Labetalol Hydrochloride injection 100 mg/20 mL (5 mg/ mL) Multiple Dose Vial 20 mL by Fosun (RX)

Labetalol Hydrochloride (HCL) injection, at a concentration of 5 mg/mL, is a medication formulated to provide effective management of acute hypertension. This injectable form allows for rapid onset of action, making it suitable for situations where immediate blood pressure reduction is necessary.

Product Details:

• Concentration: 5 mg/mL
• Volume: 20 mL per vial
• Packaging: Multiple Dose Vial
• Manufacturer: Fosun Pharma

Indications:

Labetalol HCL is indicated for the control of blood pressure in severe hypertension, including hypertensive emergencies. It achieves blood pressure reduction by blocking beta and alpha-adrenergic receptors.

Mechanism of Action:

Labetalol is a unique antihypertensive agent with nonselective beta-adrenergic blockade (both β1 and β2-adrenergic receptors) and selective alpha1-adrenergic blockade. This dual action results in decreased heart rate, myocardial contractility, and peripheral vascular resistance, thereby effectively lowering blood pressure.

Dosage and Administration:

The dosage of Labetalol HCL should be individualized according to the needs and response of the patient. It is typically administered via intravenous (IV) bolus or continuous infusion in a clinical setting.

Contraindications:

• Hypersensitivity to labetalol or any component of the formulation.
• Bronchial asthma or related bronchospastic conditions.
• Overt cardiac failure.
• Greater than first-degree heart block.
• Severe bradycardia (slow heart rate).

Warnings and Precautions:

• Labetalol should be used cautiously in patients with impaired hepatic function, as it is metabolized in the liver.
• Patients should be monitored for signs of heart failure.
• Use with caution in patients with diabetes mellitus, as it may mask signs of hypoglycemia.
• Withdrawal should be gradual to avoid rebound hypertension.

Adverse Reactions:

• Common: Dizziness, nausea, fatigue, scalp tingling, dyspepsia.
• Serious: Severe hypotension, bradycardia, heart block, bronchospasm, hepatic injury.

Storage: Store at room temperature, protected from light. Keep vials in their cartons until ready for use.

How Supplied: Labetalol HCL injection is supplied in 20 mL multiple dose vials with a concentration of 5 mg/mL. Each vial is intended for multiple uses but should be used within a specific period after first access, as per the manufacturer’s guidelines or clinical best practices.

Please consult the prescribing information and a healthcare professional for more detailed information, including comprehensive guidance on administration, potential interactions, and patient-specific considerations.