دواعي استعمال برانداجليم بلس 25/30مجم 30 قرص

Alogliptin 25 mg / pioglitazone 30 mg film-coated tablets (Prandaglim Plus) 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%): nasopharyngitis, back pain, upper respiratory tract infection.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Initiation in established NYHA Class III or IV heart failure.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• History of serious hypersensitivity to alogliptin, pioglitazone or any excipient.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Boxed warning: thiazolidinediones cause or exacerbate congestive heart failure; monitor for weight gain, dyspnoea, oedema; not recommended in symptomatic heart failure.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• Dose-related oedema; increased fracture incidence in women; possible bladder cancer risk (do not use in active bladder cancer); macular oedema reported.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 are insufficient to inform drug-associated risk; no adverse developmental effects in animal studies of either component; poorly controlled diabetes carries maternal and fetal risk.نشرة دولية لنفس التركيبة · DailyMed (US NLM)
• No information on pioglitazone or alogliptin in human milk; both are present in rat milk.نشرة دولية لنفس التركيبة · DailyMed (US NLM)

• Obtain liver tests before initiation; monitor for signs of heart failure after initiation and dose increases; regular eye examinations.نشرة دولية لنفس التركيبة · DailyMed (US NLM)