FASPIK

Active material: Ibuprofen
When ATH: M01AE01
CCF: NSAIDs
ICD-10 codes (testimony): G43, K08.8, M05, M45, M79.2, N94.4, R07, R50, R51, R52.0, R52.2
When CSF: 05.01.01.06
Manufacturer: ZAMBÓN SWITZERLAND Ltd. (Switzerland)

Pharmaceutical form, composition and packaging

◊ Pills, coated white, kapsulovidnye, with Valium on one side.

Excipients: L-arginine, natriya carbonate, krospovydon, magnesium stearate.

The composition of the shell: gipromelloza, sucrose, Titanium dioxide, macrogol 4000.

6 PC. – blisters (1) – packs cardboard.

◊ Granules for oral solution white, with a characteristic smell Minty.

Excipients: L-arginine, natriya carbonate, sodium saccharin, Aspartame, mint flavor, sucrose.

3 g – bags (12) – packs cardboard.
3 g – bags (30) – packs cardboard.

◊ Granules for oral solution white, with a distinctive Mint-aniseed odor.

Excipients: L-arginine, natriya carbonate, sodium saccharin, Aspartame, mint flavor, anise flavoring, sucrose.

3 g – bags (12) – packs cardboard.
3 g – bags (30) – packs cardboard.

Pharmacological action

NSAIDs. Ibuprofen is the active substance of the preparation Faspik – is a derivative of propionic acid has analgesic and, antipyretic and Antiinflammatory action due to non-selective blockade of Cox-1 and Cox-2, as well as inhibitory effects on the synthesis of prostaglandins.

Analgezirutee effect most pronounced inflammatory pain. Right position activity of the drug does not belong to the opioidnomu type.

Like other NSAIDs, ibuprofen has antiplatelet activity.

Analgesic effect in applying the drug Faspik is 10-45 minutes after his admission.

Pharmacokinetics

Absorption

After oral administration, the drug is well absorbed from the gastrointestinal tract. After taking the drug on an empty stomach Faspik in the form of tablets at a dose of 200 mg 400 mg C_max ibuprofen plasma is approximately 25 ug / ml 40 µg/ml, respectively and achieved within 20-30 m.

After taking the drug on an empty stomach Faspik in the form of a solution in a dose 200 mg 400 mg C_max ibuprofen plasma is approximately 26 ug / ml 54 µg/ml, respectively and achieved within 15-25 m.

Distribution

Plasma protein binding is about 99%. He slowly distributed in synovial fluid and removed from it more slowly, than from plasma.

Metabolism

Ibuprofen is metabolizmu in the liver mainly through hydroxylation and carboxylation izobutilovoj group. The metabolites are pharmacologically inactive.

Deduction

Characterized by two-phase kinetics of excretion. T_1/2 from plasma is 1-2 no. To 90% doses may be found in urine as metabolites and their conjugates. Less 1% excreted unchanged in the urine and, to a lesser extent, – the bile.

Testimony

— crazy Syndrome different Genesis;

— pain syndrome varying etiology (incl. sore throat, headache, migraine, toothache, neuralgia, post-operative pain, post-traumatic pain, Primary algomenorrhea);

is inflammatory and degenerative diseases of joints and spine (incl. rheumatoid arthritis, ankiloziruyushtiy spondylitis).

Dosage regimen

The drug is taken orally.

Adults and children over 12 years the drug is prescribed in form of tablets at an initial dose 400 mg; if necessary – by 400 mg every 4-6 no. The maximum daily dose is 1200 mg. Pill combination with a glass of water (200 ml). To reduce the risk of digestive side effects it is recommended to take the drug while eating.

The drug should not take more 7 days or in higher doses. If necessary, the use of a more long-term or in higher doses require consultation with a doctor.

As oral solution drug prescribed adults and children over 12 years drug administered in a daily dose 800-1200 mg (4-6 bags for 200 mg or 2-3 bag on 400 mg). The maximum daily dose 1200 mg.

Before taking the contents paketika dissolving in water (50-100 ml) and taken inside immediately after cooking solution during or after a meal.

To overcoming morning stiffness patients with arthritis are encouraged to take the first dose of the drug immediately upon awakening.

In patients with impaired renal function, liver or heart dose should be reduced.

Side effect

From the digestive system: NSAID-gastropathy – stomach ache, nausea, vomiting, heartburn, poor appetite, diarrhea, flatulence, constipation; rarely – izgyazwlenia gastrointestinal mucosa (in some cases complicated by perforation and bleeding); perhaps – irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, thrush, pancreatitis, hepatitis.

The respiratory system: breathlessness, bronchospasm.

From the senses: hearing loss, ringing or noise in the ears, toxic damage of the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis).

From the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations; rarely – aseptic meningitis (more frequently in patients with autoimmune diseases).

Cardio-vascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (swelling), polyuria, cystitis.

From the hematopoietic system: anemia (incl. hemolytic, aplastic), thrombocytopenia, trombotsitopenicheskaya purpura, agranulocytosis, leukopenia.

From the laboratory parameters: may increase bleeding time, reduction of the concentration of glucose in serum, decrease in QC, decrease in hematocrit or hemoglobin, increased serum creatinine concentration, increase in liver transaminases.

Allergic reactions: skin rash (usually erythematous or urticaria), itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, dyspnoea, fever, erythema multiforme exudative (incl. Stevens syndrome- Johnson), toxic epidermal necrolysis (Lyell's syndrome), eozinofilija, nasal allergy.

With long-term use the drug at high doses increases the risk of gastrointestinal mucosa ulceration, bleeding (gastro-intestinal, gum, Royal, haemorrhoid), impairment (violations of color vision, scotoma, lesions of the optic nerve).

Contraindications

- Erosive and ulcerative diseases of the gastrointestinal tract (in t. no. gastric ulcer and duodenal ulcer in the acute phase, Crohn's disease, NYAK);

- “Aspirin” asthma;

- Hemophilia and other bleeding disorders (incl. hypocoagulation), hemorrhagic diathesis;

-bleeding of different etiology;

-diseases of the optic nerve;

- Pregnancy;

- Lactation;

- Children up to age 12 years;

- Hypersensitivity to the drug;

- Hypersensitivity to aspirin or other NSAIDs history.

FROM caution the drug should be used in patients with heart failure; hypertension; liver cirrhosis with portal hypertension; hepatic and/or renal failure, nephrotic syndrome, hyperbilirubinemia; gastric ulcer and duodenal ulcer (history), gastritis, enteritis, KOLITA; blood diseases of unknown etiology (leukopenia and anaemia), as well as in elderly patients.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breast-feeding).

Application Faspika can negatively affect female fertility and is not recommended for women, planning pregnancy.

Cautions

If you experience signs of bleeding from the stomach Faspik should be abolished.

Application Faspika can mask the objective and subjective symptoms of infection, Therefore, the drug should be administered with caution to patients with infectious diseases.

Occurrence of bronchospasm in patients may, suffering from bronchial asthma or allergic reactions in history or the present.

Side effects can be reduced with the use of the drug in the minimum effective dose. With long-term use of analgesics available risk analgetic nephropathy.

Patients, Mark impairment therapy Faspikom, should discontinue treatment and complete ophthalmologic examination.

Ibuprofen can increase the activity of liver enzymes.

During treatment requires monitoring of peripheral blood and functional state of the liver and kidneys.

When symptoms of gastropathy shows careful monitoring, comprising carrying out esophagogastroduodenoscopy, blood tests, hemoglobin, gematokrita, fecal occult blood test.

In order to prevent the development of NSAID gastropathy-ibuprofen should be combined with prostaglandin E1 (Misoprostol).

If you want to determine the 17-ketosteroids drug should be discontinued for 48 h before the test.

During treatment is not recommended admission of ethanol.

The preparation contains sucrose (1 tablet – 16.7 mg, 1 bag of pellets- 1.84 g), that should be taken into account when patients relevant hereditary fructose intolerance, glucose-Galactose malabsorption syndrome or sucrase deficiency-izomaltazy.

Effects on ability to drive vehicles and management mechanisms

Patients should refrain from all activities, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: stomach ache, nausea, vomiting, lethargy, drowsiness, depression, headache, noise in ears, metabolic acidosis, coma, acute renal failure, decrease in blood pressure, bradycardia, tachycardia, Atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only during 1 h after administration), Activated carbon, alkaline water, diurez, simptomaticheskaya therapy (correction of acid-base status, FROM).

Drug Interactions

May reduce the effectiveness of furosemide and thiazide diuretic because of delays sodium, related to the inhibition of prostaglandin synthesis in the kidneys.

Ibuprofen may exacerbate the effects of indirect anticoagulants, antiagregantov, fibrinolitikov (increase the risk of bleeding complications).

Together with the appointment of acetylsalicylic acid, ibuprofen reduces the antiplatelet effect (may increase the incidence of acute coronary insufficiency in patients, receiving antiplatelet agents as low-dose acetylsalicylic acid).

Ibuprofen may reduce the effectiveness of antigipertenziveh funds (incl. blockers of slow calcium channels, and ACE inhibitors).

The literature described sporadic increase plasma concentrations of Digoxin, fenitoina and lithium while receiving ibuprofen. Funds, block tubular secretion, reduce excretion and increase plasma concentrations of ibuprofen.

Faspik, Like other NSAIDs, should be used with caution in combination with acetylsalicylic acid or other NSAIDS, tk. This increases the risk of adverse effects of the drug on the DIGESTIVE TRACT.

Ibuprofen may increase methotrexate concentration in plasma.

In combination therapy with zidovudine and Faspikom may increase the risk of gemartrozov and hematomas in HIV-infected patients, with hemophilia.

Combined use of Tacrolimus and Faspika may increase the risk of nefrotoksicski action due to a violation of the synthesis of prostaglandins in kidney.

Ibuprofen enhances the hypoglycemic effect of insulin and oral gipoglikemicakih funds; There may be a need for dose adjustment.

Described ulcerogennoe action with bleeding when combined Faspika with colchicine, Estrogen, ethanol, GCS.

Antacids reduce the absorption of cholestyramine and ibuprofen.

Caffeine reinforces analgeziruty effect Faspika.

If you are applying to Faspika with tromboliticheskimi means (alteplase, streptokinase, urokinase) increased risk of bleeding.

Цefamandol, cefoperazone, cefotetan, valproic acid, plikamicin together with the use of Faspikom increases the incidence of gipoprotrombinemii.

Mielotoksicskie means if you are applying to reinforcing manifestations gematotoksicnosti Faspika.

Ciclosporin and preparations of ibuprofen to reinforce gold prostaglandin synthesis in the kidneys, that is manifested by increased nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporin and the probability of its hepatotoxic effects.

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of gidroksilirovannyh active metabolite of ibuprofen, increasing the risk of severe hepatotoxic reactions.

Inhibitors mikrosomalnogo oxidation reduces the risk of hepatotoxic action of ibuprofen.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be kept out of the reach of children when temperature is not above 40° c. Shelf life Tablets – 2 year, granules – 3 year.