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KANARB TABLET 60MG [SIN15221P]
Active ingredients: KANARB TABLET 60MG
Product Info
KANARB TABLET 60MG
[SIN15221P]
Product information
Active Ingredient and Strength | FIMASARTAN POTASSIUM TRIHYDRATE 66.01 MG EQV FIMASARTAN POTASSIUM - 60 MG |
Dosage Form | TABLET |
Manufacturer and Country | BORYUNG CORPORATION - KOREA, REPUBLIC OF |
Registration Number | SIN15221P |
Licence Holder | ZUELLIG PHARMA PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | C09CA10 |
Indication
Kanarb® Tablets (Fimasartan Potassium Trihydrate) is indicated for the treatment of mild to moderate essential hypertension.
Recommended Dosage
Adult Hypertension
The recommended initial dose of Kanarb® Tablets is 60 mg once daily with or without food. If blood pressure is not adequately controlled at 60 mg, the dosage of Kanarb® Tablets may be increased to 120 mg once daily. Whenever possible, it is recommended that Kanarb® Tablets be taken at the same time during the day (e.g., morning).
The blood pressure lowering effect of Kanarb® Tablets is generally attained within 2 weeks, and maximal reduction is after 8 to 12 weeks of treatment.
Geriatric Use
No initial dosage adjustment is required for elderly patients (age ≤ 70 years).
Renal Impairment
No initial dosage adjustment is required for patients with mild to moderate renal impairment (creatinine clearance 30–80 mL/min). For severe renal impairment (creatinine clearance < 30 mL/min), the recommended initial dose is 30 mg once daily and the dose should not exceed 60 mg.
Hepatic Impairment
No initial dosage adjustment is required for patients with mild hepatic impairment. Kanarb® Tablets is not recommended to patients with moderate to severe hepatic impairment.
Pediatric Use
The efficacy and safety of Kanarb® Tablets has not been established in patients 18 years or younger.
Intravascular Volume-Depleted Patients (e.g., Patients receiving high doses of diuretics)
For patients whose intravascular volume is depleted, at risk for symptomatic hypotension, the initial dose of 30 mg once daily is recommended.
Contraindications
Kanarb® Tablets is contraindicated in the following patients:
Patients who are hypersensitive to any component of this product
Pregnant or nursing mothers [See Pregnant mothers (7.1) and Nursing mothers (7.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]
Hemodialysis Patients (no experience in this population)
Patients with moderate to severe hepatic impairment
Patients with hepatobiliary obstruction
Patients with diabetes or renal impairment (GFR <60 mL/min/1.73m2) who are taking aliskiren [See Drug Interactions (6) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]
Patients with diabetic nephropathy who are taking angiotensin converting enzyme (ACE) inhibitors [See Drug Interactions (6) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]
Patients with genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption (since Kanarb® Tablets contains lactose)
