Description
Release form
Granules for solution for oral administration, 400 mg
Flavor: apricot
Packaging
12 packs of multilayer foil along with medical instructions for use in a cardboard box.
Pharmacological action
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics
Ibuprofen – the active substance of the drug Faspik – is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of cyclooxygenase 1 and 2 and has an inhibitory effect on the synthesis of prostaglandins.
Analgesic effect is most pronounced for inflammatory pain. The analgesic activity of the drug is not a drug type.
Like all NSAIDs, Faspik exhibits antiplatelet activity.
The analgesic effect when using Faspika (ibuprofen in the form of a salt of L-arginine) develops 10-45 minutes after administration.
Pharmacokinetics
Absorption: well absorbed from the stomach. When using Faspika, the maximum concentration (Cmax) of ibuprofen in plasma of 26 g / ml and 56 g / ml is achieved within 15-25 minutes after taking the drug on an empty stomach at a dose of 200 mg and 400 mg, respectively.
Distribution: ibuprofen is approximately 99% bound to plasma proteins. It is slowly distributed in the synovial fluid and excreted from it more slowly than from plasma.
Biotransformation: Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive.
Excretion: has a two-phase elimination kinetics. The half-life (Ti / g) from plasma is 1-2 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and, to a lesser extent, with bile.
Indications
Feverish syndrome of various origins.
Pain syndrome of various etiologies (including sore throat, headache, migraine, toothache, neuralgia, postoperative pain, post-traumatic pain, primary algodismenorrhea).
Inflammatory and degenerative diseases of the joints and spine (including rheumatoid arthritis, ankylosing spondylitis).
Contraindications
Hypersensitivity to any of the ingredients that make up the drug.
History of hypersensitivity to acetylsalicylic acid or other NSAIDs.
Erosive-ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, Crohn’s disease, ulcerative colitis).
“Aspirin” asthma.
Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
Bleeding of any etiology.
Pregnancy.
Lactation.
Children under 12 years old.
Diseases of the optic nerve.
Caution is required in the following cases:
old age
heart failure
arterial hypertension
liver cirrhosis with portal hypertension
hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia sardancer and gastric ulcer (gastric ulcer) colitis
blood disease of unknown etiology (leukopenia and anemia).
Special instructions
Patients with infection should be prescribed the drug with caution and subject to adequate antimicrobial therapy, since ibuprofen may mask objective and subjective signs of infection.
Patients with allergic reactions and bronchial asthma (including a history of) have an increased risk of bronchospasm during ibuprofen therapy.
With prolonged use of NSAIDs, there is a chance of developing analgesic nephropathy.
In case of symptoms of gastrointestinal bleeding, Faspik is canceled.
Patients who notice visual impairment during therapy should stop taking the drug and consult an ophthalmologist.
The risk of developing side effects is reduced by taking Faspika at the lowest effective dose for the shortest possible course.
During treatment, it is necessary to periodically monitor the picture of peripheral blood and the functional state of the kidneys and liver. For 48 hours, Faspik should be canceled by patients who are shown a study to determine 17-ketosteroids.
When signs of gastropathy appear, careful monitoring of the patient’s condition is required, including fecal occult blood analysis, a blood test to determine hematocrit and hemoglobin, as well as esophagogastroduodenoscopy. To prevent the development of gastropathy associated with NSAIDs, it is recommended to combine the drug with prostaglandin E (for example, misoprostol).
Ibuprofen can negatively affect female fertility, therefore it is not recommended for women to take it during pregnancy planning.
During treatment should refrain from drinking alcoholic beverages.
1 tablet of Faspik contains 16.7 mg of sucrose. The sucrose content in granules with a dosage of 400 mg is 0, 18 XE in 1 packet and 0.54 XE in the maximum daily dose.
Impact on the ability to drive vehicles and complex mechanisms. Patients during therapy are advised to refrain from performing any work that requires a speed of reaction and increased attention, including driving a car and controlling complex mechanisms.
Faspika is contraindicated in pregnant and lactating women.
Use in childhood Faspik at a dose of 200 and 400 mg is contraindicated in children under 12 years of age, in a dosage of 600 mg for children and adolescents under 18 years of age.
For impaired renal function. Progressive kidney disease and severe renal failure with creatinine clearance (CC) of less than 30 ml / min are contraindications to the appointment of Faspika. In chronic renal failure (CC 30 ² 60 ml / min), the drug should be used with caution.
For impaired liver function. Severe liver failure and active liver disease are considered contraindications to the appointment of Faspika. With liver failure, the drug should be used with caution.
Composition of
Active ingredient: ibuprofen 400 mg
Excipients:
L-arginine sodium, sodium srdprcl, srdprcl aspartame
apricot flavor,
sucrose.
Dosage and administration of
The drug is taken orally, during or after a meal. Granules before administration should be dissolved in 50? 100 ml of water.
Dosages for adults according to indications:
ankylosing spondylitis: 400-600 mg 3-4 times a day
rheumatoid arthritis: 800 mg 3 times a day
pain: in a daily dose up to 1200 mg in several doses
post-traumatic pain: in a daily dose of 1600-2400 mg in several doses
Algodismenorea: 400 mg 3-4 times a day.
Dosages for adolescents from 12 years of age according to indications:
juvenile rheumatoid arthritis: in a daily dose of 30 40 mg / kg in 3-4 doses in equal parts
increased body temperature: from 39.2 ° C? in a daily dose of 10 mg / kg, below 39.2 ° C? 5 mg / kg
pain syndrome: in a daily dose of 5 10 mg / kg.
The maximum daily dose of Faspik: for children – 40 mg / kg, for adults – 1200 mg.
In rheumatoid arthritis, higher doses are recommended, but not more than 2400 mg per day. To overcome morning stiffness in arthritis, the first dose should be taken immediately after waking up.
Duration of taking Faspik: as an antipyretic agent – up to 3 days, anesthetic – up to 5 days. In patients with impaired liver, kidney or heart function, the dose of the drug is reduced.
Side effects of
dyspnea, bronchospasm
gastrointestinal tract (GIT): pain in the mouth, irritation or dryness of the mucous membrane of the oral cavity, aphthous stomatitis, ulceration of the mucous membrane of the gums, pancreatitis, NSAIDs, gastropathy, diarrhea, heartburn, flatulence, nausea, vomiting, abdominal pain, ulceration of the gastrointestinal mucosa, in some cases complicated by perforation and bleeding)
central and peripheral nervous system: hallucinations, nervousness, insomnia, confusion nania, irritability, dizziness, drowsiness, anxiety, psychomotor agitation, depression, headache, aseptic meningitis (more often in patients with autoimmune diseases)
cardiovascular system: increased blood pressure, tachycardia, heart failure
blood-forming organs: agranulocytosis, thrombocytopenic purpura, thrombocytopenia, thrombocytopenia hemolytic and aplastic)
urinary system: nephrotic syndrome (edema), cystitis, polyuria, allergic nephritis, acute renal failure
hepatobiliary s Topic: Hepatitis eyesight: swelling of the conjunctiva and eyelids (allergic genesis), blurred vision or double vision, toxic damage to the optic nerve, the irritation and dryness of the eyes, scotoma
organ of hearing: ringing, tinnitus, hearing loss
allergic reactions: itching, skin rash (usually urticaria and erythematous), allergic rhinitis, eosinophilia, fever, bronchospasm or shortness of breath, anaphylactoid reactions, Quincke’s edema, anaphylactic shock, toxic epidermal necrolysis (Lyell’s syndrome), multiforme exudative syndrome laboratory indicators: an increase in bleeding time, serum creatinine concentration and liver transaminase activity, a decrease in creatinine clearance, blood glucose concentration, hemoglobin or hematocrit.
With long-term administration of Faspik in high doses, the risk of ulceration of the gastrointestinal mucosa, bleeding (gingival, gastrointestinal, hemorrhoidal or uterine) and visual impairment (damage to the optic nerve, color vision, and scotoma) increases.
Overdose
Overdosage of ibuprofen may cause the following symptoms: drowsiness, inhibition, nausea, vomiting, abdominal pain, acute renal failure, metabolic acidosis, tinnitus, tinnitus coma, respiratory arrest.
After taking too much Faspik dose, if no more than an hour has passed, gastric lavage and activated charcoal should be performed. Further, alkaline drinking, forced diuresis and symptomatic therapy, including correction of blood pressure and acid-base status, are recommended.
Storage Conditions
Keep out of the reach and sight of children at temperatures up to 25 ° C.
Shelf life
3 years. Do not use after the expiration date indicated on the package.
Deystvuyushtee substance
Ibuprofen
Terms and conditions
without prescription
Dosage form
oral solution
Possible product names
Zambon Switzerland Ltd
FASPRIC 0.4 N D / R-RA / APRICOT /
Faspik granules for solution for oral administration 400 mg apricot sachet 12 pcs.
