Medication info

Oroten HCT Tablet 5/40/12.5 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Amlodipine Besylate›Strength being verifiedOlmesartan Medoxomil›Strength being verifiedHydrochlorothiazide›Strength being verified
Manufacturer / importer
고려제약(주)
Appearance
Pale yellow round film-coated tablet
Packaging
28 tablets (14 tablets/PTP × 2) / carton
Approval status
Approval withdrawn

MFDS item code 201805364 · Approved 2018.12.28

This product's status changed to Approval withdrawn on 2023.06.21. 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 uses it
Adults · Children
Adult dosage
This medication is taken once daily, with one tablet taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20/12.5 mg: administered to patients for whom blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/20 mg. - 5/40/12.5 mg: administered to patients for whom blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/40 mg.
Children's dosage
The safety and efficacy for pediatric patients under 18 years have not been established, so administration of this medication is not recommended.

Ingredients

Manufacturer
고려제약(주)

Efficacy & effects

Improvement in blood pressure control for essential hypertension

  • Essential hypertension
View approved original text

For patients with essential hypertension, if blood pressure is not adequately controlled with the combination therapy of amlodipine and olmesartan medoxomil, additional treatment may be necessary. These two drugs work by dilating blood vessels and blocking the causes of elevated blood pressure. However, sometimes blood pressure control may be difficult with either single or combination therapy alone, so it is important to consult with healthcare professionals to consider adjusting medications or exploring other treatment options. This helps manage blood pressure more effectively and reduce the risk of cardiovascular diseases. It is helpful in treating essential hypertension.

Dosage and Administration

Adult dosage

This medication is taken once daily, with one tablet taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). The recommended dosing is as follows: - 5/20/12.5 mg: administered to patients for whom blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/20 mg. - 5/40/12.5 mg: administered to patients for whom blood pressure is not adequately controlled with the combination therapy of amlodipine/olmesartan medoxomil 5/40 mg.

Children's dosage

The safety and efficacy for pediatric patients under 18 years have not been established, so 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, so it must not be taken during pregnancy. If pregnancy is confirmed, discontinue use immediately. Patients who have had allergies or hypersensitivity reactions to this medication or any of its components, women who are pregnant or breastfeeding, patients with severe hypotension or serious heart conditions, patients with severe kidney or liver diseases, and patients with electrolyte imbalances should not take this medication. Patients with reduced blood volume or electrolyte imbalances may experience hypotension; thus, the condition should be confirmed before administration, and continuous monitoring is required after treatment initiation. If hypotensive symptoms occur, rest immediately by lying down and administer fluids if necessary. This medication may affect kidney function, so patients with decreased kidney function should regularly check their kidney function and electrolyte status through blood tests. Particular caution is required when administering this medication to patients with liver disease or severe cirrhosis, certain heart valve diseases, systemic lupus erythematosus patients, and elderly individuals. This medication can cause photosensitive reactions on the skin, so avoid excessive exposure to sunlight or ultraviolet rays and consult a doctor immediately if any skin abnormalities arise. Dizziness or drowsiness may occur while taking this medication, so caution should be exercised when driving or engaging in hazardous activities. Drug interactions may occur when taken with other medications, especially lithium, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), and other antihypertensive medications; patients should consult with their doctor or pharmacist if taking these drugs. In cases of overdose, severe hypotension or heart problems may occur, requiring immediate emergency treatment, so caution is necessary to avoid exceeding the prescribed dosage. Safety and efficacy have not been established for children, and use is not recommended; elderly patients should start at a low dose considering reduced kidney and liver function. Store this medication in a location out of reach of children, and keep it away from moisture, heat, and direct sunlight.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, Quincke's edema, anaphylactic reactions, severe allergic reactions.
  • Severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes.
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, severe skin adverse reactions.
  • Shortness of breath, respiratory distress syndrome, pulmonary edema, acute respiratory distress syndrome (ARDS).
  • Yellowing of the skin or eyes (jaundice), acute hepatitis, jaundice (cholestatic jaundice).
  • Acute.

Mild side effects

  • Peripheral edema
  • headache
  • dizziness
  • upper respiratory infection
  • rhinitis
  • urinary tract infection
  • sialadenitis
  • leukopenia
  • thrombocytopenia
  • bone marrow suppression
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  • neutropenia
  • hemolytic anemia
  • aplastic anemia
  • drug hypersensitivity
  • hyperkalemia
  • hypokalemia
  • loss of appetite
  • diabetes
  • hypercalcemia
  • hyperglycemia
  • hypomagnesemia
  • hyponatremia
  • hypochloremic acidosis.

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

Pale yellow round film-coated tablet

Package unit

28 tablets (14 tablets/PTP × 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.