Neurodictivitis (Neurodiclovit)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspmodified release capsules
Composition:

One capsule contains:

active substances: diclofenac sodium 50.0 mg;

mixture of vitamins: thiamine hydrochloride 50.0 mg; pyridoxine hydrochloride 50.0 mg; cyanocobalamin 0.25 mg;

Excipients: povidone K 25 8.42 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) dispersion 30% 5.60 mg, triethyl citrate 0.60 mg, talc 3.08 mg;

shell capsule: body: titanium dioxide (E 171) 0.9240 mg, iron oxide red dye (E 172) 0.0061 mg, iron oxide yellow dye (E 172) 0.0924 mg, gelatin 45.1775 mg

lid: titanium dioxide (E 171) 0.7186 mg, iron oxide red dye (E 172) 0.5144 mg, gelatin 29.5670 mg.

Description:Hard gelatin capsules No. 1, body: light pinkish-yellow, opaque, cap: pinkish-brown, opaque. Capsule contents: white granulate mixture (diclofenac sodium) and a powder of pink color (thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin).
Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic remedy + vitamin)
Pharmacodynamics:Diclofenac has anti-inflammatory, analgesic, antiplatelet and antipyretic effect. Indiscriminately inhibiting cyclooxygenase 1 and 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the inflammatory focus.

In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac significantly reduces the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries, in the postoperative period diclofenac reduces pain and inflammatory swelling.

Thiamine (vitamin B1) in the human body as a result of the phosphorylation process is converted into cocarboxylase, which is the enzyme of many enzyme reactions. Vitamin B1 plays an important role in the carbohydrate, protein and fat metabolism. Actively involved in the processes of conduction of nervous excitation in the synapses.

Pyridoxine (vitamin B6) is necessary for the normal functioning of the central and peripheral nervous system. In phosphorylated form it is a coenzyme in the metabolism of amino acids (decarboxylation, reamination, etc.). Acts as a coenzyme of the most important enzymes that act in the nerve tissues. Participates in the biosynthesis of many neurotransmitters - such as dopamine, serotonin, noradrenaline, adrenaline, opium and gamma-aminobutyric acid (GABA).

Cyanocobalamin (vitamin B12) is necessary for normal hematopoiesis and ripening of erythrocytes, and also participates in a number of biochemical reactions that ensure the vital activity of the organism-in the transfer of methyl groups, in the synthesis of nucleic acids, protein, in the exchange of amino acids, carbohydrates, and lipids. Has a beneficial effect on the processes in the nervous system (the synthesis of nucleic acids and the lipid composition of cerebrosides and phospholipids). Coenzyme forms of cyanocobalamin - methylcobalamin and adenosylcobalamin are necessary for replication and cell growth.

The combination of B vitamins potentiates the analgesic effect of diclofenac.

Pharmacokinetics:

Absorption of diclofenac - fast and complete, food slows the absorption rate for 1 to 4 hours and reduces the maximum concentration by 40%. After oral administration, 50 mg maximum concentration (Cmax) - 1.4 μg / ml is achieved after - 2-3 hours. The concentration in the plasma is linear depending on the amount of the administered dose.

Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not noted, do not accumulate.

Bioavailability - 50%. The connection with plasma proteins is more than 99% (most of it is associated with albumins).Penetrates into the synovial fluid; the maximum concentration in the synovial fluid is observed 2-4 hours later than in the plasma. The half-life of the synovial fluid is 3-6 hours (the concentration of the active substance in the synovial fluid 4-6 hours after the administration of the drug is higher than in the plasma, and remains higher for another 12 hours). The relationship between the concentration of the drug in the synovial fluid and the clinical efficacy of the drug has not been elucidated. Metabolism: 50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. The enzyme system P450 CYP2C9 takes part in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.

The system clearance is 350 ml / min, the volume of distribution is 550 ml / kg. Half-life from the plasma - 2 hours 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% is unchanged, the rest of the dose is excreted as metabolites with bile. In patients with severe renal failure (creatinine clearance less than 10 ml / min), the excretion of metabolites with bile is increased, while there is no increase in their concentration in the blood.

In patients with chronic hepatitis or compensated cirrhosis, the pharmacokinetic parameters of diclofenac do not change. Diclofenac penetrates into breast milk.

The vitamins that make up Neurodiclovitis are water-soluble, which excludes the possibility of their cumulation in the body. Thiamine and pyridoxine. absorbed in the upper part of the small intestine, metabolized in the liver and excreted by the kidneys (about 8-10% - unchanged). The degree of absorption depends on the dose, overdose significantly increases the excretion of thiamine and pyridoxine through the intestine. The absorption of cyanocobalamin depends to a large extent on the presence in the body of the internal factor (in the stomach and upper part of the small intestine), in the future, the delivery of the vitamin in the tissue is determined by the transport protein transcobalamin. After metabolism in the liver cyanocobalamin is excreted mainly with bile, the degree of excretion by the kidneys is variable - from 6 to 30%.

Indications:

- Pain syndrome with inflammation of non-rheumatic nature

  • after injuries, operative and dental interventions;
  • with gynecological diseases - primary algodismenorea, adnexitis;
  • with inflammatory diseases of the ENT-sphere - pharyngitis, tonsillitis, otitis media

- Inflammatory, and degenerative diseases of the joints and spine (chronic polyarthritis, osteoarthritis, spondylarthrosis)

- Neuritis and neuralgia (cervical syndrome, lumbago, lumboeishalgia)

- Acute gouty arthritis

Contraindications:Hypersensitivity to the components of the drug (including other non-steroidal anti-inflammatory drugs or vitamins), erosive-ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), bleeding from the gastrointestinal tract, intracranial bleeding, complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs) (including in the history), hematopoietic disorders , hemostasis disorders (including hemophilia), inflammatory bowel disease, severe hepatic and cardiac failure, post-coronary artery bypass grafting, severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease,active liver disease, confirmed hyperkalemia, childhood, pregnancy, lactation.
Carefully:Peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease, a history of liver disease, hepatic porphyria, chronic liver failure, chronic heart failure, arterial gipertepziya, a significant reduction in circulating blood volume (including after extensive surgery), mature patients (including receiving diuretics and debilitated patients with low body weight), bronchial asthma, simultaneous glucocorticosteroids "(including prednisolone), anticoagulants ( including warfarin), antiplatelet agents (including ACK, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia , diabetes mellitus, peripheral arterial disease, smoking, chronic renal failure (creatinine clearance 30 - 60 ml / min), the presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcohol ,, severe somatic disorders.
Pregnancy and lactation:Contraindicated use of the drug during pregnancy and lactation.
Dosing and Administration:

Capsules should be taken orally while eating, without chewing and drinking plenty of fluids.

Usually, the drug is prescribed 1 capsule 1-3 times a day.

Adults Neurodiclavitis appoint 1 capsule - at the beginning of treatment 3 times a day, as a maintenance dose - 1-2 times a day. The duration of therapy depends on the nature and severity of the disease.

Side effects:

Gastrointestinal tract:

more often 1% - epigastric pain, sensation of bloating, diarrhea, nausea, constipation, flatulence, increased activity of aminotransferases, peptic ulcer with possible complications (bleeding, perforation), gastrointestinal bleeding;

vomiting, jaundice, melena, the appearance of blood in the stool, the defeat of the esophagus, aphthous stomatitis, dry mucous membranes (including the mouth), hepatitis (possibly lightning), liver necrosis, cirrhosis, hepatorenal syndrome, changes in appetite, pancreatitis , cholecystopancreatitis, colitis.

Nervous system:

more often 1% - headache, dizziness;

less than 1% - sleep disturbance, drowsiness, depression, irritability,

aseptic meningitis (usually in patients with systemic lupus erythematosus and others

systemic connective tissue diseases), convulsions, general weakness,

disorientation, nightmares, a sense of fear.

Sense organs:

more often 1% - noise in the ears;

less than 1% - blurred vision, diplopia, a violation of taste,

reversible or irreversible hearing loss, scotoma.

Skin:

more often 1% - skin itch, skin rash;

less than 1% - alopecia, urticaria, eczema, toxic dermatitis, multiforme

exudative erythema (including Stevens-Johnson syndrome), toxic

epidermal necrolysis (Lyell's syndrome), increased photosensitivity,

small-point hemorrhages, bullous eruptions.

Genitourinary system:

more often 1% - fluid retention;

less than 1% - nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia.

Hematopoiesis and the immune system:

less than 1% - anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura, worsening of the course of infectious processes (including the development of necrotizing fasciitis).

Respiratory system:

less than 1% - cough, bronchospasm, laryngeal edema, pneumonia.

The cardiovascular system:

less than 1% - increased blood pressure; heart failure, extrasystole, chest pain, myocardial infarction.

Allergic reactions:

less often 1% - Anaphylactoid reactions, anaphylactic shock (usually, develops rapidly), swelling of the lips and tongue, allergic vasculitis.

Overdose:

Symptoms: vomiting, bleeding from the gastrointestinal tract (GIT), epigastric pain, diarrhea, dizziness, tinnitus, lethargy, convulsions; rarely - increased blood pressure, acute renal failure, hepatotoxic effect, respiratory depression, coma.

Treatment: gastric lavage, Activated carbonsymptomatic therapy aimed at eliminating the increase in blood pressure,. violations of kidney function, seizures, irritation of the gastrointestinal tract, respiratory depression. Forced diuresis, hemodialysis are ineffective (due to the significant connection with proteins and intensive metabolism).

Interaction:

The drug increases the concentration in the plasma digoxin, methotrexate, lithium and cyclosporine.

Reduces the effect of diuretics, against the background of potassium-sparing diuretics increases the risk of hyperkalemia; on the background of anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase) - the risk of bleeding (more often from the gastrointestinal tract).

Reduces the effects of hypotensive and hypnotics. Increases the likelihood of side effects of other NSAIDs and glucocorticosteroids (bleeding in the gastrointestinal tract), toxicity of methotrexate and nephrotoxicity of cyclosporine. Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac. Reduces the effect of hypoglycemic agents.

Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the frequency of developed hypoprothrombinemia.

Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which increases nephrotoxicity. Simultaneous use with ethanol, colchicine, corticotropin, serotonin reuptake inhibitors and St. John's wort increases the risk of bleeding in the gastrointestinal tract.

Diclofenac enhances the effect of drugs - causing photosensitivity.

Antibacterial drugs from the quinolone group - the risk of seizures.

Drugs that block tubular secretion increase the concentration in the plasma of diclofenac, thereby increasing its toxicity. The drug reduces the antiparkinsonian efficacy of levodopa. Ethanol dramatically reduces the absorption of thiamine (blood levels may drop by 30%). Long-term treatment with anticonvulsant drugs can lead to a thiamine deficiency. The use of colchicine and biguanides reduces the absorption of cyanocobalamin. During the reception of the drug is not recommended the use of multivitamin complexes, which include vitamins of group B.

Special instructions:

During the treatment with the drug should be a systematic control of the picture of peripheral blood, liver function, kidneys, examination of feces for the presence of blood.

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course. In order to quickly achieve the desired therapeutic effect, the tablets are taken 30 minutes before meals. In other cases, take, before, during or after a meal, without chewing, squeezed with enough water.Because of the important role of prostaglandins in maintaining renal blood flow, caution should be exercised in appointing patients with cardiac or renal insufficiency, and also in the treatment of elderly patients taking diuretics and patients who for any reason have a decrease in circulating blood volume (in including after extensive surgery). If, in such cases, appoint diclofenac, recommend as a precautionary measure to monitor kidney function. If the increase in the activity of "liver" transaminases persists or increases during the administration of the drug, if clinical symptoms of hepatotoxicity (including nausea, fatigue, drowsiness, diarrhea, pruritus, jaundice) are noted, treatment should be stopped. Diclofenac (like other NSAIDs) can cause hyperkalemia. In connection with the negative effect on fertility, women who are planning to become pregnant, the drug is not recommended. In patients with infertility (including those undergoing examination) it is recommended to cancel the drug.

Effect on the ability to drive transp. cf. and fur:During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from driving transport and occupations with other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Form release / dosage:
Capsules with modified release.
Packaging:

10 capsules per blister PVC / PE / PVDC / A1.

For 3 blisters together with instructions for use in a cardboard bundle.

Storage conditions:In dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children!
Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:LS-002517
Date of registration:29.11.2011 / 12.05.2017
Expiration Date:Unlimited
The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
Manufacturer: & nbsp
Representation: & nbspVALEANT LLC VALEANT LLC Russia
Information update date: & nbsp27.06.2018
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