Drugs List

Contraindications

Acute respiratory depression

Chronic obstructive pulmonary disease

Acute asthma

Severe hepatic impairment

Acute alcoholism

Delirium tremens

Risk of paralytic ileus

Raised intracranial pressure

Head trauma

Coma

Within 2 weeks of discontinuing MAOIs

Children under 6 months

Breastfeeding ( see Lactation)

Pregnancy - all trimesters ( see Pregnancy)

Precautions and Warnings

Respiratory impairment

Hepatic impairment (see Dosage - Hepatic impairment )

Renal impairment (see Dosage - Renal impairment )

Asthma

Impaired consciousness

Shock

Myasthenia gravis

Benign prostatic hypertrophy

Obstructive or inflammatory bowel disease

Hypotension

Biliary tract disorders

Convulsive disorders

Hypothyroidism - reduce dose

Adrenocortical insufficiency - reduce dose

Elderly and debilitated patients - reduce dose

Drug abuse or history of drug abuse

Monitor liver function. Withdraw if evidence of hepatotoxic reaction

May cause dependence

May cause postural hypotension

Buprenorphine may cause drowsiness, which may affect the ability to drive or operate machinery. Therefore patients should be advised to exercise caution until they are certain they can tolerate the drug.

Athletes should be advised that treatment with buprenorphine may cause a reaction to anti-doping tests.

There is a possibility of diversion of buprenorphine into the illicit market by patients or individuals who obtain it by theft from patients or pharmacies. This may lead to new addicts using it as a primary drug of abuse, with the risk of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.

Patients should avoid alcohol.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy

Studies in rats and rabbits have evidenced foetotoxicity including post-implantation loss. In humans there is currently not sufficient data to evaluate potential malformative or foetotoxic effects when administered during pregnancy.
When administered during the last trimester buprenorphine can cause respiratory depression and withdrawal symptoms in neonates.

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 ).

Lactation

Contraindicated in lactation

Buprenorphine has the potential to inhibit lactation or milk production. In addition, buprenorphine passes into the 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

Side Effects

Nausea
Vomiting
Drowsiness
Sweating
Headache
Postural hypotension
Hallucinations
Hypotension
Dizziness
Syncope
Psychotic episodes (transient)
Rash
Urinary retention
Blurred vision
Allergic reaction
Constipation
Insomnia
Asthenia
Respiratory depression
Hepatic necrosis
Hepatitis
Withdrawal symptoms
Bronchospasm
Angioneurotic oedema
Anaphylactic shock
Diarrhoea
Abdominal pain
Anorexia
Dyspepsia
Vasodilation
Paraesthesia
Fatigue
Agitation
Anxiety
Flatulence
Taste disturbances
Angina
Hypertension
Hypoxia
Wheezing
Cough
Restlessness
Depersonalisation
Dysarthria
Impaired memory
Hypoaesthesia
Tremor
Influenza-like symptoms
Pyrexia
Rhinitis
Rigors
Muscle cramps
Myalgia
Tinnitus
Dry eyes
Paralytic ileus
Dysphagia
Concentration disturbances
Psychosis
Retching
Hyperventilation
Hiccups
Fasciculation
Dry mouth
Biliary spasm
Muscle rigidity
Bradycardia
Tachycardia
Palpitations
Oedema
Vertigo
Euphoria
Dysphoria
Mood changes
Dependence
Confusion
Sleep disturbance
Sexual dysfunction
Micturition difficulties
Ureteric spasm
Miosis
Visual disturbances
Flushing
Urticaria
Pruritis

Presentation

Solution for injection containing 324micrograms buprenorphine hydrochloride per ml, equivalent to 300micrograms buprenorphine base.

Drugs List

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Acute respiratory depression

Chronic obstructive pulmonary disease

Acute asthma

Severe hepatic impairment

Acute alcoholism

Delirium tremens

Risk of paralytic ileus

Raised intracranial pressure

Head trauma

Coma

Within 2 weeks of discontinuing MAOIs

Children under 6 months

Breastfeeding ( see Lactation)

Pregnancy - all trimesters ( see Pregnancy)

Precautions and Warnings

Respiratory impairment

Hepatic impairment (see Dosage - Hepatic impairment )

Renal impairment (see Dosage - Renal impairment )

Asthma

Impaired consciousness

Shock

Myasthenia gravis

Benign prostatic hypertrophy

Obstructive or inflammatory bowel disease

Hypotension

Biliary tract disorders

Convulsive disorders

Hypothyroidism - reduce dose

Adrenocortical insufficiency - reduce dose

Elderly and debilitated patients - reduce dose

Drug abuse or history of drug abuse

Monitor liver function. Withdraw if evidence of hepatotoxic reaction

May cause dependence

May cause postural hypotension

Buprenorphine may cause drowsiness, which may affect the ability to drive or operate machinery. Therefore patients should be advised to exercise caution until they are certain they can tolerate the drug.

Athletes should be advised that treatment with buprenorphine may cause a reaction to anti-doping tests.

There is a possibility of diversion of buprenorphine into the illicit market by patients or individuals who obtain it by theft from patients or pharmacies. This may lead to new addicts using it as a primary drug of abuse, with the risk of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.

Patients should avoid alcohol.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy

Studies in rats and rabbits have evidenced foetotoxicity including post-implantation loss. In humans there is currently not sufficient data to evaluate potential malformative or foetotoxic effects when administered during pregnancy.
When administered during the last trimester buprenorphine can cause respiratory depression and withdrawal symptoms in neonates.

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 ).

Lactation

Contraindicated in lactation

Buprenorphine has the potential to inhibit lactation or milk production. In addition, buprenorphine passes into the 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). 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.

Counselling

Buprenorphine may cause drowsiness, therefore patients should be advised to exercise caution until they are certain they can tolerate the drug.

Athletes should be advised that treatment with buprenorphine may cause a reaction to anti-doping tests.

Patients should avoid alcohol

Side Effects

Nausea
Vomiting
Drowsiness
Sweating
Headache
Postural hypotension
Hallucinations
Hypotension
Dizziness
Syncope
Psychotic episodes (transient)
Rash
Urinary retention
Blurred vision
Allergic reaction
Constipation
Insomnia
Asthenia
Respiratory depression
Hepatic necrosis
Hepatitis
Withdrawal symptoms
Bronchospasm
Angioneurotic oedema
Anaphylactic shock
Diarrhoea
Abdominal pain
Anorexia
Dyspepsia
Vasodilation
Paraesthesia
Fatigue
Agitation
Anxiety
Flatulence
Taste disturbances
Angina
Hypertension
Hypoxia
Wheezing
Cough
Restlessness
Depersonalisation
Dysarthria
Impaired memory
Hypoaesthesia
Tremor
Influenza-like symptoms
Pyrexia
Rhinitis
Rigors
Muscle cramps
Myalgia
Tinnitus
Dry eyes
Paralytic ileus
Dysphagia
Concentration disturbances
Psychosis
Retching
Hyperventilation
Hiccups
Fasciculation
Dry mouth
Biliary spasm
Muscle rigidity
Bradycardia
Tachycardia
Palpitations
Oedema
Vertigo
Euphoria
Dysphoria
Mood changes
Dependence
Confusion
Sleep disturbance
Sexual dysfunction
Micturition difficulties
Ureteric spasm
Miosis
Visual disturbances
Flushing
Urticaria
Pruritis

Overdosage

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 ).

Shelf Life and Storage

Keep cool
Protect from light

Reference Sources

British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Summary of Product Characteristics: Temgesic injection 1ml. RB Pharmaceuticals Ltd. Revised September 2010

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

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 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015