Sitagliptin And Metformin Hydrochloride
Pronunciation: JAN-yoo-met (SI-ta-GLIP-tin + met-FOR-min).
- Generic name
- sitagliptin and metformin hydrochloride
- Brand names
- Glycomet Plus, Formet Plus, Januvia Met, Janumet, Obimet Plus, Ristova Met
- Drug class
- Oral antihyperglycemic agent (DPP-4 inhibitor + biguanide)
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What sitagliptin and metformin hydrochloride is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how sitagliptin and metformin hydrochloride works
Janumet combines two antihyperglycemic agents: sitagliptin, a DPP-4 inhibitor, and metformin, a biguanide. Sitagliptin inhibits the enzyme dipeptidyl peptidase-4, increasing incretin levels (GLP-1 and GIP), which enhances glucose-dependent insulin secretion and suppresses glucagon secretion. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. (1)
What sitagliptin and metformin hydrochloride is used for
Type 2 diabetes mellitus (as an adjunct to diet and exercise)
Type 2 diabetes mellitus (as an adjunct to diet and exercise) (2)
Improve glycemic control in adults with type 2 diabetes mellitus
Improve glycemic control in adults with type 2 diabetes mellitus (2)
Before taking sitagliptin and metformin hydrochloride
Do not take / not appropriate for
- Contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²), metabolic acidosis (including diabetic ketoacidosis), or hypersensitivity to sitagliptin, metformin, or excipients. (Contraindication) (2)
- Temporarily discontinue in patients undergoing radiologic studies with iodinated contrast. (Contraindication) (2)
Tell your clinician about
(2)How to take sitagliptin and metformin hydrochloride
- General Instructions: Take Janumet exactly as prescribed by your doctor, usually twice daily with meals to reduce stomach upset.. Adult Dosing: The usual starting dose is based on your current regimen of sitagliptin and/or metformin. Doses are individualized, typically starting at 50 mg sitagliptin/500 mg metformin twice daily, with gradual adjustments as needed. Maximum dose: 100 mg sitagliptin/2000 mg metformin per day.. Pediatric Dosing: Safety and efficacy in children under 18 years have not been established; use in pediatric patients is not recommended.. Administration: Swallow tablets whole with a glass of water. Take with food to minimize gastrointestinal side effects.. When To Stop: Seek medical attention promptly if you develop symptoms of lactic acidosis or a severe allergic reaction; let the clinician you see advise on whether to continue or stop Janumet. Your doctor may also advise discontinuation ahead of certain lab tests or surgery.. Storage: Store at room temperature (68–77°F or 20–25°C), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time.
Overdose
Symptoms of overdose may include severe nausea, vomiting, abdominal pain, rapid breathing, and muscle weakness (signs of lactic acidosis). Seek emergency medical attention immediately. Supportive care and hospitalization may be required. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Abdominal pain
Incidence: Reported in the clinician-authored database; frequency not established
Upper respiratory tract infection
Incidence: Reported in the clinician-authored database; frequency not established
Hypoglycemia (when used with sulfonylurea or insulin)
Incidence: Reported in the clinician-authored database; frequency not established
Pancreatitis
Incidence: Reported in the clinician-authored database; frequency not established
Lactic acidosis
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
FDA BOXED WARNING — serious
Symptoms: FDA BOXED WARNING: Lactic acidosis is a rare but serious complication that can occur from metformin accumulation and is fatal in about half of reported cases. Risk is higher with sepsis, dehydration, excess alcohol intake, liver problems, kidney problems, and heart failure that has recently worsened. Onset can be subtle (unusual tiredness, muscle pain, trouble breathing, stomach upset, feeling unusually cold, or feeling faint). Seek emergency medical attention immediately if these symptoms occur — do not wait for the next dose or try to manage this at home.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Risk of lactic acidosis, a rare but serious complication — serious
Symptoms: Risk of lactic acidosis, a rare but serious complication. Not for use in type 1 diabetes or diabetic ketoacidosis. May cause hypoglycemia, especially when combined with other antidiabetic agents. Use caution in patients with kidney or liver impairment. Monitor for signs of pancreatitis and hypersensitivity reactions.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²), metabolic acidosis (including diabetic ketoacidosis), or hypersensitivity to sitagliptin, metformin, or excipients. Use with caution in patients with hepatic impairment, heart failure, or history of pancreatitis. Temporarily discontinue in patients undergoing radiologic studies with iodinated contrast.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Janumet may interact with other medications such as diuretics, corticosteroids, beta-blockers, and certain contrast dyes used in imaging procedures. These interactions can increase the risk of side effects or affect blood sugar control. Always inform your healthcare provider of all medicines and supplements you are taking. | (1) |
| Iodinated contrast dye (imaging procedures) | The imaging or treating team will typically pause Janumet at the time of, or before, a scan that uses iodinated contrast dye, and hold it for about 48 hours afterward, restarting only once kidney function has been rechecked and found stable. Follow the specific instructions given by the team performing the procedure. | (2) |
| Drugs cleared through the kidney (e.g., digoxin, amiloride, morphine, procainamide) | These medicines can compete with metformin for elimination by the kidneys; your care team may monitor your blood sugar control more closely if you take one of them alongside Janumet. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
There are no adequate, well-controlled studies of Janumet in pregnant women. It should be used during pregnancy only if the prescriber judges it is clearly needed, after discussing the risks and benefits; a pregnancy exposure registry exists to monitor outcomes. Discuss diabetes management planning with your healthcare provider if you are pregnant or planning pregnancy. (2)
Breastfeeding
Both sitagliptin and metformin have been found in the milk of lactating animals; it is not established whether they pass into human breast milk. Discuss the risks and benefits of breastfeeding while taking Janumet with your healthcare provider. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (2)
Renal_impairment
Janumet is contraindicated at an eGFR below 30 mL/min/1.73m^2, and starting it is not recommended at an eGFR of 30 to under 45 mL/min/1.73m^2 because the fixed-dose tablet cannot provide the lower sitagliptin dose these patients need. Kidney function should be checked before starting and at least once a year afterward. In liver impairment, metformin accumulation and lactic-acidosis risk may be higher, so the prescriber will weigh the risks and benefits carefully. (2)
Hepatic_impairment
Janumet is contraindicated at an eGFR below 30 mL/min/1.73m^2, and starting it is not recommended at an eGFR of 30 to under 45 mL/min/1.73m^2 because the fixed-dose tablet cannot provide the lower sitagliptin dose these patients need. Kidney function should be checked before starting and at least once a year afterward. In liver impairment, metformin accumulation and lactic-acidosis risk may be higher, so the prescriber will weigh the risks and benefits carefully. (2)
Monitoring
(2)Storage
Store Janumet at controlled room temperature, 20-25C (68-77F), with brief excursions to 15-30C permitted, away from moisture and heat, and out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Type 2 diabetes mellitus (as an adjunct to diet and exercise)
Dose summary: Initial dose is individualized based on the patient's current sitagliptin/metformin regimen, taken TWICE DAILY with meals (not once daily — an earlier version of this field contradicted the record's own administration instructions), typically starting at 50 mg sitagliptin/500 mg metformin twice daily and adjusted gradually; maximum 100 mg sitagliptin/2000 mg metformin per day.
Renal context: Contraindicated at eGFR <30 mL/min/1.73m^2. Not recommended to initiate at eGFR 30 to <45 mL/min/1.73m^2 (the fixed-dose tablet cannot deliver the lower sitagliptin dose these patients need). Assess renal function before starting and at least annually thereafter. (1) (2)
Frequently asked questions
What is Janumet used for?
Janumet is used to help control blood sugar levels in adults with type 2 diabetes mellitus, especially when diet and exercise alone are not enough.
How does Janumet work?
Janumet combines sitagliptin, which increases insulin release and decreases sugar production, with metformin, which reduces sugar made by the liver and improves insulin sensitivity.
What are the most common side effects?
Common side effects include diarrhea, nausea, vomiting, headache, and mild respiratory infections.
Can Janumet cause low blood sugar?
Janumet alone has a low risk of causing hypoglycemia, but the risk increases if combined with other diabetes medications like sulfonylureas or insulin.
Is Janumet safe during pregnancy or breastfeeding?
The safety of Janumet during pregnancy or breastfeeding is not well established. Consult your doctor before use if you are pregnant or breastfeeding.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double up doses.
Can I drink alcohol while taking Janumet?
It is best to avoid excessive alcohol while taking Janumet, as it increases the risk of lactic acidosis.
What happens if I take too much Janumet (Sitagliptin + Metformin)?
Taking too much Janumet can lead to severe hypoglycemia, lactic acidosis (due to metformin), and gastrointestinal upset. Symptoms may include extreme weakness, confusion, rapid breathing, and muscle pain. If an overdose is suspected, seek immediate emergency medical attention. Do not attempt to self-treat.
Can I drink alcohol while taking Janumet (Sitagliptin + Metformin)?
It is generally advised to limit or avoid alcohol consumption while taking Janumet. Alcohol can increase the risk of lactic acidosis, a rare but serious side effect associated with metformin. Additionally, alcohol can affect blood sugar levels, making glycemic control more challenging and potentially increasing the risk of hypoglycemia.
Is Janumet (Sitagliptin + Metformin) safe during pregnancy?
Janumet's safety during pregnancy has not been definitively established, and it is categorized as 'Consult doctor.' It is crucial for pregnant individuals or those planning pregnancy to discuss the risks and benefits with their healthcare provider. Alternative treatments for managing diabetes during pregnancy may be considered to ensure the best outcomes for both mother and baby.
What is the mechanism of action of sitagliptin and metformin hydrochloride?
Janumet combines two antihyperglycemic agents: sitagliptin, a DPP-4 inhibitor, and metformin, a biguanide. Sitagliptin inhibits the enzyme dipeptidyl peptidase-4, increasing incretin levels (GLP-1 and GIP), which enhances glucose-dependent insulin secretion and suppresses glucagon secretion. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. (1)
What is the generic name of Sitagliptin And Metformin Hydrochloride?
The generic name is sitagliptin and metformin hydrochloride. It is sold under brand names including Glycomet Plus, Formet Plus, Januvia Met, Janumet, Obimet Plus, Ristova Met.
What class of drug is sitagliptin and metformin hydrochloride?
Sitagliptin And Metformin Hydrochloride is classed as: Oral antihyperglycemic agent (DPP-4 inhibitor + biguanide).
References
- Janumet (Sitagliptin + Metformin) — Clinician-Authored Medicine RecordMedGuideGlobal · Global · accessed 2026-08-06 · source 1
- JANUMET (sitagliptin and metformin HCl) Tablets – Prescribing InformationU.S. Food and Drug Administration · United States · dated 2022 (cross-checked for renal thresholds) · accessed 2026-08-06 · source 2
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR HEALTH USA, LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Metformin — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- ZITUVIMET — FDA approval record (Drugs@FDA NDA216743)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- sitagliptin and metformin — RxNorm normalized drug concept (RXCUI 729717)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient sitagliptin and metformin hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- ZITUVIMET
- JANUMET