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Dehydrated Alcohol Injection USP 1. NAME OF THE MEDICINAL PRODUCT Dehydrated Alcohol (Absolute Alcohol) Injection USP Taj Pharma
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ethanol USP 98% v/v
3. PHARMACEUTICAL FORM Solution for injection
4. CLINICAL PARTICULARS 4.1 Therapeutic indications Severe and chronic pain including that caused by trigeminal neuralgia may be relieved by injection of alcohol close to the nerve. Alcohol is given intravenously in the treatment of acute poisoning from methanol. 4.2 Posology and method of administration Severe pain including trigeminal neuralgia 0.2ml, for a small nerve root to a maximum of 10ml for blockade of the coeliac ganglion. Injected into the individual nerve root or ganglion. The needle tip should ideally be located by radiographic or fluoroscopic means prior to dose delivery. Methanol poisoning A loading dose of 600 – 800mg/kg should be given. If used parenterally this should be in the form of 7.5ml/kg of a 10% infusion of Ethanol in 5% Glucose Solution for Infusion. The infusion should be given over
30minutes preferably via a central venous catheter. The standard maintenance dose, for an average patient is 120-138mg of 100% ethanol/kg/hr (1.38ml of 10% ethanol/kg/hr) by the IV route. Blood monitoring should occur every 12hours until a concentration of 1-1.5g/L is reached and thereafter at 2-4hourly intervals. After the loading dose maintenance concentrations should be reduced dependant on the normal drinking habits of the patient and any other concomitant treatments. Patients treated with Ethanol require close monitoring preferably in a critical care area because of the risk of CNS and respiratory depression. Amount Absolut e (100%) Ethanol 600 800mg/ kg
Loading Dose Over 30 minutes Standard 80-83 maintenanc mg/kg/h e dose r (nondrinker/chil d) Standard 120-138 maintenanc mg/kg/h e dose r (average adult) Standard 184-196 maintenanc mg/kg/h e dose r
Volume 5% Ethanol by IV Injection 15ml/kg
Volume 10% Ethanol by IV Injection 7.5ml/kg
1.66ml/kg/ 0.83ml/kg/ hr hr
2.76/ml/kg/ 1.38ml/kg/ hr hr
3.92ml/kg/ 1.96ml/kg/ hr hr