Nimesulide (Najsulid) granules for oral 100 mg – [30 sachets]

Description

Naisulide Pharmacodynamics
Nimesulide is a non-steroidal anti-inflammatory agent of the class of sulfonamides. It has anti-inflammatory, analgesic and antipyretic effects. Unlike non-selective NSAIDs, nimesulide mainly inhibits cyclooxygenase-2 (COX-2), inhibits the synthesis of prostaglandins in the inflammation focus; it has less pronounced inhibitory effect on cyclooxygenase-1 (COX-1).

Indications
– Pain (backache, lower back pain; pain syndrome in musculoskeletal system, including bruises, sprains and dislocations; tendonitis, bursitis; toothache);
– symptomatic treatment of osteoarthritis (osteoarthritis) with pain syndrome;
– primary algodysmenorrhea.
The drug is intended for symptomatic therapy, reduction of pain and inflammation at the time of use; nimesulide is recommended for therapy as a second-line drug.

Contraindications
– Hypersensitivity to nimesulide or other components of the drug;
– history of hyperergic reactions (bronchospasm, rhinitis, urticaria) associated with the use of acetylsalicylic acid or other NSAIDs, including nimesulide;
– complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis with intolerance to acetylsalicylic acid and other NSAIDs (including history);
– hepatotoxic reactions to nimesulide in history;
– concomitant use with other drugs with potential hepatotoxicity (e.g., other NSAIDs);
– chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase;
– period after coronary artery bypass surgery;
– febrile syndrome in colds and acute respiratory viral infections;
– suspected acute surgical pathology;
– gastric or duodenal ulcer in the acute phase; gastrointestinal erosive and ulcerative lesions; perforations or gastrointestinal bleeding in the anamnesis;
– history of cerebrovascular bleeding or other conditions associated with excessive bleeding;
– Severe clotting disorders;
– severe heart failure;
– severe renal insufficiency (creatinine clearance < 30 ml/min), confirmed hyperkalemia;
– children under 12 years of age;
– pregnancy and breastfeeding;
– alcoholism, drug addiction;
– hereditary fructose intolerance, sucrose-isomaltase deficiency and glucose-galactose malabsorption syndrome.

Dosage and administration

• Inside. The contents of the sachet is dissolved in about 100 ml of water at room temperature (white or light yellow suspension is formed).
• Prepared solution must not be stored.
• Naisulide® is used only for treatment of patients over 12 years old.
• Adults and children over 12 years of age: 1 sachet twice daily, after meals.
• Elderly patients: during treatment of elderly patients the necessity to correct daily dose is determined by physician taking into account possibility of interaction with other drugs.
• Patients with renal insufficiency: in patients with mild to moderate renal insufficiency (creatinine clearance 30-60 ml/min) a dose adjustment is not required, while in patients with severe renal insufficiency (creatinine clearance <30 ml/min) Naisulide® is contraindicated.
• Patients with hepatic impairment:
  The use of the drug Naisulide® in patients with hepatic impairment is contraindicated.
• To reduce the likelihood of side effects, it is recommended that the minimum effective dose be taken for the shortest possible time.
• Maximum daily dose for adults and children over 12 years old is 200 mg.
• Maximum duration of treatment course is 15 days.