DEHYDRATED ALCOHOL Solution for injection Ref.[8484] Active ingredients: Ethanol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2008  Publisher: Macarthys Laboratories Limited, T/A Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG

Contraindications

Known hypersensitivity to alcohol.

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.

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.

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.

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.

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.

Incompatibilities

None stated.

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