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Pharmacological group: NSAIDs.
Pharmaceutical action: Naklofen Duo - NSAIDs with analgesic, anti-inflammatory and antipyretic effects. The main mechanism of its action and the associated side effects are the indiscriminate inhibition of COX-1 and COX-2 activity, which leads to disruption of arachidonic acid metabolism, reduced synthesis of prostaglandins, prostacyclin and thromboxane. The level of various prostaglandins in the urine, gastric mucosa and synovial fluid is reduced.
Most effective for inflammatory pain. 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 edema.
Like all NSAIDs, diclofenac has antiplatelet activity. In therapeutic doses, diclofenac sodium has almost no effect on bleeding time. With long-term treatment, the analgesic effect of diclofenac sodium does not decrease.
Absorption is quick and complete. Diclofenac is contained in capsules of Naklofen Duo in the form of enteric pellets and pellets with a slow release, so the capsules of Naklofen Duo have an immediate and prolonged effect. Cmax in plasma is noted in 30-60 minutes after administration. The therapeutic concentration is maintained twice as long as with enteric film-coated pills. Plasma concentration is linearly dependent on the size of the dose taken. Changes in the pharmacokinetics of diclofenac against the background of repeated administration is not observed. It does not accumulate while observing the recommended interval between meals.
Bioavailability - 50%. Communication with plasma proteins - more than 99% (most associated with albumin). Gets into synovial fluid. Cmax in synovial fluid is observed 2-4 hours later than in plasma. Diclofenac is excreted more slowly from synovial fluid than from plasma.
Vd - 550 ml / kg. Diclofenac penetrates into breast milk.
Metabolism and excretion
50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs as a result of repeated or one-time hydroxylation and conjugation with glucuronic acid. Cytochrome P450 enzymes are involved in the metabolism of the drug. Pharmacological activity of metabolites is lower than diclofenac.
Systemic clearance is 260 ml / min, T1 / 2 - 2 h. About 70% of the administered dose is excreted as pharmacologically inactive metabolites by the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted in the form of metabolites with bile.
Pharmacokinetics in special clinical situations
In patients with severe renal insufficiency (CC less than 10 ml / min), excretion of bile metabolites is increased, while no increase in their concentration in the blood is observed.
In patients with chronic hepatitis or compensated liver cirrhosis, as well as elderly patients, the pharmacokinetic parameters of diclofenac do not change.
- inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis, Reiter's disease arthritis, rheumatic soft tissue, osteoarthritis peripheral joints and spine, including with radicular syndrome, tendovaginitis, periarthritis, bursitis, myositis, synovitis);
- pain syndrome of mild or moderate severity (neuralgia, myalgia, lumboischialgia, post-traumatic pain syndrome accompanied by inflammation, postoperative pain, headache, migraine, algodimenorrhea, adnexitis, proctitis, toothache, renal and jaundiced colic);
- as part of complex therapy of infectious and inflammatory diseases of the upper respiratory tract with severe pain (pharyngitis, tonsillitis, otitis media);
- febrile syndrome.
The drug Naklofen Duo is intended for symptomatic therapy and does not affect the progression of the disease.
Diclofenac sodium 75 mg, including:
- Diclofenac sodium (in enteric pellets) 25 mg
- Diclofenac sodium (in pellets with a prolonged release) 50 mg
Excipients: enteric pellets - sugar spheres (sucrose content not more than 92%), hyprolose (hydroxypropylcellulose), hypromellose, magnesium heavy carbonate, methacrylic acid and ethyl acrylate copolymer (1: 1) dispersion 30%, triethyl citrate, talc, titan, edetoxyd, an appendant; sodium, macrogol, sodium hydroxide; slow release pellets - sugar spheres (sucrose content not more than 92%), ammonium methacrylate copolymer (type A), ammonium methacrylate copolymer (type B), hyprolose (hydroxypropylcellulose), triethyl citrate, talc.
The composition of the contents of the capsule: enteric pellets, slow release pellets, talc *.
Body composition: gelatin (EP), titanium dioxide (E171).
The composition of the capsule cap: gelatin (EP), titanium dioxide (E171), indigo carmine dye FD & C Blue2 (E132).
Diclofenac is marketed under different brands and generic names, and comes in different dosage forms:
|Brand name||Manufacturer||Country||Dosage form|
|Naklofen Duo||Krka dd Novo mesto AO||Slovenia||capsules|
|Diclofenac||K.O.Romparm Company S.R.L||Romania||eye drops|
|Dicloran plus||Yunik Pharmaceutical||India||gel|
|Diclofenac||Biochemist Saransk||Russia||rectal suppositories|
|Diclofenac||Synthesis AKOMP||Russia||eye drops|
|Diklo-F||Sentiss Pharma||India||eye drops|
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Dosage and Administration
The drug Naklofen Duo is taken orally. The capsule should be swallowed whole, with water at the end or after a meal, usually in the morning.
Appointed individually, taking into account the severity of the disease. Adults are usually prescribed 75 mg (1 capsule) 1-2 times / day. The maximum daily dose is 150 mg.
Often - 1-10%; sometimes 0.1–1%; rarely 0.01–0.1%; very rarely - less than 0.01%, including some cases.
On the part of the digestive system: often - epigastric pain, abdominal cramps, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases; rarely - gastritis, bleeding from the gastrointestinal tract (vomiting with blood, melena, diarrhea with blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, abnormal liver function; very rarely - stomatitis, glossitis, dry mucous membranes (including the mouth), esophageal damage, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis.
On the part of the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - a violation of sensitivity, incl. paresthesias, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmarish dreams, irritability, agitation, mental disorders.
From the senses: often - vertigo; very rarely - visual impairment (blurred vision, diplopia), hearing loss, tinnitus, taste impairment.
On the part of the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis, edema.
From the side of blood formation organs: very rarely - thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis.
Allergic reactions: anaphylactic / anaphylactoid reactions, including a pronounced decrease in blood pressure and shock; very rarely - angioedema (including faces). The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions.
Since the cardiovascular system: very rarely - heartbeat, tachycardia, extrasystole, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.
On the part of the respiratory system: rarely - cough, bronchial asthma (including shortness of breath); very rarely - pneumonitis, laryngeal edema.
Dermatological reactions: often - skin rash; rarely - urticaria; very rarely - bullous rash, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, pruritus, hair loss, photosensitization, purpura, incl. allergic.
- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history of);
- the period after coronary artery bypass surgery;
- erosive and ulcerative changes of the gastric or duodenal mucosa, active gastrointestinal bleeding;
- inflammatory bowel disease in the acute phase (UC, Crohn's disease);
- cerebrovascular bleeding or other bleeding and impaired hemostasis;
- severe liver failure or active liver disease;
- severe renal failure (CC less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease;
- decompensated heart failure;
- inhibition of bone marrow hematopoiesis;
- III trimester of pregnancy;
- lactation period (breastfeeding);
- children's age (up to 18 years);
- hypersensitivity to diclofenac.
Precautions should be prescribed the drug Naklofen Duo for ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery diseases, smoking, QC less than 60 ml / min, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, infection caused by Helicobacter pylori syrup use of NSAIDs, frequent use of alcohol, severe somatic diseases, induced porphyria, epilepsy, diverticulitis, systemic diseases of the connective tissue, a significant decrease in the BCC (including le massive surgical intervention), elderly patients (administered in lower doses), including: receiving diuretics, weakened patients and patients with low body weight, in the I and II trimesters of pregnancy, with concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticoids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).
With the simultaneous use of diclofenac increases the plasma concentration of digoxin, methotrexate, lithium preparations and cyclosporine.
Diclofenac reduces the effect of diuretics, against the background of potassium-saving diuretics increases the risk of hyperkalemia.
When taking diclofenac on the background of anticoagulants, antiplatelet and thrombolytic drugs (alteplaza, streptokinase, urokinase) increases the risk of bleeding (usually from the gastrointestinal tract).
With simultaneous use of diclofenac reduces the effect of antihypertensives and hypnotic drugs.
Diclofenac increases the likelihood of side effects of other NSAIDs and GCS (bleeding from the gastrointestinal tract), the toxicity of methotrexate and cyclosporine nephrotoxicity.
Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Simultaneous use with paracetamol increases the risk of the development of the nephrotoxic effects of diclofenac.
When taken with the use of diclofenac hypoglycemic agents, hypo-or hyperglycemia may occur. With this combination of means, it is necessary to control the level of sugar in the blood;
Cefamandol, cefoperazone, cefotetan, valproic acid and plykamycin when used simultaneously with diclofenac increase the incidence of hypoprothrombinemia.
Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity.
Selective serotonin reuptake inhibitors increase the risk of bleeding from the gastrointestinal tract against the simultaneous use of diclofenac.
The simultaneous appointment of diclofenac with ethanol, colchicine, corticotropin and St. John's wort preparations increases the risk of bleeding in the gastrointestinal tract.
Drugs that cause photosensitization, increase the sensitizing effect of diclofenac to ultraviolet radiation.
Drugs that block tubular secretion, increase plasma concentration of diclofenac, thereby increasing its toxicity.
When taken together with diclofenac antibacterial drugs from the quinolone group, there is a risk of seizures.
In order to quickly achieve the desired therapeutic effect, the drug Naklofen Duo is taken 30 minutes before a meal. In other cases, take before, during or after a meal entirely, drinking plenty of water.
To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the minimum possible course.
Precautions should use the drug Naklofen Duo for ulcerative colitis and Crohn's disease due to possible exacerbation of the disease.
With prolonged 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.
Due to the important role of prostaglandins in maintaining renal blood flow, special care should be taken when prescribing the drug to patients with cardiac or renal failure, as well as in the treatment of elderly people taking diuretics and patients who for some reason have decreased BCC (for example, after major surgery). If diclofenac is prescribed in such cases, it is recommended to monitor kidney function as a precautionary measure.
Precautions should be prescribed diclofenac to patients with blood clotting disorders, with porphyria, epilepsy, as well as patients receiving anticoagulants or fibrinolytics.
When conducting long-term therapy, it is necessary to monitor the picture of peripheral blood, to analyze the feces for occult blood.
Due to the negative effect on fertility, the drug is not recommended for women wishing to become pregnant. In patients with infertility (including those 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.
The amount of sucrose contained in the preparation does not affect patients with the following conditions: enzyme lactase deficiency, galactosemia, and glucose / galactose impaired absorption syndrome.
Influence on ability to drive motor transport and control mechanisms
During the period of treatment, the rate of mental and motor reactions may decrease, therefore it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions.
Symptoms: vomiting, nausea, abdominal pain, bleeding from the gastrointestinal tract, diarrhea, headache, dizziness, tinnitus, increased excitability, hyperventilation with increased convulsive readiness, convulsions, with a significant overdose - acute renal failure, hepatotoxic action.
Treatment: gastric lavage, activated carbon, symptomatic therapy aimed at eliminating the increase in blood pressure, renal dysfunction, seizures, gastrointestinal irritation, respiratory depression. Forced diuresis, hemodialysis are ineffective (significant connection with proteins and intensive metabolism).
- Brand name: Naklofen Duo
- Active ingredient: Diclofenac
- Dosage form: modified release capsules
- Manufacturer: Krka dd Novo mesto AO
- Country of Origin: Slovenia
- Preparation of Deuterated Diclofenac for Use as an Internal Standard in Quantitative Measurement by Gas Chromatography Negative-ion Chemical Ionization Mass Spectrometry
- Baseline risk of gastrointestinal disorders among new users of meloxicam, ibuprofen, diclofenac, naproxen and indomethacin
- NMR spectroscopy of inclusion complex of sodium diclofenac with β-cyclodextrin in aqueous solution
- Directly coupled liquid chromatography with inductively coupled plasma mass spectrometry and orthogonal acceleration time-of-flight mass spectrometry for the identification of drug metabolites in urine: application to diclofenac using chlorine and sulfur detection
- Surveillance of a recently switched non-prescription medicine (Diclofenac) using a pharmacy-based approach
- Diclofenac sodium injection sterilized by autoclave and the occurrence of cyclic reaction producing a small amount of impurity
- Electroporation Introduction of Diclofenac Sodium into Human Erythrocytes and Its Determination
- Monitoring diclofenac sodium in single human erythrocytes introduced by electroporation using capillary zone electrophoresis with electrochemical detection
- Cost effectiveness of replacing diclofenac with a fixed combination of misoprostol and diclofenac in patients with rheumatoid arthritis
- Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: Results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip
- A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee
- Kinetics and mechanism of sodium N-halo-p-toluenesulfonamides oxidation of diclofenac in alkaline medium
- Misdiagnosis in patients with diclofenac-induced hemolysis: new cases and a concise review
- Synthesis, characterization and biological properties of vanadyl(IV) complexes of diclofenac and indomethacin: an experimental and theoretical study
- Release of diclofenac through gluteraldehyde crosslinked poly(vinyl alcohol)/poly(acrylic acid) alloy membranes
- Electrically modulated transport of diclofenac salts through hydrogels of sodium alginate, carbopol, and their blend polymers
- Controlled release of diclofenac sodium and ibuprofen through beads of sodium alginate and hydroxy ethyl cellulose blends
- Glutaraldehyde-crosslinked chitosan beads for controlled release of diclofenac sodium
- Controlled delivery of diclofenac sodium from calcium alginate beads loaded with a drug–resin complex
- Encapsulation of diclofenac sodium with acidic copolymer hydrogels based on PEG/poly(N-isopropylacrylamide-co-2-acrylamido-2-methyl-1-propanesulfonic acid) semi-interpenetrating network using in situ loading technique
- Alginate-based biodegradable superabsorbents as candidates for diclofenac sodium delivery systems
- Adsorption of diclofenac sodium from aqueous solution using polyaniline as a potential sorbent. I. Kinetic studies
- Kinetic Aspects of the Dissolution and Partition of Diclofenac, Alclofenac and Their Sodium Salts
- High Performance Liquid Chromatographic Determination of Diclofenac Sodium in Plasma Using Column-switching Technique for Sample Clean-up