Naklofen Duo

Naklofen Duo is a medicine from the category of NSAIDs.

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Indications of the naklofen Duo

Indicated when:

• inflammations of rheumatic origin - such pathologies as rheumatoid arthritis, Bechterew's disease, osteoarthritis, and besides spondyloarthritis, non-rheumatic rheumatism and pain in different places;
• oedemas, inflammations and pain syndromes that occur after surgery and trauma;
• gynecological inflammation or pain (for example, such as the primary form of dysmenorrhea or inflammation of the appendages).

In addition, Naklofen Duo is a good remedy for eliminating migraine attacks.

Release form

Available in capsules, 10 pieces per blister. One packet contains 2 blister plates.

Pharmacodynamics

Diclofenac is an active component of the drug - it is a nonsteroidal compound that possesses powerful antipyretic, anti-inflammatory, analgesic and antirheumatic properties. With the help of experiments it was possible to reveal that the main active mechanism of the substance is the slowing down of the GHG binding process. These elements are important components of the development of inflammatory processes, pain and fever.

In vitro tests have shown that diclofenac sodium in amounts that are similar to those achieved during treatment does not inhibit the biosynthesis of proteoglycans inside the cartilaginous tissues.

During the treatment of rheumatic pathologies due to the analgesic and anti-inflammatory properties of drugs, the pain (not only during movement, but also at rest) decreases significantly, a feeling of stiffness in the mornings, as well as a swelling in the joints. This allows you to significantly improve the patient's condition.

When eliminating inflammation caused by surgery or trauma, the medicine removes spontaneous pain, and also painful sensations arising during movement. It also helps to reduce inflammatory edema in the tissues, as well as puffiness in the surgical sutures. The use of Nuclofen Duo reduces the body's need for opioid drugs, which are used to eliminate pain syndrome after surgical operations.

In the course of clinical tests, it was found out that the drug has a powerful analgesic effect in eliminating strong or moderate pains that are non-rheumatic in nature. Also, testing revealed that the drug can relieve pain and reduce blood loss during treatment of the primary form of dysmenorrhea.

Pharmacokinetics

With oral administration of drugs, the absorption of the substance occurs rather quickly, and its value exceeds 90%, although due to the primary liver metabolism the level of bioavailability is only 60%. Peak serum medication is observed after 1-4 hours (the specific time depends on the type of drug).

Since absorption of diclofenac is carried out inside the thin and duodenum gut, food slows down its absorption, because of which the peak values of the active component inside the serum are reduced and delayed. Although food reduces the rate of absorption, it does not affect the volume of this process. With repeated use of food does not affect the plasma indices of diclofenac.

Synthesis of diclofenac with plasma protein is 99% (mainly binding with albumins).

The active substance easily passes into the synovial fluid, the indices in which are equal to 60-70% of the serum values. After 3-6 hours, the level of the substance and its decomposition products within the synovial fluid begin to exceed the serum levels. Excretion of diclofenac from the synovial fluid occurs much more slowly than a similar process in the serum.

The half-life of the substance is equal to 1-2 hours. A similar figure is observed in patients with kidney or liver failure.

The drug is almost completely metabolized inside the liver (in this case, mainly the processes of methoxylation, as well as hydroxylation). About 70% of the substance is excreted in the urine in the form of pharmacologically inactive decay products. In this case only 1% is excreted unchanged. Other decay products are excreted with feces and bile.

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Dosing and administration

At the initial stage of treatment it is recommended to take 75-150 mg per day (1-2 capsules each). A more accurate dose depends on the severity of manifestations of pathology. During a long course, it is often enough to take 1 capsule of medicine per day. If the signs of the disease show themselves most strongly at night or in the morning, you need to take the medication in the evening.

Capsules must be swallowed completely, washed down with water. It is recommended to do this together with the ingestion of food or immediately after it.

It is recommended to use medicines in the most effective dosages for a short period of time, taking into account the individual therapeutic indications of each patient.

Use of the naklofen Duo during pregnancy

It is allowed to use Naklofen Duo on the 1st and 2nd trimesters (but only in cases where the probable benefit for a woman exceeds the possible risks of negative consequences for the fetus). At the 3rd trimester this medicine is completely contraindicated.

Contraindications

Among the contraindications:

• presence in the patient of intolerance to diclofenac or other elements of drugs;
• IHD in people with angina or transferred myocardial infarction;
• cerebrovascular pathologies in people who have suffered a stroke, or in people who have episodes of micro-strokes;
• diseases in the peripheral arteries;
• active forms of gastric ulcers or ulcers of the duodenum gut, and in addition perforation or bleeding in the gastrointestinal tract;
• congestive heart failure (NYHA II-IV);
• severe forms of kidney failure (CC level is <30 ml / minute) or liver (category C according to Child-Pugh classification, presence of ascites or cirrhosis);
• intestinal inflammatory diseases (ulcerative colitis or regional enteritis);
• elimination of perioperative pain arising from coronary artery bypass grafting (or in the case of AIC);
• lactation period;
• appointment in childhood - because in capsules the active ingredient is contained in high concentrations.

Naklofen Duo, like other NSAIDs, is banned for use in people suffering from hives, bronchial asthma, acute colds, nasal polyps and other allergic manifestations that are caused by the use of aspirin or other drugs that have the ability to slow prostaglandin synthase.

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Side effects of the naklofen Duo

Drug use can cause such side effects:

• organs of the digestive tract: in some situations, diarrhea, nausea, abdominal pain, constipation, as well as swelling. Occasionally bleeding develops in the digestive tract (the appearance of melena, blood vomiting and diarrhea with a trace of blood), gastric or intestinal ulcers that are accompanied / not accompanied by perforation / bleeding. It is also possible to develop gastritis, anorexia, or vomiting. There is a rare occurrence of colitis (it aggravates its ulcerous form, develops hemorrhagic form of the disease or regional enteritis), glossitis with stomatitis, and in addition pancreatitis, frustration in the esophagus and stenosis of diaphragm-like intestinal strictures;
• organs of the digestive system: occasionally develops an acute, active chronic or asymptomatic form of hepatitis, and in addition jaundice, cholestasis and acute toxic hepatitis. There may be liver failure, a violation in her work and an increase in transaminase rates. A fulminant form of hepatitis appears;
• organs of the National Assembly: occasionally there are dizziness or headaches. More rarely there are nightmares, paresthesia, a sense of disorientation, memory disorders and psychotic disorders. In addition, there are tremors, anxiety, convulsive seizures. Developing taste disorders, aseptic form of meningitis, insomnia, stroke, a feeling of fatigue, irritability, anxiety or drowsiness, as well as depression and asthma (this includes dyspnea);
• kidney and urinary system: occasionally develops kidney failure (or its acute form), hematuria, and in addition, fluid retention occurs. Single pathologies are observed, such as tubulointerstitial nephritis, necrotic papillitis, nephrotic syndrome, and proteinuria;
• organs of the immune system: in some cases, rashes or exanthema are observed; even more rarely there may be hives or itching. The reactions of intolerance develop uniquely, phototoxic or anaphylactic manifestations (this includes bronchospasm), Quincke edema (anaphylaxis and facial swelling occur) and anaphylactoid manifestations;
• organs of the cardiovascular system: in rare cases, there are pains in the sternum, heartbeat, heart failure, vasculitis and myocardial infarction, and in addition, the blood pressure index increases; while swelling, heart failure and increased blood pressure were observed in the case of combination with NSAIDs. Epidemiological data, as well as the results of clinical tests, demonstrated that there is a high risk of thrombotic complications (amongst such cases, stroke or myocardial infarction) associated with diclofenac (prolonged intake and use of large doses of 150 mg per day);
• lymph and hematopoietic system: leuko- or thrombocytopenia, anemia (in aplastic or hemolytic form) develop sporadically, and in addition agranulocytosis;
• visual organs: in rare situations clouding or visual disturbance is observed, diplopia develops;
• auditory organs: often there is a vertigo, less often can develop auditory disorder or noise in the ears;
• subcutaneous layer, as well as skin: mostly there are rashes; often develop eczema, urticaria, bullous dermatitis, erythema (also polyform type), and in addition, Lyell or Stevens-Johnson syndrome, alopecia, photosensitivity, pruritus and purpura (also in an allergic form) and exfoliative form of dermatitis;
• organs of the sternum and mediastinum, as well as of the respiratory tract: occasionally pneumonitis develops.

With the development of severe adverse reactions, it is necessary to cancel treatment.

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Overdose

Acute overdose mainly affects the organs of the central nervous system and digestive tract, as well as the liver with kidneys. Among the manifestations of the disorder - diarrhea and vomiting, nausea and pain in the epigastrium, a state of arousal, dizziness and ringing in the ears. Sometimes there may be vomiting with blood, a disorder of consciousness, melena, kidney failure, and in addition to this, problems with breathing and seizures. In severe poisoning, liver damage can occur.

There is no specific antidote, so when eliminating intoxication, symptomatic and supportive therapies should be used. This will help in getting rid of symptoms such as seizures, kidney failure, respiratory depression, GI disorders, and lowering blood pressure. Quite low probability that such procedures as hemodialysis and forced diuresis with hemoperfusion will help to remove diclofenac from the body, because the components of this drug have a high index of synthesis with blood protein, and also undergo intensive metabolism.

If you use drugs in potentially toxic doses, you need to drink activated charcoal, and if you use doses that can carry a life threat, you should perform a disinfection of the stomach (for example, rinse or induce vomiting).

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Interactions with other drugs

Nuclofen Duo is able to increase the plasma level of digoxin, as well as lithium. In the case of a combination of diclofenac with these drugs, it is necessary to monitor the indices of these substances in the body.

Like other NSAIDs, Naklofen Duo is able to inhibit the action of diuretics. When combined with potassium-sparing diuretics, an increase in serum potassium levels is possible (therefore, these values should be carefully monitored). In addition, the combination with potassium drugs can also increase their level inside the serum, which makes it necessary to constantly monitor the patient's health.

Combination with antihypertensive and diuretics (for example, with ACE inhibitors, as well as β-blockers) can only be carried out with reservations, and people (especially the elderly) should be carefully monitored when assessing blood pressure. It will also be necessary to obtain the necessary hydration, and in addition to monitoring the work of the kidneys (not only during combined treatment, but also at its completion - this is especially true for ACE inhibitors and diuretics, since they increase the risk of developing nephrotoxicity).

Although the clinical trials failed to establish the effect of diclofenac on the function of anticoagulants, there is some information that patients who combined these substances had an increased risk of bleeding. Because of this, with this type of treatment, it is recommended to closely monitor the patient.

Combined use of NSAIDs with selective inhibitors of reverse serotonin capture can increase the likelihood of bleeding in the gastrointestinal tract.

Clinical trials have demonstrated that diclofenac is allowed to combine with antidiabetic medications, since it does not change their drug effect. But there is information that sometimes with this combination developed hyper- or hypoglycemia - in such cases, adjustment of dosages of antidiabetic drugs is necessary. Also during the treatment you need to monitor the blood sugar.

It is necessary to combine with caution the NSAIDs with methotrexate (within 24 hours before or after taking the latter), because in these cases it is possible to increase its indices inside the body, as a result of which its toxic effect also increases.

The impact of drugs from the NSAID group (including Naklofen Duo) on the process of renal synthesis of PG can increase the nephrotoxic properties of cyclosporine. As a result, people who use cyclosporine should take diclofenac in low doses.

There is some information about the occurrence of seizures in people who combine NSAIDs with quinoline derivatives.

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Storage conditions

Keep the medicine in a place that is closed from penetration of moisture, as well as access to young children. The temperature values in this case are a maximum of 30 ° C.

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Shelf life

Naklofen Duo is allowed to use in the period of 3 years from the date of release of the medicine.