Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Fever
Musculo-skeletal conditions
Osteoarthritis
Pain - mild to moderate
Rheumatoid arthritis

For the symptomatic relief of mild to moderate pain, such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, non-serious arthritic pain, migraine, cold and flu symptoms, sore throat and fever.

Contraindications

Children under 12 years
Gastrointestinal haemorrhage
Gastrointestinal perforation
Hereditary fructose intolerance
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
New York Heart Association class IV failure
Peptic ulcer
Severe hepatic impairment
Severe renal impairment
Sucrase-isomaltase insufficiency
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Restricted sodium intake
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
Hypertension
Ischaemic heart disease
New York Heart Association class II failure
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus

May precipitate bronchospasm in patients with asthma or allergy
Sodium content of formulation may be significant
High dose increases cardiovascular risk
Contains propylene glycol: may cause irritation
Preparation contains sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Discontinue if signs of gastro-intestinal ulceration occur
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Female: May cause infertility
Advise patient to take after food to reduce gastro-intestinal disturbances

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Pregnancy and Lactation

Pregnancy

Ibuprofen is relatively contraindicated during the third trimester of pregnancy.

Schaefer (2007) suggests that ibuprofen may be considered in the first two trimesters if NSAID therapy is indicated.

If treatment is unavoidable from week 28 onward monitor foetal circulation.

There is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.

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 ).

Lactation

Use ibuprofen with caution during breastfeeding.

Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breast-fed infant adversely. Because of its extremely low levels in breast milk and short half-life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers.

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
Aggravation of existing asthma
Agranulocytosis
Anaemia
Anaphylaxis
Angioedema
Arterial thrombosis
Aseptic meningitis
Asthma
Bleeding
Bronchospasm
Bruising
Bullous dermatoses
Cardiac failure
Constipation
Decreased urea excretion
Diarrhoea
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of Crohn's disease
Exfoliative dermatitis
Exhaustion
Facial swelling
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Haematemesis
Headache
Hepatic disorders
Hypertension
Hypotension
Influenza-like symptoms
Laryngeal swelling
Leucopenia
Melaena
Mouth ulcers
Nausea
Non-specific allergic reactions
Oedema
Pancytopenia
Papillary necrosis
Peptic ulceration
Pruritus
Rash
Renal failure
Serum urea increased
Shock
Sore throat
Stevens-Johnson syndrome
Tachycardia
Thrombocytopenia
Tongue swelling
Ulcerative colitis
Ulcerative stomatitis
Urticaria
Vomiting

Presentation

Tablets containing ibuprofen sodium dihydrate

Drugs List

Therapeutic Indications

Uses

Ankylosing spondylitis
Fever
Musculo-skeletal conditions
Osteoarthritis
Pain - mild to moderate
Rheumatoid arthritis

For the symptomatic relief of mild to moderate pain, such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, non-serious arthritic pain, migraine, cold and flu symptoms, sore throat and fever.

Dosage

256 mg ibuprofen sodium dihydrate is equivalent to 200 mg ibuprofen free acid.
512 mg ibuprofen sodium dihydrate is equivalent to 400 mg ibuprofen free acid.

Adults

Elderly

Children

Contraindications

Children under 12 years
Gastrointestinal haemorrhage
Gastrointestinal perforation
Hereditary fructose intolerance
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
New York Heart Association class IV failure
Peptic ulcer
Severe hepatic impairment
Severe renal impairment
Sucrase-isomaltase insufficiency
Third trimester of pregnancy

Precautions and Warnings

Elderly
Females attempting to conceive
Restricted sodium intake
Risk factors for cardiovascular disorder
Asthma
Breastfeeding
Cardiac impairment
Cerebrovascular disorder
Connective tissue disorder
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of cardiac failure
Hypertension
Ischaemic heart disease
New York Heart Association class II failure
Peripheral arterial circulatory disorder
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus

May precipitate bronchospasm in patients with asthma or allergy
Sodium content of formulation may be significant
High dose increases cardiovascular risk
Contains propylene glycol: may cause irritation
Preparation contains sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Discontinue if signs of gastro-intestinal ulceration occur
Risk of gastro-intestinal bleeding increased in the elderly
Severe gastro-intestinal side effects may occur without warning
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Female: May cause infertility
Advise patient to take after food to reduce gastro-intestinal disturbances

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Pregnancy and Lactation

Pregnancy

Ibuprofen is relatively contraindicated during the third trimester of pregnancy.

Schaefer (2007) suggests that ibuprofen may be considered in the first two trimesters if NSAID therapy is indicated.

If treatment is unavoidable from week 28 onward monitor foetal circulation.

There is a risk of premature closure of foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.

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 ).

Lactation

Use ibuprofen with caution during breastfeeding.

Ibuprofen appears in breast milk in very low concentrations and unlikely to affect the breast-fed infant adversely. Because of its extremely low levels in breast milk and short half-life ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers.

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
Aggravation of existing asthma
Agranulocytosis
Anaemia
Anaphylaxis
Angioedema
Arterial thrombosis
Aseptic meningitis
Asthma
Bleeding
Bronchospasm
Bruising
Bullous dermatoses
Cardiac failure
Constipation
Decreased urea excretion
Diarrhoea
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of Crohn's disease
Exfoliative dermatitis
Exhaustion
Facial swelling
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Haematemesis
Headache
Hepatic disorders
Hypertension
Hypotension
Influenza-like symptoms
Laryngeal swelling
Leucopenia
Melaena
Mouth ulcers
Nausea
Non-specific allergic reactions
Oedema
Pancytopenia
Papillary necrosis
Peptic ulceration
Pruritus
Rash
Renal failure
Serum urea increased
Shock
Sore throat
Stevens-Johnson syndrome
Tachycardia
Thrombocytopenia
Tongue swelling
Ulcerative colitis
Ulcerative stomatitis
Urticaria
Vomiting

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: February 2016

Reference Sources

Summary of Product Characteristics: Nurofen Express 256mg Caplets (GSL). Reckitt Benckiser (UK) Ltd. Revised November 2015.
Summary of Product Characteristics: Nurofen Express 256mg Tablets. Reckitt Benckiser (UK) Ltd. Revised June 2015.

Summary of Product Characteristics: Nurofen Joint & Back Pain Relief 256mg Tablets. Reckitt Benckiser (UK) Ltd. Revised December 2015.
Summary of Product Characteristics: Nurofen Joint & Back Pain Relief Caplets 256mg Tablets. Reckitt Benckiser (UK) Ltd. Revised December 2015.
Summary of Product Characteristics: Nurofen Max Strength Joint & Back Pain Relief 512mg Tablets. Reckitt Benckiser (UK) Ltd. Revised December 2015.