Dehydrated Alcohol (Absolute Alcohol) Injection USP Taj Pharma

Dehydrated Alcohol Injection USP

  1. NAME OF THE MEDICINAL PRODUCT

Dehydrated Alcohol (Absolute Alcohol) Injection USP Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ethanol USP 98% v/v

  1. PHARMACEUTICAL FORM

Solution for injection

  1. 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 1-2hours 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

Absolute

(100%)

Ethanol

Volume 5%

Ethanol by IV Injection

Volume 10%

Ethanol by IV Injection

Loading Dose

Over 30 minutes

600 -800mg/kg 15ml/kg 7.5ml/kg
Standard maintenance dose

(non-drinker/child)

80-83

mg/kg/hr

1.66ml/kg/hr 0.83ml/kg/hr
Standard maintenance dose

(average adult)

120-138

mg/kg/hr

2.76/ml/kg/hr 1.38ml/kg/hr
Standard maintenance dose

(drinker)

184-196

mg/kg/hr

3.92ml/kg/hr 1.96ml/kg/hr
Maintenance dose during dialysis

(non-drinker/child)

200-213

mg/kg/hr

4.26ml/kg/hr 2.13ml/kg/hr
Maintenance dose during dialysis

(average adult)

240-268

mg/kg/hr

5.36ml/kg/hr 2.68ml/kg/hr
Maintenance dose during dialysis

(drinker)

308-326

mg/kg/hr

6.52ml/kg/hr 3.26ml/kg/hr

Ethanol can be added to peritoneal dialysate at a concentration of 1-2g/L of dialysate.

4.3 Contraindications

Known hypersensitivity to alcohol.

4.4 Special warnings and precautions for use

Women and the elderly may be more susceptible to the adverse effects of alcohol ingestion. Unpleasant reactions, similar to those occurring with disulfiram may occur when alcohol is taken concomitantly with chlorpropamide, metronidazole, and some cephalosporins. Alcohol may cause hypoglycaemic reactions in patients receiving sulphonylurea (antidiabetic agents) or insulin, and may cause orthostatic hypotension in patients taking drugs with vasodilator action.

It may also aggravate peptic ulcer disease or hepatic impairment.

4.5 Interaction with other medicinal products and other forms of interaction

Alcohol may enhance the acute effects of drugs which depress the central nervous system, such as hypnotics, antihistamines, muscle relaxants, opioid analgesics, antiepileptics, antidepressants, and tranquillisers.

Alcohol is also known to interact with the following medicines or group of medicines: antihypertensive agents such as ACE inhibitors, adrenergic neurone blockers, beta-blockers, antidiabetic agents (see section 4.4), alpha blockers, angiotensin II receptor antagonists, Bromocriptine, calcium channel blockers, oral coagulants such as Coumarins, phenindione, cycloserine, antifungal agents, Hyoscine, diuretics, metronidazole, nabilone, and procarbazine.

4.6 Pregnancy and lactation

Studies indicate the oral use of alcohol during first and second trimesters can have serious effects upon the foetus, including low birth weight. Use of alcohol during third trimester can cause withdrawal syndrome in babies. To minimise these risks, pregnant women are advised to limit their intake to 1-2 drinks/week (8 or 16g of ethanol). The volume of alcohol used in nerve blocks is of such a small amount, it is extremely unlikely the foetus would be affected. The risk to the foetus from significant methanol poisoning exceeds that of the appropriate treatment.

Alcohol is freely secreted in breast milk in concentrations slightly below those in blood. In all cases the benefit must be weighed against the potential risk prior to using alcohol during pregnancy or lactation.

4.7 Effects on ability to drive and use machines

All processes requiring judgement and co-ordination are affected by alcohol and these include the driving of any form of transport and the operating of machinery.

4.8 Undesirable effects

Effects of alcohol at higher concentrations may include; nausea, vomiting, headache, dizziness and tremor. Alcohol depresses medullary action causing lethargy, amnesia, hypothermia, hypoglycaemia (especially in children), stupor, coma, respiratory depression cardiomyopathy, hypotension or hypertension and cardiovascular collapse.

At low to moderate concentrations, alcohol acts as a stimulant depresses cortical function causing loss of judgement, emotional lability, muscle incoordination, visual impairment, slurred speech, ataxia, dysarthia and nystagmus.

4.9 Overdose

Symptoms: Acute toxicity is primarily one of CNS depression.

Treatment:

In acute poisoning the stomach may be emptied by aspiration and lavage if indicated. If respiration is depressed, assisted respiration may be necessary. It is important to provide good supportive treatment and to keep the patient warm. Fluid balance should be maintained by the use of suitable electrolyte solution, and glucose may be needed for the treatment of hypoglycaemia.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Primary and continuous depressant of the central nervous system. It has a depressant action on the vasomotor-centre.

Subcutaneous tissues:

Alcohol injected hypodermically causes considerable pain followed by anaesthesia. If the injection is made close to the nerves, neuritis and nerve degeneration may occur. Injections in or near nerves are deliberately used to cause anaesthesia of protracted or even permanent character in the treatment of severe pain, for example, in tic doulourex.

Peripheral Nerves:

Alcohol blocks conduction in peripheral nerve by decreasing the maximal values of both the sodium and potassium conductances. The resting potential usually becomes slightly less negative.

5.2 Pharmacokinetic properties

Alcohol is rapidly distributed throughout the body. It readily crosses the placenta.

Alcohol is mainly metabolised in the liver and is converted by alcohol dehydrogenase to acetaldehyde and is then further oxidised to acetate. A hepatic microsomal oxidising system is also involved. About 90% to 98% of alcohol is oxidised and the remainder is excreted unchanged by the kidneys and the lungs and also in breast milk, saliva, sweat and other secretions.

5.3 Preclinical safety data

There are no additional data of relevance to the prescriber.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Not applicable

6.2 Incompatibilities

None stated

6.3 Shelf life

60 months (unopened)

6.4 Special precautions for storage

None stated

6.5 Nature and contents of container

Colourless ampoules of neutral glass packed into cartons of 10 ampoules, containing 2ml, 5ml, 10ml, 20ml, or 50ml of solution.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Dehydrated Alcohol (Absolute Alcohol) Injection USP

Ethanol

Read all of this leaflet carefully before you are given this medicine.

  • Keep this leaflet. You may need to read it
  • If you have any further questions, please ask your doctor or
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or

In this leaflet:

  1. What Dehydrated Alcohol for Injection is and what it is used for
  2. Before you are given Dehydrated Alcohol for Injection
  3. How Dehydrated Alcohol for Injection will be given
  4. Possible side effects
  5. How to store Dehydrated Alcohol for Injection
  6. Further information

 

  1. WHAT DEHYDRATED ALCOHOL FOR INJECTION IS AND WHAT IT IS USED FOR
  • Dehydrated Alcohol (Absolute alcohol) BP for Injection is a sterile solution of 100 % ethanol.

It is used to treat:

  • severe pain including trigeminal neuralgia (a severe pain in the jaw, lips, eyes and face)
  • methanol poisoning.
  1. BEFORE YOU ARE GIVEN DEHYDRATED ALCOHOL FOR INJECTION

You should NOT be given Dehydrated Alcohol for Injection if:

  • you are allergic (hypersensitive) to ethanol.

Take special care with Dehydrated Alcohol Tell your doctor if:

  • you are pregnant or breast feeding

Taking other medicines:

Tell your doctor if you are taking any of the following:

  • sleep-inducing drugs such as nitrazepam
  • antihistamines such as chlorpheniramine or promethazine, used to treat allergies
  • muscle relaxants such as atracurium
  • strong painkillers such as morphine
  • medicines used in the treatment of epilepsy, such as phenytoin
  • medicines used to treat depression such as amitriptyline or imipramine
  • tranquillisers used to treat anxiety such as diazepam
  • insulin or oral antidiabetic tablets such as chlorpropamide, used to treat diabetes, as alcohol can also reduce blood glucose levels
  • metronidazole used to treat urinary tract infections
  • cephalosporin antibiotics, such as cefalexin or cefaclor, used to treat infections
  • anti hypertensive agents used to lower blood pressure (ACE inhibitors, beta-blockers and calcium channel blockers) such as ramipril, captopril, propranolol, atenolol, diltiazem and nifedipine.
  • medicines used to thin the blood (anticoagulants), such as warfarin and acenocoumarol.

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy   and    breast-feeding: If you are pregnant or breast-feeding you should talk to your doctor before receiving this medicine.

Effects on the  ability  to  drive  and  use  machinery: Alcohol affects your judgement and co-ordination. You should not drive or operate machinery if you have recently been given this medicine.

  1. HOW DEHYDRATED ALCOHOL FOR INJECTION WILL BE GIVEN

The doctor or nurse will give you this medicine. They will decide on how much will be given to you.

Treatment of severe pain (including trigeminal neuralgia): The dose will depend on the location and severity of the pain. The Dehydrated Alcohol will be given as an injection close to the nerve.

Methanol  poisoning; The Dehydrated Alcohol is given as an infusion (drip) into a vein over 30 minutes.

If you are given too much Dehydrated Alcohol for Injection: Dehydrated Alcohol for Injection will be given to you by a doctor, therefore it is unlikely that you will be given too much or that you will miss a dose. However, if you are concerned about your treatment, please talk to your doctor or nurse.

  1. POSSIBLE SIDE EFFECTS

Like all medicines Dehydrated Alcohol for Injection can cause side effects, although not everybody gets them.

If you experience any of the following please tell your doctor or nurse immediately. These are symptoms of an allergic reaction.

  • difficulty breathing or swallowing
  • swelling of face, lips, throat or tongue
  • skin rash

Side effects which may occur with low to moderate levels of alcohol are:

  • loss of co-ordinated body movements (unsteadiness, clumsiness)
  • loss of judgement
  • mood changes/swings
  • blurred vision
  • slurred speech.

Other side effects include:

  • drowsiness, loss of energy
  • memory loss
  • loss of body heat (feeling cold)
  • low blood sugar levels (especially in children)
  • loss of consciousness or loss of awareness
  • breathing difficulties
  • coma
  • heart failure.

If any of the side effects gets serious, or you notice any side effects not listed in the leaflet, please tell your doctor or nurse.

  1. HOW TO STORE DEHYDRATED ALCOHOL FOR INJECTION

Keep    out    of    the    reach    and    sight    of    children.  Do not use Dehydrated Alcohol for Injection after the expiry date which is stated on the ampoule and carton labels. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

  1. FURTHER INFORMATION

What Dehydrated Alcohol for Injection contains:

The active ingredient is ethanol 100% v/v. There are no other ingredients.

What Dehydrated Alcohol for Injection looks like and contents of the pack:

Dehydrated Alcohol for Injection is a clear colourless solution. The  product  is  supplied  in  clear  glass  ampoules  containing  2 ml, 5 ml, 10 ml, 20 ml or 50 ml of solution. Each pack contains 10 ampoules.

Not all pack sizes may be marketed.

 

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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