Oseni Generic Name & Formulations
Legal Class
Rx
General Description
Alogliptin, pioglitazone; 12.5mg/15mg, 12.5mg/30mg, 12.5mg/45mg, 25mg/15mg, 25mg/30mg, 25mg/45mg; tabs.
Pharmacological Class
Dipeptidyl peptidase-4 (DPP-4) inhibitor + thiazolidinedione.
How Supplied
Tabs—30, 90, 500
Manufacturer
Generic Availability
NO
Oseni Indications
Indications
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Not for treatment of type 1 diabetes.
Oseni Dosage and Administration
Adult
Swallow whole; do not split tabs. Take once daily with or without food. Inadequately controlled on diet/exercise, or on metformin or alogliptin monotherapy: initially 25mg/15mg or 25mg/30mg daily. Previously on pioglitazone alone: initially 25mg/15mg, 25mg/30mg, or 25mg/45mg daily. Previously on alogliptin and pioglitazone: switch on a mg/mg basis. NYHA Class I or II HF: initially 25mg/15mg. All: max 25mg/45mg daily. Renal impairment: moderate (CrCl ≥30–<60mL/min): 12.5mg/15mg, 12.5mg/30mg, or 12.5mg/45mg daily; severe or ESRD: not recommended. Concomitant gemfibrozil or other strong CYP2C8 inhibitors: max 25mg/15mg daily.
Children
Not recommended.
Oseni Contraindications
Contraindications
NYHA Class III or IV heart failure.
Oseni Boxed Warnings
Boxed Warning
Congestive heart failure.
Oseni Warnings/Precautions
Warnings/Precautions
Symptomatic HF: not recommended. CHF: consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms (after initiation and dose increases); evaluate and consider discontinuing if develops. Edema. Discontinue if pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid is suspected or occurs. History of angioedema to other DPP-4 inhibitors. Renal impairment; monitor prior to starting therapy and periodically thereafter. Hepatic impairment; obtain LFTs before starting therapy; interrupt and evaluate if liver enzymes elevated; do not restart if liver injury is confirmed and no other etiology can be found. Active bladder cancer: not recommended. Prior history of bladder cancer: consider glycemic control benefits vs. risk of cancer recurrence. Risk of fractures (esp. females). Do regular eye exams. Resumption of premenopausal ovulation in anovulatory women may occur (may result in unintended pregnancy). Pregnancy: use adequate contraception. Nursing mothers.
Oseni Pharmacokinetics
See Literature
Oseni Interactions
Interactions
Concomitant insulin may cause fluid retention. Potentiated by strong CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin) or topiramate (monitor for adequate glycemic control). May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.
Oseni Adverse Reactions
Adverse Reactions
Nasopharyngitis, back pain, upper respiratory tract infection; fluid retention, edema, macular edema, pancreatitis, heart failure, hypersensitivity reactions, hepatic events, severe and disabling arthralgia, bullous pemphigoid.
Oseni Clinical Trials
See Literature
Oseni Note
Not Applicable
Oseni Patient Counseling
See Literature
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