Medication info

Rozaduo Tablet 5/50mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201905577 · Approved 2019.08.07

This product's status changed to Approval withdrawn on 2024.02.22. 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 for this medication is 1 tablet taken once daily, with or without food. It is recommended to take it at the same time each day (e.g., in the morning). Typically, this medication at 5/50 milligrams is administered once daily, and if blood pressure is not adequately controlled after 2 weeks, the dose may be increased to 10/50 milligrams once daily.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Ingredients

Manufacturer
대한뉴팜(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 in patients with essential hypertension whose blood pressure is not adequately controlled with single-agent therapy of amlodipine or lisinopril, and in stage 2 hypertension patients who require combination therapy to reach the target blood pressure.

How to take

Adult dose

The recommended dose for this medication is 1 tablet taken once daily, with or without food. It is recommended to take it at the same time each day (e.g., in the morning). Typically, this medication at 5/50 milligrams is administered once daily, and if blood pressure is not adequately controlled after 2 weeks, the dose may be increased to 10/50 milligrams once daily.

Child dose

The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, 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, so it should be discontinued immediately upon confirmation of pregnancy. It is safer for women of childbearing potential not to take this medication, and it is also recommended that nursing mothers avoid using this medication. Due to the blood pressure-lowering effects, dizziness or symptoms of hypotension may occur, so caution should be exercised during potentially hazardous activities such as heights or driving. This medication should not be administered to patients with severely impaired liver or kidney function, severe aortic stenosis, or in a state of shock. Caution should be taken when prescribing this medication to patients with reduced effective blood volume, those requiring strict sodium restrictions, or those with moderate to severe kidney impairment, and the patient's condition should be thoroughly assessed before administration. If used with other antihypertensive agents, the blood pressure-lowering effect may be enhanced, so it should be taken carefully according to doctor's instructions. If severe dizziness, symptoms of hypotension, allergic reactions, cardiac abnormalities, or respiratory distress occur while taking this medication, immediate consultation with a medical professional is necessary. Overdose can lead to severe hypotension and cardiac issues, so it is crucial to adhere to the prescribed dosage, and if an overdose occurs, one must go to the hospital immediately. This medication is not recommended for children and adolescents under 18 years of age as its safety and efficacy have not been established. For elderly patients, especially those over 75 years old, initial dosage adjustments are necessary, and they should consult their physician about the appropriateness of this medication.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 26 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • increased urination
  • drowsiness
  • cerebral infarction
  • skin rash
  • papular rash
  • heaviness
  • warmth sensation
  • impaired glucose tolerance
  • weakness
  • muscle cramps
  • back pain
  • leg pain
  • nasal congestion

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

Storage

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White 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

No questions yet.

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.