COMPO-NEB Inhalation Solution is a combination of the anticholinergic bronchodilator: Ipratropium Bromide, and the beta2-adrenergic bronchodilator: Salbutamol Sulfate.
Ipratropium Bromide is a quaternary ammonium derivative of atropine and is an anticholinergic drug which has bronchodilator properties. On inhalation, the onset of action is noted within 5 to 15 minutes.

Salbutamol produces bronchodilation through stimulation of beta2-adrenergic receptors in bronchial smooth muscle, thereby causing relaxation of muscle fibers. This action is manifested by an increase in pulmonary function, the onset of action is noted within 5 to 15 minutes.

Studies demonstrate that each component of COMPO-NEB Inhalation Solution contributed to the efficacy of the combination, and that COMPO-NEB Inhalation Solution was significantly more effective than ipratropium or salbutamol administered alone.

 

COMPO-NEB is indicated for the management of bronchospasm in patients suffering from chronic obstructive pulmonary disease (COPD) who require regular treatment with both ipratropium and salbutamol.

 

COMPO-NEB is contraindicated in patients with cardiac tachyarrhythmias, hypertrophic obstructive cardiomyopathy and patients with a history of hypersensitivity to any of its components or to atropine or its derivatives.

 

- Care should be taken to ensure that the nebulizer mask fits the patient's face properly and that nebulized solution does not escape into the eyes specially in patients with glaucoma or narrow anterior chambers because of ipratropium effects.

- Care should be taken to recognize ocular complications such as eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion may be signs of acute narrow-angle glaucoma.

- Special care and supervision are required in patients with idiopathic hypertrophic subvalvular aortic stenosis, in whom an increase in the pressure gradient between the left ventricle and the aorta may occur, causing increased strain on the left ventricle.

- Care should be taken with patients suffering from cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension; in patients with convulsive disorders, diabetes mellitus, hyperthyroidism and in patients who are usually responsive to sympathomimetic amines.

- Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.

- Immediate hypersensitivity reactions may occur after administration of salbutamol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema.

- Potentially serious hypokalemia may result from beta2-agonist therapy, especially in asthmatic patients ,as hypokalemia may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics: the adverse effects of hypokalemia may be exacerbated by hypoxia, and it’s dangerous specially to patients receiving digitalis treatment.

 

The safety in pregnancy has not been established. The benefits of using COMPO-NEB when pregnancy is present or suspected must be weighed against possible hazards caused to the fetus.

In nursing mothers a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

The common adverse reaction of COMPO-NEB is dry mouth, fatigue, abdominal pain, hypertension, dyspepsia, tachycardia, sinusitis, dysuria, and urinary retention.

Additional adverse reaction on the use of ipratropium or salbutamol inhalation solution singly or in combination are cases of blurred vision, taste perversion, dry mouth, paradoxical bronchospasm, bronchitis, angina, arrhythmia, lightheadedness, drowsiness, insomnia, dizziness, vertigo, CNS stimulation, weakness, itching, rash, flushing, alopecia, hypotension, increased blood pressure, gastrointestinal distress, vomiting, diarrhea, edema, constipation and urinary difficulty have been reported.

 

- COMPO-NEB should be used with caution in patients receiving other anticholinergic drugs because of possible additive effects.

- ­Xanthine derivatives and beta2-adrenergic agents may enhance the effect of COMPO-NEB Inhalation Solution.

- Other sympathomimetic bronchodilators or epinephrine should not be used concomitantly with COMPO-NEB Inhalation Solution. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

- COMPO-NEB Inhalation Solution should be administered with extreme caution to patients being treated with MAO inhibitors or tricyclic antidepressants because the action of salbutamol on the vascular system may be potentiated.

- Beta-receptor blocking agents and salbutamol inhibit the effect of each other.
Inhalation of halogenated hydrocarbon anesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists (Salbutamol).

- When use COMPO-NEB in high doses during labor it may led to inhibit uterine contractions.

 

Dosage should be individualized depended on patient case.

Adults and Children over 12 years: COMPO-NEB Inhalation solution in unit dose ampoule may be administered from a suitable nebulizer or an intermittent positive pressure ventilator. The recommended dosage is 1 UDV vial 3 or 4 times daily.
Dilution Instructions: If necessary, before use, doses may be diluted to a total nebulization volume of 3 to 5 ml with preservative-free 0.9% sterile sodium chloride solution and used immediately. Nebulize over 10 to 15 minutes at gas flow of 6 to 10 L/min. Repeat every 6 hours as necessary.

Note: Counseling on smoking cessation should be the first step in treating patients with chronic bronchitis who smoke. Smoking cessation produces symptomatic benefits and has been shown to confer a survival advantage by slowing or stopping the progression of chronic bronchitis and emphysema.

 

COMPO-NEB Inhalation Solution: A pack of 7 or 14 plastic unit dose ampoules of 2.5 ml. Each 2.5 ml ampoule contains Ipratropium Bromide Anhydrous (as monohydrate) 0.5 mg and Salbutamol Sulfate 3 mg (equivalent to Salbutamol base 2.5 mg).