Sitagliptin 25mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
For all tablet products, store them at room temperature in a dry place, avoiding the bathroom.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Follow a healthy diet plan as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Monitor your blood sugar levels regularly as instructed.
- Do not skip meals.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Severe Skin Reaction (Stevens-Johnson Syndrome): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Heart Failure: If you have a history of heart failure or kidney problems, inform your doctor. Seek immediate medical attention if you experience extreme fatigue, shortness of breath, significant weight gain, or swelling in the arms or legs.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor right away and follow your prescribed plan for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Pancreatitis: Severe stomach pain, severe back pain, or severe nausea and vomiting. Seek medical help immediately if you experience any of these symptoms.
Bullous Pemphigoid: Blisters or skin breakdown. Contact your doctor right away if you notice any of these symptoms.
Joint Pain: Severe and disabling joint pain or persistent joint pain. Seek medical attention if you experience any of these symptoms.
Other Possible Side Effects
While many people may not experience side effects or may only have mild side effects, it's essential to be aware of the following:
Headache
Common cold symptoms
* Nose or throat irritation
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help.
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain that does not go away, with or without vomiting (signs of pancreatitis).
- Allergic reactions such as swelling of the face, lips, tongue, or throat, difficulty breathing, or severe skin rash.
- Blisters or skin erosions (signs of bullous pemphigoid).
- Severe and disabling joint pain.
- Signs of heart failure: unusual shortness of breath, rapid weight gain, or swelling in your feet or legs.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
If you experience low blood sugar, do not operate a vehicle, as this can significantly increase your risk of being involved in an accident.
Monitor your blood sugar levels as directed by your doctor to ensure they remain within a healthy range. Additionally, have your blood work checked as recommended by your doctor and discuss the results with them.
Before consuming alcohol, consult with your doctor to understand any potential risks or interactions.
Adhere to the diet and exercise plan prescribed by your doctor to maintain optimal blood sugar control. Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar levels, as can changes in physical activity, exercise, or diet.
Kidney problems are a potential side effect of this medication, and in severe cases, may require hospitalization or dialysis.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Hypoglycemia (if co-administered with sulfonylurea or insulin)
- Mild prolongation of QT interval (not considered clinically significant at therapeutic doses)
- Other non-specific symptoms
What to Do:
In the event of an overdose, it is reasonable to employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment as dictated by the patient's clinical status). Sitagliptin is modestly dialyzable. Call 1-800-222-1222 (Poison Control Center) immediately.
Drug Interactions
Moderate Interactions
- Digoxin (monitor digoxin levels, as sitagliptin may slightly increase digoxin concentrations)
- Cyclosporine (co-administration with cyclosporine may increase sitagliptin exposure, but no dose adjustment is typically needed for sitagliptin)
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control and guide treatment.
Timing: Prior to initiation of therapy.
Rationale: To determine appropriate starting dose and identify need for dose adjustment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Every 3-6 months
Target: Individualized, typically <7% for most adults.
Action Threshold: If target HbA1c is not met, consider dose adjustment or addition of other antidiabetic agents.
Frequency: Periodically, especially in elderly or those with risk factors for renal impairment.
Target: Maintain within normal limits or stable for patient.
Action Threshold: If eGFR declines, adjust sitagliptin dose accordingly.
Frequency: Ongoing
Target: N/A
Action Threshold: If persistent severe abdominal pain (with or without vomiting) occurs, discontinue sitagliptin and evaluate for pancreatitis.
Frequency: Ongoing
Target: N/A
Action Threshold: If severe allergic reactions (e.g., anaphylaxis, angioedema, exfoliative skin conditions) occur, discontinue sitagliptin immediately.
Frequency: Ongoing
Target: N/A
Action Threshold: If bullous pemphigoid develops, discontinue sitagliptin.
Frequency: Ongoing
Target: N/A
Action Threshold: If severe and disabling joint pain occurs, consider discontinuing sitagliptin.
Frequency: Ongoing
Target: N/A
Action Threshold: Monitor for signs and symptoms of heart failure, especially in patients with a history of heart failure.
Symptom Monitoring
- Persistent severe abdominal pain (with or without vomiting) - possible pancreatitis
- Swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash or hives - possible hypersensitivity reaction
- Blisters or erosions on the skin - possible bullous pemphigoid
- Severe and disabling joint pain
- Unusual tiredness, shortness of breath, rapid weight gain, swelling in ankles/feet - possible heart failure
- Symptoms of hypoglycemia (if used with insulin or sulfonylurea): sweating, shakiness, dizziness, confusion, hunger, rapid heartbeat
Special Patient Groups
Pregnancy
Sitagliptin is classified as Pregnancy Category B. Animal studies have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
Lactation
Sitagliptin is excreted into the milk of lactating rats. It is not known whether sitagliptin is excreted in human milk. Caution should be exercised when sitagliptin is administered to a nursing woman. Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of untreated maternal condition.
Pediatric Use
Safety and effectiveness of sitagliptin have not been established in pediatric patients under 18 years of age. Not recommended for use in this population.
Geriatric Use
No dosage adjustment is required based on age alone. However, because sitagliptin is substantially excreted by the kidney, and elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function in elderly patients.
Clinical Information
Clinical Pearls
- Sitagliptin is generally well-tolerated with a low risk of hypoglycemia when used as monotherapy or in combination with metformin or a TZD.
- Dose adjustment is crucial for patients with renal impairment; always check renal function before initiating and periodically during treatment.
- Educate patients on the symptoms of pancreatitis (severe, persistent abdominal pain) and instruct them to seek immediate medical attention if these occur.
- Rare but serious adverse events include severe arthralgia, bullous pemphigoid, and hypersensitivity reactions.
- Can be taken with or without food, at any time of day, but consistency is recommended.
- Does not cause weight gain and may even lead to slight weight loss in some patients.
Alternative Therapies
- Other DPP-4 inhibitors (e.g., Saxagliptin, Linagliptin, Alogliptin)
- Metformin
- Sulfonylureas (e.g., Glipizide, Glyburide, Glimepiride)
- Thiazolidinediones (TZDs) (e.g., Pioglitazone, Rosiglitazone)
- GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide, Dulaglutide)
- SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin)
- Insulin
- Alpha-glucosidase inhibitors (e.g., Acarbose, Miglitol)
- Meglitinides (e.g., Repaglinide, Nateglinide)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully when you first receive your medication and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment and care.