Instruction for use: Indomethacin (Indomethacinum)

Pharmacological group

NSAIDs - Derivatives of acetic acid and related compounds

Ophthalmic products

Nosological classification (ICD-10)

G54.5 Neuralgic amyotrophy

Personeness-Turner's disease, Neural amyotrophy

H10.9 Conjunctivitis, unspecified

Trahomny conjunctivitis, catarrhal conjunctivitis, Giperpapillyarny conjunctivitis, Non-infectious conjunctivitis, purulent conjunctivitis, Purulent conjunctivitis form, Year-round conjunctivitis, purulent conjunctivitis, Subacute conjunctivitis, Secondarily infected with conjunctivitis

H35.8 Other specified retinal disorders

Cystoid macular edema, Degenerative changes in the retina, Elderly degeneration of the retina

H44.9 Disease of the eyeball, unspecified

H60.9 External otitis, unspecified

Inflammation of external auditory canal, Otitis, Chronic external otitis media

H66.9 Otitis media, unspecified

Chronic otitis, Otitis, otitis media, middle ear infections, Otitis media in children

I31.3 Pericardial effusion (non-inflammatory)

J02.9 Acute pharyngitis, unspecified

purulent pharyngitis, Acute nasopharyngitis,Limfonodulyarny pharyngitis

J03.9 Acute tonsillitis, unspecified (angina agranulocytic)

Sore throat infections, Acute tonsillitis, Angina, Follicular tonsillitis, Angina alimentary-hemorrhagic, Secondary sore throat, Sore throat primary, Angina follicular, Angina, Inflammatory diseases of the tonsils, Catarrhal angina, Lacunar angina, Acute Sore Throat, Tonsillitis, Tonsillitis acute, Tonsillar angina, Follicular sore throat, Bacterial tonsillitis

K07.6 Diseases of the temporomandibular joint

Temporomandibular joint syndrome

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

K12 Stomatitis and Related Lesions

Bacterial stomatitis, Inflammatory diseases of the oral cavity, Inflammatory diseases of tissues of the oral cavity, Inflammatory processes in the oral cavity, Fungal diseases of the mouth, Fungal infections of the oral cavity, Fungal infections and inflammatory diseases of the mouth, Diseases of the mouth, Infectious-inflammatory disease of the oral cavity, Exacerbation of inflammatory diseases of the pharynx and oral cavity, Stomatitis, Angular stomatitis, Chronic recurrent stomatitis, Ulcerative necrotic diseases of the oral mucosa, Ulcerative necrotic gingivostomatitis, Ulcerative stomatitis, Erosive-ulcerative lesion of the oral mucosa, Erosive-ulcerative lesions of the mucous membrane of the oral cavity, Erotic mucous membrane of the oral cavity, Recurrent ulcerative stomatitis

K13.7 Other and unspecified lesions of oral mucosa

Aspirin burn of the oral mucosa, Gum pain when wearing dentures, Inflammation of the mouth, Inflammation of the oral mucosa, Inflammation of the oral mucosa after radiation therapy, Inflammation of the oral mucosa after chemotherapy, Inflammation of the oral mucosa, Inflammation of the mucous membranes of the mouth, Inflammatory diseases of the oral cavity, Inflammatory process of pharynx, Disease of the oral mucosa, Injuries to the oral cavity and larynx, Injuries of the oral mucosa, Trophic diseases of the oral mucosa, Erosive-ulcerative periodontal disease, Erosive-ulcerative lesion of the oral mucosa, Erotic mucous membrane of the oral cavity, Erotic-ulcerative periodontal lesions, Erotic-ulcerative lesions of the oral mucosa, Radio-epileleitis, Irritation from dental prostheses, Irritation of the oral mucosa with dentures and braces, Oral cavity, When wearing dentures

L40.5 Arthropathy psoriasis (M07.0-M07.3 *, M09.0 *)

Arthritis psoriatic, Arthropathic form of psoriasis

M02.3 Reiter's Disease

Reiter's syndrome, Arthritis is infectious-allergic, Arthritis Reactive, Urethro-oculo-synovial syndrome

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M07.3 Other psoriatic arthropathies (L40.5 +)

Arthritis psoriatic, The generalized form of psoriatic arthritis, Psoriatic arthritis

M08 Juvenile [juvenile] Arthritis

Juvenile arthritis, Juvenile chronic polyarthritis, Juvenile chronic arthritis, Juvenile rheumatoid arthritis, Arthritis juvenile chronic

M10.0 Idiopathic Gout

Primary gout

M13.9 Arthritis, unspecified

Arthritis,Purulent arthritis (non-infectious), acute Arthritis,Pain in acute inflammatory diseases of the musculoskeletal system,Pain in chronic inflammatory diseases of the musculoskeletal system,The pain in osteoarthritis, Inflammation in osteoarthritis, Inflammatory arthropathy, Inflammatory and degenerative joint diseases, Inflammatory disease of the musculoskeletal system, Inflammatory joint disease, Inflammatory diseases of the musculoskeletal system, destructive arthritis, The disease of the musculoskeletal system, Diseases of the musculoskeletal system, Diseases of the musculoskeletal system and connective tissue, Infections musculoskeletal system, monoartrit, Non-infectious arthritis, rheumatic arthritis, Osteoarthritis, Acute inflammation of the musculoskeletal tissue, Acute inflammatory diseases of the musculoskeletal system, Acute inflammatory condition of the musculoskeletal system, Acute arthritis, Acute osteoarthritis, Post-traumatic osteoarthritis, Reactive arthritis, Chronic inflammatory diseases of the joints, Chronic arthritis, Chronic inflammatory arthritis, Chronic inflammation of the inner layer of the joint capsule, Chronic inflammation of the joint capsule,Chronic inflammatory disease of the joints, Exudative arthritis

M19.9 Arthrosis, unspecified

Change in brush with osteoarthritis, Osteoarthritis, Osteoarthrosis, Arthrosis of large joints, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Deforming arthrosis, Deforming osteoarthritis, Deforming osteoarthritis of joints, Osteoarthritis in the acute stage, Osteoarthritis of large joints, Acute pain syndrome with osteoarthritis, Post-traumatic osteoarthritis, Rheumatic osteoarthritis, Spondylarthrosis, Chronic osteoarthritis

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M54.1 Radiculopathy

Acute sciatica, Radiculopathy, Radiculitis, Radiculitis with radicular syndrome, Acute radiculopathy, Pain syndrome with radiculitis, Subacute radiculitis, Radiculitis, Chronic radiculitis, Diseases of the spinal column

M54.3 Sciatica

Ishialgia, Neuralgia of the sciatic nerve, Sciatic neuritis

M54.5 Pain below the back

Pain in the lower back, Lumbar pain, Lumbalia, Painful conditions of the spinal column, Back pain, Lower Back Pain Syndrome

M60.9 Myositis, unspecified

Neuromyositis, Extubulbar myositis

M65 Synovitis and tendosynovitis

Acute tenosynovitis, Tendovaginitis (tenovaginitis), Tendosinovit (tenosynovitis), Tendovaginitis, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Nonspecific tenosynovitis, Tendosinovit

M67.9 Lesion of synovium and tendon, unspecified

Inflammation of the tendons, Inflammation of ligaments, Inflammation of tendons with injuries, Inflammation of tendons

M70 Diseases of soft tissues associated with exercise, overload and pressure

M71.9 Bursopathy, unspecified

Bursites, Alberta disease, Acute bursitis

M75.0 Adhesive shoulder capsulitis

Acute shoulder-scapular periarthritis, Duplay's disease, Duplay Syndrome, Frozen shoulder, Shoulder-shoulder periarthritis, Periarteritis humeroscapular, Shoulder periarthritis, Pleiraptocular periarthritis, Capsule, Frozen shoulder

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.0 Other unspecified rheumatism

Degenerative rheumatic disease, Degenerative and rheumatic diseases of the tendons, Degenerative rheumatic diseases, Localized forms of rheumatism of soft tissues, Rheumatism, Rheumatism with a pronounced allergic component, Rheumatism of the articular and extraarticular, Rheumatic attack, Rheumatic complaints, Rheumatic diseases, Rheumatic disease of the spine, Relapses of rheumatism, Articular and extra-articular rheumatism, Articular and muscular rheumatism, Articular rheumatism, Articular syndrome with rheumatism, Chronic rheumatic pain, Chronic articular rheumatism, Rheumatoid diseases, Rheumatic diseases of the intervertebral disc

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

M88 Paget's disease (bones) [deforming osteitis]

Paget's disease is bone, Paget's disease, Deforming osteodystrophy, Paget's disease, Deforming osteitis, Deforming Osteoporosis, Ostoz deforming, Osteitis deforming, Osteitis with articular manifestations

M89.0 Algoneurodroystrophy

Zudeck's atrophy, Zudeck's Syndrome, Shoulder-Arm Syndrome, Steinbroke Syndrome, Shoulder-Brush Syndrome, Brachialgia syndrome, Zudeck's posttraumatic reflex atrophy, Reflex sympathetic dystrophy

M93.9 Osteochondropathy, unspecified

Keller's disease

N70 Salpingitis and oophoritis

Adnexitis, Inflammatory diseases of female genitalia, Inflammatory diseases of female genital organs, Infection of the genitals, Oophoritis, Acute adnexitis, Salpingitis, Salpingo-oophoritis, Chronic inflammatory diseases of the ovaries, Inflammation of the ovaries

N73 Other inflammatory diseases of female pelvic organs

N94.3 Premenstrual tension syndrome

Pronounced premenstrual syndrome, Menstrual psychosomatic disorder, Menstrual syndrome, Premenstrual tension, Premenstrual status, Premenstrual period, Premenstrual syndrome, Menstruation syndrome

O66.9 Unspecified obstruction

Complicated labor activity

Q28 Other congenital malformations of the circulatory system

R50 Fever of unknown origin

Malignant hyperthermia, Hyperthermia malignant

R51 Headache

Pain in the head, Cephalgia, Pain with sinusitis, Pain in the back of the head, Painful headache, Headache of vasomotor genesis, Headache of vasomotor origin, Headache with vasomotor disorders, Headache, Neurological headache, Serial headache

T14.0 Surface injury of unspecified body region

Abrasions, Scratch, Skin Wounds, Wounds of soft tissues, Hematoma, Hematoma of traumatic origin, Hematomas, Hematomas of muscles, Hematomas of soft tissues, Healing of the skin, Bruise, Bruising due to sprains and bruises, Microtrauma, External bruises, Small combing, Superficial hematoma, Superficial damage to the skin and mucous membranes, Subcutaneous hematoma, Post-traumatic hematoma, Post-traumatic disturbance of microcirculation, Skinness of the skin, Traumatic plexus lesions, Injury, Contusion of soft tissues, Joint bruise, Traumatic bruises, Traumatic injury, Primary treatment of surface contaminated wounds, Abrasion, Bruise

T14.3 Dislocation, sprain and damage to the capsular-ligamentous apparatus of the joint of the unspecified area of the body

Painful stretching of muscles, Pain and inflammation in tension, Dislocation of dislocation, Degenerative changes in the ligamentous apparatus, Edema due to sprains and bruises, Edema after interventions for sprains, Damage and rupture of ligaments, The musculoskeletal system is damaged, Damage to ligaments, Damage to the joints, Ligament ruptures, Tendon tendons,Ruptures of the tendons of muscles,Stretching, Crick, Stretching of the muscle, Sprain, Tension of the tendons, Extensions,Stretch muscles, Sprains, Tension of the tendons, Injury of the musculoskeletal system, Injuries to the joints, Injuries of capsule-articular tissues, Injuries of the osteoarticular system, Injuries to ligamentsInjuries to the joints, Joint wounds, Stretching of the ligamentous apparatus, Habitual stretching and tearing

T14.9 Injury unspecified

Pain syndrome after trauma, Pain syndrome with injuries, Pain syndrome with trauma and after surgery, Pain in case of injury, Pain of a traumatic nature, Joint pain with injuries, Postoperative and post-traumatic pain, Pain in case of injury, Pain of a traumatic origin, Severe pain syndrome of traumatic origin, Deep tissue damage, Deep scratches on the trunk, Closed injury, Minor Household Injuries, Minor skin damage, Violations of the integrity of soft tissues, Uncomplicated trauma, Extensive traumatic injury, Acute pain syndrome of traumatic origin, Edema with trauma, Postponed sports injuries, Post-traumatic pain, Soft tissue injuries, Joint wounds, Sports injuries, Injury, Traumatic pain, Traumatic pains, Traumatic infiltrate,Injuries to sports

Z100 * CLASS XXII Surgical practice

Abdominal surgery, adenomectomy, Amputation, Coronary angioplasty, Angioplasty of the carotid arteries, Antiseptic skin treatment for wounds, Antiseptic Hand, Appendectomy, atherectomy, Balloon coronary angioplasty, Vaginal hysterectomy, The coronary bypass, Interventions in the vagina and cervix, Interventions on the bladder, Intervention in the mouth, Restoration and reconstructive surgery, Hand hygiene of medical personnel, Gynecologic surgery, Gynecological intervention, Gynecological surgery, Hypovolemic shock during operations, Disinfection of purulent wounds, Disinfection of wounds edges, Diagnostic intervention, Diagnostic procedures, Cervical Diathermocoagulation, Long-surgery, Replacing the fistula catheters, Infection in orthopedic surgery, Artificial heart valve, cystectomy, Short-term outpatient surgery, Short-term operation, Short surgical procedures, Krikotireotomiya, Blood loss during surgery, Bleeding during surgery and in the postoperative period, Kuldotsentez, laser photocoagulation, laser coagulation, retinal laser coagulation, Laparoscopy, Laparoscopy in Gynecology, CSF fistula, Small gynecological operations, Small surgical procedures, Mastectomy and subsequent plastic, mediastinotomy, Microsurgical operations on the ear, Mukogingivalnye operation, suturing, Minor surgery, neurosurgical operation, Immobilization of the eyeball in ophthalmic surgery, testectomy, pancreatectomy, Perikardektomiya, The period of rehabilitation after surgery, The period of, convalescence after surgery, Percutaneous transluminal coronary angioplasty, Pleural thoracentesis, Pneumonia postoperative and posttraumatic, Preparation for surgical procedures, Preparation for surgery, Preparation of the surgeon's hands before surgery, Preparation of the colon for surgical procedures, Postoperative aspiration pneumonia in neurosurgical and thoracic surgery, Postoperative nausea, Postoperative bleeding, postoperative granuloma, postoperative shock, The early postoperative period, myocardial revascularization, Radiectomy, gastric Resection, bowel resection, uterine Resection, liver Resection, enterectomy, Resection of part of the stomach, Reocclusion of the operated vessel, Bonding tissues during surgical procedures, Removal of sutures, Condition after eye surgery, Condition after surgery, Condition after surgery in the nasal cavity, Condition after gastrectomy, Status after resection of the small intestine, Condition after tonsillectomy, Condition after removal of the duodenum, Condition after phlebectomy, Vascular surgery, Splenectomy, Sterilization of surgical instruments, Sterilization of surgical instruments, sternotomy, Dental surgery, Dental intervention in periodontal tissues, strumectomy, Tonsillectomy, Thoracic surgery, total gastrectomy, Transdermal intravascular coronary angioplasty, Transurethral resection, Turbinektomiya, Removal of a tooth, cataract surgery, Removal of cysts, tonsillectomy, Removal of fibroids, Removing the mobile primary teeth, Removing polyps, Removing broken tooth, Removal of the uterus body, Removal of sutures, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, Surgery, The surgery in the anal area, The surgery on the colon, Surgical practice, The surgical procedure, Surgical interventions, Surgery on the gastrointestinal tract, Surgical procedures on the urinary tract, Surgical procedures on the urinary system, Surgical intervention of the genitourinary system, Surgical procedures on the heart, Surgical manipulation, surgery, Surgery on the veins, Surgical intervention, Vascular surgery, Surgical treatment of thrombosis, cholecystectomy, Partial gastric resection, transabdominal hysterectomy, Percutaneous transluminal coronary angioplasty, Percutaneous transluminal angioplasty, Coronary artery bypass, tooth Extirpation, Extirpation of milk teeth, pulpectomy, pulsative cardiopulmonary bypass, tooth Extraction, teeth Extraction, cataract extraction, Electrocoagulation, endourological intervention, episiotomy, Etmoidotomiya, Complications after tooth extraction

Code CAS 53-86-1

Characteristics of Indomethacin

NSAIDs (non-steroidal anti-inflammatory drugs), an indoleacetic acid derivative.

A white or slightly yellowish powder, odorless or almost odorless. Almost nerastvorim in the water. Moderately soluble in ethanol, chloroform, ether. Soluble in alkali solutions.

Pharmacology

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Inhibits cyclooxygenase (COX (cyclooxygenase) -1 and COX-2), reduces the synthesis of PG, causing the development of pain in the focus of inflammation, increased temperature and increased tissue permeability. Has antiaggregant effect.

It causes weakening or disappearance of the pain syndrome of rheumatic and non-rheumatic nature (including pain in joints at rest and during movement, reduces morning stiffness and swelling of joints, promotes an increase in the volume of movements, inflammatory processes that occur after operations and trauma, quickly facilitates both spontaneous pain and pain during movement, reduces inflammatory edema at the wound site).

After ingestion of a single dose of 25 or 50 mg quickly absorbed, Tmax - about 2 hours; when used rectally, the absorption rate is higher. When administered orally, the bioavailability is 90-98%, with rectal administration slightly lower - 80-90%, which is probably due to insufficient suppressor retention time (less than 1 hour) to ensure complete absorption. Binding to plasma proteins is 90-98%. T1 / 2 - 4-9 hours With daily intake of 25 or 50 mg of indomethacin three times a day, the equilibrium concentration is 1.4 times higher than the concentration after a single dose. Biotransformiruetsya mainly in the liver. In blood plasma is in the form of unchanged substance and desmethyl-, desbenzoyl- and desmethyl-desbenzoylmetabolites, present in unconjugated form. Excreted mainly by the kidneys - 70% (30% - unchanged) and gastrointestinal tract - 30%. Passes through GEB, placenta, penetrates into breast milk. It is not removed during hemodialysis.

When instillation of eye drops penetrates into the anterior chamber of the eye. After a single instillation is determined in the moisture of the anterior chamber for several hours.

Carcinogenicity, mutagenicity, effects on fertility

In a 81-week study of chronic toxicity in rats when administered orally at doses up to 1 mg / kg / day, no carcinogenic effect was observed. In studies of carcinogenicity in rats (study period - 73-110 weeks) and in mice (study period - 62-88 weeks) at doses up to 1.5 mg / kg / day, indomethacin caused neoplastic or hyperplastic changes.

No indomethacin mutagenicity has been detected in a number of bacterial tests in vitro (Ames test, E. coli test with / without metabolic activation) and in a series of in vivo tests, including the test for sex-linked recessive Drosophyla flies, a micronuclear test in mice.

In studies of reproduction, incl. in two generations, at a dose level of up to 0.5 mg / kg / day, indomethacin had no effect on fertility in mice and in rats.

Use of indomethacin

For systemic use (inside, in / m, rectally)

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, arthritis in Paget and Reiter's disease, neuralgic amyotrophy (Pursonage-Turner's disease), ankylosing spondylitis (Bechterew's disease), gouty arthritis, rheumatism. Pain syndrome: headache (including menstrual syndrome) and toothache, lumbago, sciatica, neuralgia, myalgia, after injuries and surgical interventions accompanied by inflammation, bursitis and tendonitis (most effective for localization in the shoulder and forearm area). Algodismenorea, for the preservation of pregnancy, Barter's syndrome (secondary hyperaldosteronism), pericarditis (symptomatic treatment), labor (as an analgesic and tocolytic agent in preterm labor), inflammatory processes in the pelvis, incl. adnexitis, non-healing of the botulinum duct. Infectious and inflammatory diseases of ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media. Feverish syndrome (including with lymphogranulomatosis, other lymphomas and hepatic metastases of solid tumors) - in case of ineffectiveness of acetylsalicylic acid and paracetamol.

For topical application (with application to the skin)

Traumatically caused inflammation of the tendons, ligaments, muscles and joints (as a result of stretching, dislocation, after a load and bruises). Localized forms of inflammation of soft tissues, incl. tendovaginitis, tendonitis, shoulder-arm syndrome, bursitis, myalgia; radiculitis (sciatica, lumbago). Inflammatory and degenerative diseases of the musculoskeletal system (deforming osteoarthritis, rheumatoid arthritis, psoriatic arthritis, rheumatoid arthritis, humeropathy periarthritis, ankylosing spondylitis, osteochondrosis with radicular syndrome) with the exception of degenerative diseases of the hip joints.

In ophthalmology (eye drops): epithelial herpetic keratitis (including in the anamnesis), pregnancy, lactation period, children's age.

pregnancy and lactation

Teratogenic effects. Studies of teratogenicity in rats and mice using doses of 0.5; 1.0; 2.0 and 4.0 mg / kg / day, showed that at a dose of 4 mg / kg / day there was no increase in the frequency of developmental defects compared to the control group, except for delayed ossification in the fetuses (considered secondary to reduction average weight of fruit). In other studies, in mice, when using higher doses (5-15 mg / kg / day), toxicity and lethality for females, increased resorption and malformations of fetuses were detected. A comparative study in rodents using high doses of acetylsalicylic acid showed similar effects for females and their fetuses. However, reproductive studies in animals do not always predict effects in humans. Adequate and strictly controlled studies in pregnant women have not been conducted.

Nonteratogenic effects. Since the adverse effect of NSAIDs on the fetal cardiovascular system is known (premature closure of the ductus arteriosus), pregnancy should be avoided (especially in later terms).

The effects of indomethacin and other drugs of this class on the human fetus in the third trimester of pregnancy include: intrauterine closure of the arterial duct, insufficiency of the tricuspid valve and pulmonary hypertension; failure to cover the arterial duct in the postnatal period, resistant to drug correction; degenerative changes in the myocardium, platelet abnormalities leading to bleeding, intracranial hemorrhage, renal dysfunction or insufficiency, kidney damage / defect that can lead to kidney failure, oligohydramnion, gastrointestinal bleeding or perforation, increased risk of developing necrotizing enterocolitis.

In studies in rats and mice receiving indomethacin at doses of 4 mg / kg / day in the last 3 days of pregnancy, there was a decrease in body weight in females and a small number of female and fetal deaths. An increase in the frequency of neuronal necrosis in the diencephalon in viable fetuses was noted. At a dose of 2.0 mg / kg / day, there was no increase in the frequency of neuronal necrosis compared to the control group. Introduction 0.5 or 4.0 mg / kg / day in the first 3 days of life did not cause an increase in the frequency of neuronal necrosis.

Childbirth and delivery. In studies in rats, it has been shown that NSAIDs, like other agents that inhibit GH synthesis, increase the incidence of labored births, delay the onset of labor and delivery, and reduce the number of surviving pups.

Action category for fetus by FDA - S.

Indomethacin penetrates into breast milk, so you should stop breastfeeding for the duration of treatment or avoid the use of indomethacin during breastfeeding.

Side effects

Systemic side effects

From the nervous system and sensory organs: headache, dizziness, vertigo, agitation, irritability, excessive fatigue, drowsiness, depression, peripheral neuropathy, taste disorder, hearing loss, tinnitus, diplopia, blurred vision, corneal opacity, conjunctivitis.

From the cardiovascular system and blood (hematopoiesis, hemostasis): the development (aggravation) of chronic heart failure, tachyarrhythmia, edematous syndrome, increased blood pressure, bleeding (from the digestive tract, gingival, uterine, hemorrhoidal), anemia (including autoimmune hemolytic and aplastic), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

On the part of the gastrointestinal tract: NSAIDs-gastropathy, nausea, vomiting, abdominal pain, heartburn, decreased appetite, diarrhea, impaired liver function (increased liver transaminase activity, hyperbilirubinemia); with prolonged use in high doses - erosive and ulcerative lesions of the gastrointestinal tract.

On the part of the genitourinary system: renal dysfunction, proteinuria, hematuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

Allergic reactions: skin itching, rash, urticaria, exfoliative dermatitis, erythema nodosum, anaphylactic shock, bronchospasm, angioedema, toxic epidermal necrolysis (Lyell's syndrome).

Other: hyperglycemia, glucosuria, hyperkalemia, photosensitivity; aseptic meningitis (more often in patients with autoimmune diseases), increased sweating; local reactions for rectal administration: burning, itching of the skin, heaviness in the anorectal area, exacerbation of hemorrhoids.

When applied to the skin: allergic reactions; itching and hyperemia of the skin, a rash in the place of application, dry skin, burning; in isolated cases - exacerbation of psoriasis; with prolonged use - systemic manifestations.

When instilled into the eye: allergic reactions; with prolonged use - corneal opacity, conjunctivitis, systemic side effects.

Interaction

Reduces the diuretic effect of potassium-sparing, thiazide and loop diuretics. Increases (mutually) the risk of developing side effects (primarily gastrointestinal lesions) of other NSAIDs. Increases plasma concentrations of digoxin, methotrexate and Li + preparations, which can lead to increased toxicity. Sharing with paracetamol increases the risk of developing nephrotoxicity. Ethanol, colchicine, glucocorticoids and corticotropin increase the risk of bleeding in the digestive tract. Strengthens hypoglycemic action of insulin and oral hypoglycemic drugs; strengthens the effect of indirect anticoagulants, antiaggregants, fibrinolytics (alteplase, streptokinase and urokinase) and increases the risk of bleeding. Against the background of the use of potassium-sparing diuretics, the risk of hyperkalemia increases; reduces the effectiveness of uricosuric and antihypertensive drugs (including beta-blockers); increases the side effects of mineral and glucocorticoids, estrogens. Cyclosporine and gold preparations increase nephrotoxicity (by suppressing the synthesis of PG in the kidneys). Cefamandol, cefoperazone, cefotetan, valproic acid - increase the frequency of hypoprothrombinemia and the risk of bleeding. Antacids and colestyramine reduce the absorption of indomethacin. Increases the toxicity of zidovudine (due to inhibition of metabolism), in newborns increases the risk of toxic effects of aminoglycosides (because reduces renal clearance and increases the concentration in the blood). Myelotoxic drugs increase the manifestation of hematotoxicity.

Update of information

ACE inhibitors and angiotensin II antagonists

NSAIDs can reduce the antihypertensive effect of ACE inhibitors and angiotensin II receptor antagonists. Indomethacin can reduce the antihypertensive effect of captopril and losartan. These interactions should be considered in patients taking NSAIDs simultaneously with ACE inhibitors or angiotensin II antagonists. In some patients with impaired renal function, the combined use of NSAIDs and ACE inhibitors or angiotensin II antagonists can lead to further impairment of renal function, including possible acute renal failure, which is usually reversible.

Overdose

Symptoms: nausea, vomiting, severe headache, dizziness, memory impairment, disorientation; in severe cases - paresthesia, numbness of limbs and cramps.

Treatment: symptomatic therapy. Hemodialysis is ineffective.

Routes of administration

Inside, in / m, rectally, skin, conjunctival.

Precautions for Indomethacin

Particularly careful medical observation is required when indicating the history of allergic reactions to drugs of the "aspirin" series, the "aspirin" triad, peptic ulcer of the stomach and duodenum, as well as for clotting disorders, hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, depression, in children and old age.

Risk of cardiovascular complications. NSAIDs, incl. and indomethacin, may cause an increased risk of serious cardiovascular complications, incl. myocardial infarction and stroke, which can lead to death, especially with prolonged use. In patients with cardiovascular diseases or risk factors for developing cardiovascular disease, the risk is particularly high.

Risk of gastrointestinal complications. NSAIDs, incl. and indomethacin, cause an increased risk of serious GI side effects, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal, especially with prolonged use. These complications can occur at any time of use without foreboding symptoms. Elderly patients have a higher risk of serious gastrointestinal complications.

At the indication in the anamnesis of allergic reactions on NPVS apply only in urgent cases.

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

For eye drops: after removal of contact lenses, instillation is performed after 5 minutes. If there is an infection or a threat of its development, local antibacterial treatment is prescribed at the same time.

Avoid contact with eyes, mucous membranes and open wound forms for dermal application.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Update of information

Arterial hypertension

NSAIDs, incl. indomethacin, may be the cause of newly diagnosed or worsening of the current arterial hypertension, which may contribute to an increase in the incidence of cardiovascular complications.

It should be used NSAIDs, incl. indomethacin, with caution in patients with hypertension. A thorough monitoring of blood pressure is necessary at the beginning of treatment with NSAIDs and during the course of therapy.

Patients taking ACE inhibitors, thiazide or loop diuretics, or beta-adrenergic blockers may have a weakened response to antihypertensive therapy with NSAIDs.

special instructions

With an acute attack of gout, rapid-acting dosage forms are preferred