Rakstan-Sanovel (Raxtan-Sanovel)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFlurbiprofenFlurbiprofen
Dosage form: & nbspcoated tablets
Composition:
each tablet contains:
active substance: flurbiprofen 100 mg.
auxiliary substances: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, giprolase, magnesium stearate, silicon dioxide colloid. shell: dye opedrai blue (lactose monohydrate, giprolose, titanium dioxide, macrogol 4000, indigocarmine).

Description:
Oblong biconvex tablets, covered with a blue coating with a two-sided risk.

Pharmacotherapeutic group:non-steroidal anti-inflammatory drug (NSAID)
ATX: & nbsp

M.01.A.E.09   Flurbiprofen

Pharmacodynamics:
Nonsteroidal anti-inflammatory drug, has anti-inflammatory, analgesic and antipyretic effect. The main mechanism of action is associated with inhibition of prostaglandin synthesis by blocking cyclooxygenases (COX-1 and COX-2).In the implementation of the therapeutic effect of the drug involved and other mechanisms to reduce the sensitivity of tissues to mediators of inflammation.

Pharmacokinetics:
After ingestion, it is well and completely absorbed from the digestive tract and reaches a maximum concentration in the plasma (an average of 15 μg / ml) after 1-2 hours. Eating does not affect the bioavailability of the drug. The half-life on average is 6 hours. The connection with plasma proteins is more than 99%. Flurbiprofen almost completely metabolized and excreted mainly by the kidneys (glucuronides and sulfated conjugates): 20% unchanged.

Indications:
  • Diseases of the musculoskeletal system: rheumatoid and gouty arthritis, ankylosing spondylitis. rheumatic soft tissue damage;
  • Pain syndrome of mild and moderate intensity: arthralgia, myalgia, sciatica, neuralgia, toothache, headache, trauma and burns;
  • Post-traumatic and postoperative pain syndrome, accompanied by inflammation
  • Dysmenorrhea.

Contraindications:
  • hypersensitivity to flurbiprofen and other NSAIDs;
  • erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);
  • bleeding from the gastrointestinal tract and cerebrovascular bleeding;
  • bronchial asthma in combination with polyposis of the nasal mucosa;
  • decompensated chronic heart failure;
  • treatment of postoperative pain after aorto-coronary shunting;
  • violations of hemostasis (including hemophilia, lengthening bleeding time, a tendency to bleeding);
  • severe hepatic or renal insufficiency;
  • children's age till 15 years;
  • pregnancy and lactation.

Carefully:
Anemia, hemopoiesis disorders, bronchial asthma, chronic heart failure, arterial hypertension, ischemic heart disease, edematous syndrome, hepatic and / or renal failure, alcoholism, inflammatory bowel disease, diverticulitis, erosive and ulcerative diseases of the gastrointestinal tract outside of exacerbation, diabetes mellitus , a condition after extensive surgical interventions, induced porphyria, and advanced age.

Dosing and Administration:
Inside.
The daily dose of 150-200 mg: should be divided into 2-3 doses per day. Patients with acute symptoms or during exacerbation of the disease daily dose for a short time (2-3 days)can be increased to 300 mg.
Dysmenorrhea:
at the beginning of 100 mg, followed by 50 or 100 mg every 4 or 6 hours. The maximum daily dose of the drug should not exceed 300 mg.

Side effects:
On the part of the digestive system: more often 1% - nausea, vomiting, heartburn, diarrhea, constipation, abdominal pain, flatulence, increased levels of "liver" enzymes, gastrointestinal bleeding,
less than 1% - peptic ulcer with possible complications (bleeding, perforation), gastritis, jaundice, melena, the appearance of blood in the vomit, esophageal damage, aphthous stomatitis, glossitis, hepatitis.
On the part of the nervous system: more often 1% - headache, dizziness, anxiety, sleep disturbances, increased reflexes, tremor, amnesia, asthenia, depression, somnolentia;
less than 1% - ataxia, ischemic brain damage, weakness, paresthesia, convulsions.
From the senses: more than 1% - visual impairment (blurred vision, diplopia, scotoma), tinnitus, hearing loss; less than 1% - conjunctivitis, impaired sense of smell and taste;
the relationship with the use of the drug is not established - increased intraocular pressure, hemorrhage in the retina, retrobulbar neuritis.
From the skin: more often 1% - skin itching, skin rash; less than 1% - alopecia, urticaria, eczema, toxic dermatitis, multiform exudative erythema, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), increased photosensitivity.
On the part of the genitourinary system: more often 1% - fluid retention, urinary tract infection;
less than 1% - hematuria, increased uric acid, interstitial nephritis, kidney failure.
On the part of the organs of hematopoiesis and immune system: less than 1% - anemia (including hemolytic and aplastic anemia), decreased hemoglobin and hematocrit, thrombocytopenic purpura, leukopenia, thrombocytopenia, eosinophilia, agranulocytosis.
On the part of the respiratory system: more often 1% - rhinitis; less than 1% - cough, bronchospasm. From the cardiovascular system: less than 1% - increased blood pressure, vaso dilation, edema, congestive heart failure; the relationship with the use of the drug is not established - angina pectoris, arrhythmia, myocardial infarction.
Allergic reactions: less than 1% - anaphylactoid reactions, anaphylactic shock (usually develops rapidly), swelling of the lips and tongue, allergic vasculitis.
Other: less than 1% - fever, chills.

Overdose:
Symptoms of overdose: respiratory depression, nausea, epigastric pain, headache, dizziness.
Treatment: gastric lavage and symptomatic treatment.
Specific antidote for flurbiprofen does not exist.

Interaction:
Flurbiprofen may reduce the effectiveness of angiotensin-
transforming enzyme.
Joint use of the drug with anticoagulants (for example, warfarin) leads to an increased risk of developing serious bleeding.
Simultaneous use with acetylsalicylic acid leads to a significant decrease in the concentration of the drug in the blood serum.
Increases the likelihood of side effects of other non-steroidal anti-inflammatory drugs drugs and glucocorticosteroid agents
(bleeding in the gastrointestinal tract), toxicity of methotrexate and nephrotoxicity of cyclosporine.
Flurbiprofen reduces the antihypertensive activity of beta-blockers.
Reduces the effect of diuretics (furosemide, thiazide diuretics), against the background of potassium-sparing diuretics, the risk of hyperkalemia increases.

Special instructions:
During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. Like other NSAIDs, the drug can affect fertility, which should be warned by women planning a pregnancy (reducing the likelihood of pregnancy). During treatment, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Form release / dosage:
Tablets coated with 100 mg
Packaging:
5 tablets in a blister of PVC-aluminum foil. 6 blisters are placed in a cardboard box together with instructions for use

Storage conditions:
In dry, the dark place at a temperature of no higher than 30 ° C.
Keep out of the reach of children.

Shelf life:
4 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription
Registration number:LSR-001834/08
Date of registration:17.03.2008
The owner of the registration certificate:Sanovel Pharmaco-industrial trading companySanovel Pharmaco-industrial trading company Turkey
Manufacturer: & nbsp
Representation: & nbspSANOVEL branch of the company pharmaco-industrial trading companySANOVEL branch of the company pharmaco-industrial trading companyRussia
Information update date: & nbsp22.10.2015
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