Sitaclass Dm 100/10/500

SITACLASS DM 100/10/500 by MACLEODS PHARMACEUTICALS LTD is a combination medication used in the management of Type 2 Diabetes Mellitus in adults.

Name

• Brand Name: SITACLASS DM 100/10/500

Composition

SITACLASS DM 100/10/500 contains three active ingredients:

• Dapagliflozin 10 mg
• Sitagliptin 100 mg
• Metformin 500 mg

Uses

SITACLASS DM 100/10/500 is prescribed for the treatment of Type 2 Diabetes Mellitus in adults as an adjunct to diet and exercise. It works by:

• Improving blood sugar control and reducing insulin resistance.
• Promoting glucose excretion from the body through urine.
• Increasing levels of natural substances that lower blood sugar.
• Reducing sugar production by liver cells and delaying sugar absorption from the intestines.
• Aiding in weight management and reducing cardiovascular risk.
• Lowering the risk of heart failure and diabetic kidney disease.

Dosage and Administration

This medicine should be taken as advised by your doctor.

• Swallow the tablet whole with a glass of water; do not crush or chew it.
• It is usually recommended to take with meals to reduce stomach upset.
• The medicine can be taken with or without food, but it is advisable to take it consistently at the same time each day.
• Do not stop taking the medicine abruptly without consulting your doctor.

Side Effects

Common Side Effects:

• Vomiting, nausea, abdominal pain, headache, stomach upset.
• Genital infections, common cold (nasopharyngitis), diarrhea, influenza, back pain, cough.
• Urinary tract infections.

Serious Side Effects:

• Signs of lactic acidosis (weakness, breathing difficulty, stomach pain).
• Symptoms of ketoacidosis (nausea, vomiting, confusion, fruity breath).
• Painful or persistent genital or urinary infections.
• Signs of pancreatitis (severe stomach pain, nausea).
• Allergic reactions (rash, swelling, breathing problems).

Precautions

• Pregnancy and Breastfeeding: Not recommended during pregnancy and breastfeeding due to limited safety data; consult your doctor.
• Children: Not recommended for use in children below 18 years of age.
• Kidney and Liver Disease: Not recommended for patients with severe liver or kidney disease. Caution is advised as kidney or liver impairment can increase the risk of lactic acidosis.
• Alcohol: Limit alcohol consumption as it can increase the risk of lactic acidosis.
• Other Conditions: Use with caution in patients with heart disease, metabolic acidosis, diabetic ketoacidosis, pancreatitis, hypotension, or a history of urinary tract or genital infections.
• Drug Interactions: Inform your doctor about all medications, including herbal supplements, as SITACLASS DM can interact with diuretics, insulin, insulin secretagogues, carbonic anhydrase inhibitors, and certain cationic medications.
• Monitoring: Regular monitoring of blood sugar levels and kidney function is advised.

Storage

• Store in a cool and dry place away from direct heat and sunlight, preferably below 30°C.
• Keep out of the sight and reach of children and pets.

What is SITACLASS DM 100/10/500 used for?

SITACLASS DM 100/10/500 is a combination antidiabetic medicine used to manage Type 2 Diabetes Mellitus in adults. It is prescribed as an adjunct to diet and exercise to improve blood sugar control. This medicine also helps reduce the risk of heart failure and diabetic kidney disease, and can support weight loss in some patients.

How does SITACLASS DM 100/10/500 work?

SITACLASS DM 100/10/500 contains three active ingredients: Dapagliflozin (10mg), Sitagliptin (100mg), and Metformin (500mg).

• Dapagliflozin (an SGLT2 inhibitor) works by blocking the reabsorption of glucose in the kidneys, causing excess sugar to be removed from the body through urine, thereby lowering blood sugar levels.
• Sitagliptin (a DPP-4 inhibitor) increases the levels of natural substances (incretins) in the body that help the pancreas release more insulin when blood sugar is high and signal the liver to stop producing sugar.
• Metformin (a biguanide) reduces the amount of sugar produced by the liver, delays glucose absorption from the intestines, and improves the body's sensitivity to insulin.

Together, these mechanisms provide multi-targeted control of blood sugar levels.

What is the usual dosage of SITACLASS DM 100/10/500?

The typical starting dose for this combination tablet is usually one tablet once daily, taken with food to minimize gastrointestinal side effects. The dosage may be adjusted by your doctor based on your response and tolerance, but the maximum recommended daily dose of sitagliptin (100mg) should not be exceeded. Tablets should be swallowed whole and not crushed, chewed, or split.

What are the possible side effects of SITACLASS DM 100/10/500?

Common side effects may include nausea, vomiting, abdominal pain, diarrhea, stomach upset, headache, urinary tract infections, and genital fungal infections. Less common but serious side effects can include lactic acidosis (especially with metformin accumulation), pancreatitis, severe renal impairment, and hypersensitivity reactions. Symptoms of low blood sugar (hypoglycemia) can occur, especially if taken with other antidiabetic medicines or alcohol. If side effects persist or worsen, consult your doctor.

Is SITACLASS DM 100/10/500 safe during pregnancy or breastfeeding?

SITACLASS DM 100/10/500 is generally not recommended during pregnancy due to limited information on its use and potential effects on a developing baby. Your doctor may suggest alternative, safer medications like insulin or metformin monotherapy if you are pregnant or planning to become pregnant.

Similarly, it is generally not recommended while breastfeeding because it is not known how much of the medicine passes into breast milk. If deemed necessary, use during breastfeeding should be under medical supervision, and alternative medications might be suggested, especially for newborns or premature babies.

Can SITACLASS DM 100/10/500 be taken with other medications?

This medication may interact with certain other drugs. Insulin and insulin secretagogues (like glipizide, glyburide) may increase the risk of hypoglycemia, potentially requiring a dose adjustment of these medications. Diuretics (like hydrochlorothiazide, furosemide) can also interact. Always inform your doctor about all medications, herbs, and supplements you are taking to prevent unwanted effects.

What precautions should be taken while taking SITACLASS DM 100/10/500?

• Kidney and Liver Function: This medicine is not recommended for severe liver or kidney disease and should be used with caution in patients with kidney problems, as renal impairment can increase the risk of lactic acidosis. Regular monitoring of kidney function is advised.
• Alcohol: Limit alcohol consumption, as it can increase the risk of lactic acidosis.
• Dehydration: Correct volume depletion and stay well-hydrated to prevent dehydration.
• Hypoglycemia: Be aware of symptoms of low blood sugar and carry a quick source of sugar.
• Allergies: Do not take if you are allergic to any of its components.
• Pancreatitis: Watch for signs of pancreatitis and discontinue use if suspected.
• Other conditions: Inform your doctor if you have heart failure, or are undergoing radiologic studies involving iodinated contrast materials. It is contraindicated in Type 1 Diabetes and acute or chronic metabolic acidosis.

What happens if a dose of SITACLASS DM 100/10/500 is missed?

If you miss a dose, 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 double doses to make up for a missed one, as this can lead to a rapid drop in blood sugar levels.

How should SITACLASS DM 100/10/500 be stored?

SITACLASS DM 100/10/500 should be stored in a cool and dry place, away from direct sunlight, at room temperature (between 20°C to 25°C or below 30°C). Keep it out of the sight and reach of children and pets. Do not crush, break, or chew the tablets.