Instructions for use NAKLOFEN
During treatment with diclofenac, patients with a history of upper gastrointestinal diseases should be carefully monitored by their physician.
Prescribe the drug with caution to patients with ulcerative colitis and Crohn's disease due to the risk of exacerbation of diseases; patients with renal failure or severe liver failure, bleeding disorders, epilepsy, porphyria, as well as patients receiving anticoagulants or fibrinolytics.
With long-term use of diclofenac, it is possible, although in rare cases, to develop serious hepatotoxic reactions, therefore it is recommended to regularly examine liver function during treatment.
In infectious diseases, the anti-inflammatory and antipyretic effects of diclofenac may mask the symptoms of these diseases.
Patients with arterial hypertension and/or mild to moderate congestive heart failure require careful monitoring due to the possible development of fluid retention and edema during treatment with non-selective NSAIDs.
Clinical trial and epidemiological data suggest that long-term use of diclofenac, especially at high doses (150 mg daily), may be associated with a modest increase in the risk of arterial thrombosis (eg, risk of myocardial infarction or stroke).
Particular caution should be exercised when prescribing the drug to patients with uncontrolled arterial hypertension, congestive heart failure, established coronary artery disease, peripheral vascular disease and/or cerebrovascular disease. A careful analysis should be carried out before long-term administration of the drug to patients with risk factors for developing cardiovascular complications (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking).
In elderly patients, Naklofen should be used in the minimum effective dose.
The injection solution contains benzyl alcohol, which is contraindicated in newborns and children under 3 years of age. In susceptible people, especially those with a history of asthma or allergies, the metabisulfite in the injection form may cause allergic-type reactions, including symptoms of anaphylactic reaction and bronchospasm.
Impact on the ability to drive vehicles and operate machinery
No effect on the ability to drive vehicles or operate machinery has been established.
Pharmacological properties of the drug Naklofen
Diclofenac ([o-(2,6 dichloroanilino)phenyl]acetate sodium salt) is an NSAID with pronounced anti-inflammatory, analgesic and antipyretic effects. The mechanism of action is associated with the inhibition of COX and the resulting disruption of prostaglandin synthesis. By blocking the synthesis of prostaglandins, diclofenac eliminates or significantly reduces the severity of symptoms of inflammation. Diclofenac reduces prostaglandin-induced increased sensitivity of nerve endings to mechanical stimuli and biologically active substances that are formed at the site of inflammation. Helps lower body temperature, preventing the effect of prostaglandins on the hypothalamic region of the thermoregulation process, reduces the concentration of prostaglandins in menstrual blood and the intensity of pain during primary dysmenorrhea. During treatment with diclofenac, the concentration of prostaglandins in the urine, gastric mucosa and synovial fluid decreases. During the treatment of rheumatoid arthritis, the drug intensively penetrates into the joint cavity, reduces pain at rest and during movement, helps to increase the range of motion in the affected joints, and reduces morning stiffness and swelling of the joints. Naklofen is used to treat rheumatic diseases; to eliminate pain of any localization of various origins. The tablets are coated with an acid-resistant coating and dissolve after entering the intestines. Naklofen Duo contains diclofenac in the form of granules that are resistant to the action of gastric juice and prolonged-release granules, as a result of which the capsules have both rapid and prolonged action. Retard tablets are intended for long-term treatment. After oral administration, diclofenac sodium is rapidly absorbed in the duodenum and small intestine. Over 90% of the drug is absorbed, but due to metabolism during the initial passage through the liver, bioavailability is about 60%. About 99% of diclofenac binds to plasma proteins, mainly albumin. The half-life is 1–2 hours. More than 70% of diclofenac is excreted in the urine in the form of biologically inactive metabolites, only 1% is excreted unchanged. Diclofenac easily penetrates into the synovial fluid, where its concentration reaches 60–70% of the level in the blood serum. After 3–6 hours, the concentration of the drug and its metabolites in the synovial fluid is higher than in the blood serum. Diclofenac is eliminated from synovial fluid much more slowly than from blood serum.
Drug interactions Naklofen
Simultaneous administration of Naklofen with lithium salts or digoxin may cause an increase in their concentration in the blood serum. Naklofen may reduce the diuretic effect of some diuretics; its simultaneous administration with potassium-sparing diuretics can lead to the development of hyperkalemia. When administered simultaneously with acetylsalicylic acid or other NSAIDs, the risk of side effects increases. May enhance the nephrotoxic effect of cyclosporine and the toxic effects of methotrexate, reduce the effectiveness of antihypertensive drugs. Diclofenac generally does not affect the activity of oral hypoglycemic agents.
Contraindications
The medicine is contraindicated:
- if you are allergic to diclofenac or other NSAIDs ;
- in the last trimester of pregnancy ;
- for stomach and duodenal ulcers (for oral forms);
- for bronchial asthma ;
- in the presence of destructive and inflammatory bowel diseases (tablets and suppositories);
- period after coronary artery bypass surgery ;
- bleeding disorders;
- children under 6 years old.
Please be careful:
- with ischemic heart disease ;
- hyperlipidemia and dyslipidemia ;
- for diabetes mellitus ;
- in the 1st and 2nd trimester of pregnancy;
- smokers and frequent alcohol drinkers.
Release form
The medicine is produced in the form of brown-yellow round tablets. The shape is biconvex, smooth. Each tablet is coated with an enteric film coating. There are 2 packages in cardboard boxes, 10 tablets per package.
The drug is produced in the form of cone-shaped suppositories, white or white with a yellow tint. If you separate the candle, you can see a waxy white or yellowish mass inside. Rectal suppositories are in strips of 5 pieces, 2 strips in a cardboard box.
The solution for intramuscular administration is a clear, colorless or slightly yellowish liquid. The drug is produced in ampoules of 3 ml, 5 ampoules in a blister or plastic tray.
The product is also produced in the form of a white, homogeneous gel, for external use, in aluminum tubes of 60 grams.
Compound
One tablet contains 50 mg of diclofenac + corn starch, povidone, magnesium stearate, hypromellose, yellow iron oxide, methacrylic acid and ethyl acrylate copolymer, lactose monohydrate, microcrystalline cellulose, silicon dioxide, red iron oxide, titanium dioxide, talc, propylene glycol.
Contains suppositories (per suppository): 50 mg of diclofenac sodium + solid fat.
One ampoule of the product contains: 75 mg of diclofenac , benzyl alcohol, sodium disulfite, water, propylene glycol, sodium hydroxide.
Gel for external use contains (in one gram): diclofenac – 10 mg + additional substances (macrogol, isopropanol , anhydrous sodium sulfite, decyl oleate, liquid paraffin, carbomer, diethanolamine, propylene glycol, cetomacrogol).
Analogs
Level 4 ATC code matches:
Voltaren
Rapten
Zerodol
Dickloberl Retard
Dikloberl N 75
Dicloberl
Ketanov
Dolak
Panoxen
Ketorolac
Naklofen Duo
Olfen-100
Olfen-75
Neurodiclovit
Nizilat
Fanigan
Aertal
Methindol retard
Ortofen
The most common analogues: Diclak, Diclofenac, Voltaren, Rapten, Naklofen Duo, Almiral, Diclobrew, Dicloberl, Dicloreum, Olfen, Indomethacin , Fanigan Fast, Feloran, Fastum gel, Nise, Dolgit, Dolaren, Flamidez, Ketorol, Ketonal.
Side effects of the drug Naklofen
Possible side effects from the gastrointestinal tract (nausea, abdominal pain, diarrhea, constipation, dyspepsia and flatulence), headache, dizziness, which, as a rule, do not require cessation of treatment. Very rarely possible: bleeding, ulcers and perforation of the gastrointestinal tract, asymptomatic hepatitis, jaundice, acute hepatitis, chronic active hepatitis, hepatocellular necrosis and cholestasis, skin rash, itching, peripheral edema (swelling of the extremities), depression, insomnia, fatigue, anxiety , irritability or drowsiness, renal failure, hematuria. In isolated cases, the development of nonspecific hemorrhagic colitis, relapse or worsening of ulcerative colitis or the appearance of Crohn's disease, hypersensitivity reactions (bronchospasm, angioedema, anaphylactic shock), photosensitivity, anemia, thrombocytopenia, leukopenia and agranulocytosis are observed.
Indications for use
Indications for the use of Naklofen are quite varied:
- the medicine is used to alleviate the condition of rheumatism , rheumatoid arthritis , seronegative spondioarthritis ;
- for gout , arthritis and pseudogout ;
- for arthrosis , spondylosis and other degenerative diseases of the spine;
- for the treatment of bursitis , myositis , tendivitis , periarthritis , synovitis ;
- for dysmenorrhea ;
- for the treatment of Permonage-Turner disease ;
- for renal and hepatic colitis .
The medicine is also used for acute migraine pain , during and after dental operations, to relieve pain in oncology , pain after surgery and after injuries ( bruises , sprains, ligament damage ).
The drug is prescribed for infections and inflammations of the ENT organs : otitis media, pharyngitis, tonsillitis , fever .
Naklofen injections are prescribed if the use of another dosage form is not possible.
special instructions
If the drug is taken for more than 2 weeks, monitoring of liver enzyme .
If there are signs of liver disease, you should stop taking the drug and consult a specialist.
While taking the medication, an exacerbation of existing diseases in the anamnesis is possible.
Taking the drug may adversely affect female fertility .
For elderly patients, it is important to select the minimum active and effective dosage.
When taking the drug (all dosage forms except the gel), you should avoid driving a car and other processes that require high concentration and reaction speed.
Do not apply the gel under occlusive dressings , on open wounds or damaged skin.
After using the gel, you should wash your hands thoroughly and avoid contact of the drug with the eyes and mucous membranes, and avoid exposure to direct sunlight.