Properties
What is it?
STREPSILS INTENSIVE Trade Name: STREPSILS® INTENSIVE International Nonproprietary Name (INN): Flurbiprofen Dosage Form: Metered-dose spray for topical use Composition 1 spray dose (3 actuations of the dispenser) contains: Active substance: Flurbiprofen 8.75mg Excipients: Betadex 22.83mg, Disodium phosphate dodecahydrate 17.19mg, Citric acid monohydrate 0.63mg, Methylparahydroxybenzoate 1.18mg, Propylparahydroxybenzoate 0.24mg, Sodium hydroxide 1.30mg, Mint flavour (PHL 175628) 1.08mg, Cherry flavour (PHL 175629) 1.35mg, N-2,3-trimethyl-2-isopropylbutanamide 0.54mg, Sodium saccharinate 0.27mg, Hydroxypropylbetadex 12.09mg, Water 492.55mg. See blog: Strepsils - preparation for the treatment of infectious-inflammatory diseases of the oral cavity and throat Description Clear, colorless to yellowish solution. Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID) Pharmacological Properties Pharmacodynamics Flurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) that is a propionic acid derivative. Flurbiprofen has analgesic, anti-inflammatory, and antipyretic effects due to the inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) with a selective dependence on COX-1, followed by a decrease in the production of prostaglandins, which are mediators of pain, inflammation, and hyperthermic reactions. When the drug is used in a single dose (3 actuations of the dispenser), a reduction in soreness and difficulty swallowing is observed within 5 minutes of administration, significant pain reduction within 20 minutes, and swelling reduction within 30 minutes. The analgesic and anti-swelling effect lasts for approximately 6 hours. Pharmacokinetics When a single dose of the drug is used (3 actuations of the dispenser) on the oral and pharyngeal mucosa, flurbiprofen is rapidly absorbed and enters the blood plasma within 2-5 minutes. The maximum concentration of flurbiprofen in blood plasma is reached 30 minutes after administration and is 1.6 mcg/ml, which is 4 times lower compared to oral administration of 50mg flurbiprofen. This drug rapidly binds to plasma proteins and is distributed throughout the body. Flurbiprofen is metabolized mainly by hydroxylation and is excreted by the kidneys, with a half-life (T1/2) of 3-6 hours. Approximately 20-25% of the oral dose of the drug is excreted unchanged by the kidneys. Indications As a symptomatic agent for the relief of sore throat in infectious-inflammatory diseases of the upper respiratory tract. Contraindications Hypersensitivity to flurbiprofen or any component of the preparation. History of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, angioedema, urticaria, recurrent nasal or perinasal polyposis) in response to acetylsalicylic acid or other NSAIDs. Erosive-ulcerative diseases of the gastrointestinal tract (including peptic ulcer disease of the stomach and duodenum), bleeding caused by ulcer in the active phase or in history (two or more confirmed episodes of ulcer disease or ulcer bleeding). Gastrointestinal bleeding or perforation from a gastrointestinal ulcer, active ulcerative colitis, hemorrhagic and hematopoietic disorders in history, provoked by the use of NSAIDs. Pregnancy (III trimester). Lactation. Children under 12 years of age. Severe hepatic insufficiency or active liver disease. Severe renal insufficiency (creatinine clearance < 30 ml/min). Decompensated heart failure. Period after aortocoronary bypass surgery. Confirmed hyperkalemia. Glucose-6-phosphate dehydrogenase deficiency. Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis. Precautions In the presence of the diseases and/or conditions indicated in this section, consult a doctor before using this preparation. Concomitant use with other NSAIDs, a single episode of gastric ulcer disease or bleeding caused by ulcer in history, gastrointestinal diseases in history (ulcerative colitis, Crohn's disease), gastritis, enteritis, colitis, Helicobacter pylori infection, bronchial asthma or allergic diseases in the exacerbation phase or in history (possible development of bronchospasm), systemic lupus erythematosus and other systemic autoimmune diseases of connective tissue (increased risk of developing aseptic meningitis) - the risk is insignificant with short-term use of flurbiprofen, arterial hypertension and/or heart failure, edema, renal insufficiency, including dehydration (creatinine clearance < 60 ml/min), nephrotic syndrome, hepatic insufficiency, liver cirrhosis with portal hypertension, hyperbilirubinemia (the risk is insignificant with short-term use of flurbiprofen), concomitant use of medicinal products that can increase the risk of ulcer or bleeding, mainly oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), alcoholism, pregnancy (I-II trimester), elderly age. Use during pregnancy and lactation Use of the preparation is contraindicated in the III trimester of pregnancy. Flurbiprofen should be avoided during the I-II trimester of pregnancy; if the preparation is necessary, consult a doctor. There is data that flurbiprofen can penetrate into breast milk without any negative consequences for the infant's health, however, due to possible side effects, the use of the preparation during breastfeeding is not recommended. Method of administration and dosage Read the instructions carefully before using the preparation. For topical use. For short-term use only. Adults and children over 12 years of age: Spray/aerosolize 1 dose of the preparation (3 actuations of the dispenser) onto the posterior wall of the oral cavity and pharynx every 3-6 hours, not more than 5 doses in 24 hours. Duration of therapy: Not more than 3 days. Do not inhale during spraying. Before the first use of the preparation, at least four actuations of the dispenser are necessary in the direction away from you to ensure even spraying. Before each subsequent use, at least one actuation of the dispenser is necessary in the direction away from you to ensure even spraying. Side effects The risk of side effects can be minimized if the preparation is used for short courses and at the minimum effective dose necessary to relieve symptoms. The side effects listed below were observed with short-term use of the preparation. Other side effects may occur with chronic conditions and long-term use of the preparation. The frequency of occurrence of side reactions was assessed based on the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), unknown (frequency data not available). Blood and lymphatic system disorders: Unknown frequency: anemia, thrombocytopenia. Nervous system disorders: Common: dizziness, headache, paresthesia. Uncommon: drowsiness. Immune system disorders: Common: anaphylactic reactions. Cardiac disorders: Unknown frequency: heart failure, edema. Vascular disorders: Unknown frequency: increased blood pressure. Respiratory, thoracic and mediastinal disorders: Common: sensation of irritation in the throat. Uncommon: exacerbation of bronchial asthma and bronchospasm, shortness of breath, wheezing, blisters in the oral cavity and pharynx, pharyngeal hypesthesia (reduced sensitivity in the oral cavity and pharynx). Gastrointestinal disorders: Common: diarrhea, oral ulceration, vomiting, pain in the oral cavity, paresthesia of the oral cavity, pain in the oral cavity and pharynx, discomfort in the oral cavity (sensation of heat, burning or tingling in the oral cavity). Uncommon: abdominal bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning syndrome in the oral cavity), dysgeusia (change in taste perception), oral dysesthesia, vomiting. Skin and subcutaneous tissue disorders: Uncommon: skin rash, itching. Unknown frequency: severe skin reactions, including bullous reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome). Hepatobiliary system disorders: Unknown frequency: hepatitis. Mental disorders: Uncommon: insomnia. Other: Uncommon: fever, pain. If side effects indicated in the instructions worsen or deepen, or if other side effects not indicated in the instructions occur, inform your doctor. Overdose Symptoms: Nausea, vomiting, epigastric pain, rarely diarrhea. Also possible tinnitus, headache, gastrointestinal bleeding. In more severe cases, the following manifestations of the central nervous system are observed: drowsiness, rarely: excitability, blurred vision, disorientation or coma. In patients, seizures occur in rare cases. In case of severe poisoning with NSAIDs, metabolic acidosis, increased prothrombin time, likely related to the effect on blood clotting factors, may develop. Acute renal failure and liver damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, this disease may worsen. Treatment: Symptomatic, ensuring airway patency, monitoring ECG and vital signs until the patient's condition normalizes. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour after ingestion of a potentially toxic dose of flurbiprofen. Frequent or prolonged seizures should be managed by administering diazepam or lorazepam. In case of exacerbation of bronchial asthma, bronchodilators are recommended. There is no specific antidote for flurbiprofen. Interaction with other medicinal products Avoid using the preparation with the following medicinal products: Acetylsalicylic acid: Concomitant use, except for low doses of acetylsalicylic acid (not more than 75 mg per day) prescribed by a doctor, may increase the risk of side effects. Other NSAIDs, including ibuprofen and selective cyclooxygenase-2 inhibitors: Avoid simultaneous use of two or more drugs from the NSAID group due to the increased risk of side effects. Use this preparation with caution with the following medicinal products: Anticoagulants: NSAIDs can enhance the effects of anticoagulants, including warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors: Increased risk of gastrointestinal bleeding. Hypotensive agents (except angiotensin-converting enzyme (ACE) inhibitors and angiotensin II inhibitors) and diuretics: NSAIDs can reduce the effectiveness of drugs in this group and may increase nephrotoxicity due to inhibition of cyclooxygenase, especially in patients with impaired renal function (adequate fluid intake should be ensured in such patients). Ethanol: May increase the risk of side effects, especially gastrointestinal bleeding. Cardiac glycosides: Concomitant use of NSAIDs and cardiac glycosides can exacerbate heart failure, reduce glomerular filtration rate, and increase the concentration of cardiac glycosides in blood plasma. Cyclosporine: Increased risk of nephrotoxicity. Glucocorticosteroids: Increased risk of ulcer development and gastrointestinal bleeding. Lithium preparations: There is evidence of a probability of increased lithium concentration in blood plasma with NSAID use. Methotrexate: There is evidence of a probability of increased methotrexate concentration in blood plasma with NSAID use. NSAIDs should be used 24 hours before or after taking methotrexate. Mifepristone: NSAIDs should be used at least 8-12 days after taking mifepristone, as NSAIDs can reduce the effectiveness of mifepristone. Quinolone antibiotics: In patients treated with NSAIDs and quinolone antibiotics, the risk of seizures may increase. Tacrolimus: When used with NSAIDs, the risk of nephrotoxicity may increase. Zidovudine: When used with NSAIDs, the risk of hematotoxicity may increase. Oral hypoglycemic agents: Changes in blood glucose concentration may occur (increased frequency of blood glucose concentration monitoring is recommended). Phenytoin: The concentration of phenytoin in blood serum may increase (monitoring of phenytoin concentration in blood serum and dose adjustment if necessary is recommended). Potassium-sparing diuretics: Concomitant use of potassium-sparing diuretics and flurbiprofen can cause hyperkalemia. Probenecid and sulfinpyrazone: Medicinal products containing probenecid or sulfinpyrazone may inhibit the excretion of flurbiprofen. Tolbutamide and antacids: Currently, studies have not revealed interactions between flurbiprofen, tolbutamide, or antacids. Special instructions It is recommended to take the preparation for the shortest possible course and using the minimum effective dose necessary to relieve symptoms. In case of symptoms of gastropathy, monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), and fecal occult blood test. If 17-ketosteroids need to be determined, the preparation should be discontinued 48 hours before the analysis. Patients with renal or hepatic insufficiency, elderly patients, and patients taking diuretics should consult a doctor before using this preparation, as there is a risk of worsening renal function. The risk is insignificant with short-term use. Patients with arterial hypertension, including a history of hypertension, and/or patients with chronic heart failure should consult a doctor before using the preparation, as fluid retention, increased blood pressure, and edema may occur. Information for women planning pregnancy: The preparation inhibits cyclooxygenase and prostaglandin synthesis and may affect ovulation, disrupting female reproductive function (reversible after discontinuation of the preparation). Alcohol consumption is not recommended during treatment with this preparation. In case of oral irritation, skin rash, damage to mucous membranes, or other allergic reactions, discontinue use of the preparation and consult a doctor. If existing symptoms worsen or new ones appear, including signs of bacterial infection, consult a doctor immediately to review the treatment. Effect on ability to drive and operate machinery Patients experiencing dizziness, drowsiness, visual impairment or disturbance while taking flurbiprofen should avoid driving vehicles and operating machinery. Dosage form Metered-dose spray for topical use, 8.75mg/dose. 15ml (at least 45 actuations of the valve) (at least 15 doses) White, opaque high-density polyethylene bottle with a dosing device and cap. The bottle is placed in a cardboard box with instructions for use. Storage conditions Store at a temperature not exceeding 30 °C. Do not refrigerate, do not freeze. Keep out of reach of children. Shelf life 2 years. Use within 6 months after first use. Do not use after the expiry date. Dispensing regime: Pharmaceutical product group - III, available without a prescription.
