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INDOMETACIN PLUS Ointment

Instruction manual

For medical use of the drug

Structure:

Active ingredients: 1 g of ointment contains indomethacin 50 mg, dimethyl sulfoxide 50 mg;

excipients: peppermint oil, propylene glycol, polyethylene glycol 400, polyethylene glycol 1500.

Dosage form.

Ointment.

The main physico-chemical properties: ointment greenish-yellow in color with a slight specific smell.

Pharmacotherapeutic group.

Nonsteroidal anti-inflammatory drugs for topical use. code atx m02a a.

Pharmacological properties.

Pharmacodynamics

Anti-inflammatory, analgesic, antiplatelet agent. It blocks the enzyme cyclooxygenase (COX), which is involved in the conversion of arachidonic acid, resulting in impaired synthesis of prostaglandins, which play an important role in the development of inflammatory reactions, fever, pain. It inhibits the activity of mediators of inflammation, hyaluronidase, lysosomal hydrolases.

Indomethacin has anti-aggregation properties, causes a weakening or disappearance of pain of a rheumatic and non-rheumatic nature.

Dimethyl sulfoxide, penetrating biological membranes, including the skin, enhances the penetration of medicines through the intact skin, and also exhibits anti-inflammatory, analgesic and antiseptic effects.

Pharmacokinetics

With cutaneous application, indomethacin is partially absorbed into the systemic circulation. The time to reach maximum concentration in the blood is about 2 hours. Indomethacin penetrates well into tissues.

It is biotransformed in the liver with the formation of inactive metabolites of indomethacin and its conjugates with glucuronic acid. Unchanged indomethacin and inactive metabolites are excreted by the kidneys and bile.

Clinical characteristics.

Indications.

  • An additional tool in the complex treatment of acute and chronic rheumatoid arthritis, osteoarthritis, osteoarthritis, ankylosing spondylitis, psoriatic polyarthritis, gouty arthritis; localized forms of extra-articular rheumatism of the musculoskeletal system: tendonitis, synovitis, tendovaginitis, inflammation of the fascia and articular ligaments, bursitis; local symptomatic treatment of inflammation, pain and swelling with post-traumatic lesions of the musculoskeletal system - sprains, dislocations, bruises.

Contraindications

Hypersensitivity to the components of the drug. hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) with a clinical manifestation of an asthmatic attack, urticaria or allergic rhinitis. peptic ulcer of the stomach and duodenum, ulcerative colitis, bronchial asthma, rhinitis, conjunctivitis or bronchospasm while taking non-steroidal anti-inflammatory drugs, hemophilia, hypocoagulation, glucose-6-phosphate dehydrogenase deficiency, blood diseases.

Interaction with other drugs and other types of interactions.

With the cutaneous use of the drug, its interaction with other drugs has not been established. however, it should be borne in mind that with the simultaneous use of indomethacin plus increases the concentration of lithium and digoxin in the blood increases the risk of side effects of mineralocorticoids, glucocorticosteroids, estrogens; increases the risk of bleeding and enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics; potentiates the hypoglycemic effect of sulfonylurea derivatives; reduces the effectiveness of uricosuric agents, b-blockers and diuretics of the thiazide and furosemide groups.caution should be exercised when using non-steroidal anti-inflammatory drugs, at least 24 hours before the start of use or after the end of methotrexate therapy, since its level in the blood (and, accordingly, toxicity) can increase. simultaneous use with NSAID drugs, including selective cog-2 inhibitors, increases the risk of unwanted effects. with simultaneous use with antibacterial agents, the risk of seizures may increase, with ciprofloxacin, the risk of skin reactions.

Features of the application.

The drug should be applied only to intact skin areas, avoiding contact with eyes and mucous membranes. after application of the drug, wash your hands if this area is not being treated.

Restrictions on the use: it is prescribed with caution to elderly patients, as well as a history of liver, kidney, and gastrointestinal tract diseases, in the presence of dyspeptic symptoms at the time of the drug administration, in case of arterial hypertension, heart failure, immediately after serious surgery, to patients parkinsonism, epilepsy.

If there is a history of allergic reactions, the drug is prescribed only in urgent cases. During treatment, systematic monitoring of liver and kidney function, peripheral blood picture is necessary. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Use during pregnancy or lactation.

Do not use during pregnancy and lactation.

The ability to influence the reaction rate when driving or working with other mechanisms.

With increased caution, it is necessary to use the drug while driving vehicles and working with complex mechanisms.

Dosage and administration.

Adults and children over 14 years of age apply the ointment to the damaged area of ​​2.5 g (column of ointment 7.5 cm long) 2 times a day with a thin layer, easily rubbing it into the skin. to increase the effectiveness of therapy, it is possible to use occlusive dressings, as well as physiotherapeutic methods (high-frequency ultrasound therapy). the average daily dose for adults and children over 14 years old is 5 g of ointment (250 mg of indomethacin). the duration of the course of therapy is determined individually depending on the effectiveness of therapy and, as a rule, ranges from 2 to 4 weeks.

Children.

Do not use in children under 14 years of age.

Overdose.

Symptoms: dyspepsia, erosive hemorrhagic damage to the gastrointestinal tract, headache, dizziness, hepatotoxicity. it is necessary to monitor the leukocyte and platelet formulas.

Treatment: cancel the use of the drug or reduce its dose. There is no special antidote, symptomatic therapy.

Symptoms in the eyes, mucous membranes or open wounds: local irritation is observed - lacrimation, redness, burning, pain.

Treatment: abundant washing of the affected area with distilled water or saline to reduce and reduce complaints.

In case of accidental ingestion, a burning sensation in the oral cavity, salivation, nausea, and vomiting are possible. In such cases, it is necessary to rinse the oral cavity and stomach, and if necessary, carry out symptomatic treatment. To prevent overdose of the drug, it is necessary to strictly adhere to the prescribed treatment regimen.

Side effects.

On the part of the skin and subcutaneous tissue: small-pointed and erythematic-papular rashes, itching, hyperemia and burning at the site of application, peeling, dry skin, edema.

From the respiratory system: shortness of breath.

From the hepatobiliary system: increased levels of liver enzymes.

On the part of the immune system: angioedema, hypersensitivity reactions.

With prolonged use of the drug or applying to a large area of ​​the skin surface, systemic adverse reactions may occur: dyspepsia, erosive hemorrhagic damage to the gastrointestinal tract, headache, dizziness.

When used on a large surface of the skin, resorptive side effects can occur, for example, disorders of the gastrointestinal tract (including loss of appetite, nausea, vomiting, diarrhea, pain).

The composition of the drug includes propylene glycol and dimethyl sulfoxide (dimexide), which can cause skin irritation.

Shelf life.

2 years. do not apply after the expiration date indicated on the package.

Storage conditions.

Keep out of the reach of children. Store in the original packaging at a temperature not exceeding 25 ° C.

Packaging.

40 g of ointment in tubes. one tube in a pack of cardboard.

Vacation category.

Over the counter.

Tags: Dimethyl Sulfoxide, Indomethacin, Peppermint Oil