Denebol

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Denebol is a non-steroidal anti-inflammatory drug that has an analgesic, antipyretic, anti-edema effect.

Release form and composition

Denebol dosage forms:

Solution for intramuscular (i / m) injection (1 ml in ampoules, 5 ampoules in a package);
Tablets (10 pcs. In blisters);
Gel (30 g in tubes);
Rectal suppositories.

The active ingredient is rofecoxib. Active ingredient content:

1 ml of solution - 25 mg;
1 tablet - 25 mg, 50 mg;
100 mg gel - 1 mg;
1 rectal suppository - 25 mg.

Auxiliary components:

Solution: centbucridine hydrochloride, tocopherol acetate, methyl carbohydrate, physiological saline;
Tablets: corn starch, microcrystalline cellulose, beta-cyclodextrin, magnesium stearate, povidone, sodium propylparaben, colloidal silicon dioxide, sodium methylparaben, brilliant blue, sodium starch glycolate, tartrazine colored, purified talc, dry starch;
Gel: methyl salicylate, linseed oil, menthol, phenoxyethanol, triethanolamine, propylene glycol, butylated hydroxytoluene, polyoxyl, carbomer 934, polyethylene glycol, disodium edetate, hydrogenated castor oil, isopropyl alcohol, purified water;
Rectal suppositories: solid fat.

Indications for use

Diseases of the musculoskeletal system: osteoarthritis, acute and chronic periarthritis, rheumatoid arthritis, tendonitis, bursitis, as well as injuries to muscles, tendons, ligaments;
Infectious and inflammatory diseases: respiratory (pharynx, trachea, bronchi) and urinary (cystitis, urethritis, cystopyelitis) systems, in gynecology and ophthalmology (for symptomatic therapy);
Thrombophlebitis;
Pain syndrome of various origins: migraine, neuralgia, neuritis, lumbago, radicular syndrome, osteochondrosis, myalgia, algodismenorrhea;
Inflammatory processes in ENT organs: otitis media, sinusitis, laryngitis;
Dental practice: stomatitis, gingivitis, pulpitis.

Contraindications

Bronchial asthma;
Oncological diseases;
Age under 12;
A history of hypersensitivity to salicylates (aspirin) or other nonsteroidal anti-inflammatory drugs;
Pregnancy (III trimester) and breastfeeding;
Hypersensitivity to rofecoxib and / or auxiliary components of the drug.

The use of Denebol in the form of a solution for intramuscular injections is contraindicated in patients: those who have suffered myocardial infarction and / or stroke; with a progressive form of atherosclerosis; malignant arterial hypertension.

Method of administration and dosage

Solution: intravenous administration is strictly prohibited! Injected into the buttock deeply intramuscularly once a day. The dosage of the drug is prescribed by the doctor on the basis of clinical indications individually. The recommended initial daily dose is 50 mg, depending on the severity of the pain syndrome and the inflammatory process, a dose reduction of up to 25 mg is allowed. In the treatment of osteoarthritis, a dose of 12.5 mg is considered effective; if necessary, it can be increased to 25 mg. The solution is used for symptomatic therapy for 7 days, then the patient is transferred to treatment with tablets and gel;
Tablets: taken orally with a small amount of water, regardless of the meal. In osteoarthritis, treatment should be started with 12.5 mg once a day, the treatment period is 4-6 weeks. With pain syndrome and primary dysmenorrhea - 25 mg 1 time per day, used until the 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;
Gel: cannot 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. Single dose - 1-2 g, procedures are recommended up to 4 times a day. The period of use depends on the effectiveness of the treatment. After applying the drug, you must thoroughly wash your hands, do not allow the gel to get on the mucous membranes;
Suppositories: used rectally to localize acute pain of inflammatory etiology and to treat primary dysmenorrhea. Dosage - 1 suppository 2 times a day, the treatment period is not more than 1.5 months. The maximum daily dose is 50 mg.

With the simultaneous use of several forms of Denebola, 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.

Side effects

The use of the drug can cause side effects:

From the digestive system: heartburn, nausea, vomiting, diarrhea, pain and discomfort in the epigastric region, dyspepsia, aphthous stomatitis;
From the senses and the nervous system: drowsiness, confusion, dizziness, decreased speed of thought processes, hallucinations;
From the urinary system: decreased renal function, usually reversible, renal failure;
From the side of the cardiovascular system: arterial hypertension, congestive heart failure, impaired coronary and cerebral blood flow;
Allergic reactions: itching, urticaria, rash, angioedema;
Others: an increase in the level of aspartate aminotransferase (AsAT), alanine aminotransferase (ALT) in the blood, the development of edema of the lower extremities.

special instructions

Application in the I and II trimester of pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus.

Do not drink alcohol during treatment.

None of the dosage forms of Denebol are used to prevent cardiovascular pathologies.

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

Drug interactions

Simultaneous administration of the drug with certain antibiotics (rifampicin, rifamycin) reduces the concentration of rofecoxib in blood plasma by half.

Denebol should not be taken with caffeine-containing agents and / or products, this combination causes an increase in blood pressure.

The simultaneous use of the drug with angiotensin-converting enzyme (ACE) inhibitors significantly reduces the effectiveness of the antihypertensive agent, with anticoagulants - it can increase the prothrombin time.

Denebol increases the plasma concentration of methotrexate.

Rofecoxib has no effect on the pharmacokinetics of the following drugs: prednisolone, ketoconazole, digoxin, antacids, cimetidine, oral contraceptives, including norethindrol, ethinyl estradiol.

Analogs

Denebol's analogs are: Ketonal, Naproxen, Ibuprofen, Voltaren, Diclofenac, Revmoxib, Rofecoxib, Remisid, Traumeel, Orotiks, Celebrex.

Terms and conditions of storage

Store in a dry, dark place at a temperature of 16-24 ° C. Keep out of the reach of children.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!