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The dosage should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin use.
Recommended starting dose: In patients currently not treated with Metformin, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily. In patients already treated with Metformin, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily. Patients already treated with linagliptin and metformin, individual components may be switched to this combination containing the same doses of each component.
Pediatric Use: Safety and effectiveness of Linagliptin & Metformin combination in pediatric patients under 18 years of age have not been established.
Geriatric Use: Linagliptin is minimally excreted by the kidney; however, Metformin is substantially excreted by the kidney. Considering that aging can be associated with reduced renal function, Linagliptin & Metformin combination should be used with caution as age increases.
Renal Impairment: Studies characterizing the pharmacokinetics of Linagliptin and Metformin after administration of Linagliptin & Metformin combination in renally impaired patients have not been performed. Since Metformin is contraindicated in patients with renal impairment, use of Linagliptin & Metformin combination is also contraindicated in patients with renal impairment (e.g., serum creatinine >=1.5 mg/dL [males] or >=1.4 mg/dL [females], or abnormal creatinine clearance).
Hepatic Impairment: Studies characterizing the pharmacokinetics of Linagliptin and Metformin after administration of Linagliptin & Metformin combination in hepatically impaired patients have not been performed. However, use of Metformin alone in patients with hepatic impairment has been associated with some cases of lactic acidosis. Therefore, use of Linagliptin & Metformin combination is not recommended in patients with hepatic impairment.
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