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Product Prescribing Information
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BRONCHOPHANE


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  • Prescription Information
  • Composition


    Each 5 ml contains: 
    Guaiphenesin ............................................................................................ 50 mg
    Ephedrine hydrochloride ......................................................................... 7.5 mg
    Diphenhydramine hydrochloride ……......................................................... 5 mg
    Dextromethorphan hydrobromide ....................................................... 6.25 mg
    Inactive ingredients: 

    Sodium phosphate dibasic, citric acid anhydrous, sucrose, sorbitol 70%, sodium benzoate, FDC yellow no.6, peach flavor, propylene glycol, ethanol, purified water. 

                                            

    Therapeutic Indications       

      

    Acute and chronic bronchitis.
    Asthmatic bronchitis.
    Cough associated with common cold.


    Dosage and Administration       

            

    Unless prescribed by the physician the dose is as follows:
    Children more than 6 years: 1/2 teaspoonfuls 3-4 times daily.
    Adults: 1-2 teaspoonfuls 3-4 times daily.

                                                                 

    Contraindications      

                       

    Hypersensitivity to the drug and other sympathomimetic drugs.
    Porphyria.
    Patients taking monoamine oxidase inhibitors (MAOIs, certain drugs prescribed for depression, psychiatric, or emotional conditions, or Parkinson's disease) or within 2 weeks of stopping MAOIs.
    Severe coronary artery disease or cardiovascular disease.
    BRONCHOPHANE is contraindicated in children less than 6 years old.
    BRONCHOPHANE is contraindicated in pregnant women, patients with renal or hepatic impairment, and in patients treated with metronidazole or disulfiram, because of the potential risk of toxicity from the large amount of the excipient propylene glycol.

                                                                  

    Warnings and Precautions         

                    

    BRONCHOPHANE should be used with caution in: 
    Elderly patients.
    Hypertension and hyperthyroidism.
    Nervous or excitable states, diabetes, or prostatic hyperplasia. 

                                                                

    Drug Interactions          

                  

    CNS depressants and Alcohol: May increase sedation.
    MAO inhibitors: May cause severe hypertension. Do not use together.
    Antihypertensives: BRONCHOPHANE may decrease their effects.

                                                             

    Pregnancy and Lactation       

                    

    BRONCHOPHANE should not be used during pregnancy and it is not recommended during lactation. 

                                                                     

    Undesirable Effects           

                  

    These may include drowsiness, sedation, and headache.

                                                            

    Pharmacological Properties              

          

    BRONCHOPHANE is a well-tolerated balanced formula acting as expectorant and cough sedative. It contains guaiphenesin, ephedrine hydrochloride, diphenhydramine hydrochloride, and dextromethorphan hydrobromide.
    Guaiphenesin increases production of respiratory tract fluids to help liquefy and reduce viscosity of tenacious sputum. It thins respiratory secretions for easier removal. If sputum is not removed, it may support growth of bacteria and make breathing more difficult.
    Ephedrine is a sympathomimetic with direct and indirect effects on adrenergic receptors. It causes bronchodilatation, thus relieving bronchospasm and nasal congestion.
    Diphenhydramine is a sedating antihistamine with antiemetic properties. It is used for the symptomatic relief of allergic conditions including rhinitis. It has pronounced central sedative properties and is a common ingredient of compound preparations for symptomatic treatment of coughs and common cold.
    Dextromethorphan is a cough suppressant used for the relief of non-productive cough; it has a central action on the cough centre in the medulla. Dextromethorphan in the small dose provided in BRONCHOPHANE does not completely suppress the cough but calms it, without influencing the expectorant property of guaiphenesin.
    Consequently, BRONCHOPHANE provides a full range of therapeutic actions against the cough, promoting tracheobronchial secretion, relieving bronchospasm in asthmatic bronchitis, besides being helpful to control distressing coughs. 

                                                             

    Storage                         


    Store at a temperature not exceeding 30°C, away from light.

                                                            

    Packaging                

           

    BRONCHOPHANE Syrup: Bottle of 125 ml. 




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