Diajard-M

Serious Warnings

• Black Box Warning: WARNING: LACTIC ACIDOSIS. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/Liter) and anion gap acidosis.
• Before initiating treatment, assess renal function and volume status, correcting any volume depletion.
• Renal function should be monitored clinically during treatment.
• Inform your doctor about your complete medical history, especially concerning heart disease, kidney disease (including dialysis), liver disorders, alcohol use/abuse, dehydration, low blood pressure, high blood cholesterol, or a history of vaginal or penile yeast infections.
• Inform your doctor about all current and past significant medications, and if you are undergoing any surgery or medical procedures.
• Do not discontinue this medicine without informing your doctor.
• **Lactic Acidosis (Metformin-associated):** This is a rare but severe, potentially fatal complication.
• It is characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis, and nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain.
• The risk is increased with severe renal impairment, alcohol consumption, acute congestive heart failure, and conditions associated with hypoxemia.
• **Diabetic Ketoacidosis (DKA):** Risk exists, particularly in patients with type 1 diabetes mellitus.
• This medicine is not indicated for the treatment of DKA.
• **Volume Depletion:** May occur due to empagliflozin's mechanism; ensure adequate hydration, especially in the elderly.
• **Genitourinary Infections:** Increased risk of urinary tract infections, urosepsis, pyelonephritis, genital mycotic infections, and necrotizing fasciitis of the perineum (Fournier's Gangrene).
• **Hypoglycemia:** The risk of hypoglycemia increases, particularly when used in combination with insulin or insulin secretagogues.
• **Lower Limb Amputation:** There may be an increased risk of lower limb amputation.
• **Vitamin B12 Deficiency:** Metformin can lead to reduced Vitamin B12 absorption; monitoring may be necessary.
• **Hypersensitivity Reactions:** Allergic reactions, including angioedema and Stevens-Johnson Syndrome, have been reported.
• Inform your doctor if you are allergic to any constituents.
• **Stress, Surgery, and Illness:** Blood sugar control may become difficult during periods of physiological stress (e.
• g.
• , infection, injury, fever, surgery).
• Discontinue use for 48 hours before and after surgery or procedures requiring temporary discontinuation of metformin.
• Patients may experience increased ketone levels if not eating adequately; consult a doctor for potential treatment adjustments and monitoring.
• **Alcohol Consumption:** Alcohol consumption is contraindicated as it significantly increases the risk of both high and low blood sugar levels, and lactic acidosis.
• **Pregnancy and Lactation:** This medicine is not generally recommended for pregnant females; consult a doctor regarding benefits and risks if its use is absolutely necessary.
• For nursing females, consult a doctor; use only if absolutely necessary, as a decision may be needed to discontinue breastfeeding or the medicine.
• **Pediatric Use:** This medicine is not recommended for children.
• **Geriatric Use:** Older persons may be more susceptible to adverse effects such as dehydration, kidney issues, and lightheadedness (especially upon standing).
• **Driving and Operating Machinery:** May cause dizziness and sleepiness; avoid driving or operating heavy machinery until you understand how the medicine affects you.
• **Storage:** Keep this medicine at room temperature, away from sunlight and water, and out of the reach of children and pets.