Strepsils Max Pro

Strepsils Max Pro

flurbiprofen

Manufacturer:

RB (Health)

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Flurbiprofen.
Description
Each lozenge also contains the following excipients: Macrogol 300, potassium hydroxide, lemon flavour, levomenthol, liquid sucrose, liquid glucose, honey.
Action
Pharmacotherapeutic Group: Flurbiprofen. ATC Code: M01AE09.
Pharmacology: Pharmacodynamics: Flurbiprofen is a nonsteroidal anti-inflammatory drug which has potent analgesic, antipyretic and anti-inflammatory properties which are thought to result from the drug's ability to inhibit prostaglandins synthesis.
The onset of pain relief, reduction in throat soreness and reduction in throat swelling was observed 30 mins after taking a lozenge and duration of action extended 2-3 hrs.
Pharmacokinetics: Flurbiprofen is rapidly absorbed following the use of Strepsils Max Pro with plasma concentrations peaking at 30-40 min. Peak concentrations are achieved more rapidly than, but are if similar magnitude to, those achieved after an equivalent swallowed dose.
Flurbiprofen is rapidly distributed throughout the body. It is mainly metabolized by hydroxylation and excreted via the kidneys. It is extensively bound to plasma proteins and has an elimination half-life of 3-6 hrs. Flurbiprofen is excreted in very small amounts in human milk (<0.05 mcg/mL).
Toxicology: Preclinical Safety Data: In rats exposed to ≥0.4 mg/kg/day during pregnancy, an increased incidence of stillborn pregnancy has been observed. However, the relevance of this fact to humans is doubtful and not reflected in human experience with flurbiprofen so far.
Indications/Uses
Indicated for the symptomatic relief of sore throat.
Dosage/Direction for Use
Adults, Elderly and Children >12 years: 1 loz sucked/dissolved slowly in the mouth every 3-6 hrs as required.
Maximum: 5 lozenges in a 24-hr period.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a physician if symptoms persist or worsen, or if Strepsils Max Pro is required for >3 days.
It is recommended that Strepsils Max Pro should be used for a maximum of 3 days.
Overdosage
Symptoms: Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
Treatment: Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hr of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with IV diazepam or lorazepam. Give bronchodilators for asthma.
Contraindications
Hypersensitivity to flurbiprofen, aspirin, other NSAIDs, or to any of the excipients of Strepsils Max Pro.
Patients who have previously shown hypersensitivity reactions (eg, bronchospasm, asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other NSAIDs.
Existing or history of peptic ulcerations/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Severe heart failure, renal failure or hepatic failure (see Precautions).
Use in pregnancy: While no teratogenic effects have been demonstrated in animal experiments, the use of Strepsils Max Pro, if possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, flurbiprofen is contraindicated as there is a risk of premature closure of the 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.
Special Precautions
Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see texts on Gastrointestinal and Cardiovascular and Cerebrovascular Effects as follows).
The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Respiratory: Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
Other Nonsteroidal Anti-Inflammatory Drugs: The use of Strepsils Max Pro with concomitant NSAIDS including cyclooxygenase-2 selective inhibitors should be avoided (see Interactions).
Systemic Lupus Erythematosus and Mixed Connective Tissue Disease: Systemic lupus erythematosus and mixed connective tissue disease may have increased risk of aseptic meningitis (see Adverse Reactions).
Renal: Renal impairment as renal function may further deteriorate (see Contraindication & Adverse Reactions).
Hepatic: Hepatic dysfunction (see Contraindication & Adverse Reactions).
Cardiovascular and Cerebrovascular Effects: Caution (discussion with physician or pharmacist) 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.
Clinical trial and epidemiological data suggest that the use of NSAIDs particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (eg, myocardial infarction or stroke).
All NSAIDs should be prescribed at the lowest effective dose and the duration of treatment should be periodically reviewed and kept as short as possible.
All NSAIDs should not be used perioperatively in patients who have recently undergone coronary artery bypass graft (CABG) surgery and revascularisation procedures.
Impaired Female Fertility: There is some 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.
Gastrointestinal: Nonsteroidal anti-inflammatory drugs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Adverse Reactions).
Gastrointestinal bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see Contraindication), and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants eg, warfarin, selective serotonin-reuptake inhibitors (SSRIs) or antiplatelet agents eg, aspirin (see Interactions).
When gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.
Dermatological: Serious skin reactions, some of them fatal eg, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Adverse Reactions). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the 1st month of treatment. Strepsils Max Pro should be discontinued at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Use in lactation: Flurbiprofen appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.
Use In Pregnancy & Lactation
Use in pregnancy: While no teratogenic effects have been demonstrated in animal experiments, the use of Strepsils Max Pro, if possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, flurbiprofen is contraindicated as there is a risk of premature closure of the 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.
Use in lactation: Flurbiprofen appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely.
Adverse Reactions
Strepsils Max Pro have the potential for inducing transient local irritation of the buccal mucosa. The most frequently reported adverse event in clinical trials was taste perversion.
Hypersensitivity reactions have been reported and these may consist of: Nonspecific allergic reactions and anaphylaxis; respiratory tract reactivity eg, asthma, aggravated asthma, bronchospasm, dyspnoea; various skin reactions eg, pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
The list of the following undesirable effects relates to those experienced with NSAIDs at doses available over-the-counter for short-term use. In the treatment of chronic conditions, under long-term treatment, additional undesirable effects may occur.
Hypersensitivity reactions:
Uncommon: Urticaria and pruritus. Very Rare: Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Uncommon: Abdominal pain, nausea, dyspepsia. Rare: Diarrhoea, flatulence, constipation and vomiting. Very Rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. Exacerbation of colitis and Crohn's disease (see Precautions).
Nervous System: Uncommon: Headache. Very Rare: Aseptic meningitis (single cases have been reported very rarely).
Renal: Very Rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum and oedema.
Hepatic: Very Rare: Liver disorders.
Haematological: Very Rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Dermatological: Uncommon: Various skin rashes. Very Rare: Severe forms of skin reactions (bullous reactions) eg, Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System: In patients with existing autoimmune disorders (eg, systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis eg, stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see Precautions).
Cardiovascular and Cerebrovascular: Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment.
Drug Interactions
Flurbiprofen should be avoided in combination with: Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a physician as this may increase the risk of undesirable effects (see Precautions).
Other NSAIDs including Ibuprofen and Cyclooxygenase-2 Selective Inhibitors: Avoid concomitant use of ≥2 NSAIDs as this may increase the risk of undesirable effects (see Precautions).
Flurbiprofen should be used with caution in combination with: Anticoagulants: NSAIDs may enhance the effects of anticoagulants eg, warfarin (see Precautions).
Antihypertensives and Diuretics: Since NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding. (see Precautions).
Antiplatelet Agents and Selective Serotonin Reuptake Inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see Precautions).
Cardiac Glycosides: Nonsteroidal anti-inflammatory drugs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Lithium: There is evidence for potential increase in plasma levels of lithium.
Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: Nonsteroidal anti-inflammatory drugs should not be used for 8-12 days after mifepristone administration, as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of hematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Quinolone Antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Storage
Store below 30°C.
Shelf-Life: 24 months.
ATC Classification
R02AX01 - flurbiprofen ; Belongs to the class of other throat preparations.
Presentation/Packing
Loz 8.75 mg (round, pale yellow to brown, with an icon intagliated on both sides) 16's.
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