SB-Metlina Tablet

Linagliptin + Metformin Hydrochloride

2.5 mg + 850 mg

SUNMAN-BIRDEM Pharma Ltd

Pack size	30's
Unite Price	14.00 BDT

Indications

SB-Metlina Tablet is used for: Type 2 Diabetes mellitus

Adult Dose

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. Prompt-release tablets Initial dose (not currently taking metformin): 2.5 mg/500 mg PO BID Initial dose (already taking metformin): Base dose on current metformin dose (eg, if taking metformin 1000 mg BID, initiate with 2.5 mg/1000 mg PO BID) Not to exceed 2.5 mg/1,000 mg BID Extended-release tablets Individualize dose on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of linagliptin/metformin 5 mg/2000 mg Initial dose (not currently taking metformin): 5 mg/1000 mg PO qDay Initial dose (already taking metformin): 5 mg of linagliptin total daily dose and a similar total daily dose of metformin qDay Switch from prompt-release linagliptin/metformin: 5 mg of linagliptin total daily dose and a similar total daily dose of metformin qDay Hepatic impairment: Not recommended because of increased risk of lactic acidosis

Child Dose

<18 years: Safety and efficacy not established

Renal Dose

Renal impairment Obtain eGFR before starting metformin eGFR <30 mL/min/1.73 m²: Contraindicated eGFR 30-45 mL/min/1.73 m²: Not recommended to initiate treatment Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly) If eGFR falls below 45mL/min/1.73 m² while taking metformin, risks and benefits of continuing therapy should be evaluated If eGFR falls below 30 mL/min/1.73 m²: while taking metformin, discontinue the drug

Administration

Should be taken with meals to reduce the gastrointestinal undesirable effects associated with metformin.

Contra Indications

Hypersensitivity. Type 1 diabetes, diabetic ketoacidosis or pre-coma, renal failure or dysfunction (CrCl <60 mL/min), hepatic insufficiency, acute alcohol intoxication, alcoholism. Acute conditions w/ the potential to alter renal function eg dehydration, severe infection, shock, IV administration of iodinated contrast agents. Acute or chronic diseases which may cause tissue hypoxia eg cardiac or resp failure, recent MI. Lactation.

Precautions

Monitor for pancreatitis, hypoglycaemia, lactic acidosis, renal impairment. Intravascular administration of iodinated contrast agents. Co-administration of insulin. Discontinue treatment 48 hr before elective surgery w/ general, spinal or peridural anaesth. Evaluate serum electrolytes & ketones, blood glucose & if indicated, blood pH, lactate, pyruvate & metformin levels in patients w/ previously well controlled type 2 diabetes on Trajenta Duo who develops laboratory abnormalities or clinical illness. Pregnancy. Childn & adolescents <18 yr. Elderly. Lactation: Metformin excreted in human milk in low concentrations; unknown if linagliptin excreted in human milk No studies in lactating animals have been conducted with the combined components; because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

Pregnancy-Lactation

Pregnancy Limited data in pregnant women not sufficient to inform associated risk for major birth defects and miscarriage with product; published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia-related morbidity Lactation There is no information regarding presence of product in human milk, effects on breastfed infant, or effects on milk production; however, linagliptin is present in rat milk; limited studies report that metformin is present in human milk; there is insufficient information to determine effects of metformin on breastfed infant and no available information on effects of metformin on milk production; therefore, developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

Interactions

Linagliptin: Inhibits P-glycoprotein-mediated transport of digoxin (w/ low potency). Increased AUC & Cmax w/ ritonavir. Decreased steady-state AUC & Cmax, & DPP-4 inhibition at trough w/ rifampicin. Weakly inhibits CYP3A4-mediated metabolism (eg simvastatin). Metformin: Increased risk of lactic acidosis in acute alcohol intoxication. Competition on common renal tubular transport systems w/ cationic agents eliminated by renal tubular secretion (eg cimetidine). Risk of renal failure & lactic acidosis w/ intravascular administration of iodinated contrast agents.

Side Effects

Side effects of Linagliptin + Metformin Hydrochloride : >10% Hypoglycemia (with sulfonylurea) (22.9%) 1-10% Nasopharyngitis (6.3%), Diarrhea (6.3%), Hypoglycemia (without sulfonylurea) (1.4%) Frequency Not Defined Hypersensitivity (eg, urticaria, angioedema, or bronchial hyperactivity), Cough, Decreased appetite, Nausea, Vomiting, Pruritus, Pancreatitis

Mode of Action

Linagliptin: Dipeptidyl peptidase 4 (DPP-4) inhibitor; increases and prolongs incretin hormone activity from glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) which are inactivated by the DPP-4 enzyme; incretins increase insulin release and reduce glucagon secretion Metformin: Decreases hepatic glucose production; decreases GI intestinal glucose absorption; increases target cell insulin sensitivity; lowers both basal and postprandial plasma glucose and unlike sulfonylureas, does not typically produce hypoglycemia or hyperinsulinemia

Note

SB-Metlina 2.5 mg + 850 mg Tablet generic name is Linagliptin + Metformin Hydrochloride. SB-Metlina 2.5 mg + 850 mg Tablet is manufactured by SUNMAN-BIRDEM Pharma LtdSB-Metlina is availble in all over Bangladesh. Mes BD drug index information on SB-Metlina Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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