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Labetalol

لابتالول

⚠ Unverified

❤️ Cardiovascular SystemAlpha/beta blocker

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA207743 ATC C07AG01

Market / country: 🇺🇸 USA

Trandate (US)

🧮 Dose calculator

Disease / regimen

Hypertension · Regimen source: FDA Labetalol · Dosage and Administration

• Increase by 100 mg twice daily every 2–3 days; usual maintenance 200–400 mg twice daily. FDA Labetalol · Dosage and Administration

Formulation

Age *

Weight (kg) (optional)

Enter age (weight is optional for this regimen).

🛡️ Safety & information

Contraindications

⛔ Bronchial asthma; overt heart failure; greater than first-degree block; cardiogenic shock; severe bradycardia; prolonged hypotension. FDA Labetalol · Contraindications

Formulations

100 mg tablet (scored) — tablet 🇺🇸 USA FDA Labetalol · How Supplied
200 mg tablet (scored) — tablet 🇺🇸 USA FDA Labetalol · How Supplied
300 mg tablet (scored) — tablet 🇺🇸 USA FDA Labetalol · How Supplied

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Labetalol · Pregnancy
“Teratogenic Effects Pregnancy Category C Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Labetalol · Nursing Mothers
“Caution should be exercised when labetalol hydrochloride is administered to a nursing woman..”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Labetalol · Pediatric Use
“Safety and effectiveness in pediatric patients have not been established.”
👴 Older adultsNo data
The source for this drug has no section for this group.
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)ANDA207743
DailyMed (FDA label)FDA Labetalol
MedlinePlus (NIH)Labetalol
WHO ATC/DDDC07AG01
Darooyab (Iran)Labetalol

🇮🇷 Registered in Iran Darooyab · G-1725/Labetalol

Dosage forms with Iranian generic codes, per Darooyab.

09314 · LABETALOL 100MG TAB · قرص لابتالول ۱۰۰ میلی‌گرم
09315 · LABETALOL 200MG TAB · قرص لابتالول ۲۰۰ میلی‌گرم
09316 · LABETALOL 400MG TAB · قرص لابتالول ۴۰۰ میلی‌گرم
08004 · LABETALOL 5MG/ML 20ML INJ · فرآورده تزریقی لابتالول ۵ میلی‌گرم / میلی‌لیتر ۲۰ میلی‌لیتر
52006 · LABETALOL HYDROCHLORIDE INJECTION PARENTERAL 5 mg/1mL 4 mL · فرآورده تزریقی لابتالول هیدروکلراید ۵ میلی‌گرم / ۱ میلی‌لیتر ۴ میلی‌لیتر
52258 · LABETALOL HYDROCHLORIDE INJECTION PARENTERAL 5 mg/1mL 10 mL · فرآورده تزریقی لابتالول هیدروکلراید ۵ میلی‌گرم / ۱ میلی‌لیتر ۱۰ میلی‌لیتر

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Labetalol · How Supplied FDA Labetalol · Dosage and Administration FDA Labetalol · Contraindications FDA Labetalol · Pregnancy FDA Labetalol · Nursing Mothers FDA Labetalol · Pediatric Use FDA Labetalol · 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)✅ Present
Darooyab · G-1725/Labetalol
Clinical review⚠ Unverified