Sabacure Nebpules (Levosalbutamol Sulphate Nebulization Solution)

SABACURE Nebpules

Levosalbutamol Sulphate Nebulization Solution
Available Strengths: 0.31 mg / 2.5 ml and 0.63 mg / 2.5 ml

🔹 Introduction

Respiratory disorders such as asthma, COPD, and allergic bronchitis are often characterized by airway obstruction and bronchospasm.
SABACURE Nebpules deliver Levosalbutamol, a potent and selective β₂-agonist bronchodilator, offering fast, effective, and well-tolerated relief from bronchospasm—helping patients breathe easier and live better.

🔹 Composition

Each 2.5 ml sterile nebulization solution contains:

• Levosalbutamol Sulphate IP … equivalent to Levosalbutamol 0.31 mg (or 0.63 mg)
• Sodium Chloride IP … q.s.
• Water for Injection IP … q.s.

For inhalation use only.

🔹 Pharmacology & Mechanism of Action

Levosalbutamol is the R-enantiomer of racemic salbutamol and represents the active isomer responsible for bronchodilation.
It selectively stimulates β₂-adrenergic receptors in the bronchial smooth muscle, resulting in:

• Relaxation of airway muscles
• Increased airflow and oxygen exchange
• Relief from wheezing, cough, and breathlessness

Unlike racemic salbutamol, Levosalbutamol produces minimal cardiac stimulation and fewer systemic side effects, ensuring better patient compliance and safety.

🔹 Pharmacokinetics

• Onset of action: Within 5–15 minutes
• Duration: 4–6 hours
• Absorption: Rapid via pulmonary route
• Metabolism: Primarily hepatic (sulfate conjugation)
• Excretion: Through urine, mostly as inactive metabolites

🔹 Therapeutic Indications

• Bronchial Asthma (acute & chronic episodes)
• Chronic Obstructive Pulmonary Disease (COPD)
• Allergic Bronchitis
• Obstructive Airway Disease (OAD)
• Exercise-induced Bronchospasm
• Post-infectious Bronchospasm

🔹 Dosage & Administration

Adults & Adolescents (6-12 years):

• 1 Nebpule (0.31 mg / 2.5 ml) via nebulizer, 3–4 times daily or as directed by the physician.

Children (6–12 years):

• 1 Nebpule (0.63 mg / 2.5 ml) via nebulizer, up to 3 times daily.

Instructions:

• Use SABACURE Nebpules only through a jet nebulizer or ultrasonic nebulizer.
• Do not swallow or inject.
• Discard unused portion after each use.

🔹 Contraindications

• Hypersensitivity to Levosalbutamol or any formulation ingredient
• Severe cardiovascular disorders unless supervised by a physician

🔹 Special Precautions

Use with caution in patients with:

• Ischemic heart disease, arrhythmia, or hypertension
• Diabetes mellitus (may cause transient hyperglycemia)
• Hyperthyroidism
• Pregnancy or lactation (only if clearly indicated)
• Avoid co-administration with non-selective β-blockers (e.g., propranolol)

🔹 Drug Interactions

• β-blockers antagonize bronchodilatory effects.
• MAO inhibitors or tricyclic antidepressants may potentiate cardiovascular side effects.
• Concomitant use with other sympathomimetic bronchodilators should be avoided.

🔹 Adverse Reactions

Usually mild and transient:

• Tremors, nervousness, headache
• Palpitations or tachycardia (rare)
• Throat irritation, cough, or dry mouth
• Muscle cramps or nausea (occasional)

🔹 Clinical Advantages of Levosalbutamol over Racemic Salbutamol

🔹 Storage

• Store below 30 °C, protected from light and moisture.
• Do not freeze.
• Keep out of reach of children.

🔹 Presentation

• Box of 5 or 10 Nebpules × 2.5 ml each
• Each Nebpule individually packed in sterile LDPE vial

🔹 Key Benefits

✅ Rapid onset and sustained bronchodilation
✅ Improved safety profile with minimal β₁-activity
✅ Reduced tremors and tachycardia
✅ Proven efficacy in asthma and COPD management
✅ Ideal for both acute relief and maintenance therapy

💨 SABACURE Nebpules — “Breathe Easy, Live Healthy.”

A dependable bronchodilator for comprehensive respiratory care.

Marketed by:
KVN PHARMACEUTICALS
Committed to Healthy Breathing