Nurofactor (Gel, Suspension) Instructions for Use
ATC Code
M01AE01 (Ibuprofen)
Active Substance
Ibuprofen (Rec.INN registered by WHO)
Clinical-Pharmacological Group
NSAID
Pharmacotherapeutic Group
NSAID
Pharmacological Action
NSAID, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic, and antipyretic effects.
The mechanism of action is associated with the inhibition of COX activity, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins that play a major role in the pathogenesis of inflammation, pain, and fever.
The analgesic effect is due to both a peripheral mechanism (indirectly, through suppression of prostaglandin synthesis) and a central mechanism (inhibition of prostaglandin synthesis in the central and peripheral nervous system). It suppresses platelet aggregation.
Pharmacokinetics
When taken orally, Ibuprofen is almost completely absorbed from the gastrointestinal tract. Simultaneous food intake slows down the rate of absorption.
It is metabolized in the liver (90%). The elimination half-life (T1/2) is 2-3 hours.
80% of the dose is excreted in the urine, mainly in the form of metabolites (70%), 10% is excreted unchanged; 20% is excreted through the intestines in the form of metabolites.
Indications
Symptomatic treatment as an anti-inflammatory and antipyretic agent: inflammatory and degenerative diseases of the joints and spine (including rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis), joint syndrome in acute gout, psoriatic arthritis, tendinitis, bursitis, radiculitis, traumatic inflammation of soft tissues and the musculoskeletal system.
Neuralgia, myalgia, pain syndrome in infectious and inflammatory diseases of the ENT organs, adnexitis, algodysmenorrhea, headache and toothache.
Fever in infectious and inflammatory diseases, in childhood infections, in post-vaccination reactions in children (in appropriate dosage forms).
ICD codes
| ICD-10 code | Indication |
| H92.0 | Otalgia |
| K08.8 | Other specified disorders of teeth and supporting structures (including toothache) |
| M05 | Seropositive rheumatoid arthritis |
| M07 | Psoriatic and enteropathic arthropathies |
| M10 | Gout |
| M15 | Polyosteoarthritis |
| M19.9 | Unspecified arthrosis |
| M25.5 | Pain in joint |
| M42 | Spinal osteochondrosis |
| M45 | Ankylosing spondylitis |
| M47 | Spondylosis |
| M54 | Dorsalgia |
| M54.1 | Radiculopathy |
| M54.3 | Sciatica |
| M54.4 | Lumbago with sciatica |
| M65 | Synovitis and tenosynovitis |
| M70 | Soft tissue disorders related to use, overuse, and pressure |
| M71 | Other bursopathies |
| M79.1 | Myalgia |
| M79.2 | Neuralgia and neuritis, unspecified |
| N70 | Salpingitis and oophoritis |
| N94.4 | Primary dysmenorrhea |
| N94.5 | Secondary dysmenorrhea |
| R07.0 | Pain in throat |
| R50 | Fever of unknown origin |
| R51 | Headache |
| R52.0 | Acute pain |
| R52.2 | Other chronic pain |
| T14.3 | Dislocation, sprain and strain of joint and ligament of unspecified body region |
| T14.9 | Injury, unspecified |
| T88.1 | Other complications following immunization, not elsewhere classified |
| ICD-11 code | Indication |
| 8A8Z | Headache disorders, unspecified |
| 8B93.Z | Radiculopathy, unspecified |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| AB70.2 | Otalgia |
| DA0A.Z | Diseases of teeth and supporting structures, unspecified |
| FA05 | Polyosteoarthritis |
| FA0Z | Osteoarthritis, unspecified |
| FA20.0 | Seropositive rheumatoid arthritis |
| FA21.Z | Psoriatic arthritis, unspecified |
| FA25 | Gout |
| FA85.Z | Defects of vertebral end-plates, unspecified |
| FA8Z | Degenerative disease of spine, unspecified |
| FA92.0Z | Ankylosing spondylitis, unspecified |
| FB40.Z | Tenosynovitis, unspecified |
| FB50.1 | Bursitis associated with use, overuse or pressure |
| FB50.Z | Bursitis, unspecified |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| FB56.2 | Myalgia |
| GA07.Z | Salpingitis and oophoritis, unspecified |
| GA34.3 | Dysmenorrhea |
| LA30.5Z | Anomalies of tooth resorption or loss, unspecified |
| MD36.0 | Pain in throat |
| ME82 | Pain in joint |
| ME84.20 | Lumbago with sciatica |
| ME84.3 | Sciatica |
| ME84.Z | Back pain, unspecified |
| MG26 | Fever of other or unknown origin |
| MG30.Z | Chronic pain syndrome, unspecified |
| MG31.Z | Acute pain, unspecified |
| ND56.3 | Dislocation, sprain or strain of unspecified body region |
| ND56.Z | Unspecified injury of unspecified part of trunk, limb or body region |
| NE80.Z | Injury or harm arising from infusion, transfusion, or therapeutic injection, not elsewhere classified, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Suspension
It is taken orally. The individual dosing regimen depends on the indications, the severity of clinical manifestations, and the patient’s age.
A single dose for adults and children over 6 years of age is 200-400 mg. It can be taken 3-4 times a day.
The maximum daily dose for adults is 1200 mg; for children aged 12-17 years – 1000 mg; for children aged 6 to 12 years – 800 mg.
For children under 6 years of age, the dose depends on the child’s age and body weight. The maximum daily dose should not exceed 30 mg/kg of body weight with intervals between doses of 6-8 hours.
| Age | Body Weight | Dosage Regimen | Maximum Daily Dose |
| 3-6 months | 5 kg-7.6 kg | 50 mg up to 3 times/day | 150 mg |
| 6-12 months | 7.7-9 kg | 50 mg up to 3-4 times/day | 200 mg |
| 1-3 years | 10-16 kg | 100 mg up to 3 times/day | 300 mg |
| 4-6 years | 17-20 kg | 150 mg up to 3 times/day | 450 mg |
Gel
For external use. Apply to the affected area 2-3 times a day.
Adverse Reactions
From the hematopoietic system: very rarely – blood disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).
From the immune system: uncommon – hypersensitivity reactions – nonspecific allergic reactions and anaphylactic reactions, respiratory tract reactions (bronchial asthma, including its exacerbation, bronchospasm, dyspnea, shortness of breath), skin reactions (itching, urticaria, purpura, angioedema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia; very rarely – severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, angioedema or severe anaphylactic shock).
From the digestive system: uncommon – abdominal pain, nausea, dyspepsia (including heartburn, bloating); rarely – diarrhea, flatulence, constipation, vomiting; very rarely – peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis; frequency unknown – exacerbation of colitis and Crohn’s disease.
From the liver and biliary tract: very rarely – impaired liver function, increased activity of liver transaminases, hepatitis and jaundice.
From the urinary system: very rarely – acute renal failure (compensated and decompensated), especially with long-term use, in combination with an increase in plasma urea concentration and the appearance of edema, hematuria and proteinuria; nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.
From the nervous system: uncommon – headache; very rarely – aseptic meningitis.
From the cardiovascular system: frequency unknown – heart failure, peripheral edema; with long-term use, increased risk of thrombotic complications (e.g., myocardial infarction, stroke), increased blood pressure.
From the respiratory system: frequency unknown – bronchial asthma; bronchospasm; dyspnea.
From laboratory parameters: possible – decrease in hematocrit or hemoglobin, increased bleeding time, decrease in plasma glucose concentration, decrease in creatinine clearance, increase in plasma creatinine concentration, increase in liver transaminase activity.
Contraindications
Hypersensitivity to ibuprofen; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase or active peptic ulcer bleeding or history of such (2 or more confirmed episodes of peptic ulcer or peptic ulcer bleeding); history of bleeding or perforation of gastrointestinal ulcers provoked by the use of NSAIDs; severe heart failure (functional class IV according to NYHA classification); severe impairment of renal and/or liver function; optic nerve diseases, “aspirin triad”, blood disorders; period after coronary artery bypass surgery; intracranial or other bleeding; hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diatheses; third trimester of pregnancy.
With caution: simultaneous use of other NSAIDs; history of a single episode of gastric and duodenal ulcer or gastrointestinal ulcer bleeding; gastritis, enteritis, colitis, presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in the history; systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic meningitis; chickenpox; renal failure, including with dehydration (creatinine clearance less than 30-60 ml/min), nephrotic syndrome, hepatic failure, liver cirrhosis with portal hypertension; hyperbilirubinemia; arterial hypertension and/or heart failure; cerebrovascular diseases; blood diseases of unknown etiology (leukopenia and anemia); severe somatic diseases; dyslipidemia/hyperlipidemia; diabetes mellitus; peripheral artery diseases; smoking; frequent alcohol consumption; simultaneous use of drugs that may increase the risk of ulcers or bleeding, in particular, oral corticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); first and second trimester of pregnancy; breastfeeding period; elderly age.
Use in Pregnancy and Lactation
Use during pregnancy and breastfeeding is contraindicated.
Use in Hepatic Impairment
Contraindicated in severe liver impairment. Use with caution in concomitant liver diseases.
Use in Renal Impairment
Contraindicated in severe renal impairment. Use with caution in concomitant kidney diseases.
Pediatric Use
Can be used according to indications in recommended doses.
Geriatric Use
Should be prescribed with caution to elderly patients to avoid worsening of concomitant diseases.
Elderly patients have an increased frequency of adverse reactions against the background of NSAID use, especially gastrointestinal bleeding and perforations, in some cases fatal.
Special Precautions
It is recommended to prescribe Ibuprofen in the shortest possible course and at the minimum effective dose necessary to relieve symptoms. If systemic use is necessary for more than 10 days, a doctor should be consulted.
During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. If symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, complete blood count (hemoglobin determination), stool test for occult blood.
The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous tissue (e.g., necrotizing fasciitis). In this regard, it is recommended to avoid the use of ibuprofen for chickenpox.
Ibuprofen suppresses COX and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of treatment).
Effect on the ability to drive vehicles and machinery
Patients who experience dizziness, drowsiness, lethargy, or visual disturbances when taking ibuprofen should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.
Drug Interactions
With simultaneous use, Ibuprofen reduces the effect of antihypertensive agents (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).
With simultaneous use with anticoagulants, their effect may be enhanced.
With simultaneous use with corticosteroids, the risk of adverse effects from the gastrointestinal tract increases.
With simultaneous use, Ibuprofen may displace from plasma protein binding indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), oral hypoglycemic drugs sulfonylurea derivatives.
With simultaneous use with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid – the concentration of ibuprofen in the blood plasma decreases; with baclofen – a case of increased toxic effect of baclofen has been described.
With simultaneous use with warfarin, an increase in bleeding time is possible, microhematuria and hematomas have also been observed; with captopril – a decrease in the antihypertensive effect of captopril is possible; with cholestyramine – a moderately pronounced decrease in the absorption of ibuprofen.
With simultaneous use with lithium carbonate, the concentration of lithium in the blood plasma increases.
With simultaneous use with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate – the toxicity of methotrexate increases.
Simultaneous use of NSAIDs and cardiac glycosides may lead to worsening of heart failure, decreased glomerular filtration rate, and increased concentration of cardiac glycosides in the blood plasma.
There is evidence of the likelihood of an increase in the plasma concentration of methotrexate against the background of NSAID use.
With simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.
NSAIDs may reduce the effectiveness of mifepristone, so NSAIDs should be started no earlier than 8-12 days after the end of mifepristone use.
With simultaneous use of NSAIDs and tacrolimus, an increased risk of nephrotoxicity is possible.
Simultaneous use of NSAIDs and zidovudine may lead to increased hematotoxicity. There are data on an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia receiving combined treatment with zidovudine and ibuprofen.
In patients receiving combined treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.
In patients simultaneously receiving NSAIDs and myelotoxic drugs, hematotoxicity is enhanced.
With simultaneous use of ibuprofen and cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the frequency of hypoprothrombinemia development increases.
With simultaneous use of ibuprofen and drugs that block tubular secretion, a decrease in excretion and an increase in plasma concentration of ibuprofen are noted.
With simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), the production of hydroxylated active metabolites increases, increasing the risk of severe intoxication.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Oral suspension (for children, with orange or strawberry flavor) 100 mg/5 ml: bottles 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, 100 ml, 150 ml, or 200 ml
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
 |
Nurofactor | Oral suspension (for children, with orange or strawberry flavor) 100 mg/5 ml: bottles 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, 90 ml, 100 ml, 150 ml, or 200 ml |
Dosage Form, Packaging, and Composition
Oral suspension for children (with orange or strawberry flavor) from white to gray or gray with a yellowish tint, with a characteristic fruity odor.
| 5 ml | |
| Ibuprofen | 100 mg |
Excipients: polysorbate 80 (tween 80) – 0.5 mg, glycerol – 600 mg, maltitol liquid – 2111.25 mg, sucralose – 10 mg, citric acid – 20 mg, sodium citrate dihydrate (sodium citrate 2-water) – 25.45 mg, xanthan gum (xanthan resin) – 35 mg, sodium chloride – 5.5 mg, domiphen bromide – 0.5 mg, orange or strawberry flavor – 12.5 mg, purified water – up to 5 ml.
10 ml – dark glass bottles (1) – cardboard packs.*
20 ml – dark glass bottles (1) – cardboard packs.*
30 ml – dark glass bottles (1) – cardboard packs.*
40 ml – dark glass bottles (1) – cardboard packs.*
50 ml – dark glass bottles (1) – cardboard packs.*
60 ml – dark glass bottles (1) – cardboard packs.*
70 ml – dark glass bottles (1) – cardboard packs.*
80 ml – dark glass bottles (1) – cardboard packs.*
90 ml – dark glass bottles (1) – cardboard packs.*
100 ml – dark glass bottles (1) – cardboard packs*.
120 ml – dark glass bottles (1) – cardboard packs.*
150 ml – dark glass bottles (1) – cardboard packs.*
200 ml – dark glass bottles (1) – cardboard packs.*
10 ml – polymer bottles (1) – cardboard packs.*
20 ml – polymer bottles (1) – cardboard packs.*
30 ml – polymer bottles (1) – cardboard packs.*
40 ml – polymer bottles (1) – cardboard packs.*
50 ml – polymer bottles (1) – cardboard packs.*
60 ml – polymer bottles (1) – cardboard packs.*
70 ml – polymer bottles (1) – cardboard packs.*
80 ml – polymer bottles (1) – cardboard packs.*
90 ml – polymer bottles (1) – cardboard packs.*
100 ml – polymer bottles (1) – cardboard packs.*
120 ml – polymer bottles (1) – cardboard packs.*
150 ml – polymer bottles (1) – cardboard packs.*
200 ml – polymer bottles (1) – cardboard packs.*
10 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
20 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
30 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
40 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
50 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
60 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
70 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
80 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
90 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
100 ml – polyethylene terephthalate bottles (1) – cardboard packs*.
120 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
150 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
200 ml – polyethylene terephthalate bottles (1) – cardboard packs.*
* The package may include a 30 ml measuring cup or a 5 ml measuring spoon or a 10 ml dosing syringe.
Gel for external use 5%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 100 g, 120 g, 125 g, 130 g, 135 g, 140 g, 145 g, or 150 g
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Nurofactor | Gel for external use 5%: tubes 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 100 g, 120 g, 125 g, 130 g, 135 g, 140 g, 145 g, or 150 g |
Dosage Form, Packaging, and Composition
Gel for external use colorless or with a light yellow tint, transparent, with a specific odor; opalescence is allowed.
| 1 g | |
| Ibuprofen | 50 mg |
Excipients: ethanol 95% – 150 mg, propylene glycol – 100 mg, trolamine (triethanolamine) – 60 mg, dimethyl sulfoxide – 25 mg, carbomer 940 – 15 mg, methylparaben – 1.5 mg, lavender oil – 1 mg, orange flower oil (neroli oil) – 0.5 mg, purified water – up to 1 g.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
120 g – tubes (1) – cardboard packs.
125 g – tubes (1) – cardboard packs.
130 g – tubes (1) – cardboard packs.
135 g – tubes (1) – cardboard packs.
140 g – tubes (1) – cardboard packs.
145 g – tubes (1) – cardboard packs.
150 g – tubes (1) – cardboard packs.
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