Oseni

Oseni

Manufacturer:

Celltrion Healthcare

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 25 mg/15 mg FC tab Alogliptin 25 mg, pioglitazone 15 mg. Per 25 mg/30 mg FC tab Alogliptin 25 mg, pioglitazone 30 mg
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM in multiple clinical settings when treatment w/ both alogliptin & pioglitazone is appropriate.
Dosage/Direction for Use
Recommended starting dose: 25 mg/15 mg or 25 mg/30 mg once daily. Patients w/ CHF (NYHA class I or II) 25 mg/15 mg once daily. Moderate renal impairment (CrCl ≥30 to <60 mL/min) 12.5 mg/15 mg or 12.5 mg/30 mg once daily. Max: 25 mg/30 mg once daily. In combination w/ gemfibrozil or other strong CYP2C8 inhibitors Max: 25 mg/15 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. NYHA Class III or IV heart failure.
Special Precautions
Liver disease & severe renal impairment. Discontinue use if pancreatitis or serious hypersensitivity develops. History of angioedema to another DPP-4 inhibitor. Patients w/ abnormal liver test. Perform liver test in patients w/ symptoms of liver injury. Edema & risk of CHF. Risk of fracture in female patients. Active or history of bladder cancer. Concomitant use w/ insulin & insulin secretagogues, NSAIDs & coxibs. Perform regular eye exam. Adequate contraception in all premenopausal women. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Nasopharyngitis, back pain, upper resp tract infection, headache, hypoglycemia. Alogliptin: Pancreatitis; hypersensitivity reactions. Pioglitazone: Sinusitis, myalgia, pharyngitis, CHF, wt gain, edema, hepatic effects, urinary bladder tumors.
Drug Interactions
Increased exposure (AUC) & t½ of pioglitazone w/ CYP2C8 inhibitors (eg, gemfibrozil). Decreased exposure (AUC) w/ CYP2C8 inducer (eg, rifampin).
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD09 - pioglitazone and alogliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Oseni FC tab 25 mg/15 mg
Packing/Price
4 × 7's
Form
Oseni FC tab 25 mg/30 mg
Packing/Price
4 × 7's
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