Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**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.
ORAL
Medical Information
**Indication** Kanarb® Tablets (Fimasartan Potassium Trihydrate) is indicated for the treatment of mild to moderate essential hypertension.
**Contraindications** Kanarb® Tablets is contraindicated in the following patients: 1. Patients who are hypersensitive to any component of this product 2. Pregnant or nursing mothers \[See Pregnant mothers (7.1) and Nursing mothers (7.2) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 3. Hemodialysis Patients (no experience in this population) 4. Patients with moderate to severe hepatic impairment 5. Patients with hepatobiliary obstruction 6. Patients with diabetes or renal impairment (GFR <60 mL/min/1.73m2) who are taking aliskiren \[See Drug Interactions (6) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 7. Patients with diabetic nephropathy who are taking angiotensin converting enzyme (ACE) inhibitors \[See Drug Interactions (6) – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] 8. Patients with genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption (since Kanarb® Tablets contains lactose)
C09CA10
fimasartan
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
BORYUNG CORPORATION
Active Ingredients
Documents
Package Inserts
KANARB TABLET 60 & 120 MG PI.pdf
Approved: March 9, 2023