Instructions for the use of Denebol tablets, gel, injections for pathologies of the musculoskeletal system

Brief description of the drug

ATX code

M01AH02

Active substance

Rofecoxib.

Trade name of the drug

Denebol

Release form and packaging

Denebol is available in the form of an injection solution, tablets, gel, rectal suppositories:

• biconvex round tablets 25 and 50 mg in blister packaging in a cardboard pack No. 10;
• gel in a polyethylene tube in a cardboard package 30 g;
• solution for injection in ampoules 1 ml (25 mg) in cardboard packaging No. 5;
• suppository 25 mg in plastic packaging in a cardboard box No. 10.

Instructions for use are included.

Packaging of the drug Denebol

Compound

The main component for all forms of Denebol is rofecoxib. Only the amount of active ingredient differs:

• tablets: 25 and 50 mg;
• gel: 1 gram;
• injection solution: 25 mg;
• suppository: 25 mg.

Excipients:

• tablets: corn starch, microcrystalline cellulose, beta-cyclodextrin, sodium methylhydroxybenzoate, purified talc, povidone, colloidal silicon dioxide, sodium propylhydroxybenzoate, sodium starch glycolate, magnesium stearate, brilliant blue, colored tartrazine, starch;
• gel: flaxseed oil, menthol, methyl salicylate, phenoxyethanol, butylated hydroxytoluene, propylene glycol, isopropyl alcohol, purified water, carbomer, triethanolamine, denarii edetate, polyethylene glycol, hydrated castor oil, polyoxyl;
• injection solution: tocopherol acetate, centubucridine hydrochloride, methyl carbonate, saline solution;
• suppository: fish oil.

Pharmacological group

Denebol is a drug from the group of highly selective cyclooxygenase (COX) 2 inhibitors, a non-steroidal anti-inflammatory drug (NSAID).

pharmachologic effect

Anti-inflammatory, antipyretic, analgesic, decongestant.

Manufacturer

Mepro Pharmaceuticals Pvt. Ltd. for Miles Healthcare (India/UK)

Similar drugs:

• Dexamethasone Solution for intravenous and intramuscular administration
• ARTRADOL (Artradol) Lyophilisate for the preparation of solution for injection
• Dicloberl N 75 (Dicloberl N 75) Solution for injection
• Calcium gluconate Chewable tablets
• Nimesil Granules for the preparation of suspension for oral administration
• Next Oral tablets
• Dimexid Solution for local and external use
• Pulmicort Suspension for inhalation
• Ibufen Oral suspension
• Panoxen Oral tablets

** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Denebol, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

Are you interested in the drug Denebol? Do you want to know more detailed information or do you need a doctor's examination? Or do you need an inspection? You can make an appointment with a doctor - the Euro lab is always at your service! The best doctors will examine you, advise you, provide the necessary assistance and make a diagnosis. You can also call a doctor at home . Euro lab clinic is open for you around the clock.

** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Denebol is provided for informational purposes only and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

If you are interested in any other drugs and medications, their descriptions and instructions for use, information about the composition and form of release, indications for use and side effects, methods of use, prices and reviews of drugs, or you have any other questions and suggestions - write to us, we will definitely try to help you.

Pharmacodynamics: mechanism of action and effect

The drug of the NSAID group contains rofecoxib, which is a COX-2 inhibitor substance with a high degree of selectivity of action. The mechanism of the anti-inflammatory effect of the drug is based on inhibition of the process of prostaglandin production, which is carried out by inhibiting COX-2, while rofecoxib does not suppress COX-1 and, accordingly, the physiological processes associated with COX-1 in the intestines and platelets, tissues, and stomach are not disrupted. The analgesic effect begins after 10 minutes with the injection method of the drug, and its peak is observed after 4 hours, then the effect decreases over 24 hours.

The preparation in the form of a gel for topical use contains methyl salicylate, linseed oil, menthol. Methyl salicylate is effective for local muscle pain, soft tissue damage, and joint pain. Flaxseed oil is a demulsified substance and is an emollient when used topically.

Menthol, when applied externally, causes a feeling of cold, which leads to stimulation of cold receptors and stabilization of the flow of calcium ions in neuronal membranes.

Denebol is effective for pain in muscles and joints

Analogs and price

If the patient is allergic to the active substance of the drug or auxiliary components, or there are contraindications to one or another form of Denebol, then the doctor selects analogues of the drug. The main thing is that the drug contains rofecoxib, and the drug has a similar mechanism of action.

The main analogues of Denebol are the following drugs:

• Artrum gel;
• Voltaren;
• Diclofenac;
• Ibuprofen;
• Indomethacin;
• Ketonal;
• Ultraflex;
• Orotix;
• Revmoxib;
• Celebrex.

The price of the medicine differs in different pharmacies. The cost of the drug from Ukraine starts from 170 rubles. It depends on the region and manufacturer.

The shelf life of tablets is 3 years, and the gel, suppositories and solution are no more than 2 years. The drug should be stored in a place protected from light and out of reach of children at a temperature of +24ºС.

Pharmacokinetics

• Suction

When administered orally, rofecoxib is well absorbed; the bioavailability of rofecoxib averages 93%. When taking the drug once daily at a dose of 25 mg, the maximum concentration of rofecoxib (Cmax) in the blood plasma of adults is determined after approximately 2 hours and is 0.305 mcg/ml.

Bioavailability after intramuscular administration is about 100%, the time to reach Cmax of rofecoxib in blood plasma is 45 minutes. About 87% of rofecoxib is bound to plasma proteins in the body at concentrations of 0.05–25 mcg/ml.

Rofecoxib penetrates the placental and blood-brain barrier into the synovial fluid.

• Metabolism

In the body, rofecoxib breaks down into cis-dihydro and trans-dihydro derivatives of rofecoxib; about 56% of these derivatives are excreted from the body in the urine. An additional 88.8% of the drug is recovered in the form of hydroxy-glucosamide derivatives, which is a product of oxygen metabolism. The main metabolites do not inhibit COX-2 or COX-1.

• Removal

Rofecoxib is metabolized primarily in the liver and a small amount (<1%) by the kidneys. 72% of the drug is excreted in the urine in the form of metabolites, 14% in feces.

• Pharmacokinetics in special clinical situations

The pharmacokinetics of rofecoxib are independent of gender. The pharmacokinetics of rofecoxib in elderly patients (65 years and older) do not differ from those in younger patients. But therapy in elderly patients begins with the minimum recommended dose.

In patients with liver failure, a tendency to a slight increase in drug concentrations was detected. However, caution should be exercised when administering maximum doses of rofecoxib. Renal impairment does not affect the pharmacokinetics of rofecoxib, but its use in patients with severe renal impairment is not recommended.

Compound

active ingredients: rofecoxib, flaxseed oil, methyl salicylate, menthol, phenoxiethanol;

100 g gel mixed with rofecoxib 1 g, flaxseed oil 3 g, methyl salicylate 10 g, menthol 5 g, phenoxyethanol 1 g;

additional words: propylene glycol, carbomer 934, butylhydroxytoluene (E 321), polyethylene glycol 400, isopropyl alcohol, disodium edate, triethanolamine, polyethoxylated ricin, hydrogenated, purified water.

Medicine form

Gel.

Main physical and chemical properties: white pulp is a homogeneous mass with a characteristic odor found in the pulp tube.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic agents. Coxibee. Code ATX M01A N.

Pharmacological authorities

Pharmacodynamics.

Denebol gel mist rofecoxib? non-steroidal anti-inflammatory drug - a highly selective cyclooxygenase-2 inhibitor. It contains analgesics, antipyretic, anti-inflammatory power during local stagnation. COX-2 is activated in response to the ignition process. This leads to the synthesis and accumulation of inflammation mediators, suppressing prostaglandin E2, which causes inflammation, swelling and pain. The contraceptive action of rofecoxib is due to the inhibition of prostaglandin synthesis by inhibiting COX-2.

At therapeutic concentrations, the drug does not suppress cyclooxygenase-1 (COX-1). Thus, it does not influence prostaglandins, which are synthesized during the activation of COX-1, and as a result does not interfere with the normal physiological processes associated with

COX-1 in tissues, especially in the gut, intestinal tract and platelets.

Flaxseed oil is a demulsifying preparation and a softening component, which is included in the stock of preparations for local hardening. Flaxseed oil is composed of a-linoleic acid, which is an important fatty acid for the functioning of the human body.

Menthol responds to cold and has a therapeutic effect in the presence of cold, exhibits a therapeutic effect by stimulating cold receptors, stabilizing the flow of calcium ions in neuronal membranes.

Methyl salicylate, as a rubefacient, can be used to treat local pain, pain in the joints, and when the soft tissues are damaged. You can also perform pain-sedative and anti-inflammatory actions to stabilize the enzyme cyclooxygenase, and then convert it to the active form - salicylic acid.

Pharmacokinetics.

When soaked in the drug applied to the skin, the blood flow is completely cleared up. When applying a large amount of rofecosib to the skin, do not increase the concentration of the active substance in the blood plasma.

Menthol, after soaking, is biotransformed in the liver and is excreted in the form of glucoronides. Methyl salicylate quickly penetrates deep into the skin, soaks up, hydrolyzes, converts to salicylic acid anion and is excreted. The clearance of salicylates in a significant world depends on the pH level. Phenoxyethanol is adsorbed in small amounts and appears as phenoxyacetylic acid.

Indications for use of the drug

The use of Denebol is advisable for:

• diseases of the musculoskeletal system;
• acute and chronic periarthritis;
• rheumatoid arthritis;
• osteoarthritis;
• bursitis;
• tendinitis;
• traumatic injuries to muscles, ligaments and tendons;
• pain syndrome of various origins, including pain caused by lumbago, neuralgia, radicular syndrome, osteochondrosis, myalgia, neuritis, algodismenorrhea, migraine;
• toothache;
• thrombophlebitis;
• ENT and dental diseases (for example, pulpitis, stomatitis or gingivitis).

As a symptomatic remedy, Denebol is prescribed for infectious and inflammatory diseases of the pharynx, trachea and bronchial tree, diseases of the urinary system (for example, cystopyelitis or urethritis), and gynecological and ophthalmological diseases.

Denebol has a wide range of uses based on its analgesic properties.

This breadth of Denebol's application is due to its pharmacological properties, in particular, the ability to relieve pain and inflammation, and provide antiplatelet and antipyretic effects. The drug inhibits the formation of anti-inflammatory factors and prevents the release of mediators of fever, inflammation and pain. An important feature of Denebol is that, unlike most other NSAIDs, it does not have a negative effect on the condition of the digestive tract and does not provoke the development of necrotizing renal papillitis.

Nosological classification (ICD-10)

• Acute sinusitis (J01);
• Acute laryngitis and tracheitis (J04);
• Chronic sinusitis (J32);
• Chronic laryngitis and laryngotracheitis (J37);
• Otitis externa (H60);
• Non-suppurative otitis media (H65);
• Purulent and unspecified otitis media (H66);
• Diseases of the pulp and periapical tissues (K04);
• Gingivitis and periodontal diseases (K05);
• Stomatitis and related lesions (K12)

Features of application

Denebol gel should be applied only to intact skin. Contact with eyes, mucous membranes and affected skin should be avoided. If the drug accidentally gets on the mucous membranes, rinse with plenty of water.

This product contains propylene glycol, which may cause irritation. In case of severe skin irritation, rubbing should be stopped. With long-term use on large areas of skin, a systemic effect of the drug cannot be ruled out.

Use during pregnancy or breastfeeding. Clinical experience with pregnant women is limited; therefore, the use of this drug is not recommended during pregnancy or lactation. The drug is contraindicated during the third trimester of pregnancy due to the possibility of developing weakness of labor and/or premature closure of the ductus arteriosus.

It is unknown whether rofecoxib is excreted in breast milk, so the physician should make a decision regarding discontinuation of breastfeeding or discontinuation of the drug, taking into account the need for maternal use of the drug.

The ability to influence the reaction rate when driving vehicles or other mechanisms. The drug does not affect the reaction rate when driving vehicles or operating other mechanisms.

Contraindications to the use of Denebol

The use of Denebol is contraindicated in patients with a history of:

• hypersensitivity to salicylic acid or other non-steroidal drugs;
• bronchial asthma;
• cancer disease.

Denebol should not be prescribed:

• patients with hypersensitivity to the main or one of the excipients of the composition;
• children under 12 years old;
• in the third trimester of pregnancy;
• during breastfeeding, as the medicine passes into milk.

The use of Denebol in the form of a solution for intramuscular injection is contraindicated in patients:

• survivors of myocardial infarction and/or stroke;
• with a progressive form of atherosclerosis;
• with malignant arterial hypertension.

Denebol is not prescribed to patients with confirmed vascular atherosclerosis

Other restrictions:

• active ulcer or bleeding in the gastrointestinal tract;
• acute rhinitis;
• nasal polyps;
• angioedema;
• history of urticaria or other allergic reactions after taking acetylsalicylic acid or other NSAIDs, including cyclooxygenase-2 (COX-2) inhibitors.

Possible restrictions

It is prohibited to take the drug if the following contraindications exist:

1. Bronchial asthma.
2. Malignant tumor.
3. Children's age (the medicine is not prescribed for children under 12 years of age).
4. Allergy to Acetylsalicylic acid or other forms of non-steroidal drugs.
5. Pregnancy in the 3rd trimester.
6. Lactation period.
7. Allergy to the active substance of the medicine or additional components.

Denebol in the form of intramuscular injections is prohibited for patients who have had a heart attack, stroke, or suffer from atherosclerosis

Women should take this medication with caution during the 1st and 2nd trimesters of pregnancy. It is prescribed only if the benefit to the pregnant woman significantly outweighs the risk to the unborn child.

During treatment it is forbidden to drink alcohol. Doctors advise patients who take the drug to refrain from driving vehicles and various mechanisms. In case of overdose of the drug, you should take Activated Carbon and consult a doctor.

Instructions for use: methods and dosages

The dosage and method of taking Denebol depend on the form of the drug prescribed by the doctor. The dose and duration of therapy are determined by a specialist after identifying the clinical picture of the disease, symptoms and collecting anamnesis.

When using several forms of Denebol simultaneously, the total daily dose should not exceed 50 mg. A course of treatment for 4-6 weeks at a dose of no more than 25 mg per day is considered safe.

Pills

Tablets: taken orally with a small amount of water, regardless of meals.

For osteoarthritis, treatment should begin with 12.5 mg once a day, the treatment period is 4-6 weeks.

For pain syndrome and primary dysmenorrhea - 25 mg 1 time per day, used until pain is completely relieved, but not more than 3 days. Depending on the symptoms of the disease, the dose can be reduced to 12.5 mg. The maximum daily dose is 25 mg.

Rectal suppositories

Suppositories are used rectally to localize acute pain of inflammatory etiology and treat primary dysmenorrhea.

When treating primary dysmenorrhea and relieving acute pain of inflammatory origin, use 1 suppository 2 times a day. The maximum daily dose is 50 mg. The duration of the therapeutic course is no more than 1.5 months.

Gel

The gel should not be used on areas with compromised skin integrity. Apply topically by applying to painful areas of the body and rubbing into the skin with light movements. A single dose is 1-2 g, it is recommended to carry out procedures up to 4 times a day. The period of use depends on the effectiveness of treatment. After applying the drug, you must wash your hands thoroughly and avoid getting the gel on the mucous membranes.

A doctor should prescribe a Denebol treatment regimen

Injection

Intramuscular injections are often used as a short symptomatic introductory course, and after a week the patient is transferred to the gel and tablet form of the drug. When using several forms of Denebol in combination, the total daily dosage of rofecoxib should be no more than 50 mg. Courses of the drug lasting 4-6 weeks at a dosage of 25 mg are considered effective and safe. The decision to increase the dose in each specific case is made individually, depending on the indications and severity of the patient’s condition.

The solution is administered intramuscularly (into the buttock) once a day with an interval of 24 hours. Rofecoxib is recommended to be used at an initial dosage of 50 mg per day. Depending on the severity of the pain syndrome and the intensity of the inflammatory process, the indicated dosage can be reduced to 25 mg.

For osteoarthritis, the recommended daily dosage is 12.5 mg. If necessary, it is increased to 25 mg.

Intravenous administration of Denebol in solution form is strictly prohibited.

Newspaper "News of Medicine and Pharmacy" 9 (583) 2021

The article was published on p. 16-19 (World)

In his daily practice, an orthopedic traumatologist encounters two main pathological conditions that require effective, rapid and reliable treatment of pain and inflammation: injuries and diseases of the musculoskeletal system.

Injuries to the musculoskeletal system are one of the main reasons for seeking medical care in outpatient practice [28]. Injuries to the musculoskeletal system include injuries to muscles, ligaments, tendons and bone fractures. Approximately 3.7 million sports injuries occur in people of all age groups. A particularly urgent problem is the effective treatment of injuries prone to chronicity (epicondylitis, apophysitis, periarticular injuries), since they are the main cause of long-term decline in quality of life and work ability. The main focus in the treatment of injuries is usually to reduce swelling and pain [29]. For this purpose, nonsteroidal anti-inflammatory drugs (NSAIDs) have been used successfully for a long time [28]. Generally, the use of NSAIDs is associated with their anti-inflammatory and analgesic properties.

An equally large contingent of orthopedists and traumatologists are patients with degenerative-dystrophic diseases of the musculoskeletal system. Osteoarthritis (OA) is the most common form of damage to the joints and spine in industrialized countries. In the UK, it affects between 1.3 and 1.8 million people; in France, 6 million new cases are diagnosed every year; about 16% of the US population has some form of arthritis. Ukraine is no exception in this regard. The prevalence of osteoarthritis in our country is 2515.7 per 100,000, and the incidence of osteoarthritis is 497.1 per 100,000 population. The incidence among men and women of working age and retirement age also varies: in men it is 32% less (423.1) than in women (558.8), and in people of working age it is 2.7 times less (338.9 ) than among pensioners (931.1) [3]. The incidence of osteoarthritis increases sharply with age, affecting a third of the population in old and senile age [2].

OA most often affects people in older age groups, whose share in the population of developed countries is steadily growing. It is believed that after 60 years, almost every second person has OA. The economic burden of OA (medical interventions, premature death, chronic and short-term impairments) is estimated at 1–1.5% of the gross domestic product of Western countries [5]. At the same time, the patient’s quality of life is significantly reduced due to pain and, as a consequence, limited functionality.

Treatment of osteoarthritis is a difficult task for the doctor and until now remains predominantly symptomatic. The goal of treatment is to slow the progression of OA, reduce the severity of pain and inflammation, improve the patient’s quality of life, reduce the risk of exacerbation and damage to new joints, and prevent disability. A key component of OA therapy is pain relief, namely the use of NSAIDs [8]. The desired effects of all NSAIDs are pain relief and suppression of inflammation. However, when performing the above tasks, NSAIDs, by suppressing the synthesis of prostaglandins, cause a number of side effects. By blocking the synthesis of prostaglandins in the stomach, NSAIDs have an ulcerogenic effect. In the cardiovascular system, NSAIDs cause vasoconstriction. The side effect on the kidneys is a decrease in daily urine output and creatinine clearance. Therefore, the safety of anti-inflammatory and analgesic treatment comes first when managing patients with OA and other pathologies requiring the use of NSAIDs.

A modern doctor has a wide choice of modern NSAIDs, but a special place in this list is occupied by rofecoxib, a specific inhibitor of cyclooxygenase-2 (COX-2), which has the highest selectivity coefficient (IC50 COX-1/IC50 COX-2 according to Warner et al .) - 0.004, which is explained by the unique features of the stereometric structure of its molecule - the presence of a rigid side chain capable of penetrating into the hydrophilic side cavity of the COX-2 molecule and thereby non-competitively blocking the active center of this isoenzyme. For celecoxib this indicator is 0.1, nimesulide - 0.15, ibuprofen - 10, indomethacin - 33, naproxen - 100. Thus, rofecoxib inhibits prostaglandin synthesis to the least extent and, as a result, has a high safety profile [10] . Another important aspect is the fact that the selectivity of rofecoxib is practically independent of the concentration of the drug, which distinguishes it from other NSAIDs [7].

Today, Denebol is the only representative of rofecoxib on the pharmaceutical market of Ukraine

Denebol is available in tablets containing 25 and 50 mg of rofecoxib, and in the form of a 1% gel. The recommended dose for acute pain is 50 mg/day, chronic pain is 25 mg/day, depending on the severity of the pain syndrome and concomitant diseases, it can be reduced to 12.5 mg. When taken orally, Denebol is quickly absorbed from the digestive tract, and its bioavailability is over 90%. The maximum concentration in the blood plasma of the active substance of the drug Denebol, rofecoxib, is achieved 2 hours after administration. It is biotransformed mainly in the liver with the formation of 6 inactive metabolites, 70% of which are excreted by the kidneys [6].

The effectiveness and safety of the drug Denebol (tablets 25 and 50 mg) produced (Great Britain) were confirmed in the framework of a pharmacoepidemiological study, which was carried out in 9 clinical centers of Ukraine [8] with the participation of 532 patients with pain syndrome of various origins: 160 with dermatological diseases (acne and psoriatic osteoarthropathy), 126 - with otolaryngological and gynecological pathology with severe pain syndrome, 246 - with damage to joints of various origins, of which 100 people. - with high cardiovascular risk.

The study demonstrated the high analgesic and anti-inflammatory effectiveness of the drug Denebol, manifested in the regression of clinical symptoms. Only 19 patients (3.58%) had side effects. At the same time, discontinuation of the drug or adjustment of the dosage regimen was required in 0.38% of the total number of patients participating in the study. It has been proven that among the side effects of the drug Denebol, cardiovascular disorders in the form of a slight increase in blood pressure occurred in only 15.7% of patients over the age of 50 years. In patients classified as at risk due to the presence of cardiovascular disorders, its reduction can be achieved by reducing the daily dose of Denebol to 12.5 mg [7].

It should also be noted that rofecoxib, based on the results of studies conducted at the turn of the 20th and 21st centuries, has all the positive qualities put forward by the World Health Organization and necessary for its further medical use as a representative of the NSAID group:

- reduces the intensity of pain in osteoarthritis and injuries of the musculoskeletal system;

- reduces swelling of joints;

- has a chondroneutral effect;

- has a high safety profile in relation to the gastrointestinal tract (GIT);

- possibility of safe use for 6–12 months; manifestation of NSAID gastropathy as a result of taking rofecoxib for 6 months. was 0.01% per 100 patients per year (comparable to the frequency in persons not taking NSAIDs);

- possibility of safe use for 6–12 months. at a dose of 25 mg without complications from the cardiovascular system;

- does not change platelet function (therefore, the risk of bleeding is minimized);

- prolonged action - take 1 time per day.

Concerns raised about possible adverse cardiovascular effects of rofecoxib were not confirmed, and he has now been fully rehabilitated. As reported by The Associated Press “Vioxx Could Rejoin Painkillers on Market”, a specially created expert council on coxibs under the US government on February 18, 2005 decided on the advisability of their further use in clinical practice, since “the benefits outweigh the risks.” Thus, in December 2004, the FDA approved new recommendations regarding the safety of NSAIDs - rofecoxib, valdecoxib, celecoxib and naproxen:

1. Individuals with an increased risk of gastrointestinal bleeding and intolerance to non-selective NSAIDs are recommended to be prescribed selective COX-2 inhibitors.

2. The issue regarding the occurrence of cardiovascular and other complications associated with taking NSAIDs should be resolved taking into account the individual characteristics of the patient.

3. Patients should use NSAIDs and other over-the-counter medications as directed. In cases of using NSAIDs for more than 10 days, you should consult your doctor.

4. The decision to prescribe drugs is made by the doctor, justifying it based on the results of assessing the cardiovascular risk of a particular patient [1].

Rofecoxib should not be used in patients with asthma, especially that caused by acetylsalicylic acid. The drug is not used for the treatment of cancer patients and patients at increased risk from the cardiovascular system (previous heart attack, stroke, arterial hypertension (stage III), progressive clinical form of atherosclerosis).

Denebol in the treatment of musculoskeletal injuries

In studies by Jokhio et al. The analgesic effectiveness of rofecoxib and ketoprofen for ligamentous injuries was compared. 165 patients with sprains and dislocations of the joints of the upper and lower extremities were divided into two groups. The first group (n = 82 patients) received rofecoxib 25 mg per day orally, the 2nd group (n = 83) took ketoprofen 200 mg per day. The duration of therapy was 7 days. The effectiveness was assessed taking into account the speed of onset of pain relief and its severity. It was found that in the group receiving rofecoxib therapy, an analgesic effect was achieved more quickly, which persisted for 24 hours and did not require additional analgesia, in contrast to the group receiving ketoprofen (additional analgesia in 7.8% of cases) [7].

The effectiveness of rofecoxib has been demonstrated for back muscle injuries. J. Dietrich et al. (2006) studied the effectiveness and safety of rofecoxib 25 mg/day and diclofenac 150 mg/day in the treatment of 244 patients with traumatic injury to the soft tissues of the back. The evaluation criterion was the presence of severe pain (visual analogue scale (VAS) score > 50 mm). After 3 and 7 days of treatment, there was a significant reduction in pain in both groups, while the effect of the drugs did not differ significantly: –40.0 vs –42.6 mm and –58.8 vs –60.7 mm according to VAS, respectively. But while taking diclofenac, the number of complications from the gastrointestinal tract was significantly higher - 15.4%, than with rofecoxib therapy - 3.2% [7].

Denebol in the treatment of degenerative-dystrophic diseases of the musculoskeletal system

Is rofecoxib really effective in treating osteoarthritis and how safe is it?

To answer these questions, an analysis of 26 randomized controlled trials (RCTs) was conducted. They included over 20,000 patients with osteoarthritis and continued for up to 1 year. Patients in the main group took rofecoxib 12.5; 25 or 50 mg once daily. Placebo (sugar tablets), diclofenac, ibuprofen, naproxen, nimesulide, nabumetone, paracetamol, celecoxib and a combination of diclofenac and misoprostol were used as controls [17].

Based on the results obtained, it was found that rofecoxib was more effective than placebo (patient global response: risk ratio (RR) 1.75, 95% confidence interval (CI) 1.35–2.26), and at the same time much greater for the clinician Of interest are the results of comparative characteristics of the effectiveness and safety of rofecoxib and other NSAIDs used in the treatment of osteoarthritis.

Rofecoxib and diclofenac

To compare the effectiveness of rofecoxib and diclofenac, three RCTs were conducted in which some patients with OA of the knee and hip joints took rofecoxib (12.5 or 25 mg per day), and others took diclofenac 50 mg three times a day (150 mg). in a day).

After two weeks of treatment, a study by Niccoli (2002) indicated that rofecoxib and diclofenac significantly reduced pain intensity as assessed by both physicians and patients. Moreover, the decrease in pain intensity in the diclofenac group in the first 2 weeks of treatment was significantly higher. But later (12 and 52 weeks after the start of treatment), there was no statistically significant difference in effectiveness between the patient groups. However, pooled data from all three studies showed that at 1 year, fewer people taking rofecoxib were withdrawn from the study due to lack of efficacy than those who received diclofenac (RR 1.11, 95% CI 0.80– 1.54).

A two-week renal tolerability study found that both diclofenac and rofecoxib had some effect on renal function. This was expressed in a decrease in daily diuresis and creatinine clearance. However, in the diclofenac group these changes were more pronounced. It should be noted that the effects of these drugs on liver function have also been demonstrated. Thus, in patients taking diclofenac, a more pronounced increase in the levels of alanine aminotransferase and aspartate aminotransferase was observed [17]. As for gastrointestinal complications, more patients in the diclofenac group were forced to discontinue treatment due to the development of gastrointestinal side effects. In terms of cardiovascular side effects such as hypertension, palpitations and transient ischemic attack, a higher risk was again noted in the diclofenac group (increased transaminase levels - 10/230 compared with 1/232 in the rofecoxib group).

Rofecoxib and ibuprofen

Four double-blind RCTs were performed to compare the effectiveness of rofecoxib and ibuprofen in patients with osteoarthritis [20]. Patients of the first and second groups took rofecoxib at a dose of 25 and 50 mg per day, respectively, and the third group took ibuprofen 800 mg 3 times a day. The course of treatment lasted from 16 to 24 weeks. It was noted that the clinical effectiveness of rofecoxib was comparable to that of ibuprofen, and this was observed even when using a minimum dose of rofecoxib of 25 mg. Control fibrogastroscopy, which was carried out in all groups, showed a significantly lower number of erosions of the gastric mucosa in patients receiving rofecoxib.

As for comparative studies of the effectiveness and safety of rofecoxib, naproxen, nimesulide, celecoxib and the combination of diclofenac and misoprostol, with equal clinical efficacy, a more pronounced safety of rofecoxib in relation to gastrointestinal events was demonstrated compared with naproxen, nabumetone, paracetamol and the combination of diclofenac and misoprostol [19, 24].

Denebol in the prevention of heterotopic ossification after hip replacement

Heterotopic ossification (HO) is the phenomenon of formation of fully differentiated bone tissue in ectopic locations where bone is normally absent. This does not happen with any other specialized tissue. The bone tissue resulting from HO resembles normal lamellar bone. The pathophysiology of HO is not well understood. After total hip arthroplasty, the surrounding tissue is at risk of developing HO, which is likely due to the presence of osteogenesis cells in the wound bed. Local trauma likely triggers the inductive signaling pathway. Whether the development of HO in body tissues begins or not depends on the delicate balance between the local and systemic activity of osteogenic and osteoinhibitory factors [14]. The incidence of HO after total hip arthroplasty varies, according to various authors, from 10 to 90%, although the rate of clinically significant incidence is considered much lower, between 3 and 7% [9]. HO is more often observed after primary total hip arthroplasty. As a rule, the development of this complication is associated with the degree of tissue trauma during surgery, the presence of previous operations on the hip, and epidural anesthesia. It has been proven that heterotopic ossification more often develops after an anterolateral approach compared to a posterior one, as well as after a transtrochanteric approach compared to a lateral or posterolateral one [12, 23]. Men suffer more often. HO is also more common in individuals with ankylosing spondylitis, hypertrophic osteoarthritis, Forestier disease, and in patients with large body weight. Data on the effect of the type of endoprosthesis (cemented/cementless) on the incidence of HO development are very contradictory. Pulsatile lavage also does not affect the frequency of HO. The main problem in a patient with HO after endoprosthetics is a decrease in the range of motion in the prosthetic joint and, less often, the occurrence of pain. Active formation of ossification can occur within three months after surgery, and its complete maturation takes up to one year [13].

To prevent HO, minimal doses of radiation therapy [11] or non-steroidal anti-inflammatory drugs [18] are used. The preventive effect of NSAIDs in HO was first noted by Dahl [16], who used indomethacin for pain relief in the postoperative period. Other studies have also demonstrated the ability of indomethacin to prevent the development of HO. However, to obtain a positive result, it took a rather long period of use of this drug (up to 6 weeks), which resulted in a significant increase in the frequency of side effects even with a minimum period (1 week) of indomethacin administration, which, of course, represents a serious clinical problem. Attempts to reduce the use of indomethacin to 3–4 days were unsuccessful in preventing the development of HO. Given such a high risk of complications when using non-selective NSAIDs, the views of scientists and clinicians were turned to selective agents - COX-2 inhibitors. Only the effectiveness of these drugs in preventing HO remained unclear. In 2007, a prospective two-stage study was performed to determine the effectiveness of rofecoxib as a COX-2 inhibitor in the prevention of HO [21]. It included 42 patients with osteoarthritis who underwent total hip replacement. Rofecoxib was administered orally at a dose of 50 mg per day for 6 days. The patient took the first dose of rofecoxib the evening before surgery. Patients were not allowed to use other NSAIDs for the first two months after surgery. In the postoperative period, if rofecoxib was insufficiently effective as an analgesic, the use of tramadol or other drugs was allowed. Gastrointestinal disturbances were monitored daily until 7 days after surgery.

A posterolateral approach without trochanteric osteotomy was used in all patients. At 6 months postoperatively, heterotopic bone formation was assessed on radiographs using the Brooker classification. For comparison, we used the results of a study conducted by the same authors in 1999 with the participation of 2 groups of patients: those who received indomethacin for 7 days (99 people) and those who did not take NSAIDs in the postoperative period (170 people) [22].

The results of the study showed that in the rofecoxib group, only 19% of patients had minimal signs of ossification (Brooker grade 1), which is less than in the indomethacin group (24%) and disproportionately less than in patients who did not receive prophylactic treatment , in whom HO of 2, 3 and 4 degrees of intensity was observed (Table 1).

Thus, rofecoxib appears to be a promising means of preventing heterotopic ossification after primary total hip arthroplasty, which also has a much higher level of safety compared to non-selective NSAIDs.

Denebol for analgesia in the postoperative period

The analgesic effect of rofecoxib was assessed before or after surgery in patients undergoing arthroscopic knee surgery. In a clinical study, Denebol was found to provide effective analgesia in patients after arthroscopic meniscectomy. In addition, the administration of 50 mg of rofecoxib before surgery provides a longer duration of postoperative pain relief compared with the use of the drug after surgery [26]. For interventions on other segments, including large joints and long bones, rofecoxib 50 mg (2 to 4 times daily) was effective in relieving acute postoperative pain in adults [7].

Local prescription of NSAIDs

Local use of NSAIDs has a number of advantages, one of which is the ability to create a high concentration of the drug in the area of ​​inflammation, at the same time without systemic side effects. A sufficiently high concentration of the drug is necessary to penetrate the skin, muscles and synovial fluid. In addition to this, the gel form of the drugs allows for a constant and slow release of the drug [25]. In this regard, recently more and more attention has been paid to the local use of NSAIDs for the treatment of patients with acute and chronic inflammatory joint syndrome.

Denebol gel is a combined preparation for external use based on methyl salicylate and rofecoxib, which has no analogues in Ukraine

The composition of the drug Denebol gel includes rofecoxib (1.0 g), methyl salicylate (10.0 g), menthol (5.0 g) and flaxseed oil (3.0 g). This combination provides potentiation of the effect of the components and multi-stage action of the drug. At the first stage, immediately after application, menthol, stimulating the cold receptors of the skin and superficial nerve endings, has an instant distracting and analgesic effect. Alcohols, evaporating from the surface of the skin, additionally provide cooling and analgesia. This is followed by a locally irritating, analgesic and anti-inflammatory effect of methyl salicylate. Finally, the specific COX-2 inhibitor rofecoxib begins to act. The gel base ensures its sufficient bioavailability. At the same time, rofecoxib not only relieves pain, but also permanently eliminates its cause - inflammation. The next component, flaxseed oil, ensures slow absorption and prolonged action of methyl salicylate and rofecoxib, while it itself has antioxidant properties (since hypoxia is formed at the site of inflammation and the associated activation of lipid peroxidation) [4]. α-linoleic acid, which is part of flaxseed oil, facilitates the transport of gel components through the epidermal layer and basement membrane of the skin, softens it. This is especially important for people in the older age group. The effectiveness and good tolerability of the active substance of the drug rofecoxib are evidenced by the results of a number of large randomized clinical trials conducted in patients with osteoarthritis, rheumatoid arthritis and pain in the lower back [5].

To achieve faster clinical results, tablet and gel forms of the drug Denebol are combined, which allows patients to individually select a treatment regimen and reduce the dose of systemic NSAIDs depending on the severity of the pain syndrome. The recommended initial daily dose of Denebol (rofecoxib) tablets is 12.5 mg and can be increased to 25 mg. The maximum recommended daily dose is 50 mg. For effective pain relief, the gel is recommended to be used 3 times a day. The indisputable advantage of Denebol gel is the fact that applying even a large amount of gel to the skin does not lead to an increase in the concentration of rofecoxib in the blood plasma, which significantly increases the safety of its use in combination with tablet forms of the drug.

In the absence of contraindications, Denebol gel can be used to enhance the effect of physiotherapeutic procedures (ultrasound examination, electrophoresis, phonophoresis, etc.).

The combination of local and systemic use of the drug Denebol allows for rapid relief of pain, significantly improving the patient's mobility and preventing chronicity of the process due to the effective suppression of inflammation both at the systemic and local level. Such a potentiating effect is not possible when using only the oral or only the local form of the drug. In addition, this combination of forms of the drug Denebol allows you to reduce the dose of the oral form and the duration of treatment without compromising the clinical effect, which can significantly reduce the risk of the above side effects. When using drugs in this group, especially if a long course of treatment is necessary, you should be aware of contraindications and the possibility of developing undesirable side effects. Contraindications for prescribing Denebol gel: hypersensitivity to rofecoxib and other NSAIDs, third trimester of pregnancy and breastfeeding.

Thus, Denebol (rofecoxib) is an effective and safe drug for the treatment of pain and inflammation in injuries, diseases, as well as after surgical interventions on different segments of the musculoskeletal system. The combination of oral and local (gel) forms of the drug Denebol allows you to potentiate the anti-inflammatory and analgesic effect, as well as reduce the dose of the oral drug, reducing the risk of complications. High clinical effectiveness along with an affordable price make it possible to recommend Denebol for the treatment of a wide range of patients with injuries and diseases of the musculoskeletal system.

Side effects

The use of the drug may cause side effects:

• digestive system: heartburn, nausea, vomiting, diarrhea, pain and discomfort in the epigastric region, dyspepsia, aphthous stomatitis, ulcerations of the stomach, intestines, gastrointestinal bleeding; diarrhea, flatulence, dysphagia, constipation, belching, gastritis, exacerbation of inflammatory diseases of the gastrointestinal tract, intestinal perforation, esophagitis, ground, pancreatitis, colitis / exacerbation of colitis may occur;
• nervous system : drowsiness, decreased speed of thinking, dizziness, headache, anxiety, depression; sometimes there is hyperesthesia (paresthesia), insomnia, exhaustion, fatigue, aseptic meningitis, delirium, leg cramps, anxiety, confusion, hallucinations, ataxia, changes in taste, exacerbation of epilepsy, ageusia, anosmia;
• sense organs: blurred vision, conjunctivitis, otitis media, ringing in the ears;
• urinary system: renal failure, increased creatinine levels, increased blood urea nitrogen levels, interstitial nephritis, hyponatremia, urinary tract infections;
• cardiovascular system: arterial hypertension, congestive heart failure, disturbances of coronary and cerebral blood flow, chest pain, fatal intracranial hemorrhage, hemorrhage in the eye, occlusion of retinal arteries or veins; Rarely, stroke, myocardial infarction, cardiac arrhythmia (bradycardia, atrial fibrillation, premature ventricular complex, tachycardia), acute heart failure, sudden cardiac arrest, pulmonary embolism, unstable angina, pulmonary edema may occur.
• allergic reactions : itching, urticaria, rash, angioedema, pulmonary edema, Stevens-Johnson syndrome, allergic rhinitis, atopic dermatitis, vasculitis, anaphylactic shock, anaphylactic shock;
• skin: ecchymosis, bullous rash, exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, photosensitivity;
• respiratory system: infection of the upper respiratory tract, less often - sinusitis and bronchitis, flu-like symptoms, pharyngitis, rhinitis, cough, shortness of breath, bronchospasm;
• hematopoietic system : increased levels of aspartate aminotransferase (AST), alanine aminotransferase (ALAT) in the blood, development of edema of the lower extremities, agranulocytosis, leukopenia, thrombocytopenia, anemia, pancytopenia.
• other
  : sometimes - baldness, arthralgia, myositis, menstrual irregularities, hyperkalemia.

The frequency of adverse reactions and their type depend on the individual characteristics of the body, as well as the method of administration of the drug.

Taking Denebol may cause drowsiness

Pobchn reaction

Cardial discord:

persistent heart failure, swelling of the lower ends, disruption of the cerebral and coronary blood flow, pain behind the sternum, intracranial hemorrhage from a fatal hemorrhage, hemorrhage in the eye, occlusion of arteries or veins of the network, stroke, myocardial infarction, disturbance of the heart rhythm (bradycardia, migratory arrhythmia, pre-challenge complex, tachycardia), acute heart failure, raptian cardiac stasis, legen artery embolism, unstable angina, swollen leg.

On the side of the ship

: arterial hypertension.

On the side of the immune system:

angioneurotic swelling, leg swelling, allergic rhinitis, vasculitis, anaphylactic shock, anaphylaxis.

From the side of the skin and under the skin:

skins visipannya, incl. erythematous type vysipanna, bullous visip, exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, photosensitivity, Stevens-Johnson syndrome, urticaria, atopic dermatitis, itching, ecchymosis, alopecia.

On the side of the scolio-intestinal tract:

: dyspepsia, baking, discomfort/pain in the epigastric region, boredom; aphthous stomatitis, sclerosis, intestines; scutulo-intestinal bleeding., may include diarrhea, flatulence, vomiting, dysphagia, constipation, vomiting, gastritis, inflammation of the scutulo-intestinal tract, perforation of the scutum/intestine, esophagitis, melena, pancreatitis, colitis/ acute colitis.

On the side of the hepatobiliary system

: increased activity of ALT, AST, inods – hepatitis, incl. Bliskavichny, liver failure, liver necrosis.

On the side of the respiratory system and organs, the mediastinum

: infection of the upper respiratory tract, sinusitis, bronchitis, flu-like symptoms, pharyngitis, rhinitis, cough, shortness of breath, bronchospasm.

Neurological disorders

: drowsiness, weakened mental fluidity, confusion, headache, restlessness, depression. Sometimes the culprit is hyperesthesia (paresthesia), sleeplessness, sleepiness, fatigue, aseptic meningitis, madder, suede, anxiety, confusion, hallucinations, ataxia, change in taste preferences. dchuttiv, chronic epilepsy, ageusia, anosmia.

From the side of the organs

: may cause blurred vision, conjunctivitis,

On the side of the hearing and vestibular apparatus:

Otit, jingle at woohoo.

On the side of the sternoid system

: nitric deficiency, elevated creatinine levels, elevated blood nitrogen levels, interstitial nephritis, hyponatremia, thyroid infections.

On the side of the blood system and lymphatic system

: agranulocytosis, leukopenia, thrombocytopenia, anemia, pancytopenia.

Inshe:

arthralgia, myositis, menstrual cycle disorders, hyperkalemia.

Drug interactions

• When taking the drug together with ACE inhibitors, the effectiveness of antihypertensive therapy is sharply reduced.
• Rofecoxib should not be taken together with products and drugs containing caffeine due to the risk of increasing blood pressure.
• The use of a number of antibiotics (rifamycin, rifampicin) reduces the concentration of Denebol in the blood plasma.
• The use of Denebol during anticoagulant therapy may increase prothrombin time.
• Rofecoxib increases plasma concentrations of methotrexate by 23%.
• Denebol increases the concentration of methotrexate in the blood plasma.
• NSAIDs can reduce the effect of diuretics and antihypertensive drugs.
• The simultaneous use of NSAIDs and cyclosporine or tacrolimus enhances the nephrotoxic effect of the latter.
• The drug should not be used simultaneously with hemostatic agents, as well as drugs that increase blood pressure (BP).
• Denebol does not affect the pharmacokinetics of ketoconazole, prednisolone, digoxin, cimetidine, or oral contraceptives.
• Rofecoxib can be used with low doses of acetylsalicylic acid, but it does not replace the latter in the prevention of cardiovascular diseases.

Denebola release form and composition

Denebol can be found in the form of ampoules in an amount of 5 pcs. in a package (in a dosage of 25 mg). Denebol in tablets - 25 and 50 mg (10 tablets in a blister). There is also Denebol gel (30 g tube) and rectal suppositories.

1 ml of drug solution contains 25 mg of rofecoxib, saline solution, tocopherol acetate, methyl carbohydrate.

1 Denebol tablet contains 25 or 50 mg of rofecoxib. In addition, the composition includes microcrystalline cellulose, talc, sodium propylparaben, colored tartrazine, dry starch, sodium starch glycolate, etc.

A 100 g gel contains 1 g of rofecoxib, water, 10 g of methyl salicylate, as well as other components.

1 suppository contains 25 mg of rofecoxib and fish oil.

special instructions

When used together with ACE inhibitors, the effectiveness of antihypertensive treatment is reduced. It is not advisable to use Denebol simultaneously with products or medications that contain caffeine (it increases blood pressure).

Denebol in any form is not used for the prevention of diseases of the cardiovascular system. The use of the drug during treatment with anticoagulants may increase the prothrombin time.

Rofecoxib should not be prescribed to patients with a history of allergic reactions to acetylsalicylic acid.

Use with extreme caution in patients with a history of peptic ulcers or gastrointestinal bleeding.

In patients at increased risk of impaired renal perfusion, the use of rofecoxib may result in decreased renal blood flow and deterioration of renal function. This effect is most likely in patients with a history of severe renal dysfunction, decompensated heart failure, or liver cirrhosis. In this category of patients, renal function must be monitored throughout the course of treatment.

In patients with severe dehydration, rehydration is recommended before starting therapy. The risk of developing ulcers, perforations, and bleeding in the upper gastrointestinal tract increases in patients over the age of 65 years.

The drug can mask fever in infectious diseases.

Tartrazine (E 102), sodium methylparaben (E 219) and sodium propylparaben (E 217), which are part of the drug, can cause allergic reactions (possibly delayed).

The safety of using rofecoxib in therapeutic doses for 6–12 months has been established. It is forbidden to exceed recommended doses. The maximum daily dose is 50 mg.

Denebol has an antipyretic effect, so it can mask fever in infectious diseases

During pregnancy and lactation

Denebol is contraindicated in the third trimester of pregnancy due to the risk of infection of the Botalov duct in the fetus. The use of the drug is possible in the first and second trimesters if the benefit to the mother outweighs the risk to the child (there have been no strictly controlled studies on this matter). During breastfeeding, Denebol should be discontinued (passes into breast milk).

Denebol , like other drugs that inhibit prostaglandin synthesis, should not be prescribed In the first and second trimesters of pregnancy, rofecoxib is prescribed if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

The use of Denebol is possible in the first and second trimesters if the benefit to the pregnant woman outweighs the risk to the baby (there have been no strictly controlled studies).

During breastfeeding, the drug must be discontinued (passes into breast milk).

With impaired kidney function

The development of renal failure is possible; at the same time, the drug is used with caution in case of existing failure.

In childhood

Not used for children under 12 years of age.

In old age

Elderly patients have an increased risk of liver, kidney and heart dysfunction, so they should be under constant medical supervision during treatment with rofecoxib.

Impact on the ability to drive vehicles and machinery

Due to possible adverse reactions from the central nervous system, during the course of Denebol therapy, it is necessary to refrain from working with complex mechanisms and driving vehicles.

Denebol affects concentration, so it is better to avoid driving a car

Alcohol compatibility

During drug therapy, you should refrain from drinking alcoholic beverages.

Stock

dyucha speech:

rofecoxib;

1 tablet containing 50 mg or 25 mg rofecoxib;

additional speeches:

for 25 mg tablet - betacyclodextrin, corn starch, microcrystalline cellulose, povidone, sodium methylparaben (E 219), sodium propylparaben (E 217), talc, magnesium stearate, anhydrous silicon dioxide, sodium starch glycolate (type A), barvnik tartrazine

(E 102), diamantine barberry (blakitnia) (E 133);

for tablet 50 mg —

betacyclodextrin, corn starch, microcrystalline cellulose, povidone, methylparaben sodium (E 219), propylparaben sodium (E 217), talc, magnesium stearate, anhydrous silica, sodium starch Kolyat (type A), barvnik tartrazine

(E 102), diamantine barberry (blakitnia) (E 133).

Reviews

Reviews of the drug among people who often use it in their practice are positive. Some patients note side effects of the drug, especially often from the stomach, in particular gastritis. To avoid the negative effects of the drug, you must strictly adhere to the recommended duration of its use.

Patient reviews

After working in the garden, severe radiculitis began, and I even got out of bed with severe pain. They recommended injections of Denebola, after the first injection he began to get out of bed and walk, and after the third injection the pain disappeared and movements were restored.

Denebol ointment is my lifesaver! I suffer from rheumatoid arthritis, so this drug is always in my medicine cabinet.

My first acquaintance with the drug was forced. While visiting my aunt, she was simply dying from another attack of PMS; the only NSAID in the house was Denebol (left after a course of treatment for rheumatoid arthritis). I took 1 tablet and after 10 minutes the pain immediately subsided, the effect lasted until the morning.

My husband came down with radiculitis, so much so that he couldn’t get out of bed, they advised us to take this Denebol, to pierce it for 5 days. What happiness it was when, after the first injection, my husband began to get up, and on the 3rd day he was already jumping, but of course he was injected for all 5 days.

Suddenly the joint on my big toe began to hurt, my leg began to swell on the 2nd day, after taking 1 tablet, relief began two hours later, and by the 2nd day it was almost gone.

A month ago I sprained my leg, the pain was severe, I couldn’t bend or squat, any sudden movement was contraindicated. Upon examination, the doctor diagnosed a sprain. Prescribed Denebol-gel. I anointed my leg four times a day. It helped the very next day. The pain disappeared completely after four days.

I was treated with Denebol for stomatitis. Of course, the picture was terrible: the mucous membrane of the mouth turned red. Painful whitish-gray round formations with a bright red rim appeared on the cheeks, tongue, palate, and lips. In horror, I ran to the dentist. He prescribed rinsing the mouth with a solution of baking soda, a decoction of sage, and chamomile. You also need to avoid cold, hot, spicy, sour and alcoholic drinks, and do not smoke. And he prescribed Denebol for me once a day and I took it for 2 weeks. Thank God it helped.

Larisa

Great stuff! Really strong. Tablets and ointment in combination put you on your feet in 7-10 days. The effect is long lasting, for me it lasts up to six months. Diagnosis: interdisc hernia, spondoarthrosis and arachnoid cyst. Anyone who has experienced this knows what a joy it is. It's a pity that there is no gel. Nimid also helps, but it helps as long as you apply it. Stopped - and “hello,” pain. I wish he could get out of re-registration soon!

Tatiana

Expert opinion

Rheumatologists, dentists, neurologists, and gynecologists often prescribe medications to reduce the inflammatory response and pain. The non-steroidal anti-inflammatory drug Denebol shows good results. The drug is an inhibitor (delays) the inflammatory response to inflammation or damage, and also provides an analgesic effect. It is produced in the form of tablets, solution for intramuscular administration, suppositories and gel.

Denebol is actively used in cases of diseases of the musculoskeletal system - rheumatoid arthritis, periarthritis, osteoarthritis, as well as in cases of injuries and sprains of the ligamentous-muscular system.

Denebol also effectively has an analgesic effect for dental, headache, and eye pain. Neurologists prescribe the drug for osteochondrosis of the spine in the treatment of radicular syndrome.

Treatment should be prescribed and monitored by the attending physician.

Timur - doctor

Unlike other non-steroidal anti-inflammatory drugs, Denebol has a number of advantages:

selectively acts only on COX-2, as a result of which it has virtually no negative effect on the gastrointestinal mucosa;

the duration of action lasts 24 hours (one intramuscular injection is much better than several, especially when the course of treatment is several days) There have been no cases of overdose. Not used in pediatrics.

Ekaterina - doctor

Storage period and conditions

Expiration date for:

• Tablets – 3 years;
• Solution, gel, suppositories – 2 years.

Store Denebol preparations at a temperature not exceeding 25 °C in the original packaging.

Keep away from children.

Found an error in the text? Select it and press Ctrl + Enter.

• Indications for use
• Mode of application
• Side effects
• Contraindications
• Pregnancy
• Interaction with other drugs
• Overdose
• Release form
• Storage conditions
• Synonyms
• Compound
• Additionally

The drug Denebol is an anti-inflammatory drug. Denebol is used to treat diseases of the musculoskeletal system, dentistry, gynecology, and ENT diseases. Cyclooxygenase II, along with cyclooxygenase I, is involved in the formation of mediators of the inflammatory reaction: prostaglandins, prostacyclins and thromboxane, but COX-II is an inducible enzyme and is included in the reaction only in certain situations, most often during inflammation. Denebol blocks cyclooxygenase II, providing anti-inflammatory, analgesic, anti-edematous and antipyretic effects. At the same time, the drug has virtually no effect on the enzyme cyclooxygenase I, which works continuously in the body and performs many physiologically necessary functions. For example, such as regulation of metabolic processes in the tissues of the gastric and intestinal walls, platelets, bronchopulmonary system and others.

When taken orally, Denebol is quickly absorbed from the digestive tract, and the bioavailability of the drug is over 90%. The maximum concentration in the blood plasma of Denebol's active ingredient, rofecoxib, is reached two hours after administration and is about 0.300 mcg/ml. Over 80% of rofecoxib in the body forms weak bonds with plasma proteins. It is biotransformed mainly in the liver with the formation of 6 inactive metabolites, which are excreted by the kidneys in the urine (70%). In unchanged form, rofecoxib is excreted from the body through the intestines in the feces. The pharmacokinetics of Denebol in young and elderly patients are no different.

Sources

• https://medside.ru/denebol
• https://dolgojit.net/denebol.php
• https://www.piluli.kharkov.ua/drugs/drug/denebol/
• https://davlenie-vnorme.ru/mikstury/denebol-instrukcziya-po-primeneniyu-pokazaniya-dozy-analogi
• https://compendium.com.ua/info/167698/denebol-gel_/
• https://medlib.net/denebol.html
• https://www.medcentre.com.ua/medicamenty/denebol.html
• https://kostibolat.ru/ot-chego-pomogaet-lekarstvennoe-sredstvo-denebol.html
• https://www.medcentre24.ru/medicamenty/denebol.html
• https://puzkarapuz.ru/review/detail/denebol_otzyvy_sovety_i_rekomendacii_vrachej_o_preparate_den
• https://www.medcentre24.ru/medicamenty/denebol.html
• https://medlib.net/denebol.html
• https://sat-farma.com/instruction/denebol-tabl
• https://davlenie-vnorme.ru/mikstury/denebol-instrukcziya-po-primeneniyu-pokazaniya-dozy-analogi
• https://www.i-otzovik.ru/product/protivovospalitelnyy-preparat-denebol.html
• https://www.add.ua/denebol-30g-gel.html
• https://www.medcentre.com.ua/medicamenty/denebol.html