Medication info

Sevitan HCT Tablet 5/40/12.5 mg

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

MFDS item code 201903603 · Approved 2019.05.31

This product's status changed to Expired on 2024.05.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood pressure control in essential hypertension
Who takes it
Adults · Children
Adult dose
This medication is taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. The maximum dosage is 10/40/25 mg of amlodipine/olmesartan medoxomil/hydrochlorothiazide. The dosage should be adjusted at intervals of more than 2 weeks based on blood pressure control status. For patients with mild to moderate renal impairment, the dose can be up to 20/5/12.5 mg once daily.
Child dose
The safety and efficacy of this drug has not been established for pediatric patients under 18 years of age; therefore, its administration is not recommended.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Improvement of blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

The combination therapy of amlodipine and olmesartan medoxomil is used for controlling blood pressure in patients with essential hypertension, though there may be cases where blood pressure does not decrease sufficiently with this treatment. In such situations, additional therapeutic methods or medication adjustments may be necessary. It is crucial to maintain blood pressure within the normal range to prevent cardiovascular complications, and the combination medication aids in blood pressure control. However, as individual responses may vary, it is necessary to consult with healthcare professionals to determine the optimal treatment. These medications improve blood pressure control in essential hypertension.

How to take

Adult dose

This medication is taken once daily, one tablet with water, regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning) if possible. The maximum dosage is 10/40/25 mg of amlodipine/olmesartan medoxomil/hydrochlorothiazide. The dosage should be adjusted at intervals of more than 2 weeks based on blood pressure control status. For patients with mild to moderate renal impairment, the dose can be up to 20/5/12.5 mg once daily.

Child dose

The safety and efficacy of this drug has not been established for pediatric patients under 18 years of age; therefore, its administration is not recommended.

Precautions

This medicine can cause serious harm or death to the fetus or newborn if taken during the second and third trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Patients with allergies to this drug or any components, severe hypotension, heart valve problems, acute heart failure, or severe renal or liver dysfunction should not take this medication. Patients with low blood volume or decreased sodium may experience initial hypotensive symptoms at the start of treatment, requiring careful assessment of their condition and appropriate measures when necessary. This drug may affect kidney function; therefore, patients with impaired kidney function or kidney transplant recipients should undergo regular blood tests to monitor their kidney status. Patients with impaired liver function or liver cirrhosis should use caution due to the risk of hepatic coma, and it is advisable for those with severe liver impairment to avoid this medication. As this drug lowers blood pressure, patients with excessively low blood pressure or cardiovascular disease should be aware of dizziness or orthostatic hypotension while taking it. Patients taking this medication may experience heightened sensitivity to sunlight, so it is advisable to avoid sun exposure and use sunscreen when necessary. This drug may interact with various other medications, so patients should inform their doctor or pharmacist about any medications they are currently taking. Pregnant or breastfeeding women are advised not to take this medication, and breastfeeding mothers should either avoid taking it or discontinue nursing. The safety and efficacy of this drug has not been established for children under 18 years of age; thus, its use is not recommended. Elderly patients may have reduced renal and liver function, so it is recommended to start with a lower dose and carefully adjust the dosage. If any abnormal symptoms or side effects occur during treatment, patients should consult their healthcare provider immediately, especially for symptoms such as severe dizziness, difficulty breathing, swelling, and skin rashes. When storing this medication, keep it out of reach of children and store it away from moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, tightness in the chest, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in the mouth/eye mucosa, yellowing of the skin or eyes (jaundice), extreme fatigue, difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination problems

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory tract infection
  • nasopharyngitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
Show 18 more
  • neutropenia
  • agranulocytosis
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity
  • 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 may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to keep the storage temperature between 1 and 30 degrees Celsius to maintain the drug's efficacy for a prolonged period.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

30 tablets/PTP [(10 tablets/Alu-Alu X 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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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.