Alteplase
آلتپلاز (اکتیلیز)
🩸 Blood And Blood Forming OrgansThrombolytic (tPA)
Market / country: 🇺🇸 USA
Activase (US)
🧮 Dose calculator
Acute ischaemic stroke (thrombolysis) · Regimen source: FDA Activase · 2.1FDA Activase · 2
- • 10% of the total as a bolus over 1 min, the rest infused over 60 min. Only after excluding haemorrhage and checking contraindications. FDA Activase · 2FDA Activase · 4.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Active internal bleeding; recent intracranial or intraspinal surgery or serious head trauma; intracranial conditions raising bleeding risk; bleeding diathesis; severe uncontrolled hypertension. Stroke: intracranial or subarachnoid haemorrhage. MI and PE: recent stroke. FDA Activase · 4
Formulations
- 50 mg vial (1 mg/mL after reconstitution with 50 mL) — powder for injection 🇺🇸 USA FDA Activase · 3
- 100 mg vial (1 mg/mL after reconstitution with 100 mL) — powder for injection 🇺🇸 USA FDA Activase · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Activase · 8.1
“Risk Summary Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Activase · 8.2
“Risk Summary There are no data on the presence of alteplase in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Activase · 8.4
“Safety and effectiveness of Activase in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Activase · 8.5
“Acute Ischemic Stroke In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA103172
- DailyMed (FDA label)FDA Activase
- MedlinePlus (NIH)Alteplase Injection
- WHO ATC/DDDB01AD02
- Darooyab (Iran)Alteplase
🇮🇷 Registered in Iran Darooyab · G-1517/Alteplase
Dosage forms with Iranian generic codes, per Darooyab.
- 11407 · ALTEPLASE 10MG VIAL · ویال آلتپلاز ۱۰ میلیگرم
- 22174 · ALTEPLASE 20MG VIAL · ویال آلتپلاز ۲۰ میلیگرم
- 05775 · ALTEPLASE 50MG VIAL · ویال آلتپلاز ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Activase · 3FDA Activase · 2.1FDA Activase · 2FDA Activase · 4.1FDA Activase · 2.3FDA Activase · 2.2, Table 1FDA Activase · 4FDA Activase · SPL approval / marketing categoryFDA Activase · 8.1FDA Activase · 8.2FDA Activase · 8.4FDA Activase · 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)✅ PresentDarooyab · G-1517/Alteplase
- Clinical review⚠ Unverified