Oramet SR 500

Presentation: Each sustained-release (SR) film-coated tablet contains 500 mg of metformin hydrochloride. Oramet SR 500 tablets are typically white or off-white, capsule-shaped, and film-coated, possibly with markings as detailed on the packaging. They are available in blister packs. The sustained-release formulation allows for a slower release of metformin, which can help to reduce gastrointestinal side effects and permit once-daily dosing in some patients.

Indications: Oramet SR 500 is indicated as first-line therapy in the treatment of type 2 diabetes mellitus, particularly in overweight and obese adults, when diet and exercise alone have failed to provide adequate glycemic control. It can be used as monotherapy or in combination with other oral antidiabetic agents or insulin. The sustained-release formulation may be beneficial for patients who experience gastrointestinal intolerance with immediate-release metformin.

Dosage and Administration: Oramet SR 500 tablets are for oral administration and should be swallowed whole with water. They should not be crushed or chewed. It is usually taken once daily with the evening meal.

• Monotherapy and Combination with Other Oral Antidiabetic Agents: The usual starting dose is 500 mg once daily with the evening meal. After 10-15 days, the dose may be adjusted based on blood glucose measurements. A gradual dose escalation is recommended to improve gastrointestinal tolerability. The maximum recommended daily dose is 2000 mg once daily with the evening meal. In some cases, if glycemic control is not adequate at the maximum once-daily dose, a dose of 1000 mg twice daily may be considered, taken with morning and evening meals.
• Combination with Insulin: Metformin and insulin may be used in combination to achieve better blood glucose control. The usual starting dose of Oramet SR 500 is 500 mg once daily with the evening meal, while insulin dosage is adjusted based on blood glucose measurements.
• Renal Impairment: Renal function should be assessed before initiating treatment with Oramet SR 500 and regularly thereafter.
  • eGFR ≥ 45 to < 60 mL/min/1.73 m²: A starting dose of 500 mg once daily is recommended. The maximum daily dose is 2000 mg.
  • eGFR ≥ 30 to < 45 mL/min/1.73 m²: A starting dose of 500 mg once daily is recommended. The maximum daily dose is 1000 mg.
  • eGFR < 30 mL/min/1.73 m²: Metformin is contraindicated.
• Hepatic Impairment: Oramet SR 500 is generally contraindicated in patients with hepatic impairment due to the increased risk of lactic acidosis.
• Elderly: Dose adjustment should be cautious in elderly patients due to the potential for reduced renal function. Regular monitoring of renal function is advisable.

Side Effects: Very common side effects include gastrointestinal disturbances such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These are often transient and may be reduced by taking metformin with meals and with gradual dose escalation. The sustained-release formulation may lead to fewer gastrointestinal side effects compared to immediate-release metformin.

Common side effects include taste disturbance.

Rare but serious side effects include lactic acidosis (symptoms may include nausea, vomiting, abdominal pain, severe muscle cramps, severe tiredness, and difficulty breathing), which requires immediate medical attention. Decreased vitamin B12 absorption may occur with long-term use.

Precautions: Lactic acidosis is a rare but serious metabolic complication that can occur due to metformin accumulation. Risk factors include renal impairment, acute heart failure, dehydration, excessive alcohol intake, hepatic impairment, and sepsis.

Temporary discontinuation of metformin is usually required in situations of reduced renal function, such as during severe infections, dehydration, or before major surgery or iodinated contrast procedures.

Monitor renal function regularly, especially in elderly patients.

Educate patients about the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.

Caution should be exercised when Oramet SR 500 is used in combination with other medications that can affect blood glucose levels or renal function.

Inform healthcare professionals regarding pregnancy and breastfeeding status before starting treatment with Oramet SR 500. Use during pregnancy is generally not recommended unless clearly needed. Metformin is excreted in human milk, and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importanceof the drug to the mother.  

Storage:   Store at room temperature (15°C to 30°C), protected from moisture. Keep out of reach of children. Do not use after the expiry date.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.