Drugs List

Therapeutic Indications

Uses

Pain - mild to moderate
Pain - severe
Pyrexia

Contraindications

Acute alcohol intoxication
Children under 12 years
Risk of paralytic ileus
Acute asthma
Acute diarrhoea
Acute respiratory depression
Chronic obstructive pulmonary disease
Coma
Head trauma
Raised intracranial pressure
Severe hepatic impairment

Precautions and Warnings

Allergic disposition
Debilitation
Elderly
Shock
Suicidal ideation
Within 2 weeks of discontinuing MAOIs
Addison's disease
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
Cardiac failure secondary to pulmonary disorder
Cholelithiasis
Circulatory failure
Drug addiction
Drug misuse
During or immediately prior to labour
Gall bladder disorder
Hypotension
Hypothyroidism
Inflammatory bowel disease
Mild hepatic impairment
Myasthenia gravis
Non-cirrhotic alcoholic liver disease
Phaeochromocytoma
Pregnancy
Recent gastrointestinal surgery
Recent surgery of the urinary tract
Renal impairment
Respiratory impairment
Seizures
Urethral stricture

Reduce dose in hypothyroidism
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 may be subject to driving restrictions
Not all available strengths are licensed for all indications
Can cause addiction
Prolonged or excessive use may result in dependence
Advise patient to report overdose immediately, even if patient feels well
Excessive use may increase frequency of headache, may require withdrawal
Overdosage causes liver damage
Prolonged use and excessive doses may cause hepatic necrosis
May affect results of some laboratory tests
Avoid abrupt withdrawal
Reduce dose in debilitated patients
Reduce dose in elderly
For three days use only
Advise patient not to take paracetamol during treatment
Advise patient that the effects of alcohol may be potentiated
Advise patient to avoid alcohol during treatment
Advise that alcohol increases the chances of liver damage with paracetamol
Advise patient to consult a doctor if symptoms persist despite treatment
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose

Consider dose reduction in hypothyroidism and adrenocortical insufficiency (e.g Addison's disease).

Patients should be advised not to exceed the recommended dose and not to take other paracetamol containing products concurrently. Immediate medical attention should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage.

Continued use should be assessed regularly by a medical professional, with consideration of the risks and benefits.

Pregnancy and Lactation

Pregnancy

Use co-dydramol with caution during pregnancy.

The risks and benefits should be considered before administering co-dydramol to a pregnant woman because opioid analgesics cross the placenta. Animal studies have shown opioids to cause delayed ossification in mice and increased resorption in rats.

During labour, opioids enter the foetal circulation, posing a risk of opiate-typical withdrawal and respiratory depression in the neonate at birth. Gastric stasis and inhalation pneumonia in the mother during labour has also been reported. Administration of co-dydramol should be avoided during the late stages of labour and during delivery of a premature infant.

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

At normal therapeutic doses, co-dydramol is likely to be present in breast milk at very low doses and is unlikely to adversely affect the nursing infant.

However, other sources suggest neonates may be sensitive to even small doses of narcotic analgesics. Co-dydramol should therefore be avoided during breast-feeding unless the potential benefits outweigh the potential risks.

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

Abdominal pain
Agranulocytosis
Allergic reaction
Amenorrhoea
Anti-diuretic effect
Biliary spasm
Blood dyscrasias
Blurred vision
Bradycardia
Breathing difficulties
Confusion
Constipation
Convulsions
Decreased appetite
Dependence
Depression
Dizziness
Double vision
Drowsiness
Drug fever
Dry mouth
Dysphoria
Erectile dysfunction
Excitement
Facial flushing
Gastric irritation
Haemolytic anaemia
Hallucinations
Headache
Hepatic impairment
Hepatic necrosis
Hypalgesia
Hypersensitivity reactions
Hypogonadism
Hypotension
Hypothermia
Increased sweating
Infertility
Leucopenia
Malaise
Mental status changes
Methaemoglobinaemia
Micturition disorders
Miosis
Mood changes
Mucosal lesions
Muscle rigidity
Myocarditis
Nausea
Nephrotoxicity
Neutropenia
Nightmares
Oedema
Palpitations
Pancreatitis
Pancytopenia
Papillary necrosis
Paraesthesia
Paralytic ileus
Pruritus
Raised intracranial pressure
Rash
Reduced libido
Respiratory depression
Restlessness
Sedation
Sexual dysfunction
Sleep disturbances
Tachycardia
Thrombocytopenia
Thrombocytopenic purpura
Tiredness
Tolerance
Toxic megacolon
Trembling
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting
Weakness

Presentation

Oral formulations of paracetamol and dihydrocodeine.

Drugs List

Therapeutic Indications

Uses

Pain - mild to moderate
Pain - severe
Pyrexia

Dosage

The duration of treatment should not exceed 3 days without medical review.

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Acute alcohol intoxication
Children under 12 years
Risk of paralytic ileus
Acute asthma
Acute diarrhoea
Acute respiratory depression
Chronic obstructive pulmonary disease
Coma
Head trauma
Raised intracranial pressure
Severe hepatic impairment

Precautions and Warnings

Allergic disposition
Debilitation
Elderly
Shock
Suicidal ideation
Within 2 weeks of discontinuing MAOIs
Addison's disease
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
Cardiac failure secondary to pulmonary disorder
Cholelithiasis
Circulatory failure
Drug addiction
Drug misuse
During or immediately prior to labour
Gall bladder disorder
Hypotension
Hypothyroidism
Inflammatory bowel disease
Mild hepatic impairment
Myasthenia gravis
Non-cirrhotic alcoholic liver disease
Phaeochromocytoma
Pregnancy
Recent gastrointestinal surgery
Recent surgery of the urinary tract
Renal impairment
Respiratory impairment
Seizures
Urethral stricture

Reduce dose in hypothyroidism
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 may be subject to driving restrictions
Not all available strengths are licensed for all indications
Can cause addiction
Prolonged or excessive use may result in dependence
Advise patient to report overdose immediately, even if patient feels well
Excessive use may increase frequency of headache, may require withdrawal
Overdosage causes liver damage
Prolonged use and excessive doses may cause hepatic necrosis
May affect results of some laboratory tests
Avoid abrupt withdrawal
Reduce dose in debilitated patients
Reduce dose in elderly
For three days use only
Advise patient not to take paracetamol during treatment
Advise patient that the effects of alcohol may be potentiated
Advise patient to avoid alcohol during treatment
Advise that alcohol increases the chances of liver damage with paracetamol
Advise patient to consult a doctor if symptoms persist despite treatment
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose

Consider dose reduction in hypothyroidism and adrenocortical insufficiency (e.g Addison's disease).

Patients should be advised not to exceed the recommended dose and not to take other paracetamol containing products concurrently. Immediate medical attention should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage.

Continued use should be assessed regularly by a medical professional, with consideration of the risks and benefits.

Pregnancy and Lactation

Pregnancy

Use co-dydramol with caution during pregnancy.

The risks and benefits should be considered before administering co-dydramol to a pregnant woman because opioid analgesics cross the placenta. Animal studies have shown opioids to cause delayed ossification in mice and increased resorption in rats.

During labour, opioids enter the foetal circulation, posing a risk of opiate-typical withdrawal and respiratory depression in the neonate at birth. Gastric stasis and inhalation pneumonia in the mother during labour has also been reported. Administration of co-dydramol should be avoided during the late stages of labour and during delivery of a premature infant.

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

At normal therapeutic doses, co-dydramol is likely to be present in breast milk at very low doses and is unlikely to adversely affect the nursing infant.

However, other sources suggest neonates may be sensitive to even small doses of narcotic analgesics. Co-dydramol should therefore be avoided during breast-feeding unless the potential benefits outweigh the potential risks.

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.

Side Effects

Abdominal pain
Agranulocytosis
Allergic reaction
Amenorrhoea
Anti-diuretic effect
Biliary spasm
Blood dyscrasias
Blurred vision
Bradycardia
Breathing difficulties
Confusion
Constipation
Convulsions
Decreased appetite
Dependence
Depression
Dizziness
Double vision
Drowsiness
Drug fever
Dry mouth
Dysphoria
Erectile dysfunction
Excitement
Facial flushing
Gastric irritation
Haemolytic anaemia
Hallucinations
Headache
Hepatic impairment
Hepatic necrosis
Hypalgesia
Hypersensitivity reactions
Hypogonadism
Hypotension
Hypothermia
Increased sweating
Infertility
Leucopenia
Malaise
Mental status changes
Methaemoglobinaemia
Micturition disorders
Miosis
Mood changes
Mucosal lesions
Muscle rigidity
Myocarditis
Nausea
Nephrotoxicity
Neutropenia
Nightmares
Oedema
Palpitations
Pancreatitis
Pancytopenia
Papillary necrosis
Paraesthesia
Paralytic ileus
Pruritus
Raised intracranial pressure
Rash
Reduced libido
Respiratory depression
Restlessness
Sedation
Sexual dysfunction
Sleep disturbances
Tachycardia
Thrombocytopenia
Thrombocytopenic purpura
Tiredness
Tolerance
Toxic megacolon
Trembling
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting
Weakness

Effects on Laboratory Tests

Opioids may interfere with gastric emptying studies as they delay gastric emptying. Hepatobiliary imaging using technetium Tc 99m disofenin may also be affected as opioid treatment may cause constriction of the sphincter of Oddi and increase biliary tract pressure.

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 ).

Further Information

Last Full Review Date: November 2017

Reference Sources

Summary of Product Characteristics: Co-dydramol tablets. Actavis UK Ltd. Revised May 2017

Summary of Product Characteristics: Eroset 10mg/500mg Tablets. M & A Pharmachem Limited. Revised October 2017.

Summary of Product Characteristics: Co-dydramol tablets. Wockhardt UK Ltd. Revised January 2017

Summary of Product Characteristics: Co-dydramol tablets. Zentiva. Revised March 2017

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G. and Freeman, R., Wolters Kluwer Health, Philadelphia.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 November 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Record 330 - Acetaminophen
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 11 April 2017
Last accessed: 07 November 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Record 1123 - Dihydrocodeine
https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/r?dbs+lactmed:@term+@DOCNO+1123
Last revised: 04 September 2014
Last accessed: 07 November 2017

MHRA Drug Safety Update: Volume 3, Issue 2, September 2009. Over-the-counter painkillers containing codeine or dihydrocodeine.
https://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON057141
Last accessed: 07 November, 2017

MHRA 2nd September 2009. Updated advice on non-prescription medicines containing codeine or dihydrocodeine (DHC).
https://www.mhra.gov.uk/SafetyInformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON057118
Last accessed: 07 November, 2017

MHRA 19th September 2005
https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/Codeine/index.htm
Last accessed: 13 November 2017

MHRA 10th September 2012
https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/Paracetamol/index.htm
Last accessed: 13 November 2017

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: 07 November 2017 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 07 November 2017