Strepsils Intensive, spray 8.75mg/dose 15 ml

Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID), a propionic acid derivative.

Flurbiprofen has analgesic, anti-inflammatory and antipyretic effect due to inhibition of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with some selectivity to COX-1, resulting in reduced production of prostaglandins – mediators of pain, inflammation and hyperthermia.

When using the drug in a single dose (3 pressings on the dispenser), reduction of pain and difficulty in swallowing is noted after 5 minutes, a significant decrease in the intensity of pain – after 20 minutes, reduction of edema after 30 minutes after application. Analgesic and anti-edema effect of the drug lasts up to 6 hours.

Pharmacokinetics

When a single dose of the drug is applied (3 presses on the dispenser) to the oropharyngeal mucosa, flurbiprofen is quickly absorbed and determined in the blood plasma after 2-5 minutes. Maximum concentration of flurbiprofen in plasma is reached 30 minutes after application and is 1.6 mcg/ml, which is 4 times lower than when taking flurbiprofen 50 mg orally. Flurbiprofen is rapidly bound to plasma proteins and 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. About 20-25% of the oral dose of flurbiprofen 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.

Active ingredient

Flurbiprofen

How to take, the dosage

Read the instructions carefully before using the product.

For topical use. For short-term use only.

Adults and children over 12 years of age: Spray 1 dose of the product (3 pressings on the dispenser) into the back of the oropharynx every 3-6 hours, up to 5 doses in 24 hours.

The duration of therapy: not more than 3 days.

Do not inhale by spraying.

Before using the product for the first time, make at least four squeezes on the dispenser in the opposite direction from yourself until an even spray pattern appears.

For each subsequent use, apply at least one click on the pipette in the opposite direction to yourself until an even spray pattern appears.

Interaction

The concomitant use of the drug with the following drugs should be avoided:

• Acetylsalicylic acid: except at low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a physician, because co-administration may increase the risk of side effects.
• Other NSAIDs, including ibuprofen and selective cyclooxygenase-2 inhibitors: Simultaneous use of two or more drugs from the NSAID group should be avoided because of the possible increased risk of side effects.

Cautiously use with the following medicines:

• Anticoagulants: NSAIDs may increase the effects of anticoagulants, including warfarin.
• Antiaggregants and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
• Hypotensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may decrease the effectiveness of these groups and may increase nephrotoxicity due to cyclooxygenase inhibition, especially in patients with impaired renal function (adequate fluid replacement in these patients must be provided).
• Ethanol: may increase the risk of adverse reactions, especially gastrointestinal bleeding.
• Cardiac glycosides: concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, decrease glomerular filtration rate, and increase plasma concentrations of cardiac glycosides.
• Cyclosporine: increased risk of nephrotoxicity.
• Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
• Methotrexate: there is data on the possibility of increased plasma concentrations of methotrexate with NSAIDs. NSAIDs should be taken 24 hours before or after methotrexate.
• Mifepristone: NSAIDs should not be taken more than 8-12 days after mifepristone administration, because NSAIDs may decrease the effectiveness of mifepristone.
• Quinolone antibiotics: Patients treated concomitantly with NSAIDs and quinolone antibiotics may increase the risk of seizures.
• Tacrolimus: co-administration with NSAIDs may increase the risk of nephrotoxicity.
• Peroral hypoglycemic drugs: changes in blood glucose concentrations may occur (increased frequency of blood glucose monitoring is recommended).
• Phenytoin: increased serum phenytoin concentrations are possible (recommended monitoring of phenytoin serum concentrations and, if necessary, adjustment of the dose).
• Kalium-saving diuretics: co-administration of potassium-saving diuretics and flurbiprofen may lead to hyperkalemia.
• Probenecid and sulfinpyrazone: Drugs containing probenecid or sulfinpyrazone may delay excretion of flurbiprofen.
• Tolbutamide and antacids: To date, studies have shown no interaction between flurbiprofen and tolbutamide or antacids.

.

Special Instructions

It is recommended that the drug be taken for as short a course as possible and at the lowest effective dose necessary to relieve symptoms.

If symptoms of gastropathy occur, close monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), 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 impairment, as well as elderly patients and patients taking diuretics should consult a physician before using the drug, since there is a risk of impairment of renal function. In short-term use of the drug the risk is insignificant.

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

Information for women planning pregnancy: The drug suppresses cyclooxygenase and prostaglandin synthesis and may affect ovulation, impairing female fertility (reversible after discontinuation of treatment).

The intake of alcohol is not recommended during treatment.

In case of irritation in the oral cavity, skin rash, mucous membrane lesions and other manifestations of allergic reaction, you should stop using the drug and consult a physician.

If there is a worsening of symptoms or if new symptoms develop, including evidence of bacterial infection, you should see a physician immediately so that the therapy can be revised.

Contraindications

• High sensitivity to flurbiprofen or any of the drug components.
• History of hypersensitivity reactions (bronchial asthma, bronchospasm, rhinitis, Quincke’s edema, urticaria, recurrent nasal or paranasal sinus polyposis) in response to use of acetylsalicylic acid or other NSAIDs.
• Erotic ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers), ulcer bleeding in the active phase or history (two or more confirmed episodes of peptic ulcer or ulcer bleeding).
• Bleeding or gastrointestinal ulcer perforation, ulcerative colitis, history of hemorrhagic and hematopoietic disorders triggered by use of NSAIDs.
• Pregnancy (III trimester).
• Breastfeeding period.
• Children under 12 years of age.
• Severe liver failure or liver disease in active phase.
• Severe renal insufficiency (creatinine clearance < 30 ml/min).
• Decompensated heart failure.
• Period after aorto-coronary bypass.
• Confirmed hyperkalemia.
• Deficiency of glucose-6-phosphate dehydrogenase.
• Hemophilia and other clotting disorders (including hypocoagulation), hemorrhagic diathesis.

Cautions

In the presence of the diseases and/or conditions listed in this section, consult a physician before using the drug.

Concomitant use of other NSAIDs; history of a single episode of peptic ulcer disease or peptic ulcer bleeding; 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 history – bronchospasm may develop; systemic lupus erythematosus and other systemic autoimmune diseases of connective tissue (increased risk of aseptic meningitis) – with short-term use of flurbiprofen the risk is low; arterial hypertension and/or heart failure, edema; renal failure including in dehydration (creatinine clearance less than 60 ml/min), nephrotic syndrome, hepatic failure, cirrhosis with portal hypertension, hyperbilirubinemia (in short-term flurbiprofen use the risk is insignificant); concomitant use of drugs that may increase the risk of ulceration or bleeding, in particular oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) alcoholism; I-II trimester of pregnancy; old age.

Side effects

The risk of side effects can be minimized by using the drug for a short course and at the lowest effective dose necessary to control symptoms.

The following adverse reactions have been reported with short-term use. Other adverse reactions may occur with chronic conditions and long-term use.

The incidence of adverse reactions was 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 (< 1/10 000), frequency unknown (no data on frequency estimates).

Disorders of the blood and lymphatic system:

Frequency unknown: anemia, thrombocytopenia.

Nervous system disorders:

Often: dizziness, headache, paresthesia.

Infrequent: drowsiness.

Disorders of the immune system:

Rarely: anaphylactic reactions.

Cardiac disorders:

Prevalence unknown: heart failure, edema.

Vascular disorders:

Prevalence unknown: increased blood pressure.

Respiratory system, chest and mediastinum disorders:

Often: feeling of irritation in the throat.

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

Gastrointestinal tract disorders:

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

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

Skin and subcutaneous tissue disorders:

Infrequent: skin rash, itching.

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

Hepatic and biliary tract disorders:

Prevalence unknown: hepatitis.

Mental disorders:

Infrequent: insomnia.

Other:

Infrequent: fever, pain.

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

Overdose

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

In cases of severe poisoning with NSAIDs may develop metabolic acidosis, increased prothrombin time, which is probably associated with the effect on blood clotting factors. Acute renal failure and liver damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma exacerbation of this disease is possible.

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

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

Pregnancy use

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

The use of flurbiprofen in I-II trimesters of pregnancy should be avoided, if necessary the use of the drug should be consulted with a physician.

There is evidence that flurbiprofen may penetrate into the breast milk without any adverse effects on the health of the child, however, due to possible side effects the use of the drug during breast-feeding is not recommended.

Similarities

Strepsils, Strepsils Intensive, Raxtan-Sanovel