2.5 mg/1

linagliptin and metformin hydrochloride · TABLET · Boehringer Ingelheim Pharma GmbH and Co. KG

No Recall History

Plain English

is a prescription tablet containing linagliptin and metformin hydrochloride at 2.5 mg/1. Manufactured by Boehringer Ingelheim Pharma GmbH and Co. KG.

Key Facts

Brand Name
Generic Name: linagliptin and metformin hydrochloride
NDC Code (Product): 12714-802
Manufacturer: Boehringer Ingelheim Pharma GmbH and Co. KG
Strength: 2.5 mg/1
Dosage Form: TABLET
Marketing Status: DRUG FOR FURTHER PROCESSING
Marketing Start: 02/13/2012

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2 )]. Linagliptin and metformin hydrochloride tablets are a combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Limitations of Use • Not recommended in patients with type 1 diabetes mellitus ( 1 ) • Has not been studied in patients with a history of pancreatitis ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Individualize the starting dosage of linagliptin and metformin hydrochloride tablets based on the patient's current regimen ( 2.1 ) • The maximum recommended dosage is 2.5 mg linagliptin/1,000 mg metformin HCl twice daily ( 2.1 ) • Take orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal effects due to metformin ( 2.1 ) • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) o Do not use in patients with eGFR below 30 mL/min/1.73 m 2 o Initiation is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 o Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2 o Discontinue if eGFR falls below 30 mL/min/1.73 m 2 • Linagliptin and metformin hydrochloride tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.3 ) 2.1 Recommended Dosage and Administration The dosage of linagliptin and metformin hydrochloride tablets should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended dosage of 2.5 mg linagliptin/1,000 mg metformin hydroch…

Contraindications

4 CONTRAINDICATIONS Linagliptin and metformin hydrochloride are contraindicated in patients with: • severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions (5.1 )] . • acute or chronic metabolic acidosis, including diabetic ketoacidosis [see Warnings and Precautions (5.1 )]. • hypersensitivity to linagliptin, metformin, or any of the excipients in linagliptin and metformin hydrochloride, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see Warnings and Precautions (5.4 ) and Adverse Reactions (6.1 )] . Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 ) Metabolic acidosis, including diabetic ketoacidosis ( 4 ) Hypersensitivity to linagliptin, metformin, or any of the excipients in linagliptin and metformin hydrochloride ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 2 describes clinically relevant interactions with linagliptin and metformin hydrochloride. Table 2 Clinically Relevant Interactions with linagliptin and metformin hydrochloride Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with linagliptin and metformin hydrochloride may increase the risk of lactic acidosis. Intervention Consider more frequent monitoring of these patients. Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3 )]. Intervention Consider the benefits and risks of concomitant use. Alcohol Clinical …

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Lactic Acidosis [see Warnings and Precautions (5.1 )] • Pancreatitis [see Warnings and Precautions (5.2 )] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions (5.4 )] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.5 )] • Severe and Disabling Arthralgia [see Warnings and Precautions (5.6 )] • Bullous Pemphigoid [see Warnings and Precautions (5.7 )] • Heart Failure [see Warnings and Precautions (5.8 )] Most common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obser…

Frequently Asked Questions

What is undefined used for?

undefined contains linagliptin and metformin hydrochloride. It is a tablet taken as directed. Consult your doctor for specific uses.

Is undefined a controlled substance?

undefined is not classified as a controlled substance by the DEA.

What is the generic name for undefined?

The generic name for undefined is linagliptin and metformin hydrochloride. There are 8 other brand versions of linagliptin and metformin hydrochloride.

What is the NDC code for undefined 2.5 mg/1?

The NDC (National Drug Code) for undefined 2.5 mg/1 is 12714-802, listed by Boehringer Ingelheim Pharma GmbH and Co. KG.

Product NDC

12714-802

Package NDC

12714-802-01

Other Linagliptin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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