Medication info
Amlozal Tablet 5/50 mg (Amlodipine Besylate, Losartan Potassium)

Amlozal Tablet 5/50 mg (Amlodipine Besylate, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201502658 · Approved 2015.04.30 · Insurance code 650303310

Summary

Main use
Improvement in 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 every day (e.g., morning). Generally, this medication is administered at 5/50 mg once daily, and if blood pressure remains insufficiently controlled after two weeks, the dose may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy for patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medicine is used for patients with essential hypertension who find it difficult to control blood pressure with either amlodipine or losartan alone. Additionally, it is effective when administered in a combination form from the onset to patients with stage 2 hypertension to reach target blood pressure. Therefore, it helps improve hypertension effectively.

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 every day (e.g., morning). Generally, this medication is administered at 5/50 mg once daily, and if blood pressure remains insufficiently controlled after two weeks, the dose may be increased to 10/50 mg once daily.

Child dose

Safety and efficacy for patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus during pregnancy, especially in the second and third trimesters, so treatment should be discontinued immediately upon confirmation of pregnancy. Due to its potent blood pressure-lowering effects, hypotensive symptoms may occur when first administered to patients with low blood volume or those taking diuretics, so caution is advised. Patients allergic to any components of this medicine, those with severe liver dysfunction, severe aortic stenosis, or those in a state of shock should not take this medication. Patients with elevated potassium levels in the blood, severely impaired renal function, those on strict salt restrictions, and those with low blood volume should use this medicine cautiously. While taking this medication, side effects such as dizziness, headache, drowsiness, itching, swelling, indigestion, orthostatic hypotension may occur, so caution is advised. This medication may pose a risk of accidents due to dizziness when driving or operating dangerous machinery, so caution is necessary. Patients with impaired liver or kidney function may have increased concentrations of this medication in their body, necessitating special caution. When taken with other antihypertensive medications, it may enhance blood pressure-lowering effects, so it is necessary to follow a doctor's guideline. Grapefruit juice may increase blood pressure-lowering efficacy, so it is advisable not to take them together. Pregnant or breastfeeding women should not take this medication, and particularly in the case of a confirmed pregnancy, should stop taking it immediately. This medication is not recommended for patients under 18 years of age as safety and efficacy are not established. Overdosage may lead to severe hypotension and cardiac problems, so dosage should be strictly followed, and emergency medical attention is required in case of overdose. Store out of reach of children, and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in the oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden and severe reactions.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
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  • indigestion
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • systemic urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • cough
  • conjunctival injection
  • frequent urination
  • fatigue
  • increased sweating
  • purpura
  • hair loss
  • vasculitis
  • tension headache
  • sensory impairment
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste alteration
  • tremors
  • erectile dysfunction

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

Storage

This medicine should be stored in a tightly sealed container to protect it from air and moisture, at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medicine for a longer period.

Appearance and packaging

Appearance

White 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.