- Approval Id
- 9e76c894c4bb5d9a
- Drug Name
- INVOKANA™ FILM-COATED TABLETS 300 MG
- Product Name
- INVOKANA™ FILM-COATED TABLETS 300 MG
- Approval Number
- SIN14507P
- Approval Date
- 2014-02-21
- Registrant
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Licence Holder
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong><br>
<strong>Dosage – Adults 18 years of age and older</strong><br>
The recommended dose of INVOKANA™ is 100 mg or 300 mg once daily. See Table 1 for dosage recommendations based on estimated glomerular filtration rate (eGFR). The 300 mg dose may be considered for patients with an eGFR ≥ 60 mL/min/1.73 m<sup>2</sup> [CrCl ≥ 60 mL/min], who need tighter glycemic control and who have a low risk of adverse reactions associated with reduced intravascular volume with INVOKANA™ treatment (see <em>below</em> and <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>A starting dose of 100 mg once daily should be used in patients on loop diuretics and patients ≥ 75 years of age. In patients with evidence of reduced intravascular volume, correcting this condition prior to initiation of INVOKANA™ is recommended. For those patients who are tolerating INVOKANA™ 100 mg and who need tighter glycemic control, the dose can be increased to INVOKANA™ 300 mg (see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>When INVOKANA™ is used as add-on therapy with insulin or an insulin secretagogue (e.g., sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia (see <em>Warnings and Precautions</em> and <em>Adverse Reactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<img src="/TGIF/Invokana-Table1_090525.png" alt="Invokana Dosage Table 1" /><br><br>
<p><strong>Administration</strong><br>
INVOKANA™ should be taken orally once a day, preferably before the first meal of the day (see <em>Pharmacokinetic Properties</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Tablets are to be swallowed whole.</p>
<p><strong>Missed dose</strong><br>
If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.</p>
<p><strong>Special populations<br>
Pediatrics (< 18 years of age)</strong><br>
The use of INVOKANA™ in pediatric patients is not recommended.</p>
<p><strong>Elderly</strong><br>
In patients ≥ 75 years of age, the starting dose of INVOKANA™ is 100 mg once daily. Renal function and risk of volume depletion should be taken into account (see <em>Warnings and Precautions</em> and <em>Adverse Reactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
<strong>Monotherapy and Combination Therapy</strong></p>
<p>INVOKANA™ is indicated as an adjunct to diet and exercise and standard care therapy:</p>
<ul>
<li><p>to improve glycemic control in adults with type 2 diabetes mellitus.</p></li>
<li><p>to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) who have inadequate glycemic control.</p></li>
<li><p>to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adult patients with type 2 diabetes mellitus and diabetic nephropathy with albuminuria >300mg/day.</p></li>
</ul>
- Contraindications
- <p><strong>Contraindications</strong><br>
History of a serious hypersensitivity reaction to INVOKANA™.</p>
<p>Patients on dialysis.</p>
<p>Hypersensitivity to the active substance or to any of the excipients (see <em>Adverse Reactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- A10BK02
- Atc Item Name
- canagliflozin
- Pharma Manufacturer Name
- JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
- Company Detail Path
- /organization/johnson-and-johnson-international-singapore-pte-ltd
