SITAXA M XR 100/1000 Tablet

Name

• Brand Name: SITAXA M XR 100/1000 Tablet
• Manufacturer: Torrent Pharmaceuticals Ltd. (PSYCAN CND)

Composition SITAXA M XR 100/1000 Tablet is a fixed-dose combination medication containing two active ingredients:

• Sitagliptin Phosphate (100 mg)
• Metformin Hydrochloride (1000 mg)

Uses This medication is prescribed for the treatment of Type 2 Diabetes Mellitus in adults. It helps control blood sugar levels when diet and exercise alone are not sufficient. It works by increasing insulin release, decreasing sugar production by the liver, improving insulin sensitivity, and slowing glucose absorption from the intestines. Additionally, it may be used off-label for the management of insulin resistance in polycystic ovary syndrome (PCOS).

Dosage and Administration SITAXA M XR is an extended-release (XR) formulation, typically taken once daily with a meal to minimize gastrointestinal side effects. The tablet should be swallowed whole with a full glass of water and not crushed, chewed, or broken. Dosage varies based on individual needs and should be strictly followed as prescribed by a physician. Consistency in dosing is crucial for optimal blood glucose control.

Side Effects

• Common Side Effects: Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, metallic taste, headache, dizziness, constipation, upper respiratory tract infection, and back pain. Low blood sugar (hypoglycemia) can occur, especially when combined with insulin or other diabetes medicines that cause hypoglycemia.
• Serious Side Effects: Pancreatitis, severe allergic reactions (rash, itching, swelling), lactic acidosis (a rare but serious condition, particularly with metformin), and liver problems.

Precautions Before taking SITAXA M XR, inform your doctor about any history of kidney or liver problems, heart conditions, or pancreatitis. It is not recommended for patients with severe kidney impairment, Type 1 diabetes, or diabetic ketoacidosis. Alcohol consumption should be avoided or limited as it can increase the risk of lactic acidosis and affect blood sugar control. Pregnant and breastfeeding women should consult their doctor before use. Regular monitoring of blood sugar levels and kidney function is essential during treatment.

Storage Store SITAXA M XR in a cool, dry place away from direct sunlight and moisture, preferably at room temperature (20-25°C). Keep out of sight and reach of children.

What is SITAXA M XR 100/1000 used for?

SITAXA M XR 100/1000 is a combination medicine prescribed to help control high blood sugar levels in adults with type 2 diabetes mellitus. It is used alongside a healthy diet and regular exercise to improve blood sugar control. By regulating blood sugar, it helps prevent serious diabetes-related complications such as kidney damage, eye damage, nerve problems, and cardiovascular issues like heart attacks and strokes.

How does SITAXA M XR 100/1000 work?

This medication combines two active ingredients: Sitagliptin (100mg) and Metformin (1000mg).

• Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the levels of natural substances called incretins, which help to increase insulin release from the pancreas, especially after meals, and decrease the amount of sugar the liver produces. This mechanism helps regulate blood glucose levels towards normal and is less likely to cause low blood sugar when used alone.
• Metformin is a biguanide. It primarily works by reducing glucose production in the liver, decreasing the absorption of glucose from the intestines, and improving the body's sensitivity to insulin, allowing cells to utilize glucose more effectively.

What is the usual dosage for SITAXA M XR 100/1000?

SITAXA M XR 100/1000 is an extended-release (XR) formulation, typically taken once daily with a meal, preferably in the evening, to enhance effectiveness and minimize gastrointestinal side effects. The tablet should be swallowed whole with a full glass of water and not crushed, split, or chewed. Your doctor will determine the appropriate dosage based on your individual needs and current blood sugar control. The maximum recommended daily dose is usually 100 mg of sitagliptin and 2000 mg of metformin.

What are the possible side effects of SITAXA M XR 100/1000?

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, loss of appetite, and a metallic taste in the mouth. Other possible effects include headache, dizziness, constipation, sore throat, stuffy nose, and joint pain. Less common but potentially serious side effects include:

• Hypoglycemia (low blood sugar): While SITAXA M XR itself has a low risk of causing hypoglycemia when used alone, the risk increases if taken with other diabetes medications like insulin or sulfonylureas. Symptoms can include shakiness, sweating, dizziness, confusion, and a fast heartbeat.
• Lactic Acidosis: This is a rare but serious condition primarily associated with metformin, especially in patients with kidney problems, liver disease, excessive alcohol intake, or dehydration. Symptoms include unusual muscle pain, trouble breathing, stomach pain, feeling cold, dizziness, or unusual tiredness.
• Pancreatitis: There have been postmarketing reports of acute pancreatitis. If you experience severe abdominal pain, discontinue the medication and seek immediate medical attention.
• Allergic Reactions: Serious allergic reactions like rash, itching, swelling of the face, lips, tongue, or throat, and difficulty breathing can occur.

Is SITAXA M XR 100/1000 safe during pregnancy or breastfeeding?

SITAXA M XR is generally not recommended during pregnancy because there is limited information on its potential effects on a developing baby. If you are pregnant or planning to become pregnant, your doctor will need to review your treatment and may suggest a safer alternative. It is also not usually recommended while breastfeeding, as it is unknown how much of sitagliptin or metformin passes into breast milk. Your doctor should be consulted to determine the best course of action for you and your baby.

Can SITAXA M XR 100/1000 be taken with other medications?

SITAXA M XR can interact with various medications, affecting its efficacy or increasing the risk of side effects. It is crucial to inform your doctor about all other medications, supplements, and herbal remedies you are taking. Particular caution is advised with:

• Insulin or other anti-diabetic medicines (e.g., sulfonylureas): Increased risk of hypoglycemia.
• Diuretics (water pills) and certain blood pressure medications: May increase the risk of lactic acidosis or affect metformin's clearance.
• Carbonic anhydrase inhibitors: May increase the risk of lactic acidosis.
• Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine). Your doctor will need a complete picture of your medication regimen to ensure your safety and optimize your treatment.

What precautions should be taken while on SITAXA M XR 100/1000?

Several precautions are important while taking SITAXA M XR:

• Kidney and Liver Function: Inform your doctor about any kidney or liver problems, as this medication may not be suitable or may require dose adjustments. Regular monitoring of kidney function is essential.
• Alcohol Consumption: Limit or avoid excessive alcohol intake, as it can affect blood sugar control and increase the risk of lactic acidosis.
• Dehydration: Be cautious if you are dehydrated due to severe vomiting, diarrhea, fever, or reduced fluid intake, as this can increase the risk of lactic acidosis.
• Surgery and Imaging Procedures: Inform your doctor if you are scheduled for surgery or any imaging procedure involving iodinated contrast agents. SITAXA M XR may need to be stopped temporarily.
• Pancreatitis History: If you have a history of pancreatitis, inform your doctor.

What happens if a dose of SITAXA M XR 100/1000 is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should SITAXA M XR 100/1000 be stored?

Store SITAXA M XR at room temperature, away from light and moisture. Do not store it in the bathroom. Keep all medications out of the reach and sight of children and pets.