Medication info

Arosartan Tablet 5/100 Milligrams

Prescription medicationTablet경구Expired
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›100mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
Pale pink rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201903026 · Approved 2019.05.10

This product's status changed to Expired on 2024.05.10. 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 and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose is one tablet once a day, taken with water regardless of meals. It is advised to take it at the same time each day if possible (e.g., in the morning). Typically, this medication is dosed as 5/50 milligrams once a day, and if blood pressure is not sufficiently controlled after two weeks, it may be increased to 10/50 milligrams once a day.
Child dose
Safety and efficacy for pediatric patients under 18 years have not been established, so the administration of this medication is not recommended.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used in patients with essential hypertension when blood pressure cannot be sufficiently controlled with monotherapy of amlodipine or losartan. It is also used in stage 2 hypertensive patients who need to start combination therapy from the beginning to reach the target blood pressure. In summary, this medication effectively lowers blood pressure and helps manage hypertension.

How to take

Adult dose

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

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Caution is necessary when administering to patients with low blood volume, as hypotension may occur upon initial dosing. It should not be administered to patients with allergies to this medication or related drugs, pregnant or breastfeeding women, patients with severe liver dysfunction, patients with heart valve diseases, or those in a state of shock. The drug should be used with caution in patients with low blood volume or those requiring strict sodium restriction, patients with severely impaired kidney function, and patients with high serum potassium levels. There may be side effects such as dizziness, headache, drowsiness, dyspepsia, and edema, so caution is needed when driving or operating machinery. Patients with reduced liver or kidney function may have increased drug concentrations, so they should consult their physician before taking this medication. Caution is advised when taken with potassium-sparing diuretics or potassium supplements, as serum potassium levels may become dangerously high. When used with other antihypertensives, the blood pressure-lowering effect may become excessively strong; hence, it must be taken according to the physician's instructions. Pregnant or nursing women should not take this medication, and especially during pregnancy, there may be serious risks to fetal health, so consultation with healthcare professionals is vital before deciding to take it. In cases of overdose, severe hypotension, tachycardia, and shock may occur, thus requiring immediate medical attention for appropriate treatment. This medication is not recommended for children and adolescents under 18 years, as its safety and efficacy have not been established. For elderly patients with reduced kidney function, initial dosage adjustment may be necessary, and it is important to consult a physician before taking this medication. While taking this medication, regular checks of blood pressure, kidney function, liver function, and electrolyte levels should be conducted to ensure there are no abnormalities. This medication should be kept out of the reach of children and should not be transferred to another container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in mouth/eyes mucosa, severe skin adverse reactions, difficulty breathing or feeling out of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, and yellowing of the skin or eyes, extreme lethargy, liver abnormalities (jaundice), sudden and very severe headaches, thunderclap headaches,

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
  • generalized itching
  • generalized urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • frequent urination
  • drowsiness
  • cerebral infarction
  • fatigue
  • edema
  • vasculitis
  • tension increase
  • sensory decrease
  • sensory abnormality
  • peripheral neuropathy
  • syncope
  • taste disturbance

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale pink rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 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.