Medication info
AmoZaltan Tablet 10/50 mg

AmoZaltan Tablet 10/50 mg

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›50mg / 1 tabletAmlodipine Camsylate›15.68mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pale pink, oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201006206 · Approved 2010.10.15 · Insurance code 643505670

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 medication is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). Typically, this medication is administered as 5/50 mg once daily, and if blood pressure remains insufficiently controlled after 2 weeks of treatment, it may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years; therefore, the use of this medication is not recommended.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

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

  • Essential hypertension
  • stage 2 hypertension
View approved original text

This medication is used for patients with essential hypertension whose blood pressure is not adequately controlled with amlodipine or losartan monotherapy. It is also suitable for initial treatment in stage 2 hypertension patients who require combination therapy to reach the target blood pressure. It helps in effectively controlling hypertension and reducing the risk of cardiovascular complications.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, taken with water regardless of meals. It is advised to take it at the same time every day (e.g., in the morning). Typically, this medication is administered as 5/50 mg once daily, and if blood pressure remains insufficiently controlled after 2 weeks of treatment, it may be increased to 10/50 mg once daily.

Child dose

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

Precautions

This drug can cause serious harm to the fetus or newborn if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately upon confirmation of pregnancy. Taking this medication during pregnancy may reduce the fetal kidney function, leading to decreased amniotic fluid volume, which can result in limb contractures, craniofacial deformities, and lung development issues in the fetus. Patients with a reduced effective blood volume, such as those on diuretics, may experience hypotension symptoms when first taking this medication, thus caution is needed. It should not be used in patients with hypersensitivity to this drug, pregnant women, those with severe liver dysfunction, severe aortic stenosis, or in shock. This drug should be used with caution in patients with decreased effective blood volume, those on strict salt restrictions, moderate to severe renal impairment, or hyperkalemia. Possible side effects include dizziness, headache, drowsiness, weakness, chest discomfort, edema, dyspepsia, pruritus, palpitations, orthostatic hypotension, and respiratory difficulties. During treatment, avoid hazardous activities such as working at heights or operating vehicles due to dizziness from blood pressure lowering. Patients with severely impaired liver function or poor kidney function should consult a physician before taking this medication, and caution is advised when taking potassium supplements or potassium-sparing diuretics as potassium levels can increase. This drug may pose risks to the fetus during pregnancy and could be transmitted through breast milk during lactation, so its use is not recommended. Use in individuals under 18 years or over 75 years of age is not recommended. In cases of overdose, severe hypotension, tachycardia, and shock may occur, so immediate medical attention is required. This medication must be stored out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, shortness of breath, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, dyspnea or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary incontinence

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • thoracic pain
  • early satiety
  • peripheral edema
  • abdominal discomfort
  • dyspepsia
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  • nausea
  • gastroesophageal reflux
  • constipation
  • pruritus
  • urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • respiratory difficulties
  • coughing
  • conjunctival injection
  • increased urination
  • fatigue
  • lethargy
  • vasculitis
  • tension increase
  • sensory dullness
  • paresthesia
  • peripheral neuropathy
  • syncope
  • taste alteration
  • tremors
  • erectile dysfunction
  • gynecomastia

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air and moisture, at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness and ensure safe use.

Appearance and packaging

Appearance

Pale pink, oblong 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.