Medication info
Rosadipine Tablet 5/100 Milligrams (Amlodipine, Losartan Potassium)

Rosadipine Tablet 5/100 Milligrams (Amlodipine, Losartan Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amlodipine Besylate›6.944mgLosartan Potassium›100mg
Manufacturer / importer
(주)한국파비스제약
Appearance
Light pink film-coated tablet in a rectangular shape
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 201502662 · Approved 2015.04.30

Summary

Main use
Improvement in blood pressure control in essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose for adults is 1 tablet once daily, taken with water without regard to meals. It is recommended to take it at the same time each day (e.g., in the morning). Generally, 5/50 milligrams of this medication is administered once daily, and if blood pressure is not adequately controlled after 2 weeks of treatment, the dose may be increased to 10/50 milligrams once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age, so use of this medication is not recommended.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement in 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 do not achieve adequate blood pressure control with monotherapy of amlodipine or losartan. It is also used as an initial therapy for patients with stage 2 hypertension when combination therapy is needed to reach the target blood pressure. It helps to effectively lower blood pressure and reduce the risk of cardiovascular complications.

How to take

Adult dose

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

Child dose

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

Precautions

This medication may 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. Caution is required as there is a risk of decreased kidney function, hypotension, skull formation abnormalities, etc., when pregnant women take this medication. Patients with reduced intravascular blood volume may experience hypotension upon initial administration, so it should be administered after stabilizing the condition. It should not be taken by patients with allergies to the ingredients in this medication or by those with severe liver dysfunction, severe aortic stenosis, or in a state of shock. Caution is also advised when administering to patients with low blood volume or severely reduced kidney function, patients requiring strict salt restrictions, and patients with hyperkalemia. Dizziness or headache may occur during treatment, so caution is advised when driving or operating hazardous machinery. It is recommended not to use this medication while breastfeeding, and its safety and effectiveness have not been established in pediatric patients under 18 years of age. If taken with other antihypertensive drugs, the blood pressure-lowering effect may be enhanced, so consult with a healthcare professional before use. In case of overdose, severe hypotension and tachycardia may occur, and symptoms should be treated immediately at a medical institution. This medication should be kept out of reach of children, and care should be taken not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in mouth/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough and fever, jaundice, extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • abdominal discomfort
  • indigestion
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  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • dyspnea
  • cough
  • vertigo
  • conjunctival injection
  • increased urination
  • fatigue
  • edema
  • vasculitis
  • tension
  • sensory loss/paresthesia
  • peripheral neuropathy
  • syncope
  • taste disturbance
  • tremor

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Light pink film-coated tablet in a rectangular shape

Package unit

30 tablets per 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.