Cephalexin
سفالکسین
🦠 Antiinfectives For Systemic UseFirst-generation cephalosporin
Market / country: 🇺🇸 USA
Keflex (US)
🧮 Dose calculator
Acute otitis media · Regimen source: FDA Cephalexin · 2.2
- • Treat 7 to 14 days; at least 10 days for beta-hemolytic streptococcal infection. FDA Cephalexin · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Known hypersensitivity to cephalexin or other cephalosporins. FDA Cephalexin · 4
- ⛔ Safety and effectiveness not established in pediatric patients younger than one year. FDA Cephalexin · 8.4
Warnings
- • Hypersensitivity reactions FDA Cephalexin · 5.1
- • Clostridioides difficile-associated diarrhea FDA Cephalexin · 5.2
- • Seizure potential FDA Cephalexin · 5.4
- • Prolonged prothrombin time FDA Cephalexin · 5.5
Important interactions
- • Increased metformin exposure FDA Cephalexin · 7.1
- • Probenecid inhibits renal excretion of cephalexin FDA Cephalexin · 7.2
Renal adjustment
- • eGFR < 30: CrCl <30 mL/min (≥15 years): adjust per label Table 2. FDA Cephalexin · 2.4
Formulations
- 125 mg / 5 mL — suspension 🇺🇸 USA FDA Cephalexin · 3
- 250 mg / 5 mL — suspension 🇺🇸 USA FDA Cephalexin · 3
- 250 mg capsule — capsule 🇺🇸 USA FDA Cephalexin caps · How Supplied
- 500 mg capsule — capsule 🇺🇸 USA FDA Cephalexin caps · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Cephalexin · 8.1
“Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades cephalexin for oral suspension use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Cephalexin · 8.2
“Risk Summary Data from a published clinical lactation study report that cephalexin is present in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Cephalexin · 8.4
“The safety and effectiveness of cephalexin for oral suspension have been established in pediatric patients aged one year and older in clinical trials [see Indications and Usage ( 1.1 - 1.5 )] for the dosages described in the dosage and administration section [see Dosage and Administration ( 2.1 , 2.2 )].”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Cephalexin · 8.5
“Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see Warnings and Precautions ( 5.4 )].”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA062703
- DailyMed (FDA label)FDA CephalexinFDA Cephalexin caps
- MedlinePlus (NIH)Cephalexin
- WHO ATC/DDDJ01DB01
- Darooyab (Iran)Cephalexin
🇮🇷 Registered in Iran Darooyab · G-311/Cephalexin
Dosage forms with Iranian generic codes, per Darooyab.
- 00242 · CEFALEXIN 125MG/5ML 100ML POW FOR SUSP · پودر برای تهیه سوسپانسیون خوراکی سفالکسین ۱۲۵ میلیگرم / ۵ میلیلیتر ۱۰۰ میلیلیتر
- 00241 · CEFALEXIN 125MGR/SACHET · ساشه سفالکسین ۱۲۵ MGR
- 00243 · CEFALEXIN 250MG CAP · کپسول سفالکسین ۲۵۰ میلیگرم
- 00246 · CEFALEXIN 250MG/5ML 100ML POW FOR SUSP · پودر برای تهیه سوسپانسیون خوراکی سفالکسین ۲۵۰ میلیگرم / ۵ میلیلیتر ۱۰۰ میلیلیتر
- 00244 · CEFALEXIN 250MGR/SACHET · ساشه سفالکسین ۲۵۰ MGR
- 00245 · CEFALEXIN 500MG CAP · کپسول سفالکسین ۵۰۰ میلیگرم
- 15724 · CEFALEXIN 500MG TAB · قرص سفالکسین ۵۰۰ میلیگرم
- 00240 · CEFALEXIN DROP · قطره سفالکسین
- 52391 · CEFALEXIN POWDER ORAL 125 mg · پودر سفالکسین ۱۲۵ میلیگرم
- 53055 · CEFALEXIN POWDER, FOR SUSPENSION ORAL 125 mg/5mL 30 mL · سوسپانسیون خوراکی سفالکسین ۱۲۵ میلیگرم / ۵ میلیلیتر ۳۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Cephalexin · 3FDA Cephalexin caps · How SuppliedFDA Cephalexin · 2.2FDA Cephalexin · 2.2, Table 1FDA Cephalexin · 2.1FDA Cephalexin · 4FDA Cephalexin · 8.4FDA Cephalexin · 5.1FDA Cephalexin · 5.2FDA Cephalexin · 5.4FDA Cephalexin · 5.5FDA Cephalexin · 2.4FDA Cephalexin · 7.1FDA Cephalexin · 7.2FDA Cephalexin · 8.1FDA Cephalexin · 8.2FDA Cephalexin · 8.5FDA Cephalexin · SPL approval / marketing category
- 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)✅ PresentDarooyab · G-311/Cephalexin
- Clinical review⚠ Unverified