Medication info

Rozaduo Tablet 10/50mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›13.888mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
Pink rectangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201905578 · 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This product's status changed to Approval withdrawn on 2024.02.22.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 of this medication is 1 tablet once daily, to be taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after 2 weeks, the dose may be increased to 10/50 mg once daily.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and thus use of this medication 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 when blood pressure is not adequately controlled by monotherapy with amlodipine or losartan in patients with essential hypertension. It is also effective in initial treatment for stage 2 hypertension patients who require combination therapy to reach the target blood pressure. Thus, it helps to manage blood pressure reliably.

How to take

Adult dose

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

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established, and thus use of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus, particularly when taken during the second and third trimesters of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Various issues related to decreased renal function in the fetus may arise during pregnancy, so it should not be taken by women who may become pregnant. Patients with reduced intravascular blood volume, especially those on diuretics, may experience symptoms of hypotension when starting this medication, so caution is required. This medication should not be administered to patients with hypersensitivity to certain components, women who are pregnant or breastfeeding, patients with severe liver dysfunction, patients with severe aortic stenosis, or patients in a state of shock. Caution must be exercised when administering to patients with reduced intravascular blood volume or those on strict sodium restrictions, patients with moderate to severe renal impairment, and patients with hyperkalemia. Symptoms such as dizziness or headache may commonly occur when taking this medication, so caution is advised when engaging in hazardous activities such as working at heights or driving. This medication may affect liver and kidney functions, so patients with liver or kidney disease should have their condition regularly monitored. When used with other antihypertensive agents, the blood pressure-lowering effect may be increased, so it should be taken according to a physician's instructions. Taking with grapefruit juice may increase drug concentration, so concurrent use should be avoided. It is recommended that women who are pregnant or breastfeeding not take this medication to ensure the safety of the fetus and newborn. Safety and efficacy in patients under 18 years of age have not been established, and thus its use is not recommended. In case of overdose, severe hypotension and cardiac dysfunction may occur, and immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), severe overall lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • hollow edema
  • abdominal discomfort
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  • indigestion
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • generalized hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • shortness of breath
  • cough
  • conjunctival injection
  • frequent urination
  • drowsiness
  • cerebral infarction
  • lethargy
  • pain
  • weight changes
  • tension increase
  • sensory loss
  • dysesthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink 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.