Sitagliptin And Metformin Hydrochloride: Difference between revisions
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Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. | 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. | If acidosis is suspected, sitagliptin and metformin hydrochloride should be discontinued and the patient hospitalized immediately. | ||
|fdaLIADAdult= | |fdaLIADAdult=* 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. | |||
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|fdaLIADPed======Condition 1===== | |fdaLIADPed======Condition 1===== | ||
Revision as of 18:00, 22 August 2014
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
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)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- (Dosage)
Condition 2
- Dosing Information
- (Dosage)
Condition 3
- Dosing Information
- (Dosage)
Contraindications
- Condition 1
- Condition 2
- Condition 3
- Condition 4
- Condition 5
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
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Condition 2
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Postmarketing Experience
(Description)
Drug Interactions
- Drug 1
- Drug 2
- Drug 3
- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
(Description)
Labor and Delivery
(Description)
Nursing Mothers
(Description)
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Y-Site
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Admixture
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Syringe
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
Sitagliptin And Metformin Hydrochloride
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Systematic (IUPAC) name | |
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Identifiers | |
CAS number | ? |
ATC code | ? |
PubChem | ? |
Chemical data | |
Formula | ? |
Mol. mass | ? |
Pharmacokinetic data | |
Bioavailability | ? |
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Excretion | ? |
Therapeutic considerations | |
Pregnancy cat. |
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Legal status | |
Routes | ? |
Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
Clinical Studies
Condition 1
(Description)
Condition 2
(Description)
Condition 3
(Description)
How Supplied
(Description)
Storage
There is limited information regarding Sitagliptin And Metformin Hydrochloride Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Sitagliptin And Metformin Hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Sitagliptin And Metformin Hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.