mg: For patients not adequately controlled with combined therapy of Amlodipine/Olmesartan Medoxomil 5/20mg. - 5/40/12.5mg: For patients not adequately controlled with combined therapy of Amlodipine/Olmesartan Medoxomil 5/40mg.

Child dose

The safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn during the second and third trimesters of pregnancy, therefore, it must be stopped immediately if pregnancy is confirmed. Those allergic to this medication or similar ingredients should not take it. It is safest not to use this medication in pregnant or nursing individuals, patients with severe hypotension, or those with severe heart, kidney, or liver impairment. Patients with reduced blood volume or those taking diuretics should be closely monitored for hypotension upon initial use of this medication. Patients with impaired kidney function, those who have undergone kidney transplants, patients with renal artery hypertension, and those with impaired liver function should use this medication with caution, and regular blood tests and kidney function checks are necessary. This medication lowers blood pressure, which may cause dizziness or drowsiness; caution is advised when engaging in activities such as working at heights or driving. While taking this medication, interactions with other medications may occur, particularly when taking lithium, non-steroidal anti-inflammatory drugs, or other antihypertensives, so it is advisable to consult a doctor or pharmacist. Nursing women should avoid taking this medication or consider stopping breastfeeding, as the ingredients may pass into breast milk. Use in children under 18 years of age is not recommended as the safety and efficacy of this medication have not been established. Elderly patients may have reduced kidney and liver function; it is recommended to start at a low dose and monitor their condition closely. In the event of an overdose, severe hypotension and cardiac arrhythmias may occur, and immediate medical attention is required. This medication should be stored away from direct sunlight and moisture, in a place inaccessible to children, and should not be transferred to another container for safety. Additionally, this medication may cause various side effects such as skin hypersensitivity reactions, photosensitivity, electrolyte imbalances, and liver function abnormalities in some patients, so any unusual symptoms should be reported to healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema, Quincke's edema → severe allergic reactions
  • Severe rash, blistering, skin peeling, pain in mouth/eyes mucosa with high fever → severe skin reactions
  • Shortness of breath, respiratory distress syndrome, acute respiratory distress syndrome (ARDS), pulmonary edema → respiratory problems
  • Jaundice (cholestatic jaundice), hepatitis → liver abnormalities (jaundice)
  • Myocardial infarction, angina, cerebral infarction, thrombosis, embolism → serious cardiovascular abnormalities
  • Heart

Mild side effects

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

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

Storage

This medication may be sensitive to air and moisture and should be stored in a tightly sealed container. It is best to keep the storage temperature between 1 and 30 degrees Celsius. This way, the efficacy of the medication can be well maintained and used safely.

Appearance and packaging

Appearance

Grayish-red 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.