Active ingredient(s) and Contents

• Effective components

  • _Cosca EX Tab. 5/50 mg
    :Amlodipine Besylate 6.944 mg (amlodipine 5 mg)
    Losartan Potassium 50.0 mg
    
    _Cosca EX Tab. 5/100 mg
    :Amlodipine Besylate 6.944 mg (amlodipine 5 mg)
    Losartan Potassium 100.0 mg
    
    _Cosca EX Tab. 10/50 mg
    : Amlodipine Besylate 13.888 mg (Amlodipine 10 mg)
    Losartan Potassium 50.0 mg

• Other

  • _Cosca EX Tab. 5/50 mg
    Titanium Oxide, Carboxymethylcellulose Calcium, Talc, Microcrystalline Cellulose, Magnesium Stearate, D-Mannitol, Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Hydroxypropyl cellulose
    
    _Cosca EX Tab. 5/100 mg
    Carboxymethylcellulose Calcium, Ferric Oxide, red, Hydroxypropyl cellulose, Titanium Oxide, Talc, Microcrystalline Cellulose, Magnesium Stearate, Hydrated Ferric Oxide, D-Mannitol, Colloidal Silicon Dioxide, Crospovidone, Hypromellose
    
    _Cosca EX Tab. 10/50 mg
    Carboxymethylcellulose Calcium, Ferric Oxide, red, Hydroxypropyl cellulose, Titanium Oxide, Talc, Microcrystalline Cellulose, Magnesium Stearate, D-Mannitol, Colloidal Silicon Dioxide, Crospovidone, Hypromellose
    

Dosage and administration

• The recommended dose is 1 tablet once daily, and this drug should be administered with water and without regard to meals. If possible, it is recommended to take it at the same time each day (e.g., in the morning).
  It is recommended to adjust the dose with individual ingredients (amlodipine or losartan) prior to administration of this drug, but if blood pressure is not controlled by monotherapy for each ingredient as follows, consider switching to this drug immediately.
  
  
  • - 5/50 mg: Administer to patients whose blood pressure is not properly controlled by monotherapy of amlodipine 5 mg or losartan 50 mg.
  • - 5/100 mg: Administer to patients whose blood pressure is not properly controlled by monotherapy of amlodipine 5 mg or losartan 100 mg.
  
  In patients taking amlodipine and losartan in combination, the drug may be switched to this drug (a combination drug with the same content of each active ingredient) for ease of administration.
  Before administering this drug as an initial therapy in patients with stage 2 hypertension, it should be decided whether to administer this drug in consideration of the baseline blood pressure, the blood pressure goals, and the degree of reaching the expected treatment target of a combination drug compared to a single drug. The usual dose of this drug is 5/50 mg once daily, and if blood pressure is not sufficiently controlled even after administration for two weeks, the dose can be increased to 10/50 mg once daily.
  • 1. Patients with renal impairment: No dose adjustment is required in patients with mild renal insufficiency (e.g., creatinine clearances 20~50 mL/min), but in patients with moderate to severe renal impairment (e.g., creatinine clearances < 20 mL/min) and with dialysis, administration of this drug is not recommended.
  • 2. Patients with intravascular volume depletion: In patients with intravascular volume-depletion (e.g., those being treated with diuretics), the administration of this drug is not recommended (see 1. Warnings in Warnings and precautions).
  • 3. Patients with hepatic impairment: Among patients with a history of liver impairment, if losartan dose reduction (e.g., 25 mg once daily) is required, this drug is not recommended.
  • 4. Geriatric use: Adults aged 75 or older are recommended to begin losartan with an initial dose of 25 mg once daily. Therefore this drug is not recommended as an initial therapy for such patients.
  • 5. Pediatric use: The administration of this drug is not recommended as the safety and efficacy for pediatricpatients less than 18 years old have not been established.

Storage and handling

• Airtight container, keep at room temperature (1~30°C)