Flurbiprofen oromucosal
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral lozenges containing flurbiprofen
Drugs List
Therapeutic Indications
Uses
Relief of sore throat
Dosage
It is recommended that this medication should be used for a maximum of three days.
Adults
One lozenge to be sucked or dissolved slowly in the mouth every three to six hours as required. Maximum five lozenges in a 24 hour period.
Elderly
One lozenge to be sucked or dissolved slowly in the mouth every three to six hours as required. Maximum five lozenges in a 24 hour period.
Children
Children over 12 years
One lozenge to be sucked or dissolved slowly in the mouth every three to six hours as required. Maximum five lozenges in a 24 hour period.
Patients with Renal Impairment
Use with caution.
NSAIDs have been reported to cause nephrotoxicity in various forms. In patients with renal impairment, the use of NSAIDs such as flurbiprofen lozenges may result in the deterioration of renal function.
Patients with Hepatic Impairment
Use with caution.
In patients with hepatic impairment, the use of NSAIDs such as flurbiprofen lozenges may result in the deterioration of renal function.
Additional Dosage Information
To avoid local irritation, flurbiprofen lozenges should be moved around the mouth whilst sucking.
Contraindications
Children under 12 years
Predisposition to haemorrhage
Hereditary fructose intolerance
History of gastrointestinal bleeding
History of gastrointestinal perforation
History of peptic ulcer
Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
Peptic ulcer
Severe cardiac failure
Severe hepatic impairment
Severe renal impairment
Third trimester of pregnancy
Precautions and Warnings
Allergic disposition
Elderly
Asthma
Breastfeeding
Cardiac failure
Connective tissue disorder
Crohn's disease
First trimester of pregnancy
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of asthma
History of bronchospasm
History of cardiac failure
History of coagulopathy
History of gastrointestinal disorder
History of urticaria
Hypertension
Renal impairment
Second trimester of pregnancy
Systemic lupus erythematosus
Ulcerative colitis
NSAIDs may provoke or exacerbate asthma
Contains glucose
Preparation contains sucrose
The lozenge should be moved around the mouth whilst sucking
Discontinue if signs of gastro-intestinal bleeding occur
May cause bronchospasm
Discontinue if rash with systemic, allergic or mucosal symptoms occurs
Discontinue if symptoms of peptic ulcer occur
Start treatment at lowest recommended dose
Advise patients to avoid aspirin and NSAID use
Consult doctor if symptoms persist or treatment is required for > 3 days
Pregnancy and Lactation
Pregnancy
Flurbiprofen is contraindicated in the last trimester of pregnancy and should be used with caution in the first two trimesters of pregnancy.
Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) that shares the same precautions for human pregnancy use as other NSAIDs. No teratogenic effects were observed in mice, rats and rabbits administered this drug during gestation.
Like other NSAIDs, systemic use of flurbiprofen in rats has been associated with prolonged gestations, foetal growth retardation, and decreased foetal survival. In one study of pregnant rats, flurbiprofen inhibition of parturition appeared to be dose-related.
No reports describing the use of flurbiprofen during human pregnancy have been located. Flurbiprofen has a short plasma elimination half-life (5.7 hours) but other factors, such as its toxicity profile, need to be considered.
Regular use of NSAIDs during the third trimester of pregnancy may result in the premature closure of the foetal ductus arteriosus in utero and persistent pulmonary hypertension of the newborn and may cause prolonged gestation, dystocia and delayed parturition.
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 flurbiprofen with caution in breastfeeding.
Flurbiprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.
The small amounts of flurbiprofen recovered from transitional and mature breast milk seem to indicate that the risk posed by flurbiprofen to a nursing infant is slight, if it exists at all.
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
Acute renal failure (reversible)
Agranulocytosis
Allergic reaction
Anaphylaxis
Angioedema
Aplastic anaemia
Arterial thrombosis
Aseptic meningitis
Asthma
Blood disorders
Bronchospasm
Buccal irritation
Bullous reactions
Cardiac failure
Colitis
Constipation
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Epidermal necrolysis
Erythema multiforme
Exacerbation of pre-existing asthma
Flatulence
Fluid retention
Gastritis
Gastro-intestinal ulceration and bleeding
Haematemesis
Haematuria
Headache
Hearing disturbances
Hepatic impairment
Hypersensitivity reactions
Hypertension
Melaena
Mouth ulcers
Myocardial infarction
Nausea
Oedema
Papillary necrosis
Peptic ulceration
Pruritus
Rash
Stevens-Johnson syndrome
Stroke
Taste disturbances
Thrombocytopenia
Tinnitus
Ulcerative stomatitis
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: February 2016
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Paediatric Formulary Committee. BNF for Children 2015-2016. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2015.
Summary of Product Characteristics: Strefen Honey and Lemon lozenge. Reckitt Benckiser Healthcare (UK) Ltd. Revised November 2014.
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