Strepsils intensive spray dose 8.7mg 15ml

Description

Composition
Active substance:
8.75 mg flurbiprofen.
Excipients:
Betadeks 22.83 mg, Sodium hydrogen phosphate dodecahydrate 17.19 mg citric acid monohydrate 0.63 mg methyl parahydroxybenzoate 1.18 mg propyl parahydroxybenzoate 0.24 mg Sodium Hydroxide 1.30 mg Mint flavoring (PHL 175 628) 1.08 mg cherry flavoring (PHL 175 629) 1.35 mg, N-2,3-trimethyl-2-isopropylbutanamide 0.54 mg, 0.27 mg sodium saccharinate, gidroksipropilbetadeks 12.09 mg 492.55 mg water.
Description:
The clear solution from colorless to pale yellow.
Product form:
Spray for topical dosage, 8.75 mg / dose.
15 ml (at least 45 presses on the valve (not less than 15 doses)) in a white opaque bottle made of polyethylene of high density with a metering device, with the cap top. The bottle was placed in a pack carton along with instructions for medical use.
Contraindications
– Increased sensitivity to flurbiprofen or any of the components.
– Have a history of hypersensitivity reactions (asthma, bronchoconstriction, rhinitis, angioedema, urticaria, recurrent nasal polyposis or paranasal sinuses) in response to the use of aspirin or other NSAIDs.
– erosive and ulcerative diseases of the gastrointestinal (including gastric ulcer and duodenal ulcer), ulcer bleeding in the active phase or history (two or more episodes of proven peptic ulcer or bleeding ulcer).
– Bleeding ulcer or perforation of the gastrointestinal tract, ulcerative colitis, hemorrhagic and hematopoietic disorders in history, triggered by the use of NSAIDs.
– Pregnancy (III trimester).
– breast-feeding period.
– Children up to age 12 years.
– Severe liver failure or liver disease in active phase.
– severe renal insufficiency severity (creatinine clearance
– decompensated heart failure.
– The period after coronary artery bypass surgery.
– confirmation of hyperkalemia.
– Deficiency of glucose-6-phosphate dehydrogenase.
– Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
Carefully:
In the presence of diseases and / or conditions listed in this section, before application of the drug should consult a physician.
Simultaneous treatment with other NSAIDs; a history of a single episode of gastric ulcer or gastrointestinal bleeding ulcer; diseases of the gastrointestinal tract in history (ulcerative colitis, Crohn’s disease), gastritis, enteritis, colitis, the presence of Helicobacter pylori infection; bronchial asthma or allergic diseases in the acute stage or history – possibly bronchoconstriction; systemic lupus erythematosus and other systemic autoimmune connective tissue disease (increased risk of aseptic meningitis) – with short-term use of flurbiprofen negligible risk; hypertension and / or heart failure, edema; renal failure including the dehydration (creatinine clearance less than 60 mL / min), nephrotic syndrome, liver failure, cirrhosis with portal hypertension, hyperbilirubinemia (for short-term use of flurbiprofen negligible risk); concomitant use of drugs that may increase the risk of ulcers or bleeding, including oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors ( including citalopram, fluoxetine, paroxetine, sertraline); alcoholism; I-II trimester of pregnancy; elderly age.
Dosage
8.75 mg / dose
Indications
As means for the symptomatic relief of sore throat in infectious and inflammatory diseases of the upper respiratory tract.
Interaction with other drugs
It should avoid the simultaneous application of the preparation with the following drugs:
• Acetylsalicylic acid: with the exception of low-dose acetylsalicylic acid (not more than 75 mg per day), prescribed by the doctor, since the combined use 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 group of NSAIDs due to possible increased risk of side effects.
Precautions used simultaneously with the following drugs:
• Anticoagulants: NSAIDs may enhance 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) and diuretics NSAIDs may reduce the effectiveness of drugs and these groups may increase the nephrotoxicity due to inhibition of cyclooxygenase, especially in patients with impaired renal function (need to provide adequate compensation fluid in these patients).
• Ethanol: may increase the risk of adverse reactions, especially gastrointestinal bleeding.
• Cardiac glycosides: the simultaneous use of cardiac glycosides and NSAIDs can lead to aggravation of heart failure, decreased glomerular filtration rate and an increase in concentration of cardiac glycosides in blood plasma.
• Cyclosporin: increased risk of nephrotoxicity.
• Corticosteroids: increased risk of ulcers of the gastrointestinal tract and gastrointestinal bleeding.
• Lithium Drugs: There are data on the probability of increasing the concentration of lithium in blood plasma during treatment with NSAIDs.
• Methotrexate: there is evidence of the likelihood of increasing concentration of methotrexate in the blood plasma during treatment with NSAIDs. NSAIDs should be taken for 24 hours before or after taking methotrexate.
• Mifepristone: NSAIDs should be started no earlier than 8-12 days after mifepristone, as NSAIDs can reduce the efficacy of mifepristone.
• Antibiotics of the quinolone series: patients receiving collaborative care NSAIDs and quinolone antibiotics series, may increase the risk of seizures.
• Tacrolimus: when combined with the use of NSAIDs may increase the risk of nephrotoxicity.
• Zidovudine: when combined with the use of NSAIDs may increase the risk gematotoksichnosti.
• Oral hypoglycemic agents: may change the concentration of glucose in the blood (it is recommended to increase frequency of monitoring blood glucose concentrations).
• Phenytoin: may increase serum concentrations of phenytoin (recommended monitoring of serum phenytoin concentrations and, if necessary, dose adjustment).
• Potassium-sparing diuretics combined use of potassium-sparing diuretics and flurbiprofen can cause hyperkalemia.
• Probenecid and sulfinpyrazone: Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion of flurbiprofen.
• Tolbutamide and antacids: to date, studies have not revealed the interactions between flurbiprofen and tolbutamide or antacids.
Overdose
Symptoms include nausea, vomiting, epigastric pain, rarely diarrhea. It is also possible tinnitus, headache, gastro-intestinal bleeding. In more severe cases the following symptoms from the central nervous system are observed: drowsiness, rarely – excitement, 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 due to the influence of the action of clotting factors. May develop acute renal failure, liver damage, blood pressure, respiratory depression and cyanosis. Patients with asthma may increase the disease.
Treatment: symptomatic, with obligatory airway, ECG monitoring and vital signs up to the normalization condition of the patient.
We recommend the use of activated charcoal oral or gastric lavage for 1 hours after administration of potentially toxic dose of flurbiprofen. Frequent or prolonged convulsions should be to stop the intravenous administration of diazepam or lorazepam. In the case of acute asthma it recommended the use of bronchodilators. Specific antidote to flurbiprofen does not exist.
pharmachologic effect
Pharmacological group:
nonsteroidal anti-inflammatory drug (NSAID)
Pharmacodynamics:
Flurbiprofen is a nonsteroidal anti-inflammatory drug (NSAID), propionic acid derivatives.
Flurbiprofen has analgesic, antiinflammatory and antipyretic effect by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), with a selectivity to COX-1, thereby reducing the production of prostaglandins – mediators of pain, inflammation and hyperthermic response.
In applying the drug in a single dose (3 clicking on dispenser) decrease pain and difficulty in swallowing observed after 5 minutes, a significant reduction in pain intensity – 20 minutes later, the reduction of edema 30 min after application. Analgesic and anti-edema effect of the drug is continued until 6 hours.
Pharmacokinetics:
When applying a single dose (3 clicking on dispenser) on the mucosa of the oropharynx flurbiprofen rapidly absorbed and determined in plasma of 2-5 minutes. The maximum concentration of flurbiprofen in the blood plasma is 30 minutes after application and at 1.6 ug / ml, which is 4 times lower than when administered 50 mg flurbiprofen. Flurbiprofen quickly bound to plasma proteins and is distributed throughout the body.
Flurbiprofen is metabolized mainly by hydroxylation and excreted by the kidneys, the half-life (T1 / 2) is 3-6 hours. Approximately 20-25% of an oral dose of flurbiprofen excreted by the kidneys in unchanged form.
Pregnancy and breast-feeding
Do not use this drug in the III trimester.
It should avoid the use of flurbiprofen in the I-II trimester of pregnancy should consult a physician if required using the drug.
There is evidence that the flurbiprofen can pass into breast milk without any negative consequences for the health of the child, however, because of the possible effects pbochnyh use of the drug during breast-feeding is not recommended.
Conditions of supply of pharmacies
Without recipe.
side effects
The risk of side effects can be minimized if the drug use and a short course in the lowest effective dose needed to control symptoms.
The following adverse reactions were observed in short-term use of the drug. In the treatment of chronic conditions and long-term use may cause other adverse reactions.
estimates of frequency of adverse reactions produced on the basis of the following criteria: very common (> 1/10), common (by> 1/100 to 1/1000 and 1/10 000
Blood disorders and lymphatic system:
Frequency not known: anemia, thrombocytopenia.
Disorders of the nervous system:
Common: dizziness, headache, paresthesia.
Uncommon: somnolence.
Violations by the immune system:
Rare: anaphylactic reactions.
Violations of the heart:
Frequency is unknown: heart failure, edema.
Violations by vessels:
Frequency not known: high blood pressure.
Violations of the respiratory system, thorax and mediastinum:
Often: the feeling of irritation in the throat.
Uncommon: exacerbation of asthma and bronchospasm, dyspnea, wheezing, blisters in the oral cavity and pharynx, pharyngeal hypoesthesia (reduced sensitivity in the oral cavity and pharynx).
Disorders of the gastrointestinal tract:
Often the diarrhea, ulceration of the mouth, nausea, sore mouth, oral paresthesia, pain in the mouth and throat, discomfort in the mouth (feeling of warmth, tingling or burning sensation in the mouth).
Uncommon: bloating, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossalgia (burning mouth syndrome), dysgeusia (taste perception change), dysesthesia oral vomiting.
Violations of the skin and subcutaneous tissue disorders:
Uncommon: skin rash, itching.
Frequency unknown: severe skin reactions such as bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome).
Disorders of the liver and biliary tract:
hepatitis: frequency unknown.
Mental disorders:
Uncommon: insomnia.
Other:
Uncommon: fever, sore.
If any of these instructions side effects are compounded or you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
It is recommended to take the drug the maximum possible short-course, and in the lowest effective dose needed to control symptoms.
When symptoms gastropathy shown careful control, comprising carrying esophagogastroduodenoscopy, total blood (hemoglobin), analysis of fecal occult blood.
If necessary, the definition of 17-ketosteroids drug should be discontinued 48 hours prior to the study.
Patients with renal or hepatic insufficiency, as well as to older patients and patients receiving diuretics should consult a physician before using the product, since there is a risk of deterioration of renal function. At short-term use of the drug risk is negligible.
Patients with hypertension, including a history of and / or chronic heart failure, it is necessary to consult a physician before using the drug as the drug can cause fluid retention, hypertension and edema.
Information for women planning a pregnancy: the drug inhibits the cyclooxygenase and prostaglandin synthesis, and can affect ovulation, disrupting women’s reproductive function (reversible after discontinuation of treatment).
During the period of treatment is not recommended alcohol intake.
When the irritation in the oral cavity, skin rashes, mucosal lesions and other manifestations of allergic reaction, discontinue use of the drug and seek medical advice.
In case of worsening of existing symptoms or onset of new, including the signs of a bacterial infection, you should immediately consult your doctor to review treatment.
Effects on ability to transp. Wed. and fur .:
Patients marking dizziness, drowsiness, confusion or visual disturbances while taking flurbiprofen should avoid driving vehicles or machinery.
Storage conditions
Store at a temperature not higher than 30 ° C.
Do not store in the refrigerator, do not freeze.
Keep out of the reach of children.
Use within 6 months after the first application.
Dosing and Administration
Adults and children over 12 years: 1 dose (3 pressing on the dispenser) sprayed on the back of the oropharynx every 3-6 hours. Do not breathe spray.
The maximum daily dose: 5 doses (15 presses on the dispenser).
Do not exceed this dose.
Duration of treatment – no more than 3 days. If you are taking the drug within 3 days, the symptoms persist, you must stop treatment and seek medical advice.
Please read the instructions before taking the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist