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

Rosadipin Tablet 5/50 mg (Amlodipine, Losartan Potassium)

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

MFDS item code 201502663 · Approved 2015.04.30 · Insurance code 621802710

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 advised 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 two weeks, it can be increased to 10/50 mg once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, and the use of this medication is not recommended.

Ingredients

Manufacturer
(주)한국파비스제약

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 a combination of amlodipine and losartan, used in patients with essential hypertension who have difficulty controlling blood pressure with monotherapy. It is also effective for stage 2 hypertension patients who require combination therapy from the outset to reach the therapeutic target blood pressure. In other words, it helps lower blood pressure reliably, reducing the risk of cardiovascular diseases. This medication is used for the treatment of hypertension.

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 advised 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 two weeks, it can be increased to 10/50 mg once daily.

Child dose

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

Precautions

This medication can cause serious harm to the fetus if taken during pregnancy, especially in the second and third trimesters, and should be discontinued immediately once pregnancy is confirmed. Taking this medication while pregnant can lead to various problems such as decreased fetal kidney function, low blood pressure, skull formation reduction, and anuria. If it must be taken during early pregnancy, frequent ultrasounds to check the fetus's condition are necessary, and if abnormalities are found, it should be stopped immediately. Administering this medication to patients with a low blood volume may cause hypotension, so stabilization of blood volume should be ensured beforehand. This medication should not be given to patients with allergies to the active ingredients or similar substances, pregnant women or those who may be pregnant, nursing mothers, patients with severe liver dysfunction, severe aortic stenosis, or in a state of shock. Caution should be exercised when administering to patients with low blood volume or strict salt restrictions, moderate to severe kidney impairment, or hyperkalemia. Symptoms such as dizziness and headache may occur during treatment, so dangerous activities such as working at heights or driving should be avoided. This medication lowers blood pressure; therefore, when used in conjunction with other antihypertensive agents, careful attention is needed as the effects may be enhanced. Avoid taking it with grapefruit juice, as it may increase drug concentration and raise the risk of side effects. In clinical trials, side effects such as dizziness, headache, edema, itching, palpitations, orthostatic hypotension, cough, etc. have been reported. Safety has not been established for children, and it is not recommended for patients under 18 years of age. In older adults over 75 years, the initial dose of this drug may not be suitable, requiring careful use. In case of overdose, severe hypotension and tachycardia may occur, and symptoms should be reported to medical personnel immediately. Keep this medication out of reach of children and do not transfer it into another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, dyspnea, severe allergic reactions, angioedema, chest tightness, facial swelling, vasculitis, severe skin adverse reactions, exfoliative dermatitis, hemolysis, low blood pressure (shock symptoms, loss of consciousness), acute hepatitis, fulminant hepatitis, abnormal liver function (jaundice), elevated liver enzymes, severe neurological symptoms (stroke, confusion, syncope, loss of consciousness, etc.), thrombocytopenia, anemia, hypotension,

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
  • hives
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • conjunctival injection
  • frequent urination
  • fatigue
  • swelling
  • vasculitis
  • increased tension
  • sensory loss
  • sensory side effects
  • peripheral neuropathy
  • syncope
  • taste disorder
  • tremor
  • 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 protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White oblong 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.