Onglyza Tablets
Saxagliptin
5mg
Bristol Myers Squibb Company
| Pack size | 30's Bottle |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 178.00 AED |
Available as:
Indications
Onglyza Tablets is used for:
Type 2 diabetes
Adult Dose
Oral
Type 2 diabetes mellitus
Adult: 2.5 or 5 mg once daily.
Combination therapy: May need to reduce dosage of sulfonylurea or other insulin secretagogues when administered in combination
Coadministration with strong CYP450 3A4/5 inhibitors: Not to exceed 2.5 mg PO qDay
Elderly: No dosage adjustment.
Hepatic Impairment No dosage adjustment.
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
CrCl >50 mL/min: No dose adjustment required
CrCl <50 mL/min: Not to exceed 2.5 mg PO qDay
ESRD requiring hemodialysis: Not to exceed 2.5 mg PO qDay administered postdialysis
ESRD requiring peritoneal dialysis: Not studied
Administration
May be taken with or without food.
Contra Indications
Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)
Precautions
Renal impairment
Decrease dose with strong CYP450 3A4/5 inhibitors
Coadministration with thiazolidinediones (eg, rosiglitazone, pioglitazone) increases risk for peripheral edema
Pancreatitis reported with saxagliptin; monitor for signs and symptoms and discontinue if pancreatitis suspected
Serious hypersensitivity reactions with saxagliptin reported (typically within the first 3 months of therapy)
History of angioedema
Coadministration with a sulfonylurea or with insulin may increase hypoglycemia; monitor closely and adjust sulfonylurea and/or insulin dose accordingly
Congestive heart failure (CHF) risks. Observe patients for signs and symptoms of heart failure during therapy;
Lactation: Not known whether distributed in breast milk; caution advised
Pregnancy-Lactation
Pregnancy
Limited available data in pregnant women are not sufficient to determine drug-associated risk for major birth defects and miscarriage; published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk
No adverse developmental effects independent of maternal toxicity observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during period of organogenesis
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre- eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. also increases fetal risk for major malformations and macrosomia related morbidity
Lactation
There is no information regarding presence of metformin or alogliptin in human milk, effects on breastfed infant, or effects on milk production; limited published studies report that metformin is present in human milk; however, there is insufficient information to determine effects of metformin on breastfed infant and no available information on effects of metformin on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Interactions
Strong CYP3A4/5 inhibitors (eg ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir & telithromycin).
Adverse Effects
Side effects of Saxagliptin :
1-10% (selected)
Urinary tract infection (7%), Headache (7%), Hypersensitivity-related events (<4%; eg, urticaria, facial edema), Peripheral edema (<4%; increased incidence when coadministered with thiazolidinediones), Upper respiratory tract infection (3%), Gastroenteritis (2%), Hypoglycemia (1.6%)
Frequency Not Defined
Increased creatinine phosphokinase, Increased creatinine, Idiopathic thrombocytopenic purpura rash
Mechanism of Action
Dipeptidyl peptidase IV (DPP-4) inhibition that results in increased incretin hormones and enhanced glycemic control.
Note
Onglyza 5mg Tablets manufactured by Bristol Myers Squibb Company. Its generic name is Saxagliptin. Onglyza is availble in United Arab Emirates.
Farmaco UAE drug index information on Onglyza Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.