- Approval Id
- 7f19f36f5c79bab0
- Drug Name
- DBL EPHEDRINE SULFATE INJECTION 30 MG/ML
- Product Name
- DBL EPHEDRINE SULFATE INJECTION 30 MG/ML
- Approval Number
- SIN02734P
- Approval Date
- 1989-05-06
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>DBL™ Ephedrine Sulfate Injection is administered by the intramuscular, subcutaneous or intravenous route. Patients in shock may require intravenous administration to ensure absorption of the drug. When administered intravenously, the injection should be given slowly. Care should be taken to avoid extravasation, since this may result in tissue necrosis and sloughing. Ephedrine sulfate should be administered in the lowest effective dose. The parenteral adult dose should not exceed 150 mg in 24 hours.</p>
<p><strong>As a pressor</strong>: <em>Adult dose:</em> The usual adult dose is 25 to 50 mg (range 10 to 50 mg) administered intramuscularly or subcutaneously. Additional doses should be based on patient response. The intravenous route may be used if an immediate response is required. The dosage for the intravenous route is 10 to 25 mg which may be repeated every 5 to 10 minute until the desired response is obtained.</p>
<p><em>Paediatric dose:</em> The recommended paediatric dose is 3 mg/kg/day or 100 mg/m<sup>2</sup>/day via the intravenous or subcutaneous route, given in 4 to 6 divided doses.</p>
<p>During therapy with a pressor agent, blood pressure should be elevated to slightly less than the patient’s normal blood pressure. In previously normotensive patients, systolic blood pressure should be maintained at 80 to 100 mmHg. In previously hypertensive patients, systolic blood pressure should be maintained at 30 to 40 mmHg below their usual blood pressure. In some patients with very severe hypotension, maintenance of even lower blood pressure may be desirable if blood or fluid volume replacement has not been completed.</p>
<p><strong>Bronchospasm</strong>: <em>Adult dose:</em> The usual adult dose is 12.5 to 25 mg, given intramuscularly, subcutaneously or intravenously. Further dosage should be determined by patient’s response.</p>
<p><em>Paediatric dose</em>: The usual paediatric dose is 3 mg/kg or 100 mg/m<sup>2</sup> intravenously or subcutaneously, given in 4 to 6 divided doses.</p>
- Route Of Administration
- INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>Indications</strong></p>
<p>DBL™ Ephedrine Sulfate Injection is indicated in the treatment of shock unresponsive to fluid replacement. It is also indicated in the treatment of hypotension secondary to spinal anaesthesia. DBL™ Ephedrine Sulfate Injection has also been used in the treatment of bronchial asthma and reversible bronchospasm although more selective agents (beta adrenergic agonists) are now available.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>DBL™ Ephedrine Sulfate Injection is contraindicated in closed angle glaucoma, since ephedrine may exacerbate the condition.</p>
<p>Ephedrine sulfate is contraindicated in patients with pheochromocytoma, since severe hypertension may result.</p>
<p>Ephedrine sulfate is contraindicated in patients with asymmetric septal hypertrophy (idiopathic hypertrophic subaortic stenosis) since the obstruction may increase as myocardial contractility improves.</p>
<p>Ephedrine sulfate is contraindicated in patients undergoing therapy with monoamine oxidase inhibitors (MAO inhibitors), or within 14 days of ceasing such therapy, since MAO inhibitors may prolong and intensify the cardiac and pressor effects of ephedrine.</p>
<p>Ephedrine sulfate is contraindicated in patients undergoing general anaesthesia with cyclopropane or halothane or other halogenated hydrocarbons, since anaesthesia may increase cardiac irritability which may lead to arrhythmias.</p>
<p>Ephedrine sulfate is contraindicated in patients with tachyarrhythmias or ventricular fibrillation, since exacerbation of these conditions may occur.</p>
<p>Ephedrine sulfate is also contraindicated in patients with hypersensitivity to ephedrine and in patients with psychoneurosis.</p>
- Atc Code
- R03CA02
- Atc Item Name
- ephedrine
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
