Cocaine hydrochloride nasal and oromucosal
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution containing cocaine hydrochloride
Local anaesthetic+vasoconstrict;before surg:- oral,laryngeal,nasal cavities
Cocaine hydrochloride solution should only be used by those skilled in the precautions required to minimise absorption and the consequent risks of arrhythmias.
The patient's age, weight, physique, clinical condition and the degree of vascularity in the application area should be considered prior to administration.
Maximum total dose for application to mucosa in fit adults is 1.5 mg/kg.
One spray delivers 130 microlitres of solution (13 mg cocaine). The maximum dosage of 1.5 mg/kg equates to approximately 8 to 9 sprays (1 ml of solution) for a 70 kg adult. This dose must not be exceeded.
Additional Dosage Information
Some studies indicate that death can occur after use of 0.8 to 1 g of cocaine (8 to 10 ml of a 10% solution).
Some people have a cocaine idiosyncrasy and doses of only 20 mg may lead to death in these patients.
For oromucosal or nasal administration.
For topical use only. Must NOT be injected or taken.
Activate the pump three times before administration to prime the pump spray.
Not for multidose use.
Children under 18 years
Inherited abnormal plasma cholinesterase activity
Precautions and Warnings
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine is subject to driving restrictions
Treatment to be initiated and supervised by a specialist
For topical use only
Not for use in open wounds
Resuscitation facilities must be immediately available
Monitor patient closely for signs and symptoms of toxicity
Driving or operating machinery not advisable following treatment
Use with caution in patients with diabetes mellitus as cocaine sensitises the patient to adrenaline which mobilises glucose. This effect can lead to uncontrolled blood glucose levels.
Pregnancy and Lactation
Cocaine hydrochloride is contraindicated during pregnancy.
Cocaine crosses the placenta.
Administration during early pregnancy leads to a cocaine and metabolite burden in the meconium, which is formed at the end of the first trimester.
Animal and autopsy studies have shown that the cocaine metabolite benzoylecgonine preferentially accumulates in foetal tissue. Human and animal studies have shown that there are significant physiological and behavioural properties of the slowly eliminated metabolites of cocaine.
Due to the vasoconstrictive effect of cocaine and an increased maternal blood pressure leading to reduced placental blood flow, there is an increased risk of spontaneous abortion and other birth complications.
Babies have demonstrated the following symptoms following maternal administration of cocaine:
Irritability, inconsolability, hypertoxicity, tremulousness, hyperactive moro reflex, sneezing, yawning, lethargy, suck reflex, high pitched cry, poor feeding, poor weight gain, fever, diarrhoea, spitting, vomiting, tachypnoea, tachycardia, skin abrasions and respiratory distress.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Cocaine hydrochloride is contraindicated in breastfeeding.
Cocaine is excreted in breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). This medicine may be subject to police testing and has specified maximum blood levels for driving. When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them. It is an offence to drive while under the influence of this medicine. However, a patient is not committing an offence (called 'statutory defence') if: 1.The medicine has been prescribed to treat a medical or dental problem and 2.The medicine has been taken according to the instructions given by the prescriber and/or in the information provided with the medicine and 3.The medicine was not affecting the ability to drive safely. For further guidance see https://www.gov.uk
Altered bowel habit
Altered tactile sensations
Increased motor activity
Rise in body temperature
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2013
Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press
Summary of Product Characteristics: Cocaine hydrochloride solution 10% w/v. Aurum Pharmaceuticals Ltd. Revised January 2005.
Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015
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