Nemulex, 100 mg 10 pcs.

Nemulex – NSAID, has anti-inflammatory, analgesic, antipyretic and antiaggregant effect.

In contrast to other NSAIDs it selectively inhibits COX-2, inhibits synthesis of Pg in inflamed area, has less pronounced inhibitory effect on COX-1 (causes side effects related to inhibition of Pg synthesis in healthy tissues less frequently).

Indications

Active ingredient

Composition

1 sachet:

– nimesulide 100 mg

excipients:

macrogoal cetostearate (cremophor A25) – 100 mg,

citric acid anhydrous – 19 mg,

p> colloidal silica (aerosil) – 40 mg,

sucrose – 1721 mg,

orange flavoring – 20 mg.

How to take, the dosage

Ingestion.The contents of 1 sachet of Nemulex granulate is dissolved in 80-100 ml of water. The recommended dose for adults and adolescents aged 12-18 years is 100 mg (1 sachet of Nemulex) 2 times a day after meals.

The maximum daily dose for adults and adolescents aged 12-18 years is 200 mg. No dose reduction is required for elderly patients. Patients with chronic renal insufficiency need to reduce the daily dose to 100 mg.

The lowest effective dose of Nemulex should be administered for as short a period as possible to minimize the risk of adverse reactions.

The maximum duration of Nemulex should not exceed 15 days.

Interaction

There is evidence that nimesulide may decrease the bioavailability of furosemide, act as a competitor in binding plasma proteins with fenofibrate, salicylic acid, tolbutamide. Nimesulide can replace salicylic acid and furosemide (but not warfarin) in plasma proteins. It has no effect on drugs affecting blood glucose concentration and glucose tolerance in diabetic patients treated with various drugs containing sulfonylurea derivatives.

The use of nimesulide concomitantly with diuretics that have a damaging effect on renal hemodynamics is not recommended. Physiological concentrations of unsaturated fatty acids do not affect the binding of nimesulide to serum albumin. Warfarin, furosemide, glibenclamide, digitoxin did not affect nimesulide binding in therapeutic concentrations. Free fractions of methotrexate may increase significantly in the presence of nimesulide.

The administration of nimesulide in therapeutic doses orally for a short period does not change the serum profile of digoxin in patients with mild heart failure. Plasma lithium concentration is increased when concomitant administration of lithium and nimesulide. Nimesulide may increase the effect of cyclosporine on the kidneys. Nemulex use with glucocorticosteroids, serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.

Special Instructions

To reduce the risk of side effects, Nemulex should be used in the lowest effective dose with the shortest duration. If the patient’s condition does not improve, the treatment should be stopped. It is necessary to stop the drug in case of fever or if during its use the flu-like symptoms develop.
If the patients taking Nimesulide have symptoms indicating liver damage (e.g., anorexia, nausea, vomiting, abdominal pain, increased fatigability, dark urine) or increased “liver” transaminases, the drug should be stopped.

In such patients it is not recommended to prescribe Nimesulide further. Gastrointestinal bleeding or gastric or duodenal ulcer/perforation may develop at any time while using the drug, which may not be accompanied by clinically pronounced symptoms (including pain syndrome). If gastrointestinal bleeding or ulceration occurs, the drug should be discontinued.

In case of worsening of renal function, the drug Nemulex should be discontinued. In case of using the drug for more than 2 weeks, monitoring of liver function parameters is necessary. In patients with cirrhosis or with renal failure with hypoalbuminemia or hyperbilirubinemia the binding of nimesulide is reduced. Elderly patients most commonly develop side effects when taking the drug, including gastrointestinal bleeding, perforations, cardiac, renal and hepatic dysfunction.

Hence regular clinical monitoring of the patient’s condition is recommended. The use of nimesulide may adversely affect female fertility and is not recommended for women planning to become pregnant. If undesirable effects of the central nervous system and sensory organs occur while using the drug Nemulex it is necessary to refrain from driving a vehicle and engaging in activities requiring high concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity, complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis and intolerance to ASA and others. NSAIDs (including in anamnesis), erosive and ulcerative lesions of the mucous membrane of the stomach and duodenum, active gastrointestinal bleeding, cerebrovascular or other bleeding, inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase, hemophilia, etc. bleeding disorders, decompensated CHF, hepatic insufficiency or any active liver disease, hepatotoxic reactions when using nimesulide in anamnesis, alcoholism, drug abuse, marked CVD (CKR less than 30 ml/min), advanced renal disease, confirmed hyperkalemia, period after coronary artery bypass grafting, concomitant use of other hepatotoxic drugs, pregnancy, lactation, children under 12 years.

With caution. CHD, CHD, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, renal insufficiency (CK 30-60 ml/min), anamnestic data about peptic ulcer disease, Helicobacter pylori infection, elderly age, long-term use of NSAIDs, alcoholism, severe systemic diseases, concurrent use of anticoagulants (including anticonvulsants – warfarin, anticoagulant therapy).anticoagulants (including warfarin), antiplatelet agents (including ASA, clopidogrel), oral GCS, selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Allergic reactions: hypersensitivity reactions, anaphylactoid reactions.

Central nervous system disorders: dizziness, anxiety, nervousness, nightmares, headache, drowsiness, encephalopathy (Reye’s syndrome).

Skin disorders: itching, skin rash, increased sweating, erythema, dermatitis, urticaria, angioedema, facial edema, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

More urinary system disorders: edema, dysuria, hematuria, urinary retention, hyperkalemia, renal failure, oliguria, interstitial nephritis.

Gastrointestinal tract: diarrhea, nausea, vomiting, constipation, flatulence, gastritis, abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum.

Hepatic and biliary system disorders: increased “hepatic” transaminases, hepatitis, lightning hepatitis, jaundice, cholestasis.

Hematopoietic disorders: anemia, eosinophilia, thrombocytopenia, pancytopenia, purpura, prolongation of bleeding time.

Respiratory system: dyspnea, exacerbation of bronchial asthma, bronchospasm.

Senses: blurred vision.

Cardiovascular system: arterial hypertension, tachycardia, hemorrhages, “hot flashes”.
Other: general weakness, hypothermia.

Overdose

Symptoms: nausea, vomiting, somnolence, apathy, gastrointestinal bleeding, increased blood pressure, acute renal failure, respiratory depression;

Treatment: symptomatic and supportive treatment is recommended. There is no specific antidote for Nimesulide. Patients admitted to the hospital with symptoms of overdose by the drug (within 4 hours after intake or after taking a high dose) are recommended to wash the stomach, take activated charcoal (adults – 60-100 mg) and/or laxative agent of osmotic type. Regular control of liver and kidney function is necessary.

There are no data on the possibility of excretion of nimesulide with hemodialysis.

Formed diuresis and hemodialysis are ineffective due to the high protein binding of the drug.

Similarities