Instruction for use: Ketoprofen (Ketoprophenum)

Pharmacological group

NSAIDs - Propionic acid derivatives in combinations

Nosological classification (ICD-10)

G54.1 Disorders of lumbosacral plexus

Sciatica, Neurology radicular origin, spine Pathology, Sciatica lumbosacral, radiculoneuritis

I80.0 Phlebitis and thrombophlebitis of superficial vessels of lower extremities

Thrombophlebitis of superficial veins, Thrombophlebitis of superficial veins of legs, Thrombophlebitis of superficial veins, Phlebitis of superficial veins of legs, Inflammation of veins

I89.1 Lymphangitis

Lymphangitis, Lymphagitis, Lymphangitis acute

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

J04.0 Acute laryngitis

Lektorsky laryngitis, Acute catarrhal Laryngitis,Laryngitis is an acute abscess

K05.0 Acute gingivitis

Gingivitis acute, Gingivitis, Acute ulcerative-necrotic gingivitis of Vincent, Acute Ulcerative Gingivitis

K05.2 Acute periodontitis

Periodontal disease, Periodontitis, Periodontitis acute, Periodontal disease complicated by gingivitis, Pericoronite

K05.4 Periodontal disease

Alveolar pyorrhea, Amphodontosis, Chronic parodontosis, Superficial and deep periodontitis, Pyorrhea

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

K14.0 Glossitis

L98.9 Lesion of skin and subcutaneous tissue, unspecified

Adiponecrosis, Atonic leather, Diseases of the skin, Blister, Inflammatory disease of soft tissues, Inflammatory processes of epithelial tissues, Degenerative changes in the skin and mucous membranes, Degenerative changes in the skin and mucous membranes, Excess granulation, Thinning of the skin, Skin diseases, Maceration of the skin, Minor skin lesions, Surface crack and skin abrasion, Increased skin peeling, Skin lesion, Erosion of the skin, Lipedema, Local non-infectious processes of skin and soft tissues, Disturbance of skin structure, Dysfunction of the skin, Skin disorders

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

M07.2 Psoriatic spondylitis (L40.5 +)

Psoriatic spondylitis

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

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M42.9 Osteochondrosis of spine, unspecified

Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Diseases of the spinal column, Osteochondrosis of the spine with radicular syndrome

M43.6 Torticollis

Congenital torticollis

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

M65 Synovitis and tendosynovitis

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

M71 Other bursopathies

Bursitis, Bursopathy, Diseases of soft tissues, Osteoarthritis in musculo-articular diseases, Inflammatory disease of soft tissues, Subacute bursitis

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

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

N23 Renal colic unspecified

Pain in renal colic, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), renal Colic, ureteral colic, Renal colic, Renal colic with urolithiasis, Kidney disease, Spasm of smooth muscle in diseases of the urinary system, The spasm of the urinary tract, The spasm of the ureter, The spasm of the ureters, Spasms of the urinary tract, Spasms of the urinary tract

N94.4 Primary dysmenorrhea

Primary functional dysmenorrhea, Pain in primary dysmenorrhea, Primary algodismenorea, Menstrual cramps

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

S83.2 Fresh meniscus rupture

Damage to the knee meniscus

T09.5 Injury of unspecified muscle and tendon of the trunk

Muscle 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 22071-15-4

Characteristics of Ketoprofen

NSAIDs. Ketoprofen is a racemic mixture of enantiomers in which the pharmacological activity is associated with the S-enantiomer. White or almost white fine-grained or granular powder, odorless, not hygroscopic. Virtually nerastvorim in water at 20 ° C, easily soluble in ethanol, chloroform, acetone, ether, benzene and strong alkalis. Molecular weight 254.28.

Ketoprofen lysine salt: molecular weight 400.47.

Pharmacology

Pharmacological action - anti-inflammatory, antipyretic, antiaggregational, analgesic.

Inhibits the activity of COX-1 and COX-2, inhibits the synthesis of PG and LT. It has anti-bradykinin activity, stabilizes lysosomal membranes, and delays the release of enzymes that promote tissue destruction in chronic inflammation. Reduces the secretion of cytokines, inhibits the activity of neutrophils.

Anti-inflammatory effect occurs at the end of 1 week of admission. The lysine salt of ketoprofen has an equally pronounced anti-inflammatory, analgesic, antipyretic effect.

With articular syndrome, it alleviates joint pain at rest and during movement, reduces morning stiffness and swelling of the joints, contributes to an increase in the volume of movements.

When ingested, absorbed quickly and fairly fully, bioavailability - about 90%. Cmax in the blood is reached 0.5-2 hours after ingestion, after 1.4-4 hours - with rectal administration, after 15-30 minutes - with parenteral administration and after 5-8 hours - after application to the skin. When taking retarded forms, the minimum effective concentration is determined after 2-3 hours, Cmax is usually achieved within 6-7 hours. At simultaneous intake with food, the total bioavailability (AUC) does not change, the absorption rate slows down (for both normal and retarded forms) . Absorption is accompanied by the effect of "first passage" through the liver. Binding to blood plasma proteins, mainly with albumin - 99%. Equilibrium concentration in the plasma is achieved 24 hours after the start of regular intake. Easily passes through the histohematological barriers and is distributed in tissues and organs. In a significant amount does not penetrate the BBB. The level of ketoprofen in the synovial fluid is lower than in the blood, but within the therapeutic remains for a longer time (6-8 hours). Metabolised in the liver by glucuronidation. It is excreted mainly by the kidneys - 80% within 24 hours, mainly as a glucuronic derivative. T1 / 2 - (2.05 ± 0.58) h after intravenous administration; 2-4 hours after ingestion in a conventional lecture at a dose of 200 mg; (5.4 ± 2.2) h after taking a retarded form in a dose of 200 mg. With renal failure, excretion slows down.

Lysine salt of ketoprofen: Tmax after ingestion in the form of granules - 15 minutes, with parenteral administration - 20-30 minutes, with rectal - 45-60 minutes. When administered in the form of sustained-release capsules, effective concentration is achieved after 20-30 minutes and is maintained for 24 hours.

The therapeutic concentration in the synovial fluid is maintained for 18-20 hours. It is metabolized by microsomal enzymes of the liver. It is excreted by the kidneys, 60-80% - in the form of glucuronide for 24 hours.

In elderly patients, plasma and renal clearance are reduced, Cmax, AUC and unbound fractions increase with age (in women more than in men).

With the cutaneous application, a slow transdermal absorption of ketoprofen occurs, which ensures the maintenance of its concentration in inflamed tissues within the therapeutic level for a long time. It penetrates well into the synovial fluid and connective tissue. Absorption in the systemic blood flow is insignificant, bioavailability for the gel, spray - about 5%.

When using a topical solution (rinse solution) at a dose of 160 mg Tmax - 1 hour, the Cmax value is 350 mg / ml (4% concentration obtained by oral intake of 80 mg).

Carcinogenicity, mutagenicity, effects on fertility

Studies of chronic toxicity in mice when administered orally (up to 32 mg / kg / day, 96 mg / m2 / day, about 0.5 MPHR) did not reveal a carcinogenic effect of ketoprofen. In a biennial carcinogenicity study, no adverse oncogenic effect was detected in rats at doses up to 6 mg / kg / day (36 mg / m2 / day). At the same time, animals in all groups received drugs for 104 weeks, with the exception of females receiving 6 mg / kg / day (36 mg / m2 / day) for 81 weeks due to low survival. Survival in the groups receiving drugs for 104 weeks, was 6% compared with the control group.

There was no mutagenicity of ketoprofen in the Ames test. When ketoprofen was administered to male rats (up to 9 mg / kg / day, 54 mg / m2 / day), no significant effect on reproductive function and fertility was found. In female rats at doses of 6 or 9 mg / kg / day (36 or 54 mg / m2 / day) there was a decrease in the number of implants.

At high doses in rats and dogs, spermatogenesis is disturbed and inhibited, in dogs and monkeys-baboons, the weight of the testicles decreases.

Application of Ketoprofen

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

Inflammatory and degenerative diseases of the musculoskeletal system, incl. rheumatoid arthritis, nonspecific spondylitis (ankylosing and psoriatic spondylitis), gouty arthritis, pseudogout, osteoarthrosis, extraarticular rheumatism (tendovaginitis, bursitis, capsulitis). Duplication of pain syndrome of different genesis, incl. postoperative, posttraumatic pain, sciatica, myalgia, sciatica, bruises and stretch of muscles, renal colic, pain syndromes in dental, gynecological, neurological, oncological practice. Symptomatic treatment of acute pain syndrome in inflammatory diseases of the musculoskeletal system (for I / m administration only). Primary dysmenorrhea.

For topical application:

when applied to the skin - acute and chronic inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, spondyloarthritis, arthrosis, osteochondrosis); painful inflammatory or traumatic (including sports) joints, tendons, ligaments and muscles (including arthritis, periarthritis, tendonitis, tendosynovitis, bursitis, muscle contusions, sprains, ligament ruptures and tendons of the muscles, sprains, damage to the meniscus of the knee, torticollis, lumbago), phlebitis, surface vein thrombophlebitis, lymphangitis, skin inflammatory processes;

as a solution for rinsing - symptomatic treatment of inflammatory diseases of the oral cavity, pharynx and larynx (including angina, laryngitis, pharyngitis, stomatitis, glossitis, gingivitis, periodontitis, periodontitis), for analgesia in the treatment and removal of teeth (as an auxiliary Drugs).

Contraindications

Hypersensitivity (including to other NSAIDs). For systemic use: aspirin asthma, gastric and duodenal ulcer (exacerbation), ulcerative colitis (exacerbation), Crohn's disease, diverticulitis, peptic ulcer, disorders of the blood coagulation system (including hemophilia), renal and hepatic insufficiency, children and adolescence under 18, pregnancy (III trimester); for rectal administration (in addition): hemorrhoids, proctitis, proctorrhagia; for dermal application: dermatoses, eczema, infected abrasions, violation of the integrity of the skin, children under 6 years.

Ketoprofen is not indicated for the relief of pain during coronary bypass surgery.

pregnancy and lactation

Teratogenic effects. In studies in mice, ketoprofen was administered at doses up to 12 mg / kg / day (36 mg / m2 / day) and in rats at doses of 9 mg / kg / day (54 mg / m2 / day), which is approximately equivalent to 0.2 MPHR (185 mg / m2 / day), there were no teratogenic or embryotoxic effects. In separate studies in rabbits, toxic doses for females were associated with embryotoxicity, but not with teratogenicity. However, reproductive studies in animals do not always predict effects in humans.

Nonteratogenic effects. Since the adverse effects of agents that inhibit GH synthesis on the fetal cardiovascular system (premature closure of the ductus arteriosus) are known, it should be avoided during pregnancy (especially in later terms).

When ingestion or rectal administration during pregnancy, a hemodynamic disorder in the newborn is possible, which is accompanied by severe respiratory distress, and use shortly before the birth can lead to a delay.

Adequate and strictly controlled studies in pregnant women have not been conducted. Application in pregnancy in the I and II trimester is possible if the expected effect of therapy exceeds the potential risk for the fetus, in the III trimester (especially after 36 weeks) - is contraindicated because of the possible influence on the tone of the uterus.

The action category for fetus by FDA is C.

Childbirth and delivery. The effects of ketoprofen on labor and delivery in humans are unknown. Studies in rats have shown that ketoprofen at a dose of 6 mg / kg (36 mg / m2 / day), roughly equivalent to 0.2 MPD, prolongs pregnancy if it is used before the onset of labor.

Women planning a pregnancy should refrain from the use of ketoprofen, tk. on the background of its administration, the probability of implantation of the ovule may decrease.

It is not known whether ketoprofen penetrates the human breast milk. In rats at doses of 9 mg / kg (54 mg / m2 / day, about 0.3 MPHP), ketoprofen did not affect perinatal development. When ketoprofen was administered to lactating dogs, the concentration in the milk was 4-5% of the plasma concentration. Like other substances that are excreted in breast milk, it is not recommended to use ketoprofen for breastfeeding mothers.

Side effects of Ketoprofen

Systemic side effects

During clinical trials, the following side effects (possibly associated with the use of ketoprofen) were noted:

On the part of the digestive tract: buccal necrosis (for oral administration), ulcerative colitis, microvesicular steatosis, pancreatitis, aggravation of diabetes mellitus.

From the nervous system and sensory organs: dysphoria, hallucinations, nightmares, personality changes, aseptic meningitis.

Other: septicemia, shock, violation of libido, acute tubulopathy, gynecomastia.

Lysine salt ketoprofen compared with ketoprofen less often causes side effects from the gastrointestinal tract (due to the fact that the lysine salt of ketoprofen has a neutral pH and, accordingly, less irritating effect on the gastric mucosa).

Local side effects: for rectal administration - itching, heaviness in the anorectal area, exacerbation of hemorrhoids; with cutaneous application - skin allergic reactions, photosensitization, development of systemic side effects (with prolonged use on extensive skin surfaces); when using a rinse solution - sensitization (with prolonged use).

Interaction

Pharmaceutically incompatible with tramadol solution. Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytic agents, ethanol, side effects of gluco- and mineralocorticoids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics. Joint reception with other NSAIDs, glucocorticoids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, an increased risk of kidney dysfunction. Simultaneous administration with oral anticoagulants, heparin, thrombolytic agents, antiaggregants, cefoperazone, cefamandol and cefotetan increases the risk of bleeding. Increases hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary). Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Co-administration with sodium valproate causes disruption of platelet aggregation. Increases the concentration in the plasma of verapamil and nifedipine, lithium preparations, methotrexate. Antacids (including aluminum and magnesium-containing) do not affect the rate and magnitude of ketoprofen absorption. Myelotoxic drugs increase the manifestation of hematotoxicity.

Overdose

Symptoms: lethargy, dizziness, nausea, vomiting, epigastric pain - symptoms are usually reversible. There may be respiratory distress, coma, convulsions. Rarely - bleeding from the gastrointestinal tract, hypotension / hypertension, acute renal failure.

Treatment: symptomatic and supportive therapy, monitoring of the respiratory and cardiovascular system. No specific antidote was found. Hemodialysis is ineffective.

Routes of administration

Inside, in / m (intramuscularly), iv / (intravenously), rectally, dermally, topically.

Precautions for Ketoprofen

Care should be taken and careful medical supervision should be conducted if there is an indication in the anamnesis of allergic reactions to the medicine of the "aspirin" series, the "aspirin" triad, peptic ulcer of the stomach and duodenum, anemia, alcoholism, tobacco smoking, alcoholic cirrhosis, hyperbilirubinemia, liver failure , diabetes mellitus, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, blood diseases (including leukopenia, thrombocytopenia, with infringement yvaniya blood), deficiency of glucose-6-phosphate dehydrogenase, stomatitis; with caution in external application - with exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, in children under 12 years.

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

Risk of cardiovascular complications. NSAIDs 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 increase the risk of serious side effects from the gastrointestinal tract, 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.

The use of ketoprofen can mask the symptoms of an infectious disease.

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.

Avoid contact with eyes and other mucous membranes of the form for dermal application; Do not apply to open wounds or damaged skin.

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.