Medication info
Hiroten Tablet 5/100 Milligram (Amlodipine, Losartan Potassium)

Hiroten Tablet 5/100 Milligram (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Pale pink rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201502665 · Approved 2015.04.30

Summary

Main use
Improvement in blood pressure control for essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dosage of this drug is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Typically, this drug 5/50 milligrams is administered once daily, and if blood pressure is not sufficiently controlled after two weeks, the dosage may be increased to 10/50 milligrams once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, and thus, the administration of this drug is not recommended.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement in blood pressure control for essential hypertension and stage 2 hypertension

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medicine is used in patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with either amlodipine or losartan. Additionally, it is used as a first-line treatment for patients with stage 2 hypertension who require combination therapy to reach the target blood pressure. In other words, it helps to effectively manage hypertension and stabilize blood pressure.

How to take

Adult dose

The recommended dosage of this drug is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Typically, this drug 5/50 milligrams is administered once daily, and if blood pressure is not sufficiently controlled after two weeks, the dosage may be increased to 10/50 milligrams once daily.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years of age, and thus, the administration of this drug is not recommended.

Precautions

This drug can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, and in severe cases may lead to death. If pregnancy is confirmed, discontinuation must occur immediately, and women of childbearing potential should not use this drug. Patients with reduced effective circulating blood volume, such as those on diuretics, may experience low blood pressure when initially starting this medication, requiring caution. It should not be administered to patients with known allergies to any of the components, severe liver dysfunction, severe aortic stenosis, or those in a state of shock. As it may cause a drop in blood pressure and dizziness, patients should avoid high-risk activities such as operating dangerous machinery or driving. Patients with pre-existing kidney dysfunction or hyperkalemia should periodically monitor their kidney function and serum potassium levels while using this medication. When taken with other antihypertensive medications, the effect may be enhanced; therefore, it should be managed carefully under the supervision of a specialist. It is advisable to avoid drinking grapefruit juice while taking this medicine, as it may lead to excessive blood pressure lowering effects. If severe allergic reactions or symptoms of angioedema occur while using this medication, immediate medical attention must be sought. This drug is not recommended for breastfeeding women, and safety has not been adequately established for pediatric patients or elderly patients over the age of 75, necessitating caution. In case of overdose, severe hypotension and tachycardia may occur; therefore, adherence to the prescribed dosage is crucial, and any abnormal symptoms should prompt an immediate visit to the hospital. This medication should be stored out of reach of children, and transferring to other containers is not advisable as it may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, dyspnea, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and drastically reduced urine output.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
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  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • conjunctival injection
  • polyuria
  • somnolence
  • hypotension
  • sinoatrial block
  • atrioventricular block
  • abdominal discomfort
  • precordial pain
  • diarrhea
  • loose stools
  • constipation
  • skin erythema
  • maculopapular rash
  • heaviness
  • and warmth.

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture, at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

Pale pink rectangular film-coated tablet

Package unit

30 tablets/bottle

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.