Flogoxib (celecoxib) capsules 0.2 g. №10

Description

Flogoxib 0.2 g Storage:
active substance:
celecoxib;

1 capsule contains celecoxib 100 mg or 200 mg;

Flogoxib 0.2 g excipients:
lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; povidone; magnesium stearate; The capsule shell contains erythrosine (E 127), titanium dioxide (E 171), quinoline yellow (E 104), gelatin, black ink (in the case of trademarking – ST; contain Glaze shellac 45% solution in ethanol, iron oxide black ( E 172), propylene glycol, ammonia solution concentrated) (dosage 100 mg) or patented blue V (E 131), titanium dioxide (E 171), gelatin (dosage 200 mg).

Flogoxib 0.2 g Dosage form
Capsules.

Basic physical and chemical properties:
hard gelatin capsules with an opaque body and a lid of yellow (dosage 100 mg) or from light blue to blue (dosage 200 mg) color. The content of the capsules is a white powder. The presence of agglomerates of powder particles is allowed. On the capsule (dosage of 100 mg) it is allowed to apply the trademark of the enterprise – ST.

Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs. Coxibs.
ATC code M01A H01.

Pharmacological properties

Pharmacodynamics

Nonsteroidal anti-inflammatory drug (NSAID), which demonstrates anti-inflammatory, analgesic and antipyretic activity. It is believed that the mechanism of action of celecoxib is due to inhibition of prostaglandin synthesis, mainly by inhibition of cyclooxygenase-2 (COX-2); at therapeutic concentrations in humans, celecoxib does not inhibit the isoenzyme cyclooxygenase-1 (COX-1). In animals, celecoxib reduced the incidence and multiplicity of colon tumors.

Platelets. Celecoxib in single doses up to 800 mg and multiple doses of 600 mg twice daily for up to 7 days (exceeding the recommended therapeutic doses) did not reduce platelet aggregation and did not increase bleeding time. Celecoxib cannot replace acetylsalicylic acid in the prevention of cardiovascular disease because it has no effect on platelets. It is not known whether celecoxib affects platelets in increasing the risk of serious cardiovascular thrombotic adverse reactions associated with celecoxib.

Indication.

For the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

For the treatment of acute pain in adult patients.

For the treatment of primary dysmenorrhea.

Contraindication.

Hypersensitivity to celecoxib (eg anaphylactic reactions and severe skin reactions), acetylsalicylic acid, other NSAIDs or to any of the components of the drug.

Allergic reactions to sulfanilamides in the anamnesis.

Bronchial asthma, urticaria, or other allergic reactions after a history of acetylsalicylic acid or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see section 4.4).

Treatment of perioperative pain during coronary artery bypass graft surgery.

Acute gastrointestinal bleeding.