Ibuprofen and pseudoephedrine oral formulation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation of ibuprofen with pseudoephedrine hydrochloride.
Drugs List
Therapeutic Indications
Uses
Influenza - treatment of symptoms
Nasal congestion
Sinus congestion
Symptoms of common cold
Dosage
Adults
1 or 2 tablets three times a day when required. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.
Some manufacturers recommend 1 or 2 tablets every 6 hours when required. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.
Children
Children aged 15 to 18 years:
1 or 2 tablets three times a day when required. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.
Some manufacturers recommend 1 or 2 tablets every 6 hours when required. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.
Children aged 12 to 14 years:
1 or 2 tablets three times a day when required. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period.
Contraindications
Children under 12 years
Within 2 weeks of discontinuing MAOIs
Angina
Asthma, urticaria or acute rhinitis associated with NSAIDS
Benign prostatic hyperplasia
Breastfeeding
Diabetes mellitus
Gastrointestinal haemorrhage
Gastrointestinal perforation
Haematopoietic disorders
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
History of seizures
Hypertension
Hyperthyroidism
Narrow angle glaucoma
New York Heart Association class IV failure
Peptic ulcer
Phaeochromocytoma
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment
Tachycardia
Third trimester of pregnancy
Precautions and Warnings
Children 12 to 15 years
Elderly
Risk factors for cardiovascular disorder
Asthma
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Haemorrhagic stroke
Hepatic impairment
History of asthma
History of cardiac disorder
History of cardiac failure
History of colitis
History of gastrointestinal disorder
History of myocardial infarction
New York Heart Association class II failure
New York Heart Association class III failure
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis
NSAIDs may provoke or exacerbate asthma
Not all available brands are licensed for all age groups
Discontinue if signs of gastro-intestinal bleeding occur
If visual disturbances occur, perform ophthalmic evaluation
Increased risk of CNS toxicity in the elderly
Risk of gastro-intestinal bleeding increased in the elderly
Discontinue if symptoms of peptic ulcer occur
Discontinue treatment if skin rash or other allergic reaction occurs
Maintain treatment at the lowest effective dose
Female: Reduced fertility (reversible) possible with long term use
Advise patient to consult physician if condition worsens / does not improve
Pregnancy and Lactation
Pregnancy
Ibuprofen with pseudoephedrine hydrochloride is contraindicated during the 3rd trimester of pregnancy but may be used with caution during the 2nd and 3rd trimester.
Use of ibuprofen with pseudoephedrine hydrochloride is contraindicated during the 3rd trimester by the manufacturer. The manufacturer advises if possible, to avoid use during the 1st and 2nd trimester.
During the 3rd trimester, Ibuprofen is contraindicated as there is a risk of premature closure of foetal ductus arteriosus (with possible persistent pulmonary hypertension) and foetal renal impairment (which may progress to renal failure). The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.
Lactation
Ibuprofen with pseudoephedrine is contraindicated during breastfeeding.
The manufacturer advises avoiding use during breastfeeding.
Ibuprofen is present in breast milk in very low concentrations and is a prefered choice as analgesic or anti-inflammatory agent in nursing mothers (LactMed 2015). Pseudoephedrine is present in significant amounts in breast milk and has the potential for cardiovascular and neurological effects in the nursing infant. LactMed (2015) suggests pseudoephedrine excreted in breast milk is unlikely to harm the infant, but may cause occasional irritability. Some data suggests that it may inhibit milk production significantly, and repeated use may interfere with lactation. It is therefore not recommended for use in cases where lactation is not yet well established or where mothers are having difficulties producing sufficient milk.
Side Effects
Abdominal pain
Acute generalised exanthematous pustulosis
Acute renal failure (reversible)
Aggravation of existing asthma
Allergic reaction
Anaphylaxis
Angioedema
Anxiety
Aseptic meningitis
Asthma
Bronchospasm
Bullous dermatoses
Cardiac failure
Chest pain
Constipation
Decreased appetite
Depression
Diarrhoea
Difficulty in micturition
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of colitis
Exacerbation of Crohn's disease
Excitability
Exfoliative dermatitis
Facial swelling
Flatulence
Fluid retention
Gastritis
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Gastrointestinal intolerance
Haematemesis
Haematuria
Hallucinations
Headache
Hepatic impairment
Hypersensitivity reactions
Hypertension
Hypotension
Insomnia
Laryngeal swelling
Melaena
Mouth ulcers
Muscle weakness
Nausea
Oedema
Palpitations
Pancreatitis
Papillary necrosis
Peptic ulceration
Precordial pain
Pruritus
Purpura
Rash
Restlessness
Shock
Sleep disturbances
Stevens-Johnson syndrome
Sweating
Tachycardia
Thirst
Thrombocytopenia
Tinnitus
Tongue swelling
Tremor
Ulcerative stomatitis
Urinary retention
Urticaria
Vertigo
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: April 2019
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 and Flu Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised May 2018.
Summary of Product Characteristics: Nurofen Sinus Pressure & Headache Relief Tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised November 2018.
Summary of Product Characteristics: Sudafed Sinus Pressure & Pain Tablets. McNeil Products Limited. Revised September 2018.
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: 31 October 2018
Last accessed: 29 April 2019
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
Pseudoephedrine Last revised: 31 October 2018
Last accessed: 29 April 2019
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.