Vaponefrin (Racemic Epinephrine HCl)

VAPONEFRIN®

Rhône-Poulenc Rorer

Racemic Epinephrine HCl

Bronchodilator

Indications And Clinical Uses: For the symptomatic relief of bronchial obstruction due to bronchial spasm and mucous secretions associated with bronchial asthma, hay fever, chronic bronchitis, pulmonary emphysema, and other pulmonary diseases associated with bronchospasm.

Precautions: Use with caution in children under 12 years of age, in patients sensitive to sympathomimetic amines, in the presence of hypertension or cardiovascular disorders (including coronary insufficiency), in patients with a potential for cardiac arrhythmias and in those patients receiving MAO inhibitors. Do not use concurrently with other bronchodilators; may be used interchangeably with isoproterenol, but an interval of 4 hours should elapse before changing from one to the other. Do not exceed dose recommended by the physician. If difficulty in breathing persists or if the number of doses has to be increased to obtain the desired effect, a physician should be called immediately. Do not use solution if discolored or if it contains a precipitate.

Occasional patients have been reported to develop severe paradoxical airway resistance associated with the repeated, excessive use of bronchodilator inhalation preparations. The cause of this refractory state is unknown. It is advisable that in such instances the use of the solution be discontinued immediately and alternative therapy instituted, since in the reported cases the patients did not respond to other forms of therapy until the medication was withdrawn. Deaths have been reported following excessive use of bronchodilator inhalation preparations, the exact cause of which is unknown. Cardiac arrest was noted in several instances.

Adverse Reactions: In excessive dosage, epinephrine may cause bronchial edema and inflammation, palpitation, precordial ache or anginal pain, tremor, nervousness, restlessness, sleeplessness, dizziness, headache, nausea and sweating. If any of these occur, dosage should be reduced by ordering fewer inhalations or less frequent use.

Dosage And Administration: Should be used at the first sign of wheezing or shortness of breath due to bronchospasm. Add 10 to 15 drops to nebulizer and inhale deeply with mouth wide open, while compressing the rubber bulb with a sharp, quick squeeze. Take 2 or 3 inhalations. If relief is not obtained after 5 minutes, repeat inhalation. Do not repeat again before 4 hours. If difficulty in breathing still persists, contact physician immediately.

Use the smallest amount which will bring relief from wheezing or bronchospasm. After inhalations, the sputum may be pink in color due to a chemical reaction between the mucous secretions and Vaponefrin solution.

After dilution, the solution should be used within 30 minutes. Do not use solution if discolored or if it contains a precipitate.

Availability And Storage: Each mL of clear solution contains: racemic epinephrine base 2.25% as hydrochloride for inhalation therapy. Nonmedicinal ingredients: benzoic acid, chlorobutanol hemihydrate, glycerin, hydrochloric acid, purified water, sodium chloride and sodium metabisulfite. Bottles of 30 mL. Store solution in tight, light-resistant container at controlled room temperature (15 to 30°C).

VAPONEFRIN® Rhône-Poulenc Rorer Racemic Epinephrine HCl Bronchodilator

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