Indications:

CAFÉ COF L Syrup is indicated for the relief and treatment of conditions such as:

• Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD)
• Cough associated with respiratory tract infections
• Acute and chronic bronchitis
• Emphysema and other pulmonary disorders with excessive mucus production
• Mucus clearance in patients with productive cough caused by colds and respiratory conditions

Pharmacology:

1. Levosalbutamol Sulfate (1.25 mg per 5 mL):

• Levosalbutamol, also known as Levalbuterol, is a bronchodilator that belongs to the beta-2 adrenergic agonist class. It works by stimulating beta-2 receptors in the smooth muscles of the bronchi, leading to bronchodilation (relaxation of the smooth muscles of the airway). This helps in opening the airways and improving airflow in conditions like asthma and COPD.
• Levosalbutamol is the R-enantiomer of Salbutamol, which is considered to have a more targeted bronchodilatory effect with fewer side effects, particularly on cardiovascular parameters.

2. Ambroxol HCl (15 mg per 5 mL):

• Ambroxol is a mucolytic agent that reduces the viscosity of mucus in the respiratory tract, making it easier to expel. It works by promoting the production of surfactant, which helps in breaking down the mucus and making it less sticky.
• Ambroxol also stimulates the ciliary function in the respiratory tract, facilitating the clearance of mucus and other secretions, thereby helping to reduce coughing and improve breathing in conditions where excessive mucus is present.

3. Guaifenesin (50 mg per 5 mL):

• Guaifenesin is an expectorant that works by loosening and thinning mucus in the airways, making it easier to clear the air passages through coughing. This action helps relieve symptoms associated with congestion and chronic respiratory diseases, allowing for easier and more effective expectoration of mucus.
• Guaifenesin also helps in alleviating chest congestion, and when combined with Ambroxol, it offers a dual mechanism for improving mucus clearance from the respiratory tract.

Mechanism of Action:

• Levosalbutamol stimulates the beta-2 adrenergic receptors in the bronchial smooth muscles, leading to bronchodilation and improved airflow in the lungs. It is effective in reducing wheezing and shortness of breath associated with bronchospasm.
• Ambroxol acts as a mucolytic agent, helping to decrease mucus viscosity and promote mucus clearance from the airways. This helps in improving symptoms like productive cough and chest tightness.
• Guaifenesin is an expectorant that looses the mucus from the respiratory tract, facilitating the clearance of mucus and secretions, which improves breathing and reduces the severity of coughing.

Dosage and Administration:

• Adults and Children over 12 years:
  • 10 mL (2 teaspoons) three times a day, or as directed by the physician.
• Children (6 to 12 years):
  • 5 mL (1 teaspoon) three times a day, or as directed by the physician.
• Children (2 to 6 years):
  • 2.5 mL (½ teaspoon) three times a day, or as directed by the physician.

Note: The dosage may vary depending on the severity of the symptoms and the clinical condition. It is essential to follow the prescribed dose.

Contraindications:

• Hypersensitivity to any of the active ingredients (Levosalbutamol, Ambroxol, or Guaifenesin).
• Severe heart disease or arrhythmias (due to the beta-agonist effect of Levosalbutamol).
• Hyperthyroidism or pheochromocytoma (due to potential cardiovascular effects of Levosalbutamol).
• Severe renal impairment (use caution in patients with renal dysfunction due to the potential accumulation of Ambroxol).
• Children under 2 years of age: The use of this product is not recommended in children under 2 years without the guidance of a healthcare provider.

Warnings and Precautions:

• Cardiovascular Concerns: Levosalbutamol should be used cautiously in patients with cardiovascular disorders, including hypertension, arrhythmias, and coronary artery disease, as it may lead to tachycardia or palpitations.
• Asthma: Patients with asthma or COPD should be monitored for potential bronchospasm after using Levosalbutamol. In some cases, overuse of beta-agonists may cause paradoxical bronchospasm.
• Renal Impairment: Ambroxol should be used cautiously in patients with severe renal impairment. Dose adjustments may be necessary in these cases.
• Pregnancy and Lactation: Use only if clearly needed, and after evaluating the risk-benefit ratio. Consult with a healthcare provider before prescribing during pregnancy and lactation.
• Drug Abuse and Misuse: Caution should be exercised to prevent overuse, especially with the beta-agonist component (Levosalbutamol), which can lead to adverse effects.

Side Effects:

Common Side Effects:

• Tachycardia or palpitations (due to Levosalbutamol).
• Headache, dizziness, or nervousness (due to Levosalbutamol).
• Dry mouth, throat irritation, or nasal congestion (due to Ambroxol or Guaifenesin).
• Nausea or vomiting (due to Guaifenesin or Ambroxol).

Rare Side Effects:

• Allergic reactions such as skin rash, itching, or swelling (rare with any component).
• Chest pain or palpitations (due to Levosalbutamol).
• Severe dizziness or fainting.
• GI disturbances such as gastritis, diarrhea, or stomach upset.
• Respiratory distress in rare cases with bronchodilators.

Drug Interactions:

• Beta-blockers: Concurrent use with beta-blockers may reduce the bronchodilatory effect of Levosalbutamol.
• Corticosteroids: The combination of Levosalbutamol and systemic corticosteroids may lead to excessive bronchial dilation and increased risk of side effects.
• Antitussives: Use with cough suppressants (e.g., Dextromethorphan) should be approached with caution, as they may reduce the effectiveness of expectorant agents like Guaifenesin.
• Monoamine oxidase inhibitors (MAOIs): Use with MAOIs (e.g., Phenelzine) may lead to hypertensive crises due to Levosalbutamol.

Storage:

• Store in a cool, dry place at room temperature (15–30°C).
• Keep away from direct sunlight and moisture.
• Shake well before use.
• Keep out of reach of children.

Indications:

• Bronchial asthma, COPD, chronic bronchitis, and respiratory infections with excessive mucus production.

Dosage:

• Adults: 10 mL, 3 times a day
• Children (6-12 years): 5 mL, 3 times a day
• Children (2-6 years): 2.5 mL, 3 times a day

For more detailed information, consult with a healthcare provider or the prescribing guidelines.

Disclaimer: The contents herein above are specifically for Doctors or Healthcare Professionals and not for the public in general. Always consult a healthcare provider before starting the medication or supplement, especially in patients with pre-existing medical conditions or those who are pregnant or breastfeeding.