Medication info

Cevdiphin HCT Tablet 10/40/12.5mg

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

MFDS item code 201904466 · Approved 2019.06.28

This product's status changed to Expired on 2024.06.28. 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 should be taken once daily, with or without food, along with water. 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: For patients whose blood pressure is inadequately controlled with Amlodipine/Olmesartan Medoxomil 5/20mg combination therapy. - 5/40/12.5mg: For patients whose blood pressure is inadequately controlled with Amlodipine/Olmesartan Medoxomil 5/40mg.
Child dose
Safety and efficacy for pediatric patients under 18 years have not been established; hence, the use of this medication is not recommended.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

This medication is used in combination therapy with Amlodipine and Olmesartan Medoxomil when blood pressure is not adequately controlled in patients with essential hypertension. Both components work together to dilate blood vessels and effectively lower blood pressure, improving hypertension.

How to take

Adult dose

This medication should be taken once daily, with or without food, along with water. 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: For patients whose blood pressure is inadequately controlled with Amlodipine/Olmesartan Medoxomil 5/20mg combination therapy. - 5/40/12.5mg: For patients whose blood pressure is inadequately controlled with Amlodipine/Olmesartan Medoxomil 5/40mg.

Child dose

Safety and efficacy for pediatric patients under 18 years have not been established; hence, the use of this medication is not recommended.

Precautions

This drug can cause severe harm to the fetus and newborn during the 2nd and 3rd trimesters of pregnancy, so it should be discontinued immediately upon confirmation of pregnancy. Individuals with allergies to this medication or its components, pregnant women, patients with severe hypotension, or those with severely impaired cardiac or renal function should not use this drug. Patients with low blood volume or sodium may experience hypotension at the beginning of treatment, so it is important to check their condition carefully before starting the medication and to observe them closely. Patients with impaired renal function or those who have received a kidney transplant should have their blood potassium and creatinine levels monitored regularly while taking this medication, and it is recommended not to use this drug in cases of severe renal impairment. Patients with impaired liver function or progressive liver disease should be cautious as hepatic coma may occur while taking this medication, and it is advisable not to use it in cases of severe liver impairment. This medication has a blood pressure-lowering effect which may cause dizziness or symptoms of hypotension, so caution is needed while driving or operating machinery. Due to the hydrochlorothiazide component, electrolyte imbalances may occur, so sodium, potassium, and other levels should be monitored regularly through blood tests. While taking this medication, the skin may become sensitive to sunlight which could lead to photosensitivity reactions, hence prolonged sun exposure should be avoided and appropriate skin protection measures should be taken. There may be interactions with other medications, especially if the patient is taking lithium, non-steroidal anti-inflammatory drugs (NSAIDs), or other antihypertensive drugs, necessitating a consultation with a healthcare professional or pharmacist. In case of overdose, severe hypotension or cardiac arrhythmias may occur, so adherence to the prescribed dosage is essential, and any unusual symptoms should prompt immediate consultation with healthcare personnel. This medication is not recommended for children and adolescents under 18 due to lack of established safety and effectiveness. Elderly patients should start on lower doses, closely monitoring their condition.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, urination issues.

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
  • 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 or humidity, so it must be stored in a tightly closed container. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Grayish-red round film-coated tablets

Package unit

28 tablets (14 tablets/PTP X 2)/carton

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.