Invokana

Invokana

canagliflozin

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Canagliflozin
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM. Reduce risk of major adverse CV events (CV death, nonfatal MI & nonfatal stroke) in adults w/ type 2 DM & established CVD.
Dosage/Direction for Use
Adult Initially 100 mg once daily. Patients tolerating Invokana 100 mg once daily w/ eGFR ≥60 mL/min/1.73 m2 May be increased to 300 mg once daily. Patients w/ moderate renal impairment w/ an eGFR 45 to <60 mL/min/1.73 m2 100 mg once daily.
Administration
May be taken with or without food: Take preferably before the 1st meal of the day.
Contraindications
Hypersensitivity. Severe renal impairment (eGFR <30 mL/min/1.73 m2) & end-stage renal disease (ESRD) or patients on dialysis.
Special Precautions
Discontinue treatment if hypersensitivity reactions occur. Prior to initiation of therapy, consider factors in patient history that may predispose to the need for amputations (eg, history of prior amputation, peripheral vascular disease, neuropathy & diabetic foot ulcers). Monitor patients for signs & symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs & discontinue treatment if these occurs. Symptomatic hypotension may occur after initiating therapy in patients w/ impaired renal function, elderly, on either diuretics or drugs that interfere w/ the renin-angiotensin-aldosterone system, or w/ low systolic BP. Not for treatment of patient w/ type 1 DM. Discontinue use if ketoacidosis is suspected. Consider factors in patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction & alcohol abuse; that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, CHF & concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs) prior to initiation of therapy. Increased serum creatinine & decreased eGFR on intiation of therapy; risk of bone fracture; LDL-C. Not recommended in patients w/ eGFR <45 mL/min/1.73 m2. Evaluate for signs & symptoms of UTI. Evaluate prior to initiating therapy & periodically monitor renal function. Concomitant use w/ insulin & insulin secretagogues. Discontinue treatment if necrotizing fasciitis occurs & closely monitor blood glucose levels. History of genital mycotic infections especially in uncircumcised males. Pregnancy (2nd & 3rd trimester) & lactation. Ped patients <18 yr. Monitoring glycemic control w/ urine glucose test & 1,5-AG assay is not recommended.
Adverse Reactions
UTI, increased urination, thirst, constipation, nausea, female genital mycotic infections, vulvovag pruritus, male genital mycotic infections.
Drug Interactions
Decreased exposure w/ rifampin, phenytoin, phenobarb, ritonavir. Increase AUC & Cmax of digoxin.
MIMS Class
ATC Classification
A10BK02 - canagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Form
Invokana FC tab 100 mg
Packing/Price
3 × 10's
Form
Invokana FC tab 300 mg
Packing/Price
3 × 10's
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