The FDA approved Exxua™ (gepirone) extended-release tablets for the treatment of major depressive disorder.
According to the drug label, Exxua will be available in 18.2 mg, 36.3 mg, 54.5 mg, and 72.6 mg dosages, and it is recommended that treatment begin at the lowest dosage. Dosage may be increased depending on clinical response and tolerability, but maximum dosage must be capped for certain patients, including geriatric patients, patients with renal impairment, and patients with moderate hepatic impairment.
Electrolyte abnormalities must be corrected prior to starting Exxua, and electrocardiograms (ECGs) should be performed prior to initiating treatment, with additional ECGs performed during dosage titration.
In other news, the FDA also approved first-time generics for two diabetes medications.
Kombiglyze® XR (saxagliptin and metformin hydrochloride) extended-release tablets will soon be available in generic form. This medication is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.
Kombiglyze should be administered once a deal with the evening meal, and patients should be assessed for renal function prior to taking Kombiglyze.
Onglyza™ (saxagliptin) tablets will also soon be available in generic form. Onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Patients should be assessed for renal function prior to taking Onglyza. Ongylza is contraindicated in patients with pancreatis, risk factors for heart failure, and arthralgia (joint pain).
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