Strepsils Intensive external spray 875mg/dose bottle, 15ml

Composition

1 dose of spray (3 taps on the dispenser) contains:

Active ingredient:

flurbiprofen 8.75 mg;

excipients:

betadex 22,83 mg,

sodium hydrogen phosphate, dodecahydrate 17,19 mg,

citric acid monohydrate 0,63 mg,

methyl parahydroxybenzoate of 1.18 mg

parahydroxybenzoate 0,24 mg,

sodium hydroxide 1,30 mg,

mint flavor (PHL 175628) 1.08 mg,

cherry flavor (PHL 175629) 1.35 mg,

N-2,3-trimethyl-2-isopropylmalonate 0,54 mg,

sodium saccharin 0,27 mg,

hydroxypropylmethyl of 12.09 mg,

water 492,55 mg.

Pharmacological action

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID) derived from propionic acid.

Flurbiprofen has analgesic, anti-inflammatory and antipyretic effects due to the suppression of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some selectivity towards COX-1, resulting in reduced production of prostaglandins – mediators of pain, inflammation and hyperthermic reaction.

When using the drug in a single dose (3 taps on the dispenser), a decrease in soreness and difficulty swallowing is noted after 5 minutes, a significant decrease in pain intensity – after 20 minutes, a decrease in edema 30 minutes after application. The analgesic and decongestant effect of the drug lasts up to 6 hours.

Pharmacokinetics

When applying a single dose of the drug (3 taps on the dispenser) to the oropharyngeal mucosa, flurbiprofen is rapidly absorbed and detected in blood plasma after 2-5 minutes. The maximum concentration of flurbiprofen in blood plasma is reached 30 minutes after use and is 1.6 mcg / ml, which is 4 times lower than when taking 50 mg of flurbiprofen orally. Flurbiprofen binds rapidly to plasma proteins and is distributed throughout the body.

Flurbiprofen is mainly metabolized by hydroxylation and excreted by the kidneys, with a half-life (T 1/2) of 3-6 hours. Approximately 20-25% of the oral dose of flurbiprofen is excreted unchanged by the kidneys.

Indications

As a symptomatic remedy for relieving sore throat in infectious and inflammatory diseases of the upper respiratory tract.

Use during pregnancy and lactation

The use of the drug in the third trimester of pregnancy is contraindicated.

Avoid using flurbiprofen during the first and second trimesters of pregnancy, and consult your doctor if necessary.

There is evidence that flurbiprofen can pass into breast milk without any negative consequences for the health of the child, however, due to possible side effects, the use of the drug during breastfeeding is not recommended.

Contraindications

• Hypersensitivity to flurbiprofen or any of the components of the drug.
• A history of hypersensitivity reactions (asthma, bronchospasm, rhinitis, angioedema, urticaria, recurrent nasal or paranasal polyposis) in response to the use of acetylsalicylic acid or other NSAIDs.
• Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum), ulcerative bleeding in the active phase or history (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding).
• Bleeding or perforation of a gastrointestinal ulcer, ulcerative colitis, a history of hemorrhagic and hematopoietic disorders caused by the use of NSAIDs.
• Pregnancy (third trimester).
• Breast-feeding period.
• Children under 12 years of age.
• Severe liver failure or active liver disease.
• Severe renal insufficiency (creatinine clearance
• Decompensated heart failure.
• The period after aorto-coronary bypass surgery.
• Confirmed hyperkalemia.
• Glucose-6-phosphate dehydrogenase deficiency.
• Hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis.

With caution

If you have any of the diseases and / or conditions listed in this section, you should consult a doctor before using the drug.

Concomitant use of other NSAIDs; a history of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract; a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), gastritis, enteritis, colitis, the presence of Helicobacter pylori infection; bronchial asthma or allergic diseases in the acute stage or in the anamnesis-the development of bronchospasm is possible; systemic lupus erythematosus and other systemic autoimmune diseases connective tissue disorders (increased risk of developing aseptic meningitis) – with short – term use of flurbiprofen, the risk is insignificant; arterial hypertension and/or heart failure, edema; renal failure, including dehydration (creatinine clearance less than 60 ml/min), nephrotic syndrome, liver failure, cirrhosis of the liver with portal hypertension, hyperbilirubinemia (with short-term use of flurbiprofen, the risk is insignificant); concomitant use of medications that may increase the risk of ulceration or bleeding, in particular oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); alcoholism; I-II trimester pregnancy; advanced age.

Side effects

The risk of side effects can be minimized if the drug is used in a short course and at the minimum effective dose necessary to eliminate symptoms.

The following adverse reactions were observed with short-term use of the drug. In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur.

The frequency of adverse reactions is estimated based on the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥1/1000 to < 1/100), rare (≥1/10,000 to < 1/1000), very rare (

Disorders of the blood and lymphatic system:

Frequency unknown: anemia, thrombocytopenia.

Nervous system disorders:

Often: dizziness, headache, paresthesia.

Infrequently: drowsiness.

Immune system disorders:

Rare: anaphylactic reactions.

Cardiac disorders:

Frequency unknown: heart failure, edema.

Vascular disorders:

Frequency unknown: increased blood pressure.

Respiratory, thoracic and mediastinal disorders:

Often: feeling of irritation in the throat.

Infrequently: exacerbation of bronchial asthma and bronchospasm, shortness of breath, wheezing, blisters in the mouth and pharynx, pharyngeal hypesthesia (decreased sensitivity in the mouth and pharynx).

Disorders of the gastrointestinal tract:

Common: diarrhea, ulceration of the oral cavity, nausea, pain in the oral cavity, paresthesia of the oral cavity, pain in the oral cavity and pharynx, discomfort in the oral cavity (feeling of heat, burning or tingling in the mouth).

Infrequently: bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning mouth syndrome), dysgeusia (change in taste perception), oral dysesthesia, vomiting.

Skin and subcutaneous tissue disorders:

Infrequently: skin rash, pruritus.

Frequency unknown: severe skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome).

Liver and biliary tract disorders:

Frequency unknown: hepatitis.

Mental disorders:

Infrequently: insomnia.

Other services:

Infrequently: fever, pain.

If any of the side effects listed in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use of the drug with the following medications should be avoided:

• Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a doctor, since co-use may increase the risk of side effects.
• Other NSAIDs, including ibuprofen and selective cyclooxygenase-2 inhibitors: concomitant use of two or more NSAID drugs should be avoided due to the possible increased risk of side effects.

Use with caution at the same time as the following medications: :

• Anticoagulants: NSAIDs may increase the effects of anticoagulants, including warfarin.
• Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
• Antihypertensive agents (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups and may increase nephrotoxicity due to cyclooxygenase inhibition, especially in patients with impaired renal function (adequate fluid compensation should be provided in such patients).
• Ethanol: May increase the risk of adverse reactions, especially gastrointestinal bleeding.
• Cardiac glycosides: concomitant use of NSAIDs and cardiac glycosides may worsen 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 gastrointestinal ulcers and gastrointestinal bleeding.
• Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in blood plasma with the use of NSAIDs.
• Methotrexate: There is evidence for the likelihood of an increase in the concentration of methotrexate in blood plasma against the background of NSAID use. NSAIDs should be taken 24 hours before or after taking methotrexate.
• Mifepristone: NSAIDs should be started no earlier than 8-12 days after the end of mifepristone use, as NSAIDs may reduce the effectiveness of mifepristone.
• Quinolone-type antibiotics: patients receiving concomitant treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.
• Tacrolimus: when co-administered with NSAIDs, there may be an increased risk of nephrotoxicity.
• Zidovudine: when co-administered with NSAIDs, there may be an increased risk of hematotoxicity.
• Oral hypoglycemic drugs: changes in blood glucose concentration may occur (it is recommended to increase the frequency of monitoring of blood glucose concentration).
• Phenytoin: it is possible to increase the concentration of phenytoin in the blood serum (it is recommended to monitor the concentration of phenytoin in the blood serum and, if necessary, adjust the dose).
• Potassium-sparing diuretics: concomitant use of potassium-sparing diuretics and flurbiprofen may lead to hyperkalemia.
• Probenecid and sulfinpyrazone: Medications containing probenecid or sulfinpyrazone may delay the elimination of flurbiprofen.
• Tolbutamide and antacids: To date, studies have found no interactions between flurbiprofen and tolbutamide or antacids.

How to take, course of use and dosage

Please read the instructions carefully before using the product.

For topical application. Only for short-term use.

Adults and children over 12 years of age: 1 dose of the drug (3 taps on the dispenser) should be sprayed on the back wall of the oropharynx every 3-6 hours, no more than 5 doses within 24 hours.

Duration of therapy: no more than 3 days.

Do not inhale when sprayed.

Before the first application of the drug, it is necessary to make at least four taps on the dispenser in the opposite direction from yourself until a uniform spray appears.

Before each subsequent application, it is necessary to make at least one push on the dispenser in the opposite direction from yourself until a uniform spray appears.

Overdose

Symptoms: nausea, vomiting, epigastric pain, rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In more severe cases, the following central nervous system symptoms are observed: drowsiness, rarely-agitation, blurred vision, disorientation or coma. In rare cases, patients have seizures.

In cases of severe NSAID poisoning, metabolic acidosis and an increase in prothrombin time may develop, which is probably due to the influence of blood clotting factors on the action. Acute renal failure and liver damage, low blood pressure, respiratory depression, and cyanosis may occur. Patients with bronchial asthma may have an exacerbation of this disease.

Treatment: symptomatic, with mandatory provision of airway patency, monitoring of ECG and basic vital signs until the patient’s condition normalizes.

Oral use of activated charcoal or gastric lavage within 1 hour of taking a potentially toxic dose of flurbiprofen is recommended. Frequent or prolonged seizures should be stopped by intravenous use of diazepam or lorazepam. In case of exacerbation of bronchial asthma, the use of bronchodilators is recommended. There is no specific antidote to flurbiprofen.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.

When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and a fecal occult blood test.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Patients with renal or hepatic insufficiency, as well as elderly patients and patients taking diuretics, should consult a doctor before using the drug, since there is a risk of deterioration of the functional state of the kidneys. With short-term use of the drug, the risk is insignificant.

Patients with a history of hypertension and / or chronic heart failure should consult a doctor before using the drug, as the drug can cause fluid retention, increased blood pressure and edema.

Information for women planning pregnancy: the drug suppresses cyclooxygenase and prostaglandin synthesis and may affect ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).

During the treatment period, alcohol intake is not recommended.

If you experience irritation in the oral cavity, skin rash, mucosal lesions and other manifestations of an allergic reaction, you should stop using the drug and consult a doctor.

If existing symptoms worsen or new ones appear, including signs of bacterial infection, you should immediately consult a doctor to review therapy.

Storage conditions

Store at a temperature not exceeding 30 °C. Do not store in the refrigerator, do not freeze. Keep out of reach of children.

Shelf life

2 years

Active ingredient

Flurbiprofen