Medication info
Amozelten 5/50 mg

Amozelten 5/50 mg

Prescription medicationTablet경구
Ingredient · strength
Losartan Potassium›50mg / 1 tabletAmlodipine Camsylate›7.84mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200902350 · Approved 2009.03.31 · Insurance code 643504680

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 of this medication is 1 tablet once a day, taken with water regardless of meals. It is advisable to take it at the same time daily (e.g., in the morning). Typically, 5/50 mg of this medication is administered once daily. If blood pressure is not sufficiently controlled after 2 weeks of administration, the dosage may be increased to 10/50 mg once daily.
Child dose
The safety and efficacy of this medication have not been established in patients under 18 years of age, and its use is not recommended.

Ingredients

Manufacturer
한미약품(주)

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 for patients with essential hypertension whose blood pressure is not adequately controlled with monotherapy of amlodipine or losartan. It is also effective in controlling blood pressure for stage 2 hypertension patients who require combination therapy to reach target blood pressure, thus aiding in hypertension treatment. Therefore, this product plays a crucial role in managing hypertension and improving blood pressure control.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once a day, taken with water regardless of meals. It is advisable to take it at the same time daily (e.g., in the morning). Typically, 5/50 mg of this medication is administered once daily. If blood pressure is not sufficiently controlled after 2 weeks of administration, the dosage may be increased to 10/50 mg once daily.

Child dose

The safety and efficacy of this medication have not been established in patients under 18 years of age, and its use is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters. Therefore, if pregnancy is confirmed, discontinue use immediately. In patients with low blood volume or those taking diuretics, hypotension may occur, so the patient's condition should be thoroughly assessed before use. Patients allergic to any of the components of this medication, pregnant or nursing women, patients with severe liver dysfunction, aortic stenosis, or patients in shock should not take this medication. Patients with significantly low blood pressure or severely impaired kidney function, those requiring strict sodium intake restriction, and patients with hyperkalemia should use this drug cautiously. Dizziness, headache, and drowsiness may occur during use, so caution should be exercised for hazardous activities such as working at heights or driving. If taken in conjunction with other blood pressure medications, the hypotensive effect may be enhanced, so it should be taken as directed by a physician. Grapefruit juice may increase the drug's effect, so it is recommended to avoid consuming grapefruit juice. For pregnant or nursing women, it is safer not to take this medication, as it can significantly affect the fetus, especially after the second trimester. The safety and efficacy of this medication have not been established in individuals under 18 years of age, and its use is not recommended. In case of overdose, hypotension, arrhythmias, shock, etc., may occur, so strict adherence to dosage is necessary, and any abnormal symptoms should be reported to medical personnel immediately. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attack, respiratory abnormality accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 22 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • generalized urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • cough
  • conjunctival injection
  • increased urination
  • angioedema
  • erythema
  • maculopapular rash
  • hypotension
  • sinus block or atrioventricular block
  • abdominal malaise
  • diarrhea
  • loose stools
  • increased sweating

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

Storage

This medicine should be stored in a sealed container to protect it from air and moisture. The storage temperature should maintain room temperature between 1 to 30 degrees Celsius, and it should be kept away from excessively hot or cold areas.

Appearance and packaging

Appearance

White 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.