Dapacose 5 Mg Tablet (10 Tab)

DAPACOSE 5 MG TABLET

Name:

• Brand Name: DAPACOSE 5 MG TABLET
• Common Name: Dapagliflozin (5 mg)
• Manufacturer: J.B. CHEMICALS & PHARMACEUTICALS LTD.

Composition: Each tablet contains Dapagliflozin 5 mg as the active ingredient.

Uses: DAPACOSE 5 MG TABLET is primarily used for the management of:

• Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older. It helps the kidneys remove excess sugar from the body through urine.
• Heart Failure: To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure. It also lowers the amount of effort the heart needs to pump blood efficiently.
• Chronic Kidney Disease (CKD): To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with CKD.

Dosage and Administration:

• The typical starting dose for adults is 5 mg taken orally once daily, with or without food.
• Depending on the individual's response and condition, the dose may be increased to 10 mg once daily, but should not exceed 10 mg per day.
• The tablet should be swallowed whole with a glass of water. Do not crush, break, or chew the tablet.
• It is recommended to take the medicine in the morning and at a consistent time each day.
• Always follow your doctor's prescribed dosage and do not exceed it without consulting your doctor.

Side Effects:

• Common Side Effects: Urinary tract infections (UTIs), genital fungal infections (e.g., vaginal yeast infection, balanitis), increased urination (polyuria), increased thirst, dizziness, rash, back pain, nasopharyngitis (inflammation of the nasal passages and throat, like a cold), constipation, dry mouth, headache, and changes in blood lipid levels.
• Serious Side Effects (seek immediate medical attention):
  • Diabetic Ketoacidosis (DKA): Symptoms include nausea, vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness, fruity breath odor, or rapid weight loss.
  • Severe Dehydration: Signs include increased thirst, dry mouth, feeling faint or lightheaded, headache, and dark yellow or brown urine.
  • Allergic Reactions: Symptoms such as skin rash, itching, hives, swelling of the face, tongue, or throat causing difficulty in breathing and swallowing.
  • Hypoglycemia (Low Blood Sugar): Especially when used with other antidiabetic medications or alcohol. Symptoms may include feeling hungry, trembling or shaking, sweating, confusion, and difficulty concentrating.
  • Fournier's gangrene: Severe pain, tenderness, redness, or swelling in the groin or perineal area accompanied by a high temperature or feeling unwell.

Precautions:

• Contraindications: Do not take if you have type 1 diabetes, diabetic ketoacidosis, severe kidney disease, end-stage kidney disease, or are on dialysis. Avoid if you are allergic to dapagliflozin or any of its components.
• Pregnancy and Breastfeeding: Not recommended during pregnancy and breastfeeding. Consult your doctor if you are pregnant, planning pregnancy, or breastfeeding.
• Children: Not recommended for children under 10 years of age for type 2 diabetes, and generally not for heart failure or kidney disease in pediatric patients.
• Medical Conditions: Inform your doctor if you have liver problems, heart disease, history of urinary tract infections, genital infections, low blood pressure, pancreatitis, or conditions causing dehydration (e.g., severe vomiting, diarrhea).
• Alcohol Consumption: Avoid consuming alcohol as it may lead to high or low blood sugar levels and can contribute to dehydration.
• Drug Interactions: Use with caution with insulin or insulin secretagogues as it may increase the risk of low blood sugar. Certain UGT enzyme inducers (like rifampin, phenytoin) may reduce the effectiveness of dapagliflozin.
• Surgery: Inform your doctor or dentist if you are having surgery, as you may need to stop taking DAPACOSE 5 MG TABLET at least 3 days prior.
• Monitoring: Regular monitoring of blood sugar levels and kidney function is advised. Stay well-hydrated.

Storage: Store in a cool and dry place away from direct sunlight. Keep out of sight and reach of children. Maintain storage temperatures between 10ºC to 25ºC or below 30ºC.

DAPACOSE 5 MG TABLET contains dapagliflozin, a medication used to manage various conditions. Here are some frequently asked questions about DAPACOSE 5 MG TABLET:

What is DAPACOSE 5 MG TABLET used for?

DAPACOSE 5 MG TABLET is primarily used to lower blood sugar levels in adults and children aged 10 years and older with type 2 diabetes, when diet and exercise alone are not sufficient. It is also prescribed to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Additionally, it helps to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure. For patients with chronic kidney disease, DAPACOSE 5 MG TABLET can lower the risk of worsening kidney disease, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure.

How does DAPACOSE 5 MG TABLET work?

DAPACOSE 5 MG TABLET's active ingredient, dapagliflozin, belongs to a class of medicines called Sodium-Glucose Co-transporter 2 (SGLT2) inhibitors. It works by blocking the action of SGLT2 proteins in the kidneys. These proteins are responsible for reabsorbing most of the glucose back into the bloodstream. By inhibiting SGLT2, DAPACOSE 5 MG TABLET causes excess glucose to be excreted from the body through urine, thereby lowering blood sugar levels. It also affects sodium reabsorption, contributing to benefits for the heart and kidneys.

What is the usual dosage for DAPACOSE 5 MG TABLET?

For type 2 diabetes in adults and children 10 years and older, the typical starting dose is 5 milligrams (mg) once a day. Your doctor may increase this to 10 mg once daily for further blood sugar control. For adults being treated for heart failure or chronic kidney disease, the usual dose is 10 mg once a day. DAPACOSE 5 MG TABLET can be taken with or without food, but it is recommended to take it around the same time each day, preferably in the morning, to help prevent frequent nighttime urination.

What are the possible side effects of DAPACOSE 5 MG TABLET?

Common side effects include genital yeast infections (in both women and men), urinary tract infections (UTIs), increased urination (more often, in larger amounts, or at night), stuffy or runny nose, sore throat, back pain, dizziness, mild skin rash, and constipation.

More serious, but less common, side effects can occur. These include dehydration (symptoms like increased thirst, dry mouth, lightheadedness, dark urine), diabetic ketoacidosis (DKA), which is a serious condition with symptoms like nausea, vomiting, stomach pain, trouble breathing, and a fruity breath odor. Other serious side effects may involve severe UTIs, a rare but serious bacterial infection in the genital/anal area called Fournier's gangrene, signs of kidney problems (e.g., changes in urine amount, swelling in legs/feet), and allergic reactions (rash, hives, swelling of the face, lips, tongue, or throat). Low blood sugar (hypoglycemia) is generally uncommon when DAPACOSE 5 MG TABLET is taken alone but can occur if taken with other diabetes medications like insulin or sulfonylureas.

Is DAPACOSE 5 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: DAPACOSE 5 MG TABLET is generally not recommended during the second and third trimesters of pregnancy due to potential risks of kidney problems in the fetus, observed in animal studies. In the first trimester, it should only be used if the potential benefits outweigh the potential risks. If you are pregnant or planning to become pregnant, discuss the risks and benefits with your doctor.

Breastfeeding: It is not recommended to breastfeed while taking DAPACOSE 5 MG TABLET. It is unknown if the medication passes into breast milk, but there is a possible risk of side effects, including potential kidney development issues, in a breastfed child. Consult your doctor about safe feeding options for your baby if you are taking this medication.

Can DAPACOSE 5 MG TABLET be taken with other medications?

Yes, DAPACOSE 5 MG TABLET can be taken with other diabetes medications like metformin, insulin, or sulfonylureas. However, your doctor may need to adjust the dosages of these other medications to reduce the risk of low blood sugar. Caution is advised when taking DAPACOSE 5 MG TABLET with diuretics ("water pills") as this combination can increase the risk of dehydration and low blood pressure. It can also interact with lithium, potentially decreasing its levels. Always inform your doctor about all prescription and non-prescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

What precautions should be taken while taking DAPACOSE 5 MG TABLET?

Before starting DAPACOSE 5 MG TABLET, inform your doctor about any history of kidney disease (it's not recommended for severe kidney problems or if you are on dialysis), liver problems, pancreatic disease, dehydration, low blood pressure, or a history of yeast or urinary tract infections. It is crucial to stay well-hydrated, especially during exercise, hot weather, or if you experience illness causing nausea, vomiting, or diarrhea. Avoid excessive alcohol consumption, as it can increase the risk of dehydration, low blood sugar, and diabetic ketoacidosis. Your doctor may advise you to temporarily stop taking DAPACOSE 5 MG TABLET at least 3 days before any scheduled surgery or procedures that require fasting, to reduce the risk of ketoacidosis. Regular blood and urine tests will be conducted to monitor your progress and check for any unwanted effects. Be aware of the symptoms of high blood sugar, low blood sugar, and diabetic ketoacidosis, and know what to do if they occur. Practicing good personal hygiene can help prevent genital fungal infections.

What happens if a dose of DAPACOSE 5 MG TABLET is missed?

If you miss a dose of DAPACOSE 5 MG TABLET, take it as soon as you remember, provided it is 12 hours or more before your next scheduled dose. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the forgotten dose.

How should DAPACOSE 5 MG TABLET be stored?

Store DAPACOSE 5 MG TABLET in a closed container at room temperature, typically between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Keep the medicine away from excessive heat, moisture, and direct light, and do not allow it to freeze. Always keep this medication out of the reach of children. Dispose of any outdated or no longer needed medicine properly, for instance, through a medication take-back program.