Gofen 400 soft capsules 400 mg. №60

Description

Gofen Storage
active substance: ibuprofen;

1 soft capsule contains ibuprofen 400 mg;

excipients: polyethylene glycol 600, potassium hydroxide, purified water;

gelatin capsule: gelatin, sorbitol, non-crystallizing solution (E 420), purified water.

Gofen Dosage form
The capsules are soft.

Main physical and chemical properties: elongated soft capsules with a transparent shell of natural color, the contents of the capsule – a clear, colorless oily liquid.

Gofen Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of propionic acid.

ATX code M01A E01.

Pharmacological properties

Pharmacodynamics.

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), a derivative of propionic acid, which has been shown to be effective in inhibiting the synthesis of prostaglandins, mediators of pain and inflammation. Ibuprofen has analgesic, antipyretic and anti-inflammatory effects. In addition, ibuprofen inversely inhibits platelet aggregation.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation with concomitant use of these drugs. Some pharmacodynamic studies indicate that single doses of ibuprofen 400 mg within 8 hours before or within 30 minutes of immediate-release acetylsalicylic acid (81 mg) reduced the effect of acetylsalicylic acid (aspirin) on thromboxane formation or aggregation by thromboxane. Although there is uncertainty about the extrapolation of these data to the clinical situation, it cannot be ruled out that regular long-term use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid. In the case of unsystematic use of ibuprofen, such a clinically significant effect is considered unlikely.

Pharmacokinetics.

When administered orally, ibuprofen is rapidly absorbed partially in the stomach and then completely in the small intestine.

After metabolism in the liver (hydroxylation, carboxylation, conjugation), pharmacologically inactive metabolites are completely excreted mainly in the urine (90%) as well as in the bile. The half-life in healthy volunteers, as well as in patients with liver and kidney disease, is 1.8-3.5 hours. Plasma protein binding is approximately 99%. With oral administration of the usual release dosage form, the maximum concentration in blood plasma is reached in 1-2 hours. Ibuprofen is detected in plasma for more than 8 hours after taking the drug.

Indication
Symptomatic treatment of mild to moderate pain of various origins (headache, toothache, painful menstruation), including colds and fevers.

Contraindication
Hypersensitivity to ibuprofen or to any of the components of the drug.
Hypersensitivity reactions (eg, bronchial asthma, rhinitis, angioneurotic edema, or urticaria) previously seen with ibuprofen, acetylsalicylic acid (aspirin), or other NSAIDs.
Gastric ulcer / bleeding in active form or recurrence in the anamnesis (two or more pronounced episodes of peptic ulcer disease or bleeding).
History of gastrointestinal bleeding or perforation associated with NSAID use.
Severe hepatic impairment, severe renal impairment, severe heart failure (NYHA class IV).
The last trimester of pregnancy.
Cerebrovascular or other bleeding in the active phase.
Hemorrhagic diathesis or coagulation disorders.
Hematopoietic disorders of unknown etiology.
Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).