- Approval Id
- 4a854c8f9eddb603
- Drug Name
- KANARB TABLET 60MG
- Product Name
- KANARB TABLET 60MG
- Approval Number
- SIN15221P
- Approval Date
- 2017-04-24
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- <p><strong>Recommended Dosage</strong><br>
Adult Hypertension<br>
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).<br>
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.</p>
<p>Geriatric Use<br>
No initial dosage adjustment is required for elderly patients (age ≤ 70 years).</p>
<p>Renal Impairment<br>
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.</p>
<p>Hepatic Impairment<br>
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.</p>
<p>Pediatric Use<br>
The efficacy and safety of Kanarb® Tablets has not been established in patients 18 years or younger.</p>
<p>Intravascular Volume-Depleted Patients (e.g., Patients receiving high doses of diuretics)<br>
For patients whose intravascular volume is depleted, at risk for symptomatic hypotension, the initial dose of 30 mg once daily is recommended.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indication</strong><br>
Kanarb® Tablets (Fimasartan Potassium Trihydrate) is indicated for the treatment of mild to moderate essential hypertension.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Kanarb® Tablets is contraindicated in the following patients:</p>
<ol class="decimalparen">
<li>Patients who are hypersensitive to any component of this product</li>
<li>Pregnant or nursing mothers [See Pregnant mothers (7.1) and Nursing mothers (7.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</li>
<li>Hemodialysis Patients (no experience in this population)</li>
<li>Patients with moderate to severe hepatic impairment</li>
<li>Patients with hepatobiliary obstruction</li>
<li>Patients with diabetes or renal impairment (GFR <60 mL/min/1.73m<sup>2</sup>) who are taking aliskiren [See Drug Interactions (6) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</li>
<li>Patients with diabetic nephropathy who are taking angiotensin converting enzyme (ACE) inhibitors [See Drug Interactions (6) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</li>
<li>Patients with genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption (since Kanarb® Tablets contains lactose)</li>
</ol>
- Atc Code
- C09CA10
- Atc Item Name
- fimasartan
- Pharma Manufacturer Name
- ZUELLIG PHARMA PTE. LTD.
