Flurbiprofene 0.25% spray solution - irritation and inflammation of the oropharyngeal cavity 15 ml

Product Description

Spray Solution

Composition:

FLURBIPROFENE EG 0.25% Spray for oral mucosa 100 ml of solution contain: flurbiprofen 0.25 g. Excipients: ethanol 8.64 g, methyl parahydroxybenzoate 0.10 g, propyl parahydroxybenzoate 0.02 g, hydrogenated castor oil -40 polyoxyethylened 2.00 g, patent blue V colouring (E131) 0.0006 g.

Excipients

FLURBIPROFENE EG 0.25% Spray for oral mucosa: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil -40 polyoxyethylened, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavouring, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Indications Therapeutic Uses

Symptomatic treatment of irritative-inflammatory conditions, including those associated with oropharyngeal pain (e.g., gingivitis, stomatitis, pharyngitis), including as a result of conservative or extractive dental therapy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, urticaria, or allergic-type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs. Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. Flurbiprofen should not be used by patients with active or a history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure. Third trimester of pregnancy.

Dosage

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. The recommended dose is 2 sprays 3 times a day directed directly at the affected area.

Warnings and precautions

At the recommended doses, swallowing FLURBIPROFENE EG 0.25% Spray for the oral mucosa does not cause any harm to the patient as these doses are much lower than those of the single dosage of the product for systemic administration. During the first and second trimester of pregnancy, flurbiprofen should not be administered unless strictly necessary. The administration of flurbiprofen is not recommended for breastfeeding mothers. The use of FLURBIPROFENE EG 0.25% Spray for the oral mucosa, especially if prolonged, may give rise to sensitization or local irritation. In such cases, treatment should be discontinued and a doctor should be consulted to institute, if necessary, appropriate therapy. Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor.

Important information about some of the excipients

The oromucosal spray contains parahydroxybenzoates which may cause allergic reactions (possibly delayed). The colouring agent patent blue V (E131) may cause allergic reactions. Hydrogenated castor oil 40 polyoxyethylene may cause localized skin reactions. It contains a small amount of ethyl alcohol, less than 100 mg per dose.

Interactions

At the recommended doses, no interactions with other medicinal products or other types of drugs have been reported. In any case, inform your doctor if you are taking other medicines.

Side effects

The following side effects have been reported, particularly after the administration of systemic formulations. Blood and lymphatic system disorders: Thrombocytopenia, aplastic anemia, and agranulocytosis. Immune system disorders: Anaphylaxis, angioedema, allergic reaction. Psychiatric disorders: Depression. Nervous system disorders: Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue, and somnolence. Acoustic and labyrinth disorders: Tinnitus. Cardiovascular disorders: Edema, hypertension, and heart failure. Clinical studies and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Respiratory, thoracic, and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, and dyspnea). Gastrointestinal Disorders: The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage, and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen (see Contraindications section). Less frequently, gastritis, peptic ulcer, perforation, and ulcer haemorrhage have been observed. Local irritation may occur with suppositories. Pancreatitis has been reported very rarely. Skin and Subcutaneous Tissue Disorders: Skin disorders including rash, pruritus, urticaria, purpura, angioedema, and very rarely, bullous dermatoses (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema multiforme). During clinical trials with flurbiprofen patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, eruptions, numbness, and tingling), however, the incidence was low (4.6%). Renal and urinary disorders: Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, flurbiprofen should not be administered unless clearly necessary. If flurbiprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension), • renal dysfunction, which may progress to renal failure with oligo-hydroamniosis, the mother and the newborn, at the end of pregnancy, to: • possible prolongation of bleeding time, an antiplatelet effect that may occur even at very low doses, • inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.

Breastfeeding: Flurbiprofen is excreted in breast milk, however the amount excreted is only a small fraction of the maternal dose. Administration of flurbiprofen is not recommended in nursing mothers.