Medication info

Rosadipine 10/50 mg (Amlodipine, Losartan Potassium)

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

MFDS item code 201502661 · Approved 2015.04.30

This product's status changed to Expired on 2025.04.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 recommended to take it at the same time every day (e.g., in the morning). Typically, 5/50 mg of this medication is administered once daily, and if blood pressure is not sufficiently controlled after 2 weeks of administration, it may be increased to 10/50 mg once daily.
Child dose
The safety and efficacy of this medication in pediatric patients under 18 years of age have not been established, hence its use is not recommended.

Ingredients

Manufacturer
(주)한국파비스제약

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 who do not have sufficient blood pressure control with monotherapy, and it is also used as a first-line treatment for patients with stage 2 hypertension who require combination therapy to achieve target blood pressure. This helps effectively lower blood pressure to maintain health.

How to take

Adult dose

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

Child dose

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

Precautions

This medication can severely harm the fetus if taken during pregnancy, especially in the second and third trimesters, so it should be discontinued immediately if pregnancy is confirmed. As this medication lowers blood pressure, it must be used with caution in patients with low intravascular blood volume, poor kidney function, and hyperkalemia. Do not use in patients with allergies to the active ingredients or severe liver dysfunction, critical aortic stenosis, or in shock. Neurological symptoms such as dizziness, headache, and drowsiness may occur during treatment; caution should be exercised when driving or operating hazardous machinery. As this medication can have a strong blood pressure-lowering effect, special care should be taken when combined with other antihypertensive medications, and it is not recommended to consume grapefruit juice with this medication, as it may enhance the blood pressure-lowering effect. Patients with impaired liver or kidney function should have regular check-ups and adjust the dosage according to their doctor's instructions. It is advisable not to take this medication while breastfeeding, since it could be excreted into breast milk. The safety and efficacy of this medication in children or adolescents under 18 years of age have not been established, so its use is not recommended. Overdose can lead to dangerously low blood pressure and serious conditions, so it is imperative to adhere strictly to the prescribed dosage, and if an overdose is suspected, seek medical attention 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 allergic reaction), high fever accompanied by severe rash, blisters, skin peeling, pain in oral/ocular mucosa (severe skin adverse reaction), shortness of breath or difficulty breathing, asthma attack, cough with fever (respiratory issues), skin or eyes turning yellow (jaundice), extreme lethargy (liver dysfunction), sudden and severe...

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • asthenia
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 26 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • pruritus
  • urticaria
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • cough
  • conjunctival injection
  • frequent urination
  • fatigue
  • lethargy
  • lowering blood pressure
  • sinus node block
  • atrioventricular block
  • precordial pain
  • diarrhea
  • loose stools
  • skin erythema
  • papular rash
  • heaviness
  • heat sensation
  • impaired glucose tolerance

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. Moreover, the medication should be kept away from excessively hot or cold environments, ideally stored at room temperature between 1 °C to 30 °C.

Appearance and packaging

Appearance

Pink oval 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.