Kanarb Special Precautions

Drugs directly acting on the renin angiotensin system may cause injury or death to the developing fetus when administered to a pregnant woman during the second and third trimesters. Therefore, Kanarb Tablets should be discontinued when pregnancy is detected in female patients (see Use in Pregnancy & Lactation).
Patients requiring close monitoring during Kanarb Tablets treatment: Intravascular volume- or salt-depletion: These patients (e.g., patients receiving high doses of diuretics), whose renin angiotensin system is activated, may experience symptomatic hypotension at the time of initial Kanarb administration or its dosage increase. Therefore, close monitoring is required in these patients.
Renal impairment: Patients who are sensitive to drugs inhibiting the rennin angiotensin system may experience changes in the renal function. Angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists may cause oliguria, progressive hyperuremia, and rarely acute renal failure or death to patients whose renal function is dependent on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure).
Renovascular hypertension: Patients with uni-lateral or bi-lateral renal artery stenosis may have an increased risk for severe hypotension or renal failure when drugs affecting the rennin angiotensin system are administered.
Special caution is required for patients with aortic or mitral valve stenosis, obstructive or hypertrophic cardiac myopathy like other vasodilators.
Patients with primary aldosteronism generally do not respond to the drugs that inhibit the renin-angiotensin system, therefore Kanarb is not recommended in this population.
Allergy or hypersensitivity to Sunset Yellow FCF: Caution is required for patients who have an allergy or are hypersensitive to Sunset Yellow FCF (Food Yellow No.5).
Hepatic Impairment Use: The pharmacokinetics of fimasartan was compared in patients with mild and moderate hepatic impairment to healthy volunteers. A 20% decrease in AUC and 10% increase in Cmax were observed in patients with mild hepatic impairment. The AUC and Cmax in moderate hepatic impairment were increased by 6.5-fold and 5-fold, respectively. Kanarb is not recommended to moderate to severe hepatic impairment.
Effects on the Ability to Drive or Operate Machines: The effects of Kanarb Tablets on driving and the operation of machinery have not been studied. However, drowsiness and dizziness may occur sometimes with blood pressure-lowering agents, therefore patients taking Kanarb Tablets should be warned about these risks when driving or operating machinery is anticipated.
Use in Children: Safety and effectiveness in pediatric patients (age ≤18 years) have not been established.
Use in the Elderly: Kanarb has not been administered to elderly patients more than 70 years old. In a study to compare the pharmacokinetics of elderly healthy volunteers aged 65 years or more and young, healthy volunteers, the AUC of Kanarb in the elderly group increased by 69%. However, no differences in the efficacy and safety were noted in a total of 21 elderly patients (≥65 years, 9.3%), out of 226 patients receiving Kanarb in Phase 3 clinical trials, between the elderly and non-elderly populations. Therefore, no dosage adjustment with Kanarb is necessary in elderly patients (≤70 years), although greater sensitivity of some older individuals cannot be ruled out.