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Drugs List
Therapeutic Indications
Dosage
Administration
Contraindications
Precautions and Warnings
Pregnancy and Lactation
Side Effects
Monograph

Precautions and Warnings

Start treatment at lowest recommended dose. Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration.

Elderly patients are at increased risk of the serious consequences of adverse reactions, especially gastro-intestinal bleeding and perforation which may be fatal.

Caution is required in patients with renal, cardiac or hepatic impairment. Renal function should be monitored in patients with renal impairment since it may deteriorate following the use of any NSAID.

Bronchospasm may be precipitated in patients suffering from, or with previous history of bronchial asthma or allergic disease.

Caution is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Avoid high dose ibuprofen in patients with cardiovascular disorders or risk factors for cardiovascular events.

In patients with existing auto-immune disorders, such as systemic lupus erythematosus and mixed connective tissue disease, single cases of symptoms of aseptic meningitis have been observed.

Gastrointestinal disorders and chronic inflammatory intestinal disease may be exacerbated.

Gastrointestinal bleeding, ulceration or perforation can occur at any time during treatment with or without warning symptoms or a previous history of serious gastrointestinal events.

GI effects such as GI bleeding, ulceration or perforation, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or previous history of serious GI effects. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms particularly in the initial stages of treatment.

If gastrointestinal bleeding or ulceration occur, withdraw treatment immediately.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely 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 within the first month of treatment in the majority of cases. Ibuprofen lysine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

May cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Pregnancy - see Pregnancy .

Lactation - see Lactation .

The ability to drive or operate machinery may be affected by side effects such as tiredness and dizziness.

Some formulations contain sucrose. Use with caution in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome.

Pregnancy and Lactation

Pregnancy

Ibuprofen lysine is contraindicated during the 3rd trimester of pregnancy and should be used with caution in the first 2 trimesters.

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen during the first and second trimesters should, if possible, be avoided. NSAIDs have been associated with spontaneous abortions and congenital abnormalities. During the 3rd trimester, Ibuprofen lysine is contraindicated as 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. 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 lysine is therefore not recommended in women attempting to conceive (Briggs, 2011).

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 ).

Licensed in pregnancy? - No. Contraindicated during third trimester.

Recommended for use in pregnancy? - No

Pregnancy-specific adverse effects on the mother - The onset of labour may be delayed and the duration increased with an increased bleeding tendency

Other information - The use of Ibuprofen lysine is therefore not recommended in women attempting to conceive as there is limited evidence that drugs which inhibit cyclooxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation.

Lactation

Use with caution during breast feeding.

At the time of writing there are is limited published experience concerning the use of Ibuprofen lysine during breast feeding. 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

Drug excreted in breast milk? - Yes in low levels

Considered suitable or recommended by manufacturer? - Yes

Presentation

Tablets containing 342mg ibuprofen lysine (equivalent to 200mg ibuprofen).

Tablets containing 684mg ibuprofen lysine (equivalent to 400mg ibuprofen).

Soluble oral powder containing 400mg ibuprofen (as ibuprofen lysinate).

Drugs List

FEMINAX EXPRESS 342mg tablets

ibuprofen lysine 342mg tablets

ibuprofen lysine 684mg tablets

NUROFEN EXPRESS 684mg caplets

NUROFEN MAXIMUM STRENGTH MIGRAINE PAIN 684mg caplets

NUROFEN MIGRAINE PAIN tablets

Therapeutic Indications

Uses

Rheumatic or muscular pain, backache, neuralgia, dental pain, and dysmenorrhoea

Migraine and headache

Symptomatic relief of cold and flu symptoms

Not all brands are licensed for all indications.

Dosage

Adults

Tablet formulation
Initially 200mg to 400mg ibuprofen.
Followed by 200mg or 400mg every four hours if necessary to a maximum total dose of 1200mg in 24 hours.

Soluble oral powder formulation
Initially 400mg ibuprofen.
Followed by 400mg every four hours if necessary to a maximum total dose of 1200mg in 24 hours.

Elderly

No special dosage modifications are required. It is recommended to monitor the elderly carefully.

Children

Children over 12
See Dosage-Adult.

Children under 12
Contraindicated in children under 12 years.

Patients with Renal Impairment

Use with caution in patients with mild to moderate renal impairment. Monitor renal function since it may deteriorate following the use of any NSAID.

Contraindicated in severe renal impairment.

Patients with Hepatic Impairment

Use with caution in patients with mild to moderate hepatic impairment.

Contraindicated in severe hepatic impairment.

Additional Dosage Information

The minimum effective dose should be used for the shortest time necessary to relieve symptoms.

The patient should consult a doctor if symptoms persist or worsen, or if ibuprofen is required for more than 5 days when treating pain and 3 days when treating fever.

Administration

Tablet formulation
For oral administration. To be taken with water with or after food.

Soluble oral powder
Dissolve the contents of the sachet in a glass of water, stir, and drink immediately.

Contraindications

Active peptic ulcer
History of peptic ulcer
History of gastro-intestinal bleeding or perforation
Third trimester of pregnancy
Severe heart failure
Severe renal impairment
Severe hepatic impairment
Severe dehydration
Cerebrovascular or other active bleeding
Coagulation disorders or bleeding diathesis
Children under 12 years