Nimulid for children with fever: reviews by Komarovsky, instructions for use, indications, contraindications

Nosological classification (ICD-10)

• M06.9 Rheumatoid arthritis, unspecified
• M07.3 Other psoriatic arthropathies (L40.5+)
• M10.9 Gout, unspecified
• M19.9 Arthrosis, unspecified
• M42 Osteochondrosis of the spine
• M45 Ankylosing spondylitis
• M54.1 Radiculopathy
• M54.3 Sciatica
• M54.4 Lumbago with sciatica
• M54.5 Pain in the lower back
• M67.9 Lesion of synovium and tendon, unspecified
• M71.9 Bursopathy, unspecified
• M79.1 Myalgia
• T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of a joint of an unspecified area of ​​the body
• T14.9 Injury, unspecified
• Z100* CLASS XXII Surgical practice

Compound

Pharmacodynamics

Nimulide is an NSAID from the sulfonanilide class. Has anti-inflammatory, analgesic and antipyretic effects.

Nimesulide is a NSAID, the mechanism of action of which is associated with selective inhibition of COX-2 and effects on a number of other factors - suppression of platelet activating factor, tumor necrosis factor alpha, suppression of proteinases and histamine. By selectively suppressing COX-2, it reduces the biosynthesis of PG at the site of inflammation and has a less pronounced inhibitory effect on COX-1 (less likely to cause side effects associated with inhibition of PG synthesis in healthy tissues).

General characteristics

Nimulid is a hormonal drug that has antipyretic, analgesic and anti-inflammatory effects. The drug has an antioxidant effect: it stops the growth of harmful microbes, thereby avoiding intoxication of the body. This destroys the source of inflammation, which speeds up the healing process. Nimulid reduces bronospasms.

The drug is used in ENT practice, dentistry, and also for the treatment of diseases of muscles, joints and bones.

Komarovsky often prescribes Nimulid to a child, since the drug does not disrupt the microflora of the gastrointestinal tract. The medicine is excreted from the body through urine and, to a lesser extent, through feces.

Pharmacokinetics

Absorption when taken orally is high (food intake reduces the rate of absorption without affecting its degree). Communication with plasma proteins - 95%, with erythrocytes - 2%, with lipoproteins - 1%, with acidic alpha 1-glycoproteins - 1%. Changing the dose does not affect the degree of binding. Cmax - 3.5–6.5 mg/l. Vd - 0.19–0.35 l/kg.

Penetrates into the tissues of the female genital organs, where after a single dose its concentration is about 40% of the concentration in plasma. Penetrates well into the acidic environment of the inflammation site (40%) and synovial fluid (43%). Easily penetrates histohematic barriers.

Metabolized in the liver by tissue monooxygenases. The main metabolite, 4-hydroxynimesulide (25%), has similar pharmacological activity, but due to a decrease in molecular size, it is able to quickly diffuse through the hydrophobic COX-2 channel to the active binding site of the methyl group. 4-Hydroxynimesulide is a water-soluble compound, the elimination of which does not require glutathione and phase II metabolic conjugation reactions (including sulfation, glucuronidation).

T1/2 of nimesulide is about 1.56–4.95 hours, 4-hydroxynimesulide is 2.89–4.78 hours. 4-Hydroxynimesulide is excreted by the kidneys (65%) and bile (35%), and undergoes enterohepatic recirculation.

In patients with renal failure (creatinine clearance 1.8–4.8 l/h or 30–80 ml/min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide does not change significantly.

Side effects

Nimulid has side effects, which include:

• Allergy;
• Rash;
• Central nervous system disorders;
• Urinary problems;
• Gastrointestinal disorders;
• Heart rhythm disturbances;
• Problems with blood flow;
• Visual impairment.

To reduce the risk of side effects, it is necessary to take tablets in the minimum dose and for the shortest duration.

If the temperature does not subside when taking Nimulid for children, Komarovsky advises stopping treatment and contacting your pediatrician again. If the tablets are taken for more than 2 weeks, liver monitoring must be prescribed.

Contraindications

Pills

hypersensitivity to nimesulide and components of the drug;

erosive and ulcerative changes in the mucous membrane of the stomach and duodenum;

inflammatory bowel diseases in the acute phase;

active gastrointestinal bleeding;

severe impairment of liver and/or kidney function, severe renal failure (Cl creatinine <30 ml/min);

progressive kidney disease;

severe liver failure or active liver disease;

severe heart failure;

severe blood clotting disorders;

confirmed hyperkalemia;

period after coronary artery bypass surgery;

anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, nasal polyps, asthma);

pregnancy and breastfeeding;

children's age up to 12 years.

Lozenges

hypersensitivity to the active substance or auxiliary components;

complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history);

erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;

inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the acute phase;

hemophilia and other bleeding disorders;

decompensated heart failure;

liver failure or any active liver disease;

severe renal failure (creatinine Cl <30 ml/min);

progressive kidney disease;

confirmed hyperkalemia;

period after coronary artery bypass surgery;

anamnestic data on the development of hepatotoxic reactions when using nimesulide preparations;

concomitant use of potentially hepatotoxic substances;

alcoholism, drug addiction;

pregnancy, breastfeeding period;

children's age up to 12 years.

With caution (tablets, lozenges): coronary heart disease, cerebrovascular diseases, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine Cl <60 ml/min.

Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, old age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant therapy with the following drugs - anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral corticosteroids (eg prednisolone), SSRIs (eg citalopram, fluoxetine, paroxetine, sertraline).

Nimulid suspension bottle 50mg/5ml 60ml

A country

India
Country of manufacture may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Nimesulide

Compound

The active substance is nimesulide.

pharmachologic effect

Anti-inflammatory, antipyretic, analgesic. Selectively inhibits cyclooxygenase-2, suppresses prostaglandin synthesis at the site of inflammation. Inhibits lipid peroxidation and does not affect hemostasis and phagocytosis. After oral administration, it is well absorbed from the gastrointestinal tract. Maximum concentration is achieved after 1.5–2.5 hours. The half-life is 2-3 hours. Biotransformed in the liver. The main metabolite is the pharmacologically active hydroxynimesulide. It is excreted primarily by the kidneys. It does not accumulate with long-term use. Nise gel is a new generation non-steroidal anti-inflammatory drug (NSAID) from the sulfonamide class. It has a local analgesic and anti-inflammatory effect. When applied topically, it causes a weakening or disappearance of pain at the site of application of the gel, including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints. Helps increase range of motion.

Indications for use

Osteoarthritis, osteoarthritis, bursitis, tendonitis, pain and inflammatory processes (in case of injuries, in the postoperative period, gynecological and infectious-inflammatory diseases). Nise gel: inflammatory and degenerative diseases of the musculoskeletal system (articular syndrome with rheumatism and exacerbation of gout, rheumatoid arthritis , psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, inflammatory damage to ligaments, tendons, bursitis, sciatica, lumbago). Muscle pain of rheumatic and non-rheumatic origin. Post-traumatic inflammation of soft tissues and the musculoskeletal system (damage and rupture of ligaments, bruises).

Interaction

It can increase the effectiveness and toxicity of many drugs, due to their displacement from sites of binding to plasma proteins and an increase in the free fraction in the blood (with the simultaneous administration of hydantoin and sulfonamides, regular medical supervision is required). Enhances the effect of medications that reduce blood clotting; increases plasma lithium levels.

Side effect

Headache, dizziness, drowsiness; very rarely - thrombocytopenia; nausea, heartburn, stomach pain, tarry stools, melena; petechiae, purpura; oliguria; allergic reactions (exanthema, erythema, urticaria). Nise gel: Local reactions: itching, urticaria, peeling, transient change in skin color (not requiring discontinuation of the drug). If any adverse reactions occur, you should stop using the drug and consult your doctor. When applying the gel to large areas of the skin, the development of systemic adverse reactions cannot be ruled out: heartburn, nausea, vomiting, diarrhea, gastralgia, ulceration of the gastrointestinal mucosa, increased activity of “liver” transaminases; headache, dizziness; fluid retention, hematuria; allergic reactions (anaphylactic shock, skin rash); thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Contraindications

Hypersensitivity, peptic ulcer of the stomach and duodenum in the acute stage, severe dysfunction of the liver and kidneys, bleeding from the gastrointestinal tract, type 2 diabetes mellitus, arterial hypertension, congestive heart failure, pregnancy, lactation. Restrictions for use: children's age (up to 12 years ).

Overdose

Symptoms: increased severity of side effects. Treatment: gastric lavage, administration of activated charcoal.

special instructions

Prescribed with caution to elderly patients, with cardiovascular diseases, including arterial hypertension, bleeding tendency, disorders of the upper gastrointestinal tract, impaired renal function, during treatment with anticoagulants and antiplatelet agents. If visual disturbances occur, you should immediately stop taking the drug and consult an ophthalmologist. Patients with diabetes mellitus and patients on a low-calorie diet should take into account that the drug contains sucrose. Prescribe with caution to patients whose work requires increased attention and reaction speed.

Dispensing conditions in pharmacies

On prescription

Side effects

Frequency is classified depending on occurrence - very common (>10); often (<10–<100); uncommon (<100–<1000); rare (<1000–<10000); very rare (<10,000).

From the gastrointestinal tract: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, stomatitis, tarry stools, gastrointestinal bleeding, ulcer and/or perforation of the stomach or duodenum.

From the side of the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome).

From the respiratory system: infrequently - shortness of breath; very rarely - bronchospasm; Possible exacerbation of bronchial asthma.

From the cardiovascular system: infrequently - arterial hypertension; rarely - tachycardia, hemorrhages, hot flashes.

From the senses: rarely - blurred vision.

Skin and mucous membranes: infrequently - itching, rash, increased sweating; rarely - erythema, dermatitis.

Liver and biliary system: often - increased activity of liver transaminases; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis.

Kidneys and urinary system: infrequently - edema; rarely - dysuria, hematuria, urinary retention, hyperkalemia; very rarely - renal failure, oliguria, interstitial nephritis.

From the hematopoietic organs: rarely - anemia, eosinophilia; very rarely - thrombocytopenia, pancytopenia, purpura, prolonged bleeding time.

Allergic reactions: rarely - hypersensitivity reactions; very rarely - anaphylactoid reactions, urticaria, angioedema, facial swelling, exudative erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

General reactions: rarely - general weakness; very rarely - hypothermia.

If other side effects not mentioned above occur or if you feel unwell, you should consult a doctor immediately.

When to call an ambulance?

There is no need to call an ambulance. No isolated increase in temperature is a reason for this. Isolated means that there are no other threatening symptoms, such as an unclear rash, severe shortness of breath or a bulging fontanel. Yes, an ambulance can always lower the temperature - with a lytic mixture or a hormone. But this is not necessary and may cause harm. The drug that forms the basis of the lytic mixture - analgin (metamizole) - is prohibited in children throughout the civilized world. In addition, the ambulance is more likely to offer hospitalization.

Fever is not an emergency condition. If it worries you, lower your temperature and go to the doctor. Or call a doctor at home as planned.

Source: telegram.me/fediatrix

Interaction

The effect of medications that reduce blood clotting is enhanced when used simultaneously with nimesulide.

Nimesulide may reduce the effect of furosemide. Reduces the therapeutic effect of antihypertensive drugs. Nimesulide may increase the possibility of side effects while taking methotrexate.

Plasma lithium levels increase when lithium and nimesulide are taken simultaneously.

Due to the high degree of binding of nimesulide to plasma proteins, patients who are simultaneously treated with hydantoin and sulfonamides should be under medical supervision, undergoing examinations at short intervals.

Nimesulide may enhance the effect of cyclosporine on the kidneys.

Use with GCS and serotonin reuptake inhibitors increases the risk of bleeding from the gastrointestinal tract.

How to reduce temperature?

Since this question is asked only by parents of young children, I will not write about medications for older children.

There are only three home remedies for kids to reduce their fever: the physical method, paracetamol (acetaminophen) and ibuprofen. If the child's arms and legs are warm, he needs to be undressed, you can hang him with wet towels, wipe him with water at room temperature, wrap his head in a wet scarf, or even put him in a cool shower. Whether or not to give medicine is your choice. Depends on your level of panic and your child's behavior. Small children cool down well on their own; sometimes it’s enough just to free them from their clothes. If your hands and feet are cold—vasospasm has begun—the physical method is not recommended, and the only option left is medication.

Directions for use and doses

Pills

Inside. Adults and children over 12 years old (body weight >40 kg) - 1 tablet. 2 times a day. The tablets are taken after meals with sufficient liquid. The maximum daily dose is 5 mg/kg.

Patients with chronic renal failure require a reduction in the daily dose to 100 mg.

The course of treatment is as prescribed by the doctor.

Lozenges

The minimum effective dose should be used for the shortest possible short course.

Adults and children over 12 years of age (body weight >40 kg) - usually at a dose of 100 mg (1 tablet) 2 times a day at the end or after meals. The tablet should be placed on the tongue, where it immediately begins to dissolve. Swallow the saliva in which the tablet has dissolved.

Release form and composition

Nimulid is produced in 4 types:

• Tablets for oral administration: 10 pieces in 1 package, in a cardboard box from 1 to 3 blisters (10-30 pieces);
• Absorbable tablets: 10 pieces per package, 1 or 2 blisters (10-20 pieces) in a cardboard box;
• Suspension: 60 ml bottle with measuring cap;
• Gel for external application (tube of 10, 20 or 30 g).

The main active ingredient of the drug is nimesulide. Additional substances depend on the form in which the drug is produced. Flavoring agents are added to the suspension so that children can easily take the medicinal substance.

Overdose

Symptoms: apathy, drowsiness, nausea, vomiting. Gastrointestinal bleeding, arterial hypertension, acute renal failure, and respiratory depression may occur.

Treatment: The patient requires symptomatic treatment and supportive care. There is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting, take activated carbon (60–100 g per adult), and osmotic laxatives. Forced diuresis and hemodialysis are ineffective due to the high binding of the drug to proteins.

special instructions

Nimulide should be used with caution in patients with a history of bleeding, patients with upper gastrointestinal diseases, or patients receiving anticoagulants. Since Nimulide is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced depending on creatinine Cl levels.

Given reports of visual disturbances in patients taking other NSAIDs, treatment should be stopped immediately if any visual disturbance occurs and the patient should be examined by an ophthalmologist.

The drug can cause fluid retention in tissues, so patients with high blood pressure and cardiac dysfunction should use Nimulid with extreme caution.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Patients who experience severe side effects: dizziness, drowsiness, blurred vision, must be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

How to decide whether to lower the temperature?

The answer is simple, regardless of the cause of the temperature. It doesn’t matter whether it is associated with an infection or a post-vaccination reaction, with teething or other reasons.

We lower the temperature when the child feels unwell.

There is nothing so beneficial about a rise in temperature that you have to endure it, and nothing so harmful that you need to take medicine while feeling normal. Therefore, when deciding on the issue of fever reduction, we look not at the thermometer, but at the child. If he feels bad, he’s breathing heavily, lethargic, his muscles or head hurt - you even lower 37.8. But if you can't get a child at 38.8 to get the medicine into him, then there's no need for the medicine.