Salomax B

• Chronic Obstructive Pulmonary Disease (COPD):
  Maintenance treatment to relieve symptoms and reduce exacerbations in patients with moderate to severe COPD.
• Asthma:
• Maintenance and prophylactic treatment of bronchial asthma, including persistent asthma requiring both bronchodilation and anti-inflammatory therapy.
• Suitable for patients inadequately controlled with inhaled corticosteroids alone or those requiring combination therapy.
• Management of acute exacerbations in conjunction with systemic corticosteroids and bronchodilators.
• Other Clinically Accepted Uses:
• Prevention of exercise-induced bronchospasm when persistent inflammation and bronchospasm coexist.

• Adults and Adolescents (≥12 years):
• Inhalation (MDI or DPI):
  Typical dose ranges from 1 to 2 inhalations twice daily (morning and evening).
  Each inhalation commonly contains salbutamol 100–200 mcg and budesonide 200–400 mcg, depending on formulation.
• Dose should be individualized according to symptom severity and response.
• Children (6–11 years):
• Dosing usually lower; 1 inhalation twice daily, with budesonide dose adjusted to 200 mcg or less per inhalation.
• Elderly:
• No specific dose adjustment required; monitor for side effects.
• Special Populations:
• Renal or Hepatic Impairment:
  No formal dose adjustment recommendations; use cautiously.
• Administration Notes:
• Inhaler technique is critical for efficacy; patients should be instructed on proper use.
• Rinse mouth after inhalation to reduce risk of oropharyngeal candidiasis.
• Duration:
• Long-term maintenance therapy; treatment is usually continuous with periodic assessment.

Salbutamol is a selective β2-adrenergic receptor agonist that induces relaxation of bronchial smooth muscle by increasing intracellular cyclic AMP, resulting in rapid bronchodilation and relief of bronchospasm. Budesonide is a potent corticosteroid that exerts anti-inflammatory effects by binding to glucocorticoid receptors, inhibiting multiple inflammatory mediators such as cytokines and prostaglandins, reducing airway inflammation, edema, and hyperresponsiveness. The combination provides both immediate bronchodilation and long-term control of airway inflammation, improving respiratory function in obstructive airway diseases.

• Salbutamol:
• Rapid absorption after inhalation; peak plasma concentrations within 5 to 15 minutes.
• Oral bioavailability ~50%; metabolized in liver by sulfation; eliminated renally as metabolites and unchanged drug.
• Half-life approximately 3.8 to 6 hours.
• Budesonide:
• High pulmonary deposition after inhalation; systemic bioavailability ~39% due to first-pass metabolism.
• Rapid hepatic metabolism primarily by CYP3A4 to inactive metabolites.
• Plasma half-life approximately 2 to 3.6 hours.
• Excreted mainly via urine as metabolites.

• Pregnancy:
• Both salbutamol and budesonide are classified as FDA Pregnancy Category C.
• Budesonide has extensive human data indicating relatively low risk when used appropriately.
• Salbutamol lacks adequate controlled studies; use only if clearly needed.
• Use during pregnancy only when benefits outweigh potential risks.
• Lactation:
• Both drugs are excreted in breast milk in low amounts.
• Use with caution; monitor infants for side effects.

• Primary Therapeutic Class:
  Combination bronchodilator and corticosteroid inhaler.
• Subclass:
• Salbutamol: Short-acting β2-adrenergic agonist (SABA).
• Budesonide: Inhaled corticosteroid (ICS).

• Known hypersensitivity to salbutamol, budesonide, or any excipients.
• Acute episodes of asthma requiring immediate bronchodilation (this combination is for maintenance, not rescue therapy).
• Severe hypersensitivity to milk proteins (in some inhaler formulations).
• Concomitant use with non-selective MAO inhibitors or tricyclic antidepressants without supervision.

• Systemic Corticosteroid Effects:
  Risk of adrenal suppression, growth retardation in children, osteoporosis, cataracts with long-term use of budesonide.
• Paradoxical Bronchospasm:
  Rare but serious; discontinue immediately if occurs.
• Cardiovascular Effects:
  Salbutamol may cause tachycardia, arrhythmias; caution in patients with cardiovascular disease.
• Infections:
  Increased risk of oral candidiasis and respiratory infections with budesonide; rinse mouth after use.
• High-Risk Groups:
  Use caution in elderly, patients with tuberculosis, glaucoma, or osteoporosis.
• Monitoring:
  Regular assessment of lung function, growth in children, and signs of corticosteroid side effects recommended.

• Common Side Effects:
• Tremor
• Headache
• Palpitations
• Throat irritation and hoarseness
• Oral candidiasis (thrush)
• Cough
• Serious/Rare Side Effects:
• Paradoxical bronchospasm
• Allergic reactions (rash, angioedema)
• Hypokalemia (with salbutamol)
• Cataracts and glaucoma (long-term corticosteroid use)
• Onset:
  Side effects may occur soon after administration or with prolonged use.

• Salbutamol:
• Beta-blockers may reduce efficacy.
• MAO inhibitors and tricyclic antidepressants may potentiate cardiovascular effects.
• Budesonide:
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase systemic corticosteroid levels and risk of systemic effects.
• Caution with other immunosuppressants or corticosteroids.
• Drug-Food:
  No significant interactions reported.
• Drug-Alcohol:
  No significant interactions; alcohol may increase corticosteroid side effects.

• International asthma and COPD guidelines recommend combined inhaled corticosteroid and short-acting beta-2 agonist therapy for moderate to severe disease or inadequate symptom control with monotherapy.
• Emphasis on patient education for inhaler technique and adherence.
• No major changes in approved indications or dosing recently.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture, heat, and direct sunlight.
• Keep inhalers and nebulizer solutions tightly closed when not in use.
• Do not freeze.
• Keep out of reach of children.
• Follow manufacturer’s instructions for opened solutions or devices.