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Saxagliptin

ساکساگلیپتین

⚠ Unverified

🍽️ Alimentary Tract And MetabolismDPP-4 inhibitor

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA205994 ATC A10BH03

Market / country: 🇺🇸 USA

Onglyza (US)

🧮 Dose calculator

Disease / regimen

Type 2 diabetes mellitus · Regimen source: FDA Saxagliptin · 2.1

• With strong CYP3A4/5 inhibitors max 2.5 mg. Do not cut, crush or chew. FDA Saxagliptin · 2.3 FDA Saxagliptin · 2.1

Formulation

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🛡️ Safety & information

Contraindications

⛔ History of serious hypersensitivity to saxagliptin (anaphylaxis, angioedema, exfoliative skin conditions). FDA Saxagliptin · 4

Warnings

• Pancreatitis; heart failure; hypoglycaemia with insulin or sulfonylureas; hypersensitivity; severe arthralgia; bullous pemphigoid. FDA Saxagliptin · 5

Renal adjustment

• eGFR < 45: eGFR <45: 2.5 mg once daily. FDA Saxagliptin · 2.2

Formulations

5 mg tablet — tablet 🇺🇸 USA FDA Saxagliptin · 3
2.5 mg tablet — tablet 🇺🇸 USA FDA Saxagliptin · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Saxagliptin · 8.1
“Risk Summary Limited data with saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Saxagliptin · 8.2
“Risk Summary There is no information regarding the presence of saxagliptin in human milk, the effects on the breastfed infant, or the effects on milk production.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Saxagliptin · 8.4
“The safety and effectiveness of saxagliptin as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus have not been established. in pediatric patients..”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Saxagliptin · 8.5
“Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function [ see Dosage and Administration (2.2)and Clinical Pharmacology (12.3) ].”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)ANDA205994
DailyMed (FDA label)FDA Saxagliptin
MedlinePlus (NIH)Saxagliptin
WHO ATC/DDDA10BH03
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Saxagliptin · 3 FDA Saxagliptin · 2.1 FDA Saxagliptin · 2.3 FDA Saxagliptin · 4 FDA Saxagliptin · 5 FDA Saxagliptin · 2.2 FDA Saxagliptin · SPL approval / marketing category FDA Saxagliptin · 8.1 FDA Saxagliptin · 8.2 FDA Saxagliptin · 8.4 FDA Saxagliptin · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · search
Clinical review⚠ Unverified