Medication info
Rozaalpos 5/50 mg (Amlodipine, Losartan Potassium)

Rozaalpos 5/50 mg (Amlodipine, Losartan Potassium)

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

MFDS item code 201603728 · Approved 2016.06.22

Summary

Main use
Improvement of blood pressure control in essential hypertension and stage 2 hypertension.
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (e.g., in the morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not adequately controlled after 2 weeks of administration, the dose may be increased to 10/50 mg once daily.
Child dose
The safety and efficacy of this medication in pediatric patients under the age of 18 have not been established; therefore, administration is not recommended.

Ingredients

Manufacturer
제이더블유중외제약(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 who have difficulty controlling blood pressure with amlodipine or losartan alone. Additionally, it assists in managing blood pressure effectively when used as an initial treatment in stage 2 hypertension patients who require combination therapy to reach their target blood pressure. Therefore, this drug plays a significant role in the treatment of hypertension and improves blood pressure control.

How to take

Adult dose

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

Child dose

The safety and efficacy of this medication in pediatric patients under the age of 18 have not been established; therefore, administration is not recommended.

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters. If pregnancy is confirmed, discontinue use immediately. When this medication is administered for the first time to patients with low intravascular blood volume, hypotension may occur, so these patients should stabilize their condition before administration. Patients with allergies to any of the components in this medication, pregnant or breastfeeding women, those with severe liver disease, severe aortic stenosis patients, or those in a state of shock should not take this medication. Patients with reduced intravascular blood volume, those requiring strict sodium restriction, patients with moderate to severe renal impairment, and those with hyperkalemia should use this medication with caution. While taking this medication, symptoms such as dizziness, headache, or drowsiness may occur, so care is needed when engaging in dangerous tasks such as working at heights or driving. If taken in combination with other antihypertensive agents, the blood pressure-lowering effect may be enhanced, so it is essential to follow the physician’s instructions. Taking this medication with grapefruit juice may increase its blood concentration and elevate the risk of side effects, so it is advisable to avoid it. It is safer for pregnant or breastfeeding women not to take this medication, especially during pregnancy when it poses a risk to the fetus; discontinuation is necessary. The safety and efficacy of this medication for children have not been established, so it is recommended that children under the age of 18 do not take it. In cases of overdose, severe hypotension or arrhythmias may occur, so the dosage must be strictly adhered to, and in the case of an overdose, immediate medical attention is required. This medication should be stored out of the reach of children, and it is important not to transfer it to another container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pit edema
  • abdominal discomfort
Show 26 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • shortness of breath
  • cough
  • conjunctival injection
  • increased urination
  • drowsiness
  • cerebral infarction
  • fatigue
  • vasculitis
  • increased tension
  • sensory loss
  • abnormal sensations
  • peripheral neuropathy
  • syncope
  • taste abnormalities
  • tremors
  • erectile dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius.

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.