Drugs List

Therapeutic Indications

Uses

Congestive symptoms associated with colds
Influenza - treatment of symptoms

Contraindications

Children under 12 years
Predisposition to haemorrhage
Within 2 weeks of discontinuing MAOIs
Benign prostatic hyperplasia
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of gastrointestinal bleeding
History of peptic ulcer
Hypertension
Hyperthyroidism
Peptic ulcer
Phaeochromocytoma
Pregnancy
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Allergic disposition
Elderly
Asthma
Breastfeeding
Cardiovascular disorder
Cerebrovascular disorder
Coagulopathy
Connective tissue disorder
Crohn's disease
Diabetes mellitus
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of asthma
History of cardiac disorder
History of gastrointestinal disorder
Narrow angle glaucoma
Peripheral arterial circulatory disorder
Renal impairment
Systemic lupus erythematosus
Ulcerative colitis

May precipitate bronchospasm in patients with asthma or allergy
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Discontinue if signs of gastro-intestinal ulceration occur
May prolong bleeding time
Discontinue if severe skin reaction occurs
Maintain treatment at the lowest effective dose
Female: Reduced fertility (reversible) possible with long term use
Advise patient not to exceed stated dose
Refer to doctor if symptoms persist after 10 days treatment

The inhibition of renal prostaglandin synthesis by NSAIDs may interfere with renal function, especially in the presence of renal disease. A deterioration in renal function could possible lead to renal failure. Avoid NSAID therapy if possible. If not, check serum creatinine 48 to 72 hours after initiating treatment and discontinue if levels are raised.

Patients with mixed connective tissue disorders such as systemic lupus erythematosus may be especially susceptible to aseptic meningitis. This has also been reported in patients with no underlying chronic disease.

Use with caution in patients with coagulopathies as NSAIDs including ibuprofen can interfere with platelet aggregation and can prolong bleeding time.

There is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of ibuprofen is therefore not recommended in women attempting to conceive (Briggs, 2015).

MHRA/CHM advice (March 2008)
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.

Pregnancy and Lactation

Pregnancy

The combination of ibuprofen with phenylephrine hydrochloride is contraindicated in 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.

Phenylephrine is contraindicated during all trimesters of pregnancy as phenylephrine may promote uterine contraction and peripheral vasoconstriction, with the possibility of foetal hypoxia.

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 the combination of ibuprofen with phenylephrine hydrochloride 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.

No data is available on phenylephrine's secretion into human milk but it is considered likely that small amounts will probably be transferred. The effects of this exposure are unknown.

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
Anaemia
Anaphylaxis
Angioedema
Aseptic meningitis
Asthma
Bleeding
Bronchospasm
Bruising
Bullous reactions
Constipation
Diarrhoea
Disorientation
Dizziness
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Exhaustion
Facial swelling
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Haematemesis
Haemolytic anaemia
Headache
Hepatic failure
Hypersensitivity reactions
Hypertension
Hypotension
Influenza-like symptoms
Laryngeal swelling
Leucopenia
Melaena
Mouth ulcers
Myocardial infarction
Nausea
Neck stiffness
Oedema
Palpitations
Pancytopenia
Papillary necrosis
Peptic ulceration
Pruritus
Rash
Renal failure
Shock
Sore throat
Stevens-Johnson syndrome
Stroke
Tachycardia
Thrombocytopenia
Tinnitus
Tongue swelling
Toxic epidermal necrolysis
Ulcerative stomatitis
Urinary retention
Urticaria
Vomiting

Presentation

Oral formulations of ibuprofen and phenylephrine hydrochloride

Drugs List

Therapeutic Indications

Uses

Congestive symptoms associated with colds
Influenza - treatment of symptoms

Dosage

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

Adults

Children

Patients with Renal Impairment

Contraindications

Children under 12 years
Predisposition to haemorrhage
Within 2 weeks of discontinuing MAOIs
Benign prostatic hyperplasia
Gastrointestinal haemorrhage
Gastrointestinal perforation
History of gastrointestinal bleeding
History of peptic ulcer
Hypertension
Hyperthyroidism
Peptic ulcer
Phaeochromocytoma
Pregnancy
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment

Precautions and Warnings

Allergic disposition
Elderly
Asthma
Breastfeeding
Cardiovascular disorder
Cerebrovascular disorder
Coagulopathy
Connective tissue disorder
Crohn's disease
Diabetes mellitus
Gastrointestinal disorder
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of asthma
History of cardiac disorder
History of gastrointestinal disorder
Narrow angle glaucoma
Peripheral arterial circulatory disorder
Renal impairment
Systemic lupus erythematosus
Ulcerative colitis

May precipitate bronchospasm in patients with asthma or allergy
Advise ability to drive/operate machinery may be affected by side effects
Some formulations contain sucrose
Discontinue if signs of gastro-intestinal bleeding occur
Advise patients to report signs or symptoms of gastro-intestinal ulcer
Discontinue if signs of gastro-intestinal ulceration occur
May prolong bleeding time
Discontinue if severe skin reaction occurs
Maintain treatment at the lowest effective dose
Female: Reduced fertility (reversible) possible with long term use
Advise patient not to exceed stated dose
Refer to doctor if symptoms persist after 10 days treatment

The inhibition of renal prostaglandin synthesis by NSAIDs may interfere with renal function, especially in the presence of renal disease. A deterioration in renal function could possible lead to renal failure. Avoid NSAID therapy if possible. If not, check serum creatinine 48 to 72 hours after initiating treatment and discontinue if levels are raised.

Patients with mixed connective tissue disorders such as systemic lupus erythematosus may be especially susceptible to aseptic meningitis. This has also been reported in patients with no underlying chronic disease.

Use with caution in patients with coagulopathies as NSAIDs including ibuprofen can interfere with platelet aggregation and can prolong bleeding time.

There is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. The use of ibuprofen is therefore not recommended in women attempting to conceive (Briggs, 2015).

MHRA/CHM advice (March 2008)
Children should not be given more than one cough or cold preparation at a time because different brands may contain the same active ingredient; care should be taken to give the correct dose.

Pregnancy and Lactation

Pregnancy

The combination of ibuprofen with phenylephrine hydrochloride is contraindicated in 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.

Phenylephrine is contraindicated during all trimesters of pregnancy as phenylephrine may promote uterine contraction and peripheral vasoconstriction, with the possibility of foetal hypoxia.

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 the combination of ibuprofen with phenylephrine hydrochloride 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.

No data is available on phenylephrine's secretion into human milk but it is considered likely that small amounts will probably be transferred. The effects of this exposure are unknown.

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
Anaemia
Anaphylaxis
Angioedema
Aseptic meningitis
Asthma
Bleeding
Bronchospasm
Bruising
Bullous reactions
Constipation
Diarrhoea
Disorientation
Dizziness
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Exfoliative dermatitis
Exhaustion
Facial swelling
Fever
Flatulence
Gastritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Haematemesis
Haemolytic anaemia
Headache
Hepatic failure
Hypersensitivity reactions
Hypertension
Hypotension
Influenza-like symptoms
Laryngeal swelling
Leucopenia
Melaena
Mouth ulcers
Myocardial infarction
Nausea
Neck stiffness
Oedema
Palpitations
Pancytopenia
Papillary necrosis
Peptic ulceration
Pruritus
Rash
Renal failure
Shock
Sore throat
Stevens-Johnson syndrome
Stroke
Tachycardia
Thrombocytopenia
Tinnitus
Tongue swelling
Toxic epidermal necrolysis
Ulcerative stomatitis
Urinary retention
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: November 2017.

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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

Summary of Product Characteristics: Nurofen Cold & Flu Relief 200mg/5mg Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised November 2021.

Summary of Product Characteristics: Nurofen Day & Night Cold & Flu 200mg/5mg Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised January 2016.

Summary of Product Characteristics: Nurofen Sinus & Blocked Nose 200mg/5mg Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised January 2016.

Summary of Product Characteristics: Nurofen Sinus Pain Relief 200mg/5mg Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised January 2016.

Summary of Product Characteristics: Sudafed Sinus Pain Relief 200mg/6.1mg Tablets. Galpharm Healthcare Limited. Revised February 2017.

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ibuprofen. Last revised: 04 February 2016
Last accessed: 22 November 2017