الوصف الطبي
Antidiabetic agent belongs to Biguanide group used in treatment and prevention of type 2 diabetes mellitus and treatment of polycystic ovary syndrome.
الدلالة و الاستخدام
-Prevention of type 2 diabetes mellitus: For prediabetic patients, particularly for those with BMI ≥35 kg/m2, age <60 years, and patients with prior gestational diabetes mellitus, in whom lifestyle interventions fail to improve glycemic indices: Immediate release formulations: Oral: Initial: 850 mg once daily for 1 month, then increase to 850 mg twice daily; unless GI adverse effects warrant a longer titration period.
-Treatment of type 2 diabetes mellitus:
A-Immediate release:
1-Initial: Oral: 500 mg once or twice daily or 850 mg once daily.
2-Dosage adjustments: Oral: The dose should be increased gradually to minimize GI adverse effects. Titrate the dose by 500 mg or 850 mg increments every 7 days (range: 5 days to 1 month).
3-Usual maintenance dosage: Oral: 1 g twice daily or 850 mg twice daily. Maximum dose: Oral: 2.55 g/day. If doses >2 g/day are needed, consider administering in 3 divided doses to minimize GI adverse effects.
B-Extended release:
1-Initial: Oral: 500 mg to 1 g once daily
2-Dosage adjustments: Oral: The dose should be increased gradually to minimize GI adverse effects. Titrate the dose by 500 mg increments every 7 days (range: 7 days to 6 weeks). Maximum dose: Oral: 2 g/day.
-Treatment of gestational diabetes mellitus: Immediate release: Oral: Initial: 500 mg once or twice daily; increase dosage to meet glycemic targets, typically over 1 to 2 weeks, up to a maximum of 2 to 2.5 g daily in 2 to 3 divided doses.
-Polycystic ovary syndrome (PCOS):
A-Treatment of oligomenorrhea due to PCOS: Immediate release: Oral: Dosage range: 1.5 to 2 g daily in 2 to 3 divided doses; to minimize GI adverse effects, it is recommended to initiate therapy with 500 mg once or twice daily and gradually increased the dose in 500 mg increments every 7 days.
-For the rest of indication and usage refer to Dosage and Administration.
المكونات النشطة
Metformin Hydrochloride
الجرعة و طريقة الاستعمال
-Administer with a meal to decrease GI upset.
-Extended release tablets: Swallow whole; do not crush, cut, or chew.
-Indication and usage (continue):
B-Prevention of ovarian hyperstimulation syndrome (OHSS) in patients with PCOS undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI): Immediate release: Oral: Dosage range: 1 to 2.55 g daily in 2 to 3 divided doses.
-Treatment of antipsychotic-induced weight gain:
1-Immediate release: Oral: Dosage range: 750 mg to 2 g daily in 2 to 3 divided doses. Doses up to 2.55 g/day have also been used. To minimize GI adverse effects, it is recommended to initiate therapy with 250 mg or 500 mg twice daily or 850 mg once daily, and increased the dose gradually based on tolerability.
2-Extended release: Oral: Initial: 500 mg once daily and titrated dosage upwards in 500 mg increments every 2 to 6 weeks based on tolerability. Maintenance dosage range: 1 to 2 g once daily.
-Pediatric dosing:
-Treatment of type 2 diabetes mellitus:
A-Immediate-release tablet or solution: Children ≥10 years and adolescents: Oral: Initial: 500 to 1,000 mg once daily or 500 mg twice daily; increase dose every 1 to 2 weeks as tolerated in 500 to 1,000 mg increments; maximum dose: 1,000 mg twice daily or 850 mg 3 times daily.
B-Extended-release: Children ≥10 years and adolescents: 1-Oral suspension: Oral: 500 mg once daily in the evening; titrate dose in 500 mg increments at weekly intervals as tolerated; maximum daily dose: 2,000 mg/day once daily with evening meal. 2-Tablets: Oral: Initial: 500 to 1,000 mg once daily for 7 to 14 days; may increase dose in 500 to 1,000 mg increments every 1 to 2 weeks as tolerated; maximum daily dose: 2,000 mg/day.
الاّثار الجانبية
-Diarrhea, nausea, flatulence, dyspepsia, vomiting, and abdominal pain, lactic acidosis, vitamin B12 deficiency and subsequent anemia and neuropathy.
-Chest discomfort, flushing, palpitations, diaphoresis, hypoglycemia, abdominal distention, abdominal distress, abdominal pain, abnormal stools, dyspepsia, heartburn, chills, dizziness, headache, asthenia, myalgia, dyspnea, flu-like symptoms, upper respiratory tract infection, hemolytic anemia, hepatic injury and encephalopathy.
نصائح احترازية
-Should not be given to patients suffering from hypersensitivity to metformin.
-Should not be given to patients suffering from severe renal dysfunction (If the glomerular filtration rate is <30 mL/minute/1.73 m2).
-Should not be given to patients suffering from acute or chronic metabolic acidosis with or without coma.
-Should not be given to patients suffering from severe hepatic dysfunction.
-Use cautiously in patients with heart failure.
-Not indicated for use in patients with type 1 diabetes mellitus or with diabetic ketoacidosis.
-Administration of iodinated contrast agents has been associated with postcontrast acute kidney injury (AKI); acute decreases in renal function have been associated with an increased risk of lactic acidosis due to reduced metformin excretion.
-Intensive glucose control (HbA1c <6.5%) has been linked to increased risk for cardiovascular mortality and hypoglycemia requiring assistance.
-Older adults are more likely to experience vitamin B12 deficiency with long-term use of metformin.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
التخزين
Store at room temperature.
تفاعلات الأدوية
-Alcohol (Ethyl): May enhance the adverse/toxic effect of Metformin.
-Alpha-Lipoic Acid: May enhance the hypoglycemic effect of antidiabetic agents.
-Beta-blockers: May enhance the hypoglycemic effect of antidiabetic agents. Symptoms of hypoglycemia, particularly tachycardia, may be also be blunted.
-Cephalexin: May increase the serum concentration of Metformin.
-Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents.
-Iodinated Contrast Agents: May enhance the adverse/toxic effect of Metformin.
-Lamotrigine: May increase the serum concentration of Metformin.
-Levoketoconazole: May increase the serum concentration of Metformin.
-Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects.
-Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Metformin.
-Ondansetron: May increase the serum concentration of Metformin.
-Quinolones: May enhance the hypoglycemic effect of agents with blood glucose lowering effects.
-Salicylates: May enhance the hypoglycemic effect of agents with blood glucose lowering effects.
-Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects.
-Thiazide diuretics: May diminish the therapeutic effect of antidiabetic agents.
-Topiramate: May enhance the adverse/toxic effect of Metformin.
-Trimethoprim: May increase the serum concentration of Metformin.
-Verapamil: May diminish the therapeutic effect of Metformin.
-Vitamin K antagonists (eg, warfarin): Metformin may diminish the anticoagulant effect of Vitamin K antagonists.
الحمل والرضاعة
-Metformin crosses the placenta. An increased risk of birth defects or adverse fetal/neonatal outcomes has not been observed following maternal use of metformin for gestational diabetes mellitus or type 2 diabetes mellitus. Agents other than metformin are currently recommended to treat diabetes mellitus in pregnancy.
-Metformin may be used in patients who are breastfeeding. Metformin is present in breast milk. The relative infant dose (RID) of metformin is 1.08%, breastfeeding is considered acceptable when the RID is <10, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
-Ask your physician before taking any medication during pregnancy and lactation.