دواعي استعمال برانداجليم ميت 12.5/500محم 30 اقراص

Alogliptin 12.5 mg / metformin 500 mg film-coated tablets (Prandaglim Met) by Eva Pharma, Egypt; 30 tablets (3 strips).

• Adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (not for type 1 diabetes)DailyMed (US NLM)

• Most common (>=4%): upper respiratory tract infection, nasopharyngitis, diarrhoea, hypertension, headache, back pain, urinary tract infection.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Severe renal impairment (eGFR <30 mL/min/1.73 m2).نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• History of serious hypersensitivity to alogliptin, metformin or any excipient.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Boxed warning: metformin-associated lactic acidosis (risk factors include renal or hepatic impairment, age >=65, contrast studies, surgery, hypoxic states, excess alcohol); discontinue and hospitalise if suspected.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• Acute pancreatitis has been reported; discontinue promptly if suspected.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• Heart failure: consider risks and benefits in patients at risk; consider discontinuation if heart failure develops.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• Serious hypersensitivity (anaphylaxis, angioedema, Stevens-Johnson syndrome) and postmarketing hepatic failure have been reported; interrupt if liver injury is detected.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• Hypoglycaemia risk with insulin or insulin secretagogues (consider lower doses); severe arthralgia and bullous pemphigoid reported with DPP-4 inhibitors.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Limited data with the combination or alogliptin are insufficient; published metformin data show no clear association with major birth defects or miscarriage.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• No data for alogliptin in human milk; limited published studies report metformin in human milk.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Assess eGFR before initiation and periodically; stop at or before iodinated contrast imaging in at-risk patients and re-check eGFR 48 hours after.نشرة دولية لنفس التركيبة · DailyMed (US NLM)