(sit a glip' tin)
P / L : Caution during pregnancy & lactation
||See TERMINOLOGY & ABBREVIATIONS ||
Indication(s) & Usage
Monotherapy and Combination Therapy
Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Sitagliptin 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 Sitagliptin.
Dosage & Administration
The recommended dose of Sitagliptin is 100 mg once daily. Sitagliptin can be taken with or without food.
Patients with Renal Insufficiency
For patients with mild renal insufficiency (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), no dosage adjustment for Sitagliptin is required.
For patients with moderate renal insufficiency (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the dose of Sitagliptin is 50 mg once daily.
For patients with severe renal insufficiency (CrCl less than 30 mL/min, approximately corresponding to serum creatinine levels of greater than 3.0 mg/dL in men and greater than 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Sitagliptin is 25 mg once daily. Sitagliptin may be administered without regard to the timing of dialysis.
Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sitagliptin and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When Sitagliptin is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.
Treatment: Supportive measures; remove unabsorbed material from the GI tract, clinical monitoring and institute supportive therapy as needed.
Type 1 diabetes. Diabetic ketoacidosis.
Discontinue treatment if there are signs of hypersensitivity. Caution when used with sulphonylureas and/or other antidiabetic medications; monitor blood glucose regularly. Renal impairment; dose adjustment may be needed. Children <18 yr. Pregnancy, lactation.
Headache, diarrhoea, upper respiratory tract infection, nasopharyngitis. Angioedema, exfoliative dermatitis, hypoglycaemia.
Concurrent use may increase serum levels of digoxin. Increased risk of hypoglycaemia when used with sulphonylureas.
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
Store at 20-25°C.
Sitagliptin inhibits dipeptidyl peptidase IV (DPP-IV), resulting in prolonged active incretin levels. Incretin hormones increases insulin synthesis and release from pancreatic beta-cells and reduces glucagon secretion from pancreatic alpha-cells. Reduced glucagon secretion leads to decreased hepatic glucose production.
A10BH01 - sitagliptin.
Search Google: Sitagliptin
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|GLIPITA 100MG||Beximco Pharmaceuticals Ltd||Sitagliptin Phosphate INN eq. to Sitagliptin 100mg||Film Coated Tablet||10's: 470.00 MRP|
|GLIPITA 50MG||Beximco Pharmaceuticals Ltd||Sitagliptin Phosphate INN eq. to Sitagliptin 50mg||Film Coated Tablet||10's: 240.00 MRP|
|SIGLITA 100||Square Pharmaceuticals Ltd.||Sitagliptin 100mg||Tablet||1x10's: 301.00 MRP|
|SIGLITA 50||Square Pharmaceuticals Ltd.||Sitagliptin 50mg||Tablet||2x10's: 361.00 MRP|
|Sitagil 100||Incepta Pharmaceuticals Limited||Sitagliptin Phosphate INN eq.to Sitagliptin 100mg||Tablet||10x1's:MRP 470 Tk|
|Sitagil 25||Incepta Pharmaceuticals Limited||Sitagliptin Phosphate INN eq.to Sitagliptin 25mg||Tablet||10x1's:MRP 120 Tk|
|Sitagil 50||Incepta Pharmaceuticals Limited||Sitagliptin Phosphate INN eq.to Sitagliptin 50mg||Tablet||10x1's:MRP 240 Tk|
Notice (US Market):
[Posted 03/14/2013] ISSUE: FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.
BACKGROUND: Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
RECOMMENDATIONS: FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute's (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information. FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.
The Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.
At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels. For more information visit the FDA website at:http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high.
How should this medicine be used?
Sitagliptin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take sitagliptin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sitagliptin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Sitagliptin helps to control high blood sugar but does not cure diabetes. Continue to take sitagliptin even if you feel well. Do not stop taking sitagliptin without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor for more information.
What special precautions should I follow?
Before taking sitagliptin,
- tell your doctor if you are allergic to sitagliptin or any other medications.
- tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: digoxin ; insulin; and certain oral medications for diabetes including acetohexamide, chlorpropamide, glimepiride (Amaryl), glipizide, glyburide, tolazamide, and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had diabetes , diabetic ketoacidosis (a serious condition that may occur when blood sugar is too high), pancreatitis (swelling of the pancreas), gallstones, high levels of triglycerides (fatty substances) in your blood, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sitagliptin, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sitagliptin.
- talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar.
- talk to your doctor about the symptoms of high and low blood sugar and other complications of diabetes, what to do if you develop these symptoms, and how to prevent these conditions.
What special dietary instructions should I follow?
Be sure to follow all diet and exercise recommendations made by your doctor or dietician.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Sitagliptin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stuffed or runny nose
- sore throat
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- ongoing pain, that begins in the upper left or middle of the stomach but may spread to the back
- loss of appetite
Sitagliptin may cause severe or life-threatening inflammation of the pancreas. Talk to your doctor about the risks of taking this medication.
Sitagliptin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
This medication may cause other side effects. Consult your doctor if you have any unusual problems while taking this.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref. US National Library of Medicine
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
|| Back to top ||
*Trademark name & prescribing information are the property of their respective Manufacturers.