Sitazit M Er 1000mg Tab

SITAZIT M ER 1000MG Tablet by GLENMARK PHARMACEUTICALS

Name

• Common Name: Sitagliptin and Metformin Hydrochloride Extended-Release Tablets
• Brand Name: SITAZIT M ER 1000MG (also known by other brand names such as Janumet XR)

Composition

SITAZIT M ER 1000MG contains two active ingredients:

• Sitagliptin: 100 mg (a dipeptidyl peptidase-4 (DPP-4) inhibitor)
• Metformin Hydrochloride: 1000 mg (a biguanide, extended-release formulation)

Uses

SITAZIT M ER 1000MG is prescribed as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 Diabetes Mellitus. It helps to lower high blood sugar levels, thereby reducing the risk of serious complications such as kidney damage, blindness, nerve problems, and may lessen the risk of heart attack or stroke. Sitagliptin increases insulin release, especially after meals, and decreases the amount of sugar the liver makes, while Metformin reduces glucose production in the liver, decreases intestinal glucose absorption, and improves insulin sensitivity.

Dosage and Administration

This medication is typically taken orally once daily with a meal, preferably the evening meal. The tablets should be swallowed whole and not crushed, split, or chewed to ensure the extended-release properties are maintained. The dosage is individualized based on the patient's current regimen, effectiveness, and tolerability. For patients not currently on metformin, a common starting dose for the extended-release formulation is 100 mg sitagliptin/1000 mg metformin once daily, with gradual dose escalation recommended to reduce gastrointestinal side effects. The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin.

Side Effects

• Common Side Effects: Nausea, vomiting, diarrhea, headache, runny or stuffy nose, sore throat, upper respiratory tract infection, stomach ache, indigestion, gas, metallic taste, decreased vitamin B12 levels, weakness, and low blood sugar (hypoglycemia), especially when used in combination with sulfonylureas or insulin.
• Serious Side Effects:
  • Lactic Acidosis: A rare but very serious condition that can be fatal, characterized by unusual muscle pain, trouble breathing, stomach pain with nausea/vomiting/diarrhea, dizziness, lightheadedness, cold hands or feet, and unusual tiredness or weakness.
  • Pancreatitis: Severe and persistent stomach pain, possibly radiating to the back, with or without nausea and vomiting.
  • Allergic Reactions: Rash, hives, swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing.
  • Bullous Pemphigoid: Blisters or erosion of the skin.
  • Kidney Problems: Worsening kidney function, sometimes requiring dialysis.
  • Heart Failure: Symptoms like increasing shortness of breath, swelling of feet/ankles/legs, unusually fast weight gain, or unusual tiredness.
  • Severe Joint Pain: Persistent joint pain.

Precautions

• Lactic Acidosis: The risk of lactic acidosis is increased with severe kidney problems, uncontrolled diabetes, serious infections, prolonged fasting, excessive alcohol intake, dehydration, liver problems, and conditions causing reduced oxygen supply (e.g., acute severe heart disease). Discontinue use and seek immediate medical attention if symptoms occur.
• Pancreatitis: Inform your doctor if you have a history of pancreatitis, gallstones, high blood triglyceride levels, or alcoholism, as these may increase the risk.
• Kidney/Liver/Heart Conditions: Use with caution in patients with kidney, liver, or heart problems. Renal function should be assessed before starting and annually during treatment.
• Dehydration: Temporarily stop taking the medication if experiencing conditions that lead to severe dehydration (e.g., severe vomiting, diarrhea, fever).
• Alcohol Intake: Limit alcohol consumption to minimize the risk of lactic acidosis and hypoglycemia.
• Medical Procedures: May need to discontinue the medication temporarily before certain imaging procedures involving injectable dyes or surgery.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding.
• Vitamin B12 Levels: Metformin can decrease vitamin B12 levels; regular monitoring may be advised.
• Drug Interactions: Concomitant use with insulin or sulfonylureas may increase the risk of low blood sugar, requiring dose adjustments of these medications.

Storage

Store at room temperature, ideally between 20°C to 25°C (68°F to 77°F), and keep below 30°C. Protect from light and moisture. Keep the container tightly closed and out of the reach of children.

SITAZIT M ER 1000MG TAB by GLENMARK PHARMACEUTICALS is a combination medication containing Sitagliptin (100mg) and Metformin (1000mg) in an extended-release formulation. It is used to manage high blood sugar levels in adults with type 2 diabetes mellitus.

What is SITAZIT M ER 1000MG TAB used for?

SITAZIT M ER 1000MG TAB is used along with a proper diet and exercise program to improve blood sugar control in adults with type 2 diabetes mellitus. This helps to prevent serious complications of diabetes, such as kidney damage, blindness, nerve problems, and may reduce the risk of heart attack or stroke.

How does SITAZIT M ER 1000MG TAB work?

This medicine combines two active ingredients: Sitagliptin and Metformin. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by increasing the levels of natural substances called incretins. Incretins help control blood sugar by increasing insulin release from the pancreas, especially after meals, and by signaling the liver to reduce sugar production. Metformin is a biguanide that lowers glucose production in the liver, delays glucose absorption from the intestines, and enhances the body's sensitivity to insulin, helping it use sugar more effectively.

What is the usual dosage for SITAZIT M ER 1000MG TAB?

For adults not currently treated with metformin, an initial dose may be 100 mg of sitagliptin and 1000 mg of metformin once a day. The dosage may be adjusted by your doctor based on your blood sugar control, but usually should not exceed 100 mg of sitagliptin and 2000 mg of metformin per day. This extended-release tablet is typically taken once daily with a meal, preferably in the evening, and should be swallowed whole without crushing, splitting, or chewing.

What are the possible side effects of SITAZIT M ER 1000MG TAB?

Common side effects can include low blood sugar (hypoglycemia), upset stomach, indigestion, gas, diarrhea, nausea, vomiting, headache, weakness, runny or stuffy nose, and sore throat. More serious but rare side effects include lactic acidosis, severe joint pain, pancreatitis (severe stomach/abdominal/back pain), and serious allergic reactions (rash, swelling of the face/lips/tongue/throat). Long-term use of metformin can also lead to vitamin B12 deficiency.

Is SITAZIT M ER 1000MG TAB safe during pregnancy or breastfeeding?

Sitagliptin is generally not recommended during pregnancy due to limited information on its effects on a developing baby. Metformin can cause changes in the menstrual cycle, potentially increasing the risk of pregnancy. During breastfeeding, sitagliptin is not usually recommended as the amount that passes into breast milk is not well established, though it is likely to be small. Metformin passes into breast milk in small amounts. Your doctor will need to review your treatment and may suggest safer alternatives during pregnancy and breastfeeding.

Can SITAZIT M ER 1000MG TAB be taken with other medications?

Yes, but caution is advised as it can interact with several medications. Combining it with insulin or other antidiabetic medications can increase the risk of low blood sugar. Diuretics and certain cationic medicines (like cimetidine, digoxin, triamterene, and trimethoprim) may also interact. Other drugs like carbonic anhydrase inhibitors, some antibiotics, and medications for blood pressure or heart conditions can affect blood sugar levels or increase the risk of side effects like lactic acidosis. Always inform your doctor and pharmacist about all medications, supplements, and herbal products you are taking.

What precautions should be taken with SITAZIT M ER 1000MG TAB?

It is important to have your kidney function checked before starting and regularly during treatment, as severe renal impairment is a contraindication. Avoid or limit alcohol consumption as it can increase the risk of lactic acidosis and low blood sugar. Be aware of symptoms of lactic acidosis (unusual tiredness, dizziness, muscle pain, difficulty breathing, stomach discomfort) and seek immediate medical attention if they occur. Pancreatitis has been reported, so tell your doctor about any severe stomach pain. You should also be cautious if you have severe breathing problems, liver disease, or a history of allergic reactions to sitagliptin or metformin. Stay hydrated, especially during illness, as dehydration can increase the risk of lactic acidosis.

What happens if a dose is missed?

If you miss a dose of SITAZIT M ER 1000MG TAB, take it as soon as you remember. However, if it is almost time for your next scheduled 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 SITAZIT M ER 1000MG TAB be stored?

This medicine should be stored in a closed container at room temperature, away from heat, moisture, and direct light. Keep it out of reach of children.