Sitagliptin And Metformin Hydrochloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]
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Black Box Warning
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WARNING: LACTIC ACIDOSIS
See full prescribing information for complete Boxed Warning.
Lactic acidosis: Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, sitagliptin and metformin hydrochloride should be discontinued and the patient hospitalized immediately. |
Overview
Sitagliptin And Metformin Hydrochloride is a anti-diabetic drug that is FDA approved for the treatment of diabetes mellitus type 2. There is a Black Box Warning for this drug as shown here. Common adverse reactions include asthenia, headache, nasopharyngitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- The dosage of sitagliptin and metformin should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.
- Sitagliptin and metformin should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. Sitagliptin and metformin must not be split or divided before swallowing.
- The starting dose of sitagliptin and metformin should be based on the patient's current regimen. Sitagliptin and metformin should be given twice daily with meals. The following doses are available:
- 50 mg sitagliptin/500 mg metformin hydrochloride
- 50 mg sitagliptin/1000 mg metformin hydrochloride
- The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.
- The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin 850 mg twice daily, the recommended starting dose of sitagliptin and metformin is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
- Patients treated with an insulin secretagogue or insulin.
- Coadministration of sitagliptin and metformin with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
- No studies have been performed specifically examining the safety and efficacy of sitagliptin and metformin in patients previously treated with other oral antihyperglycemic agents and switched to sitagliptin and metformin . Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sitagliptin And Metformin Hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sitagliptin And Metformin Hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sitagliptin And Metformin Hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sitagliptin And Metformin Hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sitagliptin And Metformin Hydrochloride in pediatric patients.
Contraindications
Sitagliptin and metformin is contraindicated in patients with:
- Renal impairment (e.g., serum creatinine levels greater than or equal to 1.5 mg/dL for men, greater than or equal to 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
- History of a serious hypersensitivity reaction to Sitagliptin or metformin, such as anaphylaxis or angioedema.
Warnings
|
WARNING: LACTIC ACIDOSIS
See full prescribing information for complete Boxed Warning.
Lactic acidosis: Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, sitagliptin and metformin hydrochloride should be discontinued and the patient hospitalized immediately. |
Conidition 1
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Gastrointestinal
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Hypersensitive Reactions
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Postmarketing Experience
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Drug Interactions
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Use in Specific Populations
Pregnancy
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Labor and Delivery
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Nursing Mothers
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Pediatric Use
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Geriatic Use
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
Administration
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Monitoring
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IV Compatibility
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Y-Site
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Admixture
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Syringe
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TPN/TNA
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Overdosage
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Chronic Overdose
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Pharmacology
Sitagliptin And Metformin Hydrochloride
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Clinical Studies
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Storage
There is limited information regarding Sitagliptin And Metformin Hydrochloride Storage in the drug label.
Images
Drug Images
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Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Sitagliptin And Metformin Hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Sitagliptin And Metformin Hydrochloride Brand Names in the drug label.
Look-Alike Drug Names
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
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References
The contents of this FDA label are provided by the National Library of Medicine.