Indometacin, 10% ointment, 40g – Borisov

Composition

Each tube (40 g) contains-Active ingredient-Indometacin-4.0 g; excipients: dimethyl sulfoxide, urea, macrogol 400, macrogol 1500, propylene glycol, levomentol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Pharmacological action

Indometacin has anti-inflammatory, analgesic and antipyretic properties, as well as some antiplatelet effects.

Suppresses the activity of anti-inflammatory factors, reduces platelet aggregation. By inhibiting cyclooxygenase 1 and 2, it disrupts arachidonic acid metabolism, reduces the amount of prostaglandins (Pg) both in the inflammatory focus and in healthy tissues, and suppresses the exudative and proliferative phases of inflammation.

When applied externally, it causes a weakening or disappearance of rheumatic and non-rheumatic pain syndrome (including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints, helps to increase the volume of movement; in inflammatory processes that occur after operations and injuries, quickly relieves both spontaneous pain and pain during movement, reduces inflammatory swelling at the wound site).

Indications

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

Contraindications

Hypersensitivity to the active or any of the excipients of the drug. Hypersensitivity to aspirin (ASA) or other nonsteroidal anti-inflammatory drugs (NSAIDs) with the clinical manifestation of an asthmatic attack, urticaria, or allergic rhinitis. Coagulopathies, leukopenia, thrombocytopenia. Stomach and duodenal ulcers in the acute stage. Children under 14 years of age.

Side effects

From the digestive system:  nausea, anorexia, vomiting, abdominal pain and discomfort, constipation or diarrhea, erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract; rarely-intestinal strictures, stomatitis, gastritis, flatulence, bleeding from the sigmoid colon or diverticula, jaundice, hepatitis.

From the central nervous system and peripheral nervous system: dizziness, headache, depression, fatigue; rarely-anxiety, fainting, drowsiness, seizures, peripheral neuropathy, muscle weakness, involuntary muscle movements, sleep disorders, mental disorders (depersonalization, psychotic episodes), paresthesia, dysarthria, parkinsonism.

From the cardiovascular system:  edema, increased blood pressure, tachycardia, chest pain, arrhythmia, palpitation, hypotension, congestive heart failure, hematuria.

Allergic reactions:  rarely-pruritus, urticaria, angiitis, erythema nodosum, skin rash, exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, hair loss, acute respiratory distress, sharp drop in blood pressure, anaphylactic reactions, angioedema, dyspnoea, bronchial asthma, pulmonary edema.

From the hematopoietic system:  rarely-leukopenia, petechiae or ecchymoses, purpura, aplastic and hemolytic anemia, thrombocytopenia, DIC syndrome.

From the side of the senses:  rarely – impaired visual clarity, diplopia, orbital and periorbital pain, tinnitus, hearing disorders, deafness.

From the urinary system:  rarely-proteinuria, nephrotic syndrome, interstitial nephritis, impaired renal function, renal failure.

From the side of metabolism:  rarely – hyperglycemia, glucosuria, hyperkalemia.

Other services:  rarely-vaginal bleeding, hot flashes, increased sweating, nosebleeds, enlarged and strained mammary glands, gynecomastia.

Local reactions:  at the site of intravenous use, in some cases – the formation of an infiltrate, abscess; with rectal use, irritation of the rectal mucosa, tenesmus, exacerbation of chronic colitis are possible.

For external use:  itching, redness, rash at the application site.

How to take, course of use and dosage

How to use: topically, on the skin. Apply the ointment to the affected area 3-4 times a day, gently rubbing into the skin until complete resorption. The amount of ointment required for one application depends on the area of the lesion and is approximately 4-5 cm. Apply after at least a 6-hour interval. The duration of treatment is 7-10 days. If there is no improvement in symptoms during this time, treatment should be reviewed. Children. Do not use under 14 years of age.

Overdose

Symptoms:  nausea, vomiting, severe headache, dizziness, memory loss, disorientation. In severe cases, paresthesia, numbness of the limbs, convulsions.

Treatment:  symptomatic therapy. Hemodialysis is ineffective.

Form of production

Ointment for external use

Storage conditions

Store in a dry place, protected from light, at temperatures below 25 °C.

Shelf life

5 years

Active ingredient

Indometacin

Dosage form

ointment