Ibutard capsules 300 mg. №20

Description

IBUTARD COMPOSITION
active substance: ibuprofen

1 capsule contains ibuprofen (sustained release pellets) 300 mg

auxiliary substances: in the composition of the pellets – spherical sugar, povidone, talc, ethylcellulose, shellac in the capsule – azorubin (E 122), gelatin.

IBUTARD DOSAGE FORM
Sustained-release capsules.

IBUTARD MAIN PHYSICAL AND CHEMICAL PROPERTIES:
hard capsules with a transparent red cap and a transparent colorless body, which contain pellets of white with a yellowish or cream shade.

PHARMACOLOGICAL GROUP
Non-steroidal anti-inflammatory drugs. Propionic acid derivatives. Ibuprofen. ATX code М01А Е01.

PHARMACOLOGICAL PROPERTIES

Pharmacological.

Ibuprofen is an NSAID drug (NSAID), a propionic acid derivative, that effectively inhibits the synthesis of prostaglandins – mediators of pain and inflammation. Ibuprofen has antipyretic, anti-inflammatory and analgesic effects. In addition, ibuprofen reversibly inhibits platelet aggregation.

Experimental ex vivo data indicate that with the simultaneous use of ibuprofen can competitively inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation. Although there is uncertainty about the extrapolation of these data to the clinical situation, the possibility that regular and prolonged use of ibuprofen can reduce the cardioprotective effect of low doses of acetylsalicylic acid cannot be ruled out. With irregular use of ibuprofen, the occurrence of such clinically significant effects is considered unlikely.

Pharmacokinetics.

Ibuprofen is well absorbIbutardIbutarded from the gastrointestinal tract, actively binds to blood plasma proteins, about 99%. With oral administration of a conventional-release dosage form, peak plasma concentration is reached after 1–2 hours.

Ibuprofen is metabolized in the liver (hydroxylation, carboxylation).

Inactive metabolites are completely excreted from the body, mainly in the urine (90%), as well as in the bile. The half-life in healthy people and patients with liver and kidney diseases is 1.8-3.5 hours. T1 / 2 of ibuprofen from the sustained-release forms is about 8:00. Ibutard 300 prolonged-release capsules provide a 12-hour drug action (ibuprofen is released slowly, thereby maintaining a constant concentration of the drug in the blood).

At doses ranging from 200 to 400 mg, linear kinetics of ibuprofen was observed. At higher doses, nonlinear kinetics of the drug was observed.

In elderly patients, there are no significant differences in the pharmacokinetic profile.

INDICATIONS
Symptomatic treatment of headache, including migraine, toothache, dysmenorrhea, neuralgia, back pain, joint pain, muscle pain, rheumatic pain, as well as symptoms of colds and flu.

CONTRAINDICATIONS
Known or suspected hypersensitivity to ibuprofen or other components of the drug
hypersensitivity reactions (acute asthmatic attacks or asthma symptoms, urticaria, nasal polyposis, anaphylaxis, rhinitis, angioedema) when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) – the risk of lethal anaphylactic reactions due to the possibility of cross-hypersensitivity
history of gastrointestinal bleeding / perforation associated with previous NSAID therapy
active form of peptic ulcer / bleeding or perforation, two or more episodes of peptic ulcer disease / bleeding or perforation in anamnesis
active inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
recent cerebrovascular bleeding or other bleeding disorders
disorders of hematopoiesis or blood clotting
diseases of the optic nerve (optic neuritis)
severe dysfunction of the liver, kidneys
severe uncontrolled heart failure (NYHA IV)
severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).