- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for injection containing papavertum
Enhancement of anaesthesia
Relief of chronic severe pain
Treatment of post-operative pain
Do not repeat the dose more often than every 4 hours.
Response to opioids varies greatly between patients. Individualise dose according to degree of analgesia required and side effects experienced.
7.7mg or 15.4mg as a single dose. Dose should not be repeated more than once during 4 hours
In patients who are ill, the initial dose should not exceed 7.7mg
The initial dose should not exceed 7.7mg.
Following doses can be 7.7mg - 15.4mg
6 to 12 years:
3.85mg to 7.7mg maximum single dose
1 year to 5 years:
1.93-3.85mg maximum single dose
1 month to 1 year:
154 micrograms/kg per dose
Under 1 month:
115 micrograms/kg per dose
Patients with Renal Impairment
Glomerular filtration rate between 10 and 20 ml/minute: Reduce does down to 60 to 75 percent of usual dose and administer every 6 to 8 hours.
Glomerular filtration rate equal to or below 10 ml/minute: Reduce does down to 25 to 50 percent of usual dose and administer every 6 to 8 hours.
Patients with Hepatic Impairment
Use with caution and give reduced doses.
Subcutaneous or intramuscular injection
Subcutaneous or intramuscular injection. Intravenous injection may also be used but the dose should be reduced to 25-50% of the intramuscular/subcutaneous
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute respiratory depression
Cardiac failure secondary to pulmonary disorder
Chronic obstructive pulmonary disease
Raised intracranial pressure
Precautions and Warnings
Benign prostatic hyperplasia
History of seizures
Asthma: avoid use during acute exacerbations
Children under 18 years: Increased risk of rare and severe adverse effects
Hepatic cirrhosis: hepatic coma may be precipitated
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine is subject to driving restrictions
High addiction potential
May cause dependence
Potential for withdrawal symptoms
Tolerance may develop with continued use
Do not withdraw this drug suddenly
The use of codeine is not recommended in children under 18 years of age as it has been associated with rare but serious adverse reactions. Younger children may be more susceptible and codeine should not be used in children under 12 years of age.
Codeine should not be used in children under 18 years who are undergoing the removal of tonsils due to an increased risk of severe breathing difficulties.
Pregnancy and Lactation
Caution when treating pregnant patients as the safety of papaveretum has not been established.
Papaveretum has been used for many years with no apparent ill consequence. However, the active constituents of papaveretum can cross the placental barrier.
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 14-17 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 ).
Caution when treating lactating women.
The active constituents of papaveretum are secreted 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
May cause drowsiness. Advise patient that if affected they should not drive or operate machinery until certain the effects have worn off.
Difficulty in micturition
Diminution of potency
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 (https://www.toxbase.org/).
As with morphine overdose the symptoms may include pin point pupils, respiratory depression and coma.. Convulsions, especially in children and rhabdomyolysis leading to renal failure. Circulatory failure may occur in severe cases.
If respiration is dangerously depressed naloxone should be used. Artificial respiration may be necessary.
Last Full Review Date: July 2013
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
Summary of product characteristics for Papaveretum Injection BP 15.4mg in 1ml from Macarthys Laboratories Ltd dated June 2003
Summary of product characteristics for Papaveretum Injection BP 7.7mg in 1ml from Macarthys Laboratories Ltd dated June 2003
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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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.