Drugplain

JANUMET XR 1000 mg/1

sitagliptin and metformin hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Merck Sharp & Dohme LLC

No Recall History
Plain English

JANUMET XR is a tablet, film coated, extended release containing sitagliptin and metformin hydrochloride at 1000 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.

Key Facts

Brand Name
JANUMET XR
Generic Name
sitagliptin and metformin hydrochloride
NDC Code (Product)
0006-0081
Manufacturer
Merck Sharp & Dohme LLC
Strength
1000 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA202270
Marketing Start
02/02/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood glucose increased1,502 reports
diarrhoea1,377 reports
nausea1,093 reports
drug ineffective988 reports
fatigue890 reports
acute kidney injury822 reports
vomiting767 reports
weight decreased709 reports
dizziness633 reports
pancreatitis626 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE JANUMET ® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET XR is a combination of sitagliptin, 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 for the treatment of type 1 diabetes. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 ) Limitations of Use JANUMET XR should not be used in patients with type 1 diabetes mellitus. JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR. [See Warnings and Precautions (5.2) .]

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Take JANUMET XR orally once daily with a meal. Patients taking two JANUMET XR tablets should take the tablets together. ( 2.1 ) Individualize the dosage of JANUMET XR on the basis of the patient’s current regimen, effectiveness, and tolerability. ( 2.1 ) The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin HCl extended-release. ( 2.1 ) The recommended starting dose in patients not currently treated with metformin is 100 mg sitagliptin and 1000 mg metformin HCl once daily, with gradual dose escalation recommended to reduce the gastrointestinal effects due to metformin. ( 2.1 ) The starting dose in patients already treated with metformin should provide sitagliptin dosed as 100 mg and the dose of metformin already being taken once daily. For patients taking metformin HCl 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin and 1000 mg metformin HCl extended-release tablets once daily. ( 2.1 ) Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET and JANUMET XR. ( 2.1 ) Prior to initiation, assess renal function with estimated gl…

Contraindications

4 CONTRAINDICATIONS JANUMET XR is 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. History of a serious hypersensitivity reaction to JANUMET XR, sitagliptin, or metformin such as anaphylaxis or angioedema. [See Warnings and Precautions (5.7) ; Adverse Reactions (6.2) . ] Severe renal impairment: eGFR below 30 mL/min/1.73 m 2 . ( 4 ) Metabolic acidosis, including diabetic ketoacidosis. ( 4 ) History of a serious hypersensitivity reaction (e.g., anaphylaxis or angioedema) to JANUMET XR, sitagliptin, or metformin. ( 5.7 , 6.2 )

Drug Interactions

Drug Interactions The concomitant use of JANUMET XR with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance or increase metformin accumulation [see Drug Interactions (7) ]. Therefore, consider more frequent monitoring of patients.

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Heart Failure [see Warnings and Precautions (5.3) ] Acute Renal Failure [see Warnings and Precautions (5.4) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.5) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.8) ] Bullous Pemphigoid [see Warnings and Precautions (5.9) ] The most common adverse reactions reported in ≥5% of patients simultaneously started on sitagliptin and metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 …

Frequently Asked Questions

What is JANUMET XR used for?

JANUMET XR contains sitagliptin and metformin hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is JANUMET XR a controlled substance?

JANUMET XR is not classified as a controlled substance by the DEA.

What is the generic name for JANUMET XR?

The generic name for JANUMET XR is sitagliptin and metformin hydrochloride. There are 10 other brand versions of sitagliptin and metformin hydrochloride.

What is the NDC code for JANUMET XR 1000 mg/1?

The NDC (National Drug Code) for JANUMET XR 1000 mg/1 is 0006-0081, listed by Merck Sharp & Dohme LLC.

Product NDC

0006-0081

Package NDC

0006-0081-14

Other JANUMET XR Dosages

Other Sitagliptin Brands

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

Data from openFDA · Public domain (CC0 1.0)