Sitaphil Plus Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Summary of the safety profile: There have been no therapeutic clinical trials conducted with Metformin Hydrochloride + Sitagliptin tablets, however bioequivalence of Metformin Hydrochloride + Sitagliptin with co-administered sitagliptin and metformin has been demonstrated. Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported. Hypoglycemia has been reported in combination with sulfonylurea (13.8%) and insulin (10.9%).
Sitagliptin and metformin: Tabulated list of adverse reactions: Adverse reactions are listed as follows as MedDRA preferred term by system organ class and absolute frequency (Table 2).
Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data). (See Table 2.)

Click on icon to see table/diagram/image

View ADR Reporting Link

Sitaphil Plus Adverse Reactions

metformin + sitagliptin

Manufacturer:

Theon Pharmaceuticals

Distributor:

Phil Asia Pharma

Marketer:

Ambica