Naklofen - instructions for use, analogs, reviews and release forms (50 mg and 100 mg CP tablets, 75 mg Duo and Protect capsules, rectal supplements, gel or ointment, injections in ampoules) for the treatment of arthritis in adults, children and pregnancy

In this article, you can read the instructions for using the drug Naklofen. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Naklofen in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of naclofen in the presence of existing structural analogues. Use to treat arthritis, arthrosis and other inflammatory joint diseases and pain in adults, children, as well as during pregnancy and lactation.

Naklofen - is a non-steroidal anti-inflammatory drug (NSAID), which has analgesic, anti-inflammatory and antipyretic effects.

The main mechanism of its action is the indiscriminate inhibition of the activity of the enzyme cyclooxygenase 1 and 2 (COX1 and COX2). which leads to a disruption of the metabolism of arachidonic acid, a decrease in the synthesis of prostaglandins. prostacyclin and thromboxane.

The most effective for inflammatory pain. In rheumatic diseases, the anti-inflammatory and analgesic effect of Diclofenac (the active substance of the drug Naklofen) contributes to a significant reduction in 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. Like all NSAIDs, diclofenac has antiaggregant activity. In therapeutic doses, diclofenac has virtually no effect on bleeding time. With prolonged treatment, the analgesic effect of diclofenac does not decrease.

Composition

Diclofenac sodium + auxiliary substances.

Diclofenac diethylamine + diclofenac sodium + excipients (gel Naklofen).

Diclofenac sodium + Lansoprazole + auxiliary substances (Naklofen Protect).

Pharmacokinetics

Naklofen actively penetrates into the synovial fluid, where it reaches 60-70% of serum concentrations. After 3-6 hours after intramuscular injection, the concentrations of the active substance and metabolites in the synovial fluid are higher than in the serum. Diclofenac from the synovial fluid is excreted faster than from the serum. It is almost completely metabolized in the liver, mainly by hydroxylation, followed by conjugation with glucuronic acid and sulfation. Approximately 70% of diclofenac is excreted by the kidneys in the form of pharmacologically inactive metabolites. Only 1% of the drug is excreted unchanged, the rest of the metabolites through the intestine. In elderly patients, pharmacokinetic parameters without significant changes.

Indications

Diseases that require the achievement of a rapid anti-inflammatory or analgesic effect:

• inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic,juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis, arthritis with Reiter's disease, rheumatic soft tissue, osteoarthritis of peripheral joints and spine, including radicular syndrome, tendonitis, periarthritis, bursitis, myositis, synovitis;
• pain or mild to moderate severity: neuralgia, myalgia, sciatica, post-traumatic pain, accompanied by inflammation, postoperative pain, headache, migraine, tuberculosis, adnexitis, proctitis, toothache, renal and biliary colic.

Naklofen is intended for symptomatic therapy and does not affect the progression of the disease.

Forms of release

Tablets coated with enteric coating 50 mg.

Capsules with modified release (Naklofen Duo).

Solution for intramuscular injection (injections in ampoules for injection).

Rectal Candles 50 mg.

Gel for external use 1% (sometimes mistakenly called ointment or cream).

Capsules with prolonged release (Naklofen Protect).

The tablets of the prolonged action, covered with a cover of 100 mg (Naklofen SR).

Instructions for use and dosage

Pills

Inside, without chewing, during or after a meal, with a small amount of water.

Adults and adolescents with 15 years (and weighing more than 45 kg) - 50 mg 2-3 times a day. When the optimal therapeutic effect is achieved, the dose is gradually reduced and switched to maintenance treatment at a dose of 100 mg / day. The maximum daily dose is 150 mg.

Capsules Naklofen Duo

The drug is taken orally. The capsule should be swallowed whole, with water at the end or after meals, usually in the morning.

Assigned individually, taking into account the severity of the disease. Adults usually appoint 75 mg (1 capsule) 1-2 times a day. The maximum daily dose is 150 mg.

Ampoules

Intramuscularly. Single dose for adults - 75 mg (1 ampoule). If necessary, repeated administration is possible, but not earlier than 12 hours (patients with renal colic can be re-injected after 30 minutes). When using other dosage forms, diclofenac should not be exceeded by a maximum daily dose of 150 mg.

Duration of use no more than 2 days, if necessary, further pass to oral, or rectal administration of diclofenac.

Do not mix Naklofen with other drugs in the same syringe.

Rectal Candles

Rectally.If patients with oral diclofenac forms are not well tolerated, Naklofen can be administered rectally in the form of suppositories at appropriate doses. When combining several dosage forms (in addition to oral administration of the drug), it should be borne in mind that the daily dose of diclofenac should not exceed 150 mg.

Adults with an initial dose of 100-150 mg per day (1 suppository 2-3 times a day), depending on the severity of the disease. To adolescents aged 15 years and over, one suppository is recommended no more than 2 times a day. The maintenance dose is usually 100 mg per day (1 suppository 2 times a day).

The minimum effective dose should be used as little as possible.

Gel

Outwardly. Adults and adolescents over 12 years of age, a strip of gel 5-10 cm long is applied to the affected area and gently rubbed into the skin 2-3 times a day. Children aged 6 to 12 years are treated with a strip no more than 3 cm not more often than 2 times a day. When using the drug for more than 10 days should consult with your doctor.

Capsules Protect

The kit is designed for combined intake of two kinds of capsules. Separate application of diclofenac capsules is possible only in the absence of ulcerative lesions of the stomach and / or duodenum and the risks of its development.

Diclofenac

Inside, squeezed a small amount of liquid, during or immediately after a meal. The initial dose is 1 capsule (75 mg) once a day. The maximum daily dose is 2 capsules / day (150 mg). At the expressed painful syndrome, it is possible to accept at once a daily dose of a preparation (2 capsules 1 time a day). In case of erosive-ulcerative lesions of the mucous membrane of the stomach or duodenum, one capsule (75 mg) per day should be limited to no more than 8 weeks.

Lansoprazole

Inside, whole, preferably in the morning, before eating.

The initial dose is 15 mg per day (1 capsule). The maximum dose is 30 mg per day (2 capsules). In case of erosive-ulcerative lesions of the mucous membrane of the stomach or duodenum, 30 mg per day (2 capsules) should be used. Elderly patients, as well as patients with impaired renal and / or liver function, do not need dose adjustment.

If it is impossible to swallow the capsule entirely, it must be opened, the contents mixed with a small amount of apple juice and swallowed without chewing.

The same actions are possible if the substance is injected through a nasogastric tube. Duration of dose 30 mg per day (2 capsules) not more than 8 weeks. A dose of 15 mg per day (1 capsule) can be used up to 12 months.

Side effect

• epigastric pain;
• nausea, vomiting;
• diarrhea, constipation;
• dyspepsia;
• flatulence;
• anorexia;
• gastritis;
• proctitis;
• bleeding from the digestive tract (vomiting with blood, melena, diarrhea with an admixture of blood);
• Gastrointestinal ulcers (with or without bleeding or perforation);
• hepatitis;
• jaundice;
• stomatitis;
• glossitis;
• dryness of mucous membranes (including the mouth);
• damage to the esophagus;
• diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease);
• pancreatitis;
• headache;
• dizziness;
• drowsiness;
• memory disorders;
• convulsions;
• anxiety;
• aseptic meningitis;
• disorientation;
• depression;
• insomnia;
• nightmares";
• irritability;
• mental disorders;
• vertigo;
• impaired vision (blurred vision, diplopia);
• hearing impairment;
• noise in ears;
• a violation of taste sensations;
• acute renal insufficiency;
• hematuria;
• proteinuria;
• interstitial nephritis;
• papillary necrosis;
• Thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis;
• anaphylactic / anaphylactoid reactions, including a marked decrease in blood pressure (BP) and shock
• angioedema (incl.persons);
• palpitation, extrasystole;
• chest pain;
• increased blood pressure;
• vasculitis;
• heart failure;
• myocardial infarction;
• cough;
• bronchial asthma (including dyspnea);
• pneumonitis;
• laryngeal edema;
• skin rash;
• hives;
• bullous eruptions;
• eczema, incl. multiform and Stevens-Johnson syndrome;
• Lyell's syndrome;
• exfoliative dermatitis;
• itching;
• hair loss;
• photosensitization;
• purpura, incl. allergic.

Contraindications

• period after aortocoronary shunting;
• erosive and ulcerative changes in the mucosa of the stomach or duodenum, active gastrointestinal bleeding;
• inflammatory bowel disease, in the phase of exacerbation (NNC, Crohn's disease);
• cerebrovascular bleeding or other bleeding and hemostasis disorders;
• severe hepatic impairment or active liver disease;
• marked renal failure (creatinine clearance less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease;
• Decompensated heart failure;
• oppression of bone marrow hematopoiesis;
• 3 trimester of pregnancy, the period of breastfeeding;
• limitations and contraindications for children (see below for instructions);
• hypersensitivity to diclofenac; with 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, polyps of the nasal mucosa, asthma).

Application in pregnancy and lactation

The use of Naklofen in pregnant women is possible only when the expected benefit exceeds the potential risk to the fetus. Diclofenac is not recommended for use during the last trimester of pregnancy.

Despite the fact that diclofenac is found in breast milk in small amounts, its use during breast-feeding is not recommended.

Use in children

Contraindicated for children under 15 years. Solution for intramuscular injection, Duo and Protect capsules, CP tablets are contraindicated in children and adolescents under 18 years of age. The gel is allowed to use with caution in children after 6 years of age.

Application in elderly patients

Use with caution in elderly patients.

special instructions

In order to quickly achieve the desired therapeutic effect, take the drug 30 minutes before meals. In other cases, take before, during or after a meal wholly, with plenty of water.

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

Caution should be used drug Naklofen with ulcerative colitis and Crohn's disease because of a possible exacerbation of the disease.

With long-term use of diclofenac, it is possible, although in rare cases, the development of serious hepatotoxic reactions, and therefore it is recommended to regularly examine the function of the liver.

Because of the important role of prostaglandins in maintaining renal blood flow, care should be taken when administering the drug to patients with cardiac or renal insufficiency, as well as in the treatment of elderly people taking diuretics and patients who for any reason have a decrease in circulating blood volume (for example , after a major surgical intervention).If diclofenac is prescribed in such cases, it is recommended to monitor kidney function as a precautionary measure.

With caution should be prescribed Naklofen in patients with violations of blood clotting, porphyria, epilepsy, as well as in patients receiving anticoagulants or fibrinolytics.

When carrying out long-term therapy, it is necessary to monitor the picture of peripheral blood, to conduct a fecal occult blood test.

In connection with the negative effect on fertility, women who want to become pregnant, the drug is not recommended. In patients with infertility (including undergoing examination) it is recommended to cancel the drug.

Patients taking the drug should refrain from drinking alcohol.

In infectious diseases, the anti-inflammatory and antipyretic effects of diclofenac sodium can mask the symptoms of these diseases.

Influence on the ability to manage motor vehicles and work with mechanisms

During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Drug Interactions

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; against the background of anticoagulants, antiplatelet agents and thrombolytic drugs (alteplase, streptokinase, urokinase) increases the risk of bleeding (more gastrointestinal).

Reduces the effect of hypotensive and hypnotic drugs. Increases the likelihood of side effects of other NSAIDs and glucocorticosteroids (bleeding from 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 drugs.

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

Cyclosporine and gold preparations increase the effect of Naclofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.Selective serotonin reuptake inhibitors increase the risk of bleeding from the digestive tract.

Simultaneous administration with ethanol (alcohol), colchicine, corticotropin and preparations of St. John's wort increases the risk of bleeding in the gastrointestinal tract. Medicines that cause photosensitivity, increase the sensitizing effect of diclofenac to ultraviolet radiation. Drugs that block tubular secretion, increase the concentration in the plasma of diclofenac, thereby increasing its toxicity.

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

Analogues of Naklofen

Structural analogs for the active substance:

• Artrex;
• Beliefed;
• Voltaren;
• Voltaren Emulgel;
• Diklak;
• Diklobene;
• Dicluberl;
• Diqlovit;
• Diklogen;
• Diclomax;
• Diclomelan;
• Diclonac;
• Diclonat P;
• Dicloran;
• Diclorium;
• Diclofen;
• Diclofenac;
• Diclofenacol;
• Diphene;
• Dorosan;
• Naklof;
• Naklofen Duo;
• Naklofen SR;
• Sodium diclofenac;
• Orthophene;
• Orthofer;
• Orthoflex;
• Rapten Duo;
• Rapent Rapid;
• Revmavek;
• Redwood retard;
• Remetan;
• Sanfinak;
• SwissSet;
• Feloran;
• Feloran retard;
• Flotac.

Similar medicines:

Other medicines: