Universal reference book for medicines
Name of the drug: NEURODICLOVIT (NEURODICLOVIT)

Active substance: comb.
drug
Type: NSAIDs in combination with B vitamins

Manufacturer: VALEANT (Russia) manufactured by GLPHARMA (Austria)
Composition, form of production and packaging
Capsules with modified release
hard gelatinous, size 1, with a body of light pinkish-yellow color and a cap of a pinkish-brown color, opaque;
the content of the capsules is a mixture of white granulate (diclofenac sodium) and powder of pink color (thiamine hydrochloride, pyridoxine hydrochloride, cyanocobalamin).
1 caps.

diclofenac sodium 50 mg

thiamine hydrochloride (Vit B 1 ) 50 mg

pyridoxine hydrochloride (Vit B 6 ) 50 mg

cyanocobalamin (Vit B 12 ) 250 μg

Excipients: Povidone K25 - 8.42 mg, copolymer of methacrylic acid and ethyl acrylate (1: 1) dispersion of 30% - 5.6 mg, triethyl acetate - 0.6 mg, talc - 3.08 mg.

The composition of the capsule body: titanium dioxide (E171) - 0.924 mg, iron oxide red (E172) 0.0061 mg, iron oxide yellow oxide (E172) - 0.0924 mg, gelatin 45.1775 mg.

Composition of capsule capsule: titanium dioxide (E171) - 0.7186 mg, iron oxide red (E172) - 0.5144 mg, gelatin - 29.567 mg.

10 pieces.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

NSAIDs in combination with vitamins of group B. Diclofenac has anti-inflammatory, analgesic, antiplatelet and antipyretic effect.
By indiscriminately inhibiting COX-1 and COX-2, it breaks the metabolism of arachidonic acid, reduces the number 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. In injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.
Thiamine (vitamin B 1 ) in the human body as a result of phosphorylation processes is converted into cocarboxylase, which is a coenzyme of many enzyme reactions.Vitamin B 1 plays an important role in carbohydrate, protein and fat metabolism.
Actively involved in the processes of conduction of nervous excitation in the synapses.
Pyridoxine (vitamin B 6 ) 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). 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, epinephrine, histamine and GABA.
Cyanocobalamin (vitamin B 12 ) 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, 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

Diclofenac

Suction

Absorption of diclofenac is fast and complete.
Food slows the absorption rate by 1-4 hours and reduces C max by 40%. After oral administration of diclofenac in a dose of 50 mg of C max is achieved after 2-3 hours and is 1.4 μg / ml. The concentration in the plasma is linear depending on the amount of the dose taken. Bioavailability - 50%.
Distribution

Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not noted, do not accumulate.
Binding to plasma proteins is more than 99% (most of it is associated with albumins). Penetrates into the synovial fluid. C max in synovial fluid is observed 2-4 hours later than in plasma. Diclofenac is excreted in breast milk. V d - 550 ml / kg.
Metabolism

50% of the active substance is metabolized during the "first pass" through the liver.
Metabolism occurs as a result of multiple or one-time hydroxylation and conjugation with glucuronic acid. The isozyme CYP2C9 is involved in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.
Excretion

T 1/2 of the synovial fluid is 3-6 hours. The concentration of diclofenac in the synovial fluid is 4-6 hours after taking the drug more than in the plasma, and remains above the plasma values ​​for another 12 hours. The relationship between the concentration of the drug in the synovial fluid with the clinical efficacy of the drug is not clear.
The system clearance is 350 ml / min. T 1/2 from the plasma - 2 h. 65% of the administered dose is excreted as metabolites by the kidneys, less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites with bile.
In patients with severe renal failure (CC <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.

Vitamins B 1 , B 6 , B 12

The vitamins that make up Neurodiclovitis are water-soluble, which excludes the possibility of their cumulation in the body.

Thiamin and pyridoxine are 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 inflammations of non-rheumatic nature (after traumas, operative and dental interventions, with gynecological diseases - primary algodismenorea, adnexitis, in inflammatory diseases of ENT organs - pharyngitis, tonsillitis, otitis);

- inflammatory and degenerative diseases of the joints and spine (chronic polyarthritis, rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthrosis);

- neuritis and neuralgia (cervical syndrome, lumbago, sciatica);

- acute gouty arthritis;

- rheumatic soft tissue damage.

DOSING MODE

Capsules should be taken orally while eating, without chewing and drinking with a lot of liquid.

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

From the digestive system:> 1% - epigastric pain, sensation of bloating, diarrhea, nausea, constipation, flatulence, increased liver enzymes, peptic ulcer with possible complications (bleeding, perforation), gastrointestinal bleeding;
<1% - vomiting, jaundice, melena, the appearance of blood in the stool, esophageal damage, aphthous stomatitis, dry mucous membranes (including the mouth), hepatitis (possibly lightning fastness), liver necrosis, cirrhosis, hepatorenal syndrome, appetite change , pancreatitis, cholecystopancreatitis, colitis.
From the nervous system: > 1% - headache, dizziness;
<1% - sleep disturbance, drowsiness, depression, irritability, aseptic meningitis (usually in patients with systemic lupus erythematosus and other systemic connective tissue diseases), convulsions, general weakness, disorientation, nightmares, fear.
From the sense organs: > 1% - noise in the ears;
<1% - blurred vision, diplopia, taste disorder, reversible or irreversible hearing loss, scotoma.
Dermatological reactions: > 1% - skin itching, skin rash;
<1% - alopecia, urticaria, eczema, toxic dermatitis, multi-form exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, small-spot hemorrhages, bullous eruptions.
From the urinary system: > 1% - fluid retention;
<1% - nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, papillary necrosis, acute renal failure, azotemia.
On the part of the hematopoiesis system: <1% - anemia (including hemolytic and aplastic anemia), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

On the part of the respiratory system: <1% - cough, bronchospasm, laryngeal edema, pneumonia.

From the cardiovascular system: <1% - increased blood pressure, congestive heart failure, extrasystole, chest pain, myocardial infarction.

Allergic reactions: <1% - anaphylactoid reactions, anaphylactic shock (usually develops rapidly), swelling of the lips and tongue, allergic vasculitis.

Other: <1% - worsening of the course of infectious processes (including the development of necrotizing fasciitis).

CONTRAINDICATIONS

- erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

- gastrointestinal bleeding;

- intracranial bleeding;

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

- disorders of hematopoiesis;

- violations of hemostasis (including hemophilia);

- Inflammatory bowel disease;

severe hepatic impairment;

active liver disease;

- renal failure of severe degree (QC less than 30 ml / min);

- progressive kidney disease;

- severe heart failure;

- period after aortocoronary shunting;

- confirmed hyperkalemia;

- Pregnancy;

- lactation period (breastfeeding);

- childhood;

- hypersensitivity to the components of the drug;

- hypersensitivity to other NSAIDs or vitamins.

With caution: gastric ulcer and duodenal ulcer, ulcerative colitis, Crohn's disease, liver disease in history, hepatic porphyria, chronic hepatic insufficiency, chronic heart failure, arterial hypertension, a significant decrease in BCC (including after extensive surgery), elderly patients (including those receiving diuretics, weakened patients and low body weight), bronchial asthma, simultaneous reception of GCS (including prednisolone), anticoagulants (including warfarin), and
(including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, chronic renal insufficiency (KK 30-60 ml / min), presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, smoking.
PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation (breastfeeding).

In connection with the negative effect on fertility, it is not recommended to prescribe a drug for women planning to become pregnant.

In patients with infertility (including those undergoing examination) it is recommended to cancel the drug.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.

APPLICATION FOR CHILDREN

Contraindicated: children's age .

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.

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 from the gastrointestinal tract, the drug should be applied at the lowest effective dose 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 eating, without chewing, squeezed with enough water.
Because of the important role of prostaglandins in maintaining renal blood flow, care should be taken when assigning to patients with cardiac or renal insufficiency, as well as for the treatment of elderly patients receiving diuretics, and patients who for any reason have a decrease in BCC after extensive surgery.
If in such cases diclofenac is prescribed, then as a precautionary measure it is recommended to monitor the kidney function.
If the increase in hepatic transaminase activity persists or increases during the administration of the drug, if clinical signs of hepatotoxicity (including nausea, fatigue, drowsiness, diarrhea, pruritus, jaundice) are noted, treatment should be discontinued.

Diclofenac (like other NSAIDs) can cause hyperkalemia.

During the reception of the drug is not recommended the use of multivitamin complexes, which include vitamins of group B.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, it is possible to reduce the speed of mental and motor reactions, so patients should refrain from driving transport and practicing other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

Symptoms: vomiting, bleeding from the gastrointestinal tract, epigastric pain, diarrhea, dizziness, tinnitus, lethargy, convulsions;
rarely - increased blood pressure, acute renal failure, hepatotoxic effect, respiratory depression, coma.
Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating blood pressure increase, renal dysfunction, seizures, gastrointestinal irritation, respiratory depression.
Forced diuresis, hemodialysis are ineffective (due to significant binding to plasma proteins and intensive metabolism).
DRUG INTERACTION

With the simultaneous use of Neurodiclavitis increases the concentration in the plasma digoxin, methotrexate, lithium and cyclosporine.

With the simultaneous use of Neurodiclavitis reduces the effect of diuretics, against the background of potassium-sparing diuretics, the risk of hyperkalemia increases.

With the simultaneous use of Neurodiclavitis and anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase), the risk of bleeding increases (more often gastrointestinal bleeding).

With the simultaneous use of Neurodiclavitis reduces the effects of hypotensive and hypnotics.

With the simultaneous use of Neurodiclavitis increases the likelihood of side effects of other NSAIDs and GCS (gastrointestinal bleeding), toxicity of methotrexate and nephrotoxicity of cyclosporine.

Acetylsalicylic acid reduces the concentration of diclofenac in the blood.

Simultaneous use of Neurodiclavitis with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.

With the simultaneous use of Neurodiclavitis reduces the effect of hypoglycemic agents.

When used simultaneously with Neurodiclovitis, cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin increase the incidence of hypoprothrombinemia.

Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which increases the risk of developing nephrotoxicity.

Simultaneous appointment of Neurodiclovitis with ethanol, colchicine, corticotropin, serotonin reuptake inhibitors and St. John's wort increases the risk of developing gastrointestinal bleeding.

Diclofenac enhances the effect of drugs that cause photosensitivity.

Drugs that block tubular secretion, increase the concentration in the plasma of diclofenac, thereby increasing its toxicity.

Neurodiclavitis 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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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