Justoza M 5/500 Tablet

JUSTOZA M 5/500 TABLET by MANKIND PHARMA LTD

Name

• Brand Name: JUSTOZA M 5/500 TABLET
• Common Name: Dapagliflozin and Metformin tablets

Composition JUSTOZA M 5/500 TABLET is a combination medicine containing two active ingredients:

• Dapagliflozin: 5 mg (a sodium-glucose co-transporter-2 (SGLT-2) inhibitor)
• Metformin: 500 mg (a biguanide)

Uses This medication is primarily used to treat Type 2 Diabetes Mellitus in adults. It helps to:

• Control high blood sugar levels.
• Improve glycemic control in conjunction with diet and exercise.
• Enhance insulin sensitivity and reduce glucose production in the liver.
• Promote the excretion of excess glucose from the body through urine.
• Reduce the risk of serious diabetes complications like kidney damage, eye problems, nerve issues, and heart disease.
• May be used alongside other diabetes medications such as insulin or GLP-1 receptor agonists like liraglutide for better blood sugar control.

Dosage and Administration

• Take JUSTOZA M 5/500 TABLET orally, usually once daily in the morning, with or without food, as directed by your doctor.
• Swallow the tablet whole with a glass of water; do not crush, chew, or break it.
• The dosage is determined by your doctor based on your medical condition and response to treatment.
• Consistency is crucial; take it at the same time each day to help remember.
• Do not stop taking the medicine abruptly without consulting your doctor, as this can lead to increased blood sugar levels.

Side Effects Common side effects may include:

• Frequent urination
• Mild skin rash or itchy skin
• Diarrhea
• Stomach pain or discomfort, abdominal pain
• Loss of appetite
• Nausea, vomiting
• Headache
• Dizziness
• Female genital infections, genital mycotic infections (yeast or fungal infections)
• Nasal inflammation (nasopharyngitis), sore throat, nasal congestion
• Urinary tract infections

Serious side effects (seek immediate medical attention if experienced):

• Lactic acidosis (symptoms include nausea, vomiting, stomach pain, muscle cramps, severe tiredness, difficulty breathing, dizziness, lightheadedness, reduced body temperature, and low blood pressure).
• Hypoglycemia (low blood sugar), characterized by extreme weakness, tremors, sweating, confusion, trouble speaking, or fast heartbeats.

Precautions

• Allergies: Do not take if allergic to dapagliflozin, metformin, or any components of the tablet.
• Kidney/Liver Disease: Not recommended for patients with severe kidney or liver disease, or moderate to severe kidney disease.
• Pregnancy and Breastfeeding: Consult your doctor. Generally not recommended in the second and third trimesters of pregnancy or for breastfeeding mothers due to potential risks.
• Alcohol: Avoid alcohol consumption as it may increase the risk of lactic acidosis and low blood sugar.
• Other Conditions: Inform your doctor about any history of heart failure, recent heart attack, severe infection (septicemia), diabetic ketoacidosis, dehydration, hypoxemia, or uncontrolled diabetes.
• Age Restrictions: Not recommended for children and adolescents under 18 years of age, or individuals aged 85 years or older.
• Drug Interactions: Inform your doctor about all other medications, including prescription, over-the-counter drugs, vitamins, and herbal supplements, to avoid potential interactions.
• Monitoring: Regular monitoring of blood sugar levels is essential. Your doctor may also recommend periodic blood tests to check kidney function.
• Hydration and Hygiene: Drink plenty of fluids to prevent dehydration and practice good genital hygiene to reduce the risk of fungal infections.

Storage

• Store in a cool and dry place away from sunlight.
• Keep out of sight and reach of children.
• Store at temperatures between 10ºC to 25ºC or below 30ºC.

JUSTOZA M 5/500 TABLET is a combination medicine containing Dapagliflozin (5mg) and Metformin (500mg), primarily used to manage type 2 diabetes mellitus in adults.

What is JUSTOZA M 5/500 TABLET used for?

JUSTOZA M 5/500 TABLET is prescribed for adults with type 2 diabetes mellitus to help control high blood sugar levels, in conjunction with diet and exercise. It is also used to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Furthermore, it can lower the risk of worsening kidney disease, cardiovascular death, and hospitalization for heart failure in patients with type 2 diabetes and chronic kidney disease.

How does JUSTOZA M 5/500 TABLET work?

This medicine contains two active ingredients: Dapagliflozin and Metformin. Dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) protein in the kidneys, which prevents the reabsorption of glucose and leads to its excretion through urine, thus lowering blood sugar. Metformin, a biguanide, reduces glucose production in the liver, decreases the absorption of sugar from the intestines, and improves the body's sensitivity to insulin, allowing for better glucose utilization.

What is the usual dosage for JUSTOZA M 5/500 TABLET?

For adults with type 2 diabetes not currently taking dapagliflozin, the recommended starting dose for dapagliflozin is typically 5 mg once daily. The metformin dose is individualized by your doctor, usually starting at 500 mg once daily, and can be gradually increased to minimize gastrointestinal side effects. The maximum recommended daily dose is 10 mg of dapagliflozin and 2000 mg of metformin. This combination tablet is typically taken orally once daily with the evening meal.

What are the possible side effects of JUSTOZA M 5/500 TABLET?

Common side effects may include genital fungal infections, urinary tract infections, increased urination, headache, nausea, vomiting, diarrhea, runny or stuffy nose, sore throat, and back pain. More serious side effects, though rare, can include lactic acidosis (a build-up of lactic acid in the blood), ketoacidosis (high ketones in the blood), severe allergic reactions, dehydration, and acute kidney injury.

Is JUSTOZA M 5/500 TABLET safe during pregnancy or breastfeeding?

JUSTOZA M 5/500 TABLET is generally not recommended during pregnancy, especially during the second and third trimesters, due to potential risks to the developing baby's kidneys. Insulin is often the preferred treatment for diabetes during pregnancy. For breastfeeding mothers, use is also not recommended as it's unclear how much of the medication passes into breast milk and there's a theoretical risk to the infant's developing kidney.

Can JUSTOZA M 5/500 TABLET be taken with other medications?

It can be taken with some other medications, but caution is advised. If taken with insulin or insulin secretagogues (like sulfonylureas), your doctor may need to adjust their dosage to reduce the risk of low blood sugar (hypoglycemia). Diuretics ("water pills") may increase the risk of dehydration, and certain drugs that affect metformin clearance (e.g., cimetidine, ranolazine, vandetanib, dolutegravir) can increase metformin levels in the body. Always inform your doctor about all medicines, supplements, or herbal products you are currently taking.

What precautions should be taken while using JUSTOZA M 5/500 TABLET?

It is crucial to monitor kidney function regularly before and during treatment, especially in elderly patients. Limit alcohol consumption as it can increase the risk of lactic acidosis. Stay well-hydrated. Your doctor may instruct you to temporarily stop this medicine before any major surgery or diagnostic tests involving iodinated contrast dyes. This medication is not for type 1 diabetes. Be vigilant for symptoms of lactic acidosis, ketoacidosis, and serious infections.

What happens if a dose of JUSTOZA M 5/500 TABLET is missed?

If you miss a dose, take it as soon as you remember, preferably with food. 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 the missed one.

How should JUSTOZA M 5/500 TABLET be stored?

Store the medicine in its original container at room temperature, typically between 20°C and 25°C (68°F and 77°F). Keep it in a dry place, away from excessive heat, moisture, and direct light. Ensure it is kept out of the reach and sight of children and pets.