Introduction About SITACIP GM 50/1/1000 TABLET

SITACIP GM 50/1/1000 TABLET is used to manage type 2 diabetes mellitus when diet, exercise and the single agent does not result in adequate glycemic control. It is a combination of Glimepiride,  Metformin and Sitagliptin which belongs to a group of medicines called Antidiabetic agents. Glimepiride lowers blood glucose levels by increasing the amount of insulin released by the pancreas. Metformin decreases the amount of glucose you absorb from your food and the amount of glucose made by the liver. Sitagliptin helps control blood sugar levels by increasing substances (incretins) in the body that make the pancreas release more insulin.

Before taking SITACIP GM 50/1/1000 TABLET inform your doctor if you have type 1 diabetes mellitus, diabetic ketoacidosis, severe liver or kidney disease, acute heart problems. Inform your doctor if you are pregnant or breastfeeding before taking the medicine. SITACIP GM 50/1/1000 TABLET is not suitable for use by children and adolescents under 18 years of age.

Avoid consumption of alcohol during management with SITACIP GM 50/1/1000 TABLET as it may increase or decrease the blood sugar lowering action of SITACIP GM 50/1/1000 TABLET and increases the risk of lactic acidosis. The most common side effects of taking SITACIP GM 50/1/1000 TABLET are taste disturbance, nausea, diarrhea, stomachache, and vomiting. Contact your doctor if any of the above symptoms worsen.

Uses Of SITACIP GM 50/1/1000 TABLET

• It is used to manage type 2 diabetes mellitus

How SITACIP GM 50/1/1000 TABLET Works

SITACIP GM 50/1/1000 TABLET is a combination of Glimepiride, Metformin, and Sitagliptin. Metformin decreases blood glucose levels by decreasing hepatic glucose production, decreasing the intestinal absorption of glucose, and in muscles by increasing insulin sensitivity and improving peripheral glucose uptake and utilization. Glimepiride blocks the ATP-sensitive potassium channel by binding non-specifically to the B sites of both sulfonylurea receptor-1 (SUR1) and sulfonylurea receptor-2A (SUR2A) subunits as well as the A site of SUR1 subunit of the channel to promote insulin secretion from the beta cell. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar when there is too much sugar in the blood.

How to use SITACIP GM 50/1/1000 TABLET

Take SITACIP GM 50/1/1000 TABLET as advised by your physician. Swallow SITACIP GM 50/1/1000 TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking SITACIP GM 50/1/1000 TABLET without informing your doctor.

Side Effects Of SITACIP GM 50/1/1000 TABLET

How To Manage Side Effects

Bloating

Eat smaller and more frequent meals. Eat and drink slowly, and exercise regularly. If the bloating does not improve, contact your doctor.

Diarrhea

Drink lots of fluids, such as water or fruit juices, to keep yourself hydrated. Do not take any medicine on your own to manage diarrhea. Contact your doctor if your diarrhea does not improve.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Consult your doctor if your headache worsens.

Nausea And Vomiting

Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if your nausea and vomiting do not improve.

Stomach Pain

Rest and relax. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heating pad on your stomach. Do not self-manage on your own; consult your doctor if the symptom does not improve on its own.

Warning & Precautions

Pregnancy

Contraindicated

SITACIP GM 50/1/1000 TABLET may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Consult your doctor for advice.

Breastfeeding

Contraindicated

SITACIP GM 50/1/1000 TABLET is not recommended for breast-feeding women as it may pass through the breast milk, since there are no limited studies available. A decision on whether to continue should be made, considering the benefit and the potential risk of adverse effects on the child. Consult your doctor before taking the medicine.

Driving and Using Machines

Use with Caution

SITACIP GM 50/1/1000 TABLET have no or negligible influence on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin. In addition, patients should be alerted to the risk of hypoglycaemia.

Alcohol

Consult your doctor

Avoid consumption of alcohol during management with SITACIP GM 50/1/1000 TABLET as it may increase or decrease the blood sugar lowering action of SITACIP GM 50/1/1000 TABLET and increases the risk of lactic acidosis. Consult your doctor for advice before taking SITACIP GM 50/1/1000 TABLET.

Kidney

Consult your doctor

SITACIP GM 50/1/1000 TABLET is not recommended for use in patients with severe kidney disease and it should be used with caution in patients with kidney disease and your dose will be adjusted if needed depending upon kidney function. Consult your doctor before taking SITACIP GM 50/1/1000 TABLET.

Liver

Consult your doctor

SITACIP GM 50/1/1000 TABLET is not recommended if you have severe liver disease, and it should be used with caution in patients with liver disease and your dose will be adjusted if needed depending upon liver function. Consult your doctor before taking SITACIP GM 50/1/1000 TABLET.

Allergy

Contraindicated

Do not take SITACIP GM 50/1/1000 TABLET if you are allergic (hypersensitive) to Glimepiride, Metformin or Sitagliptin or other sulfonylureas (such as glipizide, glibenclamide) or sulphonamides (such as sulfamethoxazole).

Use In Pediatrics

Contraindicated

SITACIP GM 50/1/1000 TABLET is generally not recommended for use in children and adolescents (under 18 years of age). Consult the child’s doctor for advice.

Use In Geriatrics

Consult your doctor

A lower dose is required, and close monitoring of glycaemic levels and onset of gastrointestinal symptoms is necessary for elderly patients. Consult your doctor before taking SITACIP GM 50/1/1000 TABLET.

Interactions

A. Drug-Drug interactions:

• Imidazoles (Ex. Miconazole, Fluconazole)
• Antibiotics (Ex. Rifampin, vancomycin)
• Diuretics (Ex. Furosemide)
• Calcium-channel blockers (Ex. Nifedipine)
• Potassium-sparing diuretic (Ex. Amiloride, triamterene)
• Cardiac glycosides (Ex. digoxin, morphine, procainamide, quinidine, quinine)
• H2 blockers (Ex. Ranitidine)
• Antibacterial drugs (Ex. Trimethoprim)
• Corticosteroids
• Anti-psychotics (Ex. Phenothiazine)
• Anti-Thyroid agents
• Estrogens, Oral contraceptives
• Anti-convulsants (Ex. Phenytoin)
• Pyridinecarboxylic acids (Ex. Nicotinic acid)

Overdosage:

If you or anyone else take too much of SITACIP GM 50/1/1000 TABLET, contact your doctor immediately or go to a nearest hospital straight away. Overdosage symptoms of SITACIP GM 50/1/1000 TABLET includes risk of low blood sugar levels, and it may cause lactic acidosis. Symptoms of lactic acidosis include vomiting, bellyache with muscle cramps, general feeling of not being well with severe tiredness, reduced body temperature, low heartbeat, and difficulty in breathing.

Synopsis

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FAQs About SITACIP GM 50/1/1000 TABLET

References

1. KD. Tripathi. Insulin, Oral Antidiabetic Drugs and Glucagon. Essentials of medical pharmacology. Eight edition. 2019. Page-299.

2. Kesavadev J, Pillai PBS, Shankar A, Krishnan G, Jothydev S. Sitagliptin 100 mg vs glimepiride 1-3 mg as an add-on to insulin and metformin in type 2 diabetes (SWIM). Endocr Connect. 2017. [Accessed on June 15, 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5670271/

3. Merck Sharp & Dohme B.V. Electronic Medicines Compendium (EMC). [Revised in June 2023] [Accessed on June 15, 2024] https://www.medicines.org.uk/emc/files/pil.564.pdf

4. Brown & Burk UK Limited. Electronic Medicines Compendium (EMC) [Revised in December 2020] [Accessed on June 15, 2024] https://www.medicines.org.uk/emc/files/pil.10743.pdf

5. Elara Pharma services Limited. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on June 15, 2024] https://www.medicines.org.uk/emc/files/pil.13160.pdf

6. Laboratorios Liconsa, S. A. Electronic Medicines Compendium (EMC). [Revised in November 2021] [Accessed on June 15, 2024] https://www.medicines.org.uk/emc/files/pil.14063.pdf

7. TORRENT PHARMACEUTICALS LTD. Glimepiride and Metformin. [Revised in July 2019] [Accessed on June 15, 2024] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2642.pdf

Useful Diagnostic Tests

• HbA1C, Also known as Glycated Hemoglobin, Glycosylated Hemoglobin
• Blood Glucose Fasting (FBS)
• Random Blood Sugar (RBS)
• Post Prandial Blood Sugar (PPBS)
• Insulin-Fasting
• Insulin Postprandial (PP)
• Vital Diabetes Care
• Extended Diabetes Care
• Advance Diabetes Care
• Comprehensive Diabetes Care