Medication info
Amlodipine / Losartan Tablets 5/100 mg (Amlodipine, Losartan Potassium)

Amlodipine / Losartan Tablets 5/100 mg (Amlodipine, Losartan Potassium)

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

MFDS item code 201507871 · Approved 2015.11.25 · Insurance code 649102910

Summary

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

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is effective for patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with either amlodipine or losartan. It is also used in the initial treatment for stage 2 hypertension patients when combination therapy is needed to reach target blood pressure. Thus, it aids in managing blood pressure effectively in patients with difficult-to-control hypertension.

How to take

Adult dose

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

Child dose

The safety and effectiveness of this medication in pediatric patients under 18 years have not been established, and its administration is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially during the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. Patients with reduced blood volume, such as those on diuretics, may experience symptoms of low blood pressure when using this medication for the first time, so caution is required. Patients allergic to any of the ingredients of this medication, pregnant women or those likely to become pregnant, nursing mothers, patients with severe liver dysfunction, severe aortic stenosis, and patients in shock should not use this medication. Patients with low blood volume or those on strict salt restriction, moderate to severe renal impairment, or hyperkalemia should use this medication with caution. This medication can cause various side effects, including dizziness, headache, drowsiness, swelling, dyspepsia, skin rash, palpitations, orthostatic hypotension, and shortness of breath, so consult a doctor immediately if any unusual symptoms occur. When taking this medication, avoid hazardous tasks such as operating dangerous machinery or driving, especially if there are issues with liver or kidney function that might require dose adjustment. This medication may enhance the blood pressure-lowering effect when used with other antihypertensive drugs, so caution is warranted with co-administration. Avoid taking this medication with grapefruit or grapefruit juice, as it may excessively amplify the effects of this medication. Pregnant or nursing women should not use this medication, especially during pregnancy, to avoid potential risks to the fetus. The safety and effectiveness of this medication in children under 18 years have not been established, so it is not recommended for use in this population. In case of overdose, severe hypotension and cardiac issues may occur, so adhere strictly to the prescribed dosage, and if an overdose is suspected, visit a healthcare facility immediately. This medication should be stored out of reach of children, and do not change the storage container as it may adversely affect the quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (angioedema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, respiratory distress, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and significantly decreased 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
  • facial flushing
  • shortness of breath
  • cough
  • conjunctival injection
  • frequent urination
  • hypotension
  • sinoatrial block
  • atrioventricular block
  • precordial pain
  • diarrhea
  • loose stools
  • skin erythema
  • maculopapular rash
  • heaviness in the head
  • warmth
  • and glucose intolerance.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture exposure. Additionally, it is safest to store the medication at room temperature between 1 and 30 degrees Celsius, away from extremes of heat and cold.

Appearance and packaging

Appearance

Pale pink rectangular film-coated tablets

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.