Product Description

Product Summary

Labetalol injection is a prescription-only antihypertensive used for severe hypertension emergencies, including hypertensive crises, perioperative blood pressure control, and pregnancy-induced hypertension (preeclampsia/eclampsia). Each vial contains labetalol hydrochloride (5mg/mL), a combined alpha- and beta-blocker that rapidly lowers blood pressure without compromising cardiac output. Available in Kenyan hospitals under strict medical supervision.

Key Benefits

• Dual-Action Control: Blocks α₁-receptors (reduces peripheral resistance) and β-receptors (lowers heart rate/cardiac output).
• Rapid BP Reduction: Onset within 2–5 minutes IV; peak effect in 5–15 minutes.
• Urgent-Use Flexibility:
  • IV Bolus: For acute crises (e.g., stroke risk, aortic dissection).
  • IV Infusion: For sustained control in ICU/operating rooms.
• Pregnancy-Safe: First-line for severe hypertension in pregnancy (does not reduce placental blood flow).
• Hemodynamic Stability: Maintains cerebral/coronary perfusion better than pure beta-blockers.

Composition

Active Ingredient per Vial:

• Labetalol Hydrochloride:
  • 20mg/4mL (5mg/mL concentration)
  • 100mg/20mL (5mg/mL concentration)

Other Ingredients:
Sodium chloride, hydrochloric acid (for pH adjustment), water for injection.

Free From:
Preservatives, antimicrobial agents.

Bioavailability:
100% systemic absorption IV; hepatic metabolism (half-life: 4–6 hours).

How to Use

Dosage:

• Severe Hypertension (Non-Pregnant):
  • IV Bolus: 20mg slow IV push over 2 minutes. Repeat 40–80mg every 10 mins until BP controlled (max 300mg).
  • IV Infusion: 0.5–2 mg/minute; titrate to response.
• Pregnancy-Induced Hypertension:
  • IV Bolus: 20mg IV over 2 minutes; repeat 20–80mg every 10–30 mins (max 220mg).
  • IV Infusion: 1–2 mg/minute; reduce once systolic BP <160 mmHg.
• Perioperative Control:
  • IV Bolus: 5–20mg increments to maintain target BP.

Administration:

• IV Bolus: Dilute to 5mg/mL with saline/dextrose; inject slowly (≥2 minutes).
• IV Infusion: Dilute in 500–1000mL saline/dextrose; use infusion pump.
• Monitoring:
  • Continuous ECG, BP (every 1–5 mins initially), heart rate.
  • Stop if systolic BP drops >30% below baseline or HR <50 bpm.

Duration:

• Short-term (hours to days) until oral therapy is feasible.

Potential Side Effects

Common Reactions:

• Nausea, dizziness, scalp tingling.
• Postural hypotension (if bolus too rapid).
• Bradycardia, bronchospasm (in asthmatics).

Serious Risks:

• Cardiovascular: Heart block, cardiac failure, severe hypotension.
• Respiratory: Bronchospasm (contraindicated in asthma/COPD).
• Hepatic: Elevated liver enzymes (rare; monitor if used >72 hours).
• Neonatal: Bradycardia/hypotension if used near delivery.

Precautions:

• Avoid if:
  • Asthma, COPD, severe bradycardia (<45 bpm), heart block (≥2nd degree), cardiogenic shock, decompensated heart failure.
  • Hypersensitivity to labetalol.
• Medical History:
  • Diabetes (masks hypoglycemia symptoms), liver/kidney impairment, pheochromocytoma.
• Drug Interactions:
  • Other Antihypertensives (e.g., nifedipine): Additive hypotension.
  • CYP2D6 Inhibitors (e.g., fluoxetine): Increase labetalol levels.
  • Anesthetics (e.g., fentanyl): Enhance hypotension.
• Pregnancy/Breastfeeding:
  • Category C: Safe for acute hypertension in pregnancy; avoid near delivery (neonatal risks).
  • Excreted in breast milk (use with caution).

Frequently Asked Questions (FAQs)

1. Is Labetalol injection available over-the-counter in Kenya?
   No – prescription-only, restricted to hospitals/ICUs. Available at Kenyatta National Hospital, Aga Khan University Hospital, and major referral centers.

2. How much does it cost?
   ~KES 2,000–5,000 per vial (20mg/4mL); rarely covered by NHIF.

3. Why use Labetalol instead of other antihypertensives?
   Dual-action mechanism provides rapid, controlled BP reduction without compromising organ perfusion—ideal for emergencies.

4. Can it be used for chronic hypertension?
   No – transition to oral therapy (e.g., labetalol tablets, nifedipine) once stable.

5. Are there Kenyan alternatives?
   Yes – Hydralazine (cheaper, first-line in pregnancy) or Sodium Nitroprusside (for ICU-managed crises).

6. How does it benefit users in Kenya?

   • Pregnancy Safety: Critical for managing preeclampsia (12% of Kenyan maternal deaths).
   • Stroke Prevention: Rapid BP control reduces hemorrhagic stroke risk.
   • Cost-Effective: Shorter ICU stays vs. nitroprusside (which requires invasive monitoring).

7. What if BP drops too low?
   Stop infusion; elevate legs; give IV fluids/vasopressors (e.g., dopamine) if severe.

8. Can it be given orally?
   No – injection is for emergencies only. Oral labetalol is available for maintenance.

Who Can Benefit

• Hypertensive Emergencies:
  • Diastolic BP >120 mmHg with organ damage (e.g., encephalopathy, renal failure).
  • Aortic dissection, acute heart failure.
• Pregnant Women:
  • Severe preeclampsia/eclampsia (systolic BP ≥160 mmHg).
• Perioperative Patients:
  • BP control during surgery (e.g., cardiac, neurosurgery).
• ICU Patients:
  • Autonomic hyperreflexia, withdrawal syndromes.