Denebol

Denebol – non-steroidal anti-inflammatory drug, has anesthetic, febrifugal, antiedematous effect.

Form of release and structure

Dosage forms of Denebol:

• Solution for intramuscular injections (in oil) (on 1 ml in ampoules, in packaging of 5 ampoules);
• Tablets (on 10 pieces in blisters);
• Gel (on 30 g in tubas);
• Rectal candles.

Active ingredient – рофекоксиб. Content of active ingredient:

• 1 ml of solution – 25 mg;
• 1 tablet – 25 mg, 50 mg;
• 100 mg of gel – 1 mg;
• 1 rectal candle – 25 mg.

Auxiliary components:

• Solution: tsentbukridina hydrochloride, tocopherol acetate, метилкарбогидрат, normal saline solution;
• Tablets: corn starch, microcrystallic cellulose, a beta cyclodextrin, magnesium stearate, povidone, sodium propylparaben, silicon dioxide colloid, sodium methylparaben, diamond blue, sodium krakhmalglikolit, tartrazine the color, purified talc, dry starch;
• Gel: methyl salicylate, linseed oil, menthol, phenoxyethanol, trietanolamine, propylene glycol, butylated hydroxytoluene, polioksit, carbomer 934, polyethyleneglycol, dinatrium эдетат, the castor oil hydrogenated isopropyl alcohol, the water purified;
• Rectal candles: solid fat.

Indications to use

• Musculoskeletal system diseases: osteoarthritis, acute and chronic periarthritis, pseudorheumatism, tendinitis, bursitis, and also injuries of muscles, sinews, sheaves;
• Infectious and inflammatory diseases: respiratory (a throat, a trachea, bronchial tubes) and urinary (cystitis, an urethritis, tsistopiyelit) systems, in gynecology and ophthalmology (for symptomatic therapy);
• Thrombophlebitises;
• Pain syndrome of various genesis: migraine, neuralgia, neuritis, lumbago, radicular syndrome, osteochondrosis, mialgiya, альгодисменорея;
• Inflammatory processes in ENT organs: otitis, sinusitis, laryngitis;
• Dental practice: stomatitis, ulitis, pulpitis.

Contraindications

• Bronchial asthma;
• Oncological diseases;
• Age up to 12 years;
• Hypersensitivity to salicylates (aspirin) or to other non-steroidal anti-inflammatory drugs in the anamnesis;
• Pregnancy period (III trimester) and breastfeeding;
• Hypersensitivity to a rofekoksib and/or auxiliary components of drug.

Denebol's use in the form of solution for injections in oil is contraindicated to patients: had a myocardial infarction and/or a stroke; with the progressing atherosclerosis form; malignant arterial hypertension.

Route of administration and dosage

• Solution: intravenous administration is strictly forbidden! Enter into a buttock deeply intramusculary once a day. The drug dosing is appointed by the doctor on the basis of clinical indications individually. The recommended initial daily dose – 50 mg, depending on degree of manifestation of a pain syndrome and inflammatory process is allowed a dose decline to 25 mg. At treatment of an osteoarthritis the dose of 12,5 mg is considered effective, its increase to 25 mg is in case of need allowed. Solution is applied to symptomatic therapy within 7 days, then the patient is transferred to treatment by tablets and gel;
• Tablets: accept inside, washing down with a small amount of water, irrespective of meal. At an osteoarthritis treatment it is necessary to begin with reception 12,5 mg of 1 times a day, the treatment period – 4-6 weeks. At a pain syndrome and primary dysmenorrhea – on 25 mg of 1 times a day, apply before full stopping of pain, but no more than 3 days. Depending on disease symptoms the dose can be reduced to 12,5 mg. The maximum daily dose – 25 mg;
• Gel: it is impossible to use on sites with the broken integrity of skin. Apply locally, by drawing on painful zones of a body and rubbing in in skin by the easy movements. The single dose – 1-2 g, procedures is recommended to carry out to 4 times a day. The period of use depends on efficiency of treatment. After putting drug it is necessary to wash up carefully hands, not to allow hit of gel on mucous membranes;
• Candles: apply rektalno to localization of an acute pain of an inflammatory etiology and therapy of primary dysmenorrhea. Dosing – on 1 suppository 2 times a day, the treatment period no more than 1,5 months. The maximum daily dose – 50 mg.

At simultaneous use of several forms Denebola the total daily dose should not exceed 50 mg. The course of treatment within 4-6 weeks in a dose no more than 25 mg a day is considered safe.

Side effects

Use of drug can cause side effects:

• From the alimentary system: heartburn, nausea, vomiting, diarrhea, pains and discomfort in epigastric area, dyspepsia, aphthous stomatitis;
• From sense bodys and nervous system: drowsiness, confusion of consciousness, dizziness, reduction in the rate of thought processes, hallucinations;
• From an urinary system: depression of function of kidneys, as a rule, reversible, renal failure;
• From cardiovascular system: arterial hypertension, congestive heart failure, disturbances of a coronary and brain blood-groove;
• Allergic reactions: itch, urticaria, rash, Quincke's disease;
• Others: increase in level of aspartate aminotransferase (ASAT), alaninaminotranspherase (ALAT) in blood, edematization of the lower extremities.

Special instructions

Use in I and II trimesters of pregnancy is possible if the expected advantage for mother exceeds potential risk for a fruit.

It is impossible to take alcohol during treatment.

Any of dosage forms of Denebol is not applied to prevention of cardiovascular pathologies.

In view of possible side effects from a nervous system, patients for the entire period of treatment are recommended to refrain from control of vehicles and mechanisms.

Medicinal interaction

The concomitant use of drug with some antibiotics (rifampicin, Rifamycinum) reduces concentration of a rofekoksib in a blood plasma twice.

It is impossible to accept Denebol together with kofeinsoderzhashchy means and/or products, such combination causes increase in arterial pressure.

Simultaneous use of drug with inhibitors of an angiotensin-converting enzyme (APF) considerably reduces efficiency of an antihypertensive, with anticoagulants – can increase a prothrombin time.

Denebol increases concentration of a methotrexate in a blood plasma.

The Rofekoksib does not exert impact on pharmacokinetics of the following medicines: Prednisolonum, кетоконазол, digoxin, antacids, Cimetidinum, oral contraceptives, including норэтиндрол, ethinylestradiol.

Terms and storage conditions

To store in the dry, protected from light place at a temperature of 16-24 °C. To protect from children.