Posidapam Extended-Release Tablets 5/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Adult dose

This medication is generally taken once daily with dinner. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of extended-release metformin daily, administered as 2 tablets of 5 mg/1000 mg. For those with no prior experience of diabetes medication, the initial regimen is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dosage should be incrementally adjusted.

This medication is used to treat diabetes and contains two main active ingredients. Firstly, metformin hydrochloride, one of the components, helps lower blood sugar, but can rarely cause a serious side effect known as lactic acidosis. Lactic acidosis is a dangerous condition that occurs when there is an abnormal accumulation of lactic acid in the body and can present symptoms like difficulty breathing, muscle pain, fatigue, and abdominal pain. Secondly, dapagliflozin, the other component, helps control blood sugar by promoting the excretion of sugar from the kidneys into the urine. However, it can cause fluid volume depletion and low blood pressure, so caution is advised, particularly for patients with impaired kidney function, older adults, or those on diuretics. This medication should not be administered to patients with severe kidney impairment, dehydration, severe infections, unstable heart function, Type 1 diabetes, pregnant or breastfeeding women, etc. Additionally, using this medication in conjunction with insulin or sulfonylureas can increase the risk of hypoglycemia, so dosage adjustments are necessary when using these medications together. This medication can increase the risk of genital infections and urinary tract infections, so if related symptoms occur, patients should consult healthcare professionals immediately. Regular monitoring of kidney function and fluid status is required during treatment, and any abnormal symptoms should be promptly reported to a physician. Women who are pregnant or may become pregnant should not take this medication, and breastfeeding women should also avoid it. Finally, the risk of lactic acidosis may increase when taken with alcohol, so excessive drinking should be avoided during treatment. This medication has not established safety and efficacy in children, so it should not be used in pediatric patients. It is important to follow the prescribed dosage and instructions from a doctor and to receive regular check-ups while being vigilant for adverse reactions.

Serious side effects

• Severe lactic acidosis (related to metformin)
• Severe hypoglycemia
• Cardiovascular collapse (shock), acute myocardial infarction
• Severe renal impairment and acute kidney injury
• Severe allergic reactions (in cases of hypersensitivity)
• Severe skin adverse reactions (such as severe rash with fever)
• Respiratory issues (e.g., difficulty breathing)
• Liver abnormalities (jaundice)
• Serious neurological symptoms (such as headache, seizures, confusion of consciousness)
• Severe edema or urinary abnormalities

Mild side effects

• Vulvovaginitis, balanitis, genital infections
• Urinary tract infections
• Fungal infections
• Hypoglycemia (when co-administered with insulin or sulfonylureas)
• Dizziness
• Constipation
• Dry mouth
• Lumbago
• Dysuria
• Polyuria

This medication should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept at room temperature between 1 and 30 degrees Celsius. By doing so, the medication's efficacy can be safely maintained.

Appearance

Orange rectangular extended-release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP) x 5]