Torva

/ Unipharm

One tablet a day. No dose adjustment for renal of hepatic impairment is required.

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, in monotherapy and combination therapy.

Patients with a history of a hypersensitivity to linagliptin.

Renal impairment: No dose adjustment for renal of hepatic impairment is required.
Hepatic Impairment: No dose adjustment is recommended for patients with hepatic impairment. Insulin secretagogues are known to cause hypoglycemia. The use of linagliptin in combination with an insulin secretagogue (e.g., sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with linagliptin.
See prescribing information for full details.

Nasopharyngitis, hyperlipidemia, cough.
See prescribing information for full details.

DInducers of P-glycoprotein or CYP3A4 Enzymes Rifampin decreased linagliptin exposure suggesting that the efficacy of Linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a P-gp or CYP3A4 inducer.

Pregnancy and Lactation: Category B – Reproduction studies have been performed in rats and rabbits. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Linagliptin crossed the placenta into the fetus following oral dosing in pregnant rats and rabbits.
Lactation: It is not known whether this drug is excreted in human milk. 

During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose) there were no dose-related clinical adverse drug reactions. There is no experience with doses above 600 mg in humans. In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient’s clinical status. Linagliptin is not expected to be eliminated to a therapeutically significant degree by hemodialysis or peritoneal dialysis.