Composition, form of production and packaging
Suspension for injection 1 ml
triamcinolone acetonide 40 mg
1 ml - ampoules (5) - packings of cellular contour (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
GCS. Suppresses the function of white blood cells and tissue macrophages. Limits the migration of leukocytes to the area of ​​inflammation. Violates the ability of macrophages to phagocytosis, as well as to the formation of interleukin-1. Promotes the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of ​​inflammation. Reduces the permeability of capillaries due to the release of histamine. Suppresses the activity of fibroblasts and the formation of collagen.
Inhibits the activity of phospholipase A 2 , which leads to suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of COX (mainly COX-2), which also contributes to a decrease in the production of prostaglandins.
Reduces the number of circulating lymphocytes (T- and B-cells), monocytes, eosinophils and basophils due to their movement from the vascular bed into the lymphoid tissue; suppresses the formation of antibodies.
Suppress the release of the pituitary ACTH and? -lipotropin, but does not reduce the level of circulating? -endorphin. Oppresses the secretion of TSH and FSH.
PHARMACOKINETICS
In systemic use, it is metabolized mainly in the liver and partially in the kidneys. The main way of metabolism is 6 -? - hydroxylation. It is excreted by the kidneys.
INDICATIONS
Systemic application (i / m administration):
- hay fever;
- chronic obstructive airways diseases (eg, bronchial asthma, chronic spastic bronchitis), with severe forms and negative results of local treatment;
- skin diseases and contact dermatitis, characterized by itching, flaking or blistering, for example, contact dermatitis, pemphigoid, psoriasis, herpetiform dermatitis, atopic, exfoliative and eczematoid dermatitis.
Topical application:
Intra-articular administration:
- after systemic administration, for residual inflammatory processes in one or more joints in chronic inflammatory diseases of the joints;
- with exudative arthritis, gout and false gout;
- with active forms of arthrosis;
- with edema of joints;
- with blockade of the shoulder joint as a result of wrinkling of the joint bag;
- additionally with intra-articular injections of radionuclides or chemicals and with chronic inflammation of the inner layer of the joint capsule.
Introduction to the affected area
- with inflammation of the mucous bag, inflammation of the periosteum, as well as exostoses (cyst formations near the joints);
- with certain skin diseases, for example, with isolated psoriatic plaques, chronic simple lichen (limited neurodermatitis), ring-shaped granuloma, flat lichen, alopecia areata, discoid lupus erythematosus, and also in kelloids.
To administer to the area of ​​the lesion with inflammation of the tendon and tendon sheath, as well as in the epicondylitis of the shoulder ("tennis elbow"), Kenalog 10 mg / ml is recommended.
DOSING MODE
Before use, shake the contents of the ampoule. Kenalog 40 mg / ml is a suspension, so it should not be administered iv. Care should also be taken with regard to unintentional intravascular injections, especially to the left side of the face, the scalp, and also to the buttock.
Systemic application (w / m)
The dose is determined individually; it depends on the nature of the disease and should be consistent with the goals of the therapy.
In the systemic treatment of adults and adolescents over 16 years of age (see contraindications), 1 ml of the drug (= 40 mg) is injected slowly through a deep intramuscular injection. Do not enter iv and s. In severe cases, doses of up to 80 mg may be required. With deep intra-annual injection, the possible development of tissue atrophy should be avoided. After injection, it should be tightly pressed for 1-2 minutes with a sterile napkin to the injection site.
For the treatment of hay fever and other seasonal allergic diseases , one injection of the Kenalog 40 mg / ml per year during the pollen season is usually sufficient.
If several injections are necessary, the interval between injections should be at least 4 weeks.
Local application
With intraarticular administration, the dose is determined by the size of the joint and the severity of the symptoms.
Usually for adults and children over 12 years (see contraindications) the following doses of the drug are used:
Small joints (for example, phalanges of fingers and toes) - up to 10 mg.
Joints of medium size (for example, brachial, elbow) - 20 mg.
Large joints (for example, hip, knee) - 20-40 mg.
If several joints are affected, the total dose of the drug can be up to 80 mg. If you need to use smaller doses, you should use Kenalog 10 mg / ml. To ensure faster relief of symptoms, 40 mg / ml Kenalog can be administered in combination with a local anesthetic (not containing a vasoconstrictor). Injections should be carried out in such a way as to avoid the creation of a drug depot in the subcutaneous adipose tissue. When injecting, the conditions of the strictest aseptic should be observed.Before the intra-articular injection, the skin area is prepared, as before the surgical operations. Re-apply the drug should not be earlier than 2 weeks.
When intramuscular introduction with small lesions : inflammation of the mucous bag (bursitis), inflammation of the periosteum and exostoses, adults and children over the age of 12 years (see contraindications), depending on the size and localization of the treated lesions, administer up to 10 mg of the drug and in lesions of large size - from 10 to 40 mg of the drug. If it is necessary to use smaller doses, it is recommended to use Kenalog 10 mg / ml.
Kenalog 40 mg / ml diluted with saline solution of sodium chloride and fan-shaped enter into the area characterized by the greatest pain. You should avoid creating large depots of the drug. A canal of 40 mg / ml can also be mixed with a local anesthetic. In the treatment of exostosis, Kenalog 40 mg / ml is injected with a thick cannula after aspiration directly into the cyst space.
Repeat the drug should not be earlier than 2 weeks.
When injected into the area of ​​subcutaneous lesions, 1 ml of the drug at a concentration of 40 mg / ml is diluted with a local anesthetic that does not contain a vasoconstrictor and is mixed in a syringe. Injection is carried out horizontally into the area between the skin and the subcutaneous layer to ensure anesthesia of the infiltrate. As an indicative dose, 1 mg of the drug per 1 cm 2 of the skin surface is recommended. When treating several lesions in one dose, the daily dose of the drug to adults should not exceed 30 mg, and children (see contraindications) -10 mg. If it is necessary to use smaller doses of the drug, it is recommended to use Kenalog 10 mg / ml. With keloids, Kenalog 40 mg / ml can be directly introduced into the tissue of the rumen without dilution; do not enter s / k. Re-apply the drug should not be earlier than 2 weeks.
The duration of the drug depends on the nature and severity of the disease and is determined by the doctor. It varies from a single intravenous administration of hay fever to a course that lasts for several years, for example, in severe forms of bronchial asthma. If after 3-5 local injections (intra-articular, intramuscular injections, injections into the area of ​​subcutaneous lesions) there is no satisfactory response, the drug should be withdrawn and another form of treatment should be prescribed.
SIDE EFFECT
In rare cases, irrespective of the nature and frequency of the drug, there are reactions of increased sensitivity, for example, redness (flushes), formation of skin blisters, disturbance of cardiac activity and blood circulation, caused, incl. and the presence of benzyl alcohol in the preparation.
When repeated injections into the subcutaneous adipose tissue at a location near the site of the previous injection, tissue atrophy can occur, which is usually reversible.
After intraarticular injections , aseptic necrosis of bone tissue (head of the hip and humerus), as well as a sensation of fever, may be observed; in some cases, the appearance of a transitory painful irritation at the site of injection.
With repeated topical application , skin tightening, thinning of the skin, widening of small skin vessels, steroid acne, skin blisters, increased hair growth, inflammation of hair follicles, changes in pigmentation and inflammation of the skin around the mouth can be observed.
With systemic or repeated topical application, there may be side effects characteristic of systemic treatment with glucocorticoids: full-moon face syndrome, Cushing's syndrome, muscle weakness, muscular atrophy, bone tissue atrophy, decreased glucose tolerance, diabetes mellitus (impairment of compensation with existing diabetes mellitus or activation of latent diabetes mellitus), violation of the secretion of sex hormones (menstrual disorder, increased hair growth, impotence), changes in skin, for example (striae rubrae), bleeding on the skin and mucous membranes (petechien, ekchymosen), steroid acne, increased release of potassium, functional suppression or adrenal atrophy, inflammatory processes in the vessels (vasculitis, withdrawal syndrome after prolonged therapy), ulcerative inflammation of the mucosa Gastrointestinal ulcer, stomach ulcer, suppression of immunity and increased risk of infections, slowing healing of wounds and bone fractures, rupture of tendons, growth disorders in children, aseptic necrosis of bone tissue (head of hip or shoulder ti), headaches, sweating, dizziness, increased intracranial pressure, accompanied by symptoms of congestive nipple optic nerve, glaucoma, cataracts, mental disorders, increasing the risk of thrombosis, pancreatitis.
Such side effects of corticoids, such as weight gain, water retention in the body and increased blood pressure, are usually not observed after the use of the Kenalog preparation. Nevertheless, when taking the drug, medical supervision is recommended.
CONTRAINDICATIONS
For topical application:
- chickenpox;
- conditions after immunization;
- skin lesions of a tuberculous or syphilitic nature;
- fungal diseases;
- bacterial skin lesions;
- inflammation of the skin around the mouth (rosacea).
Kenalog 40 mg / ml not to enter intraarticularly if there is an infection nearby.
When systemic or repeated topical application of the drug should take into account the following contraindications for the systemic use of glucocorticoids:
Absolute contraindications:
- Ulcer of the stomach and duodenum;
- severe condition of bone atrophy;
- mental illness in the medical history;
- viral diseases, for example herpetic pemphigus (herpes simplex), herpes zoster (viremic phase), chicken pox;
- infections caused by amoeba;
- fungal infections of internal organs;
- poliomyelitis of childhood, with the exception of the bulbar-encephalitis form;
- depending on the specific situation, at the time from 8 weeks before the vaccination to 2 weeks after vaccination;
- glaucoma.
Use in severe infections only in conjunction with causal therapy.
Kenalog 40 mg / ml should not be used in / m in children under 12 years of age and in adolescents under 16 years.
Relative contraindications
Care should be taken with gastric and duodenal ulcers in the history of the disease, with severe muscle diseases, diverticulitis, fresh intestinal anastomoses, with a tendency to thrombosis and embolism, with carcinomas with a tendency to metastasis, diabetes mellitus (see side effects), acute glomerulonephritis, with chronic nephritis, swelling of the lymph nodes in the post-immunization period BCG.
In the treatment of corticosteroids, activation of the tuberculosis process can occur.
In children (see above) Kenalog 40 mg / ml apply only when absolutely necessary.
PREGNANCY AND LACTATION
Do not use Kenalog during the first 5 months of pregnancy, because animal studies indicate a teratogenic effect (the appearance of fetal anomalies), and there are no safety data for the drug during pregnancy. With prolonged use of the drug can not exclude the violation of fetal growth inside the uterus. When using the drug at the end of pregnancy, there is a risk of atrophy of the adrenal glands of the fetus.
Glucocorticoids pass into breast milk, so breast-feeding during treatment with the drug should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
Be careful with acute glomerulonephritis, with chronic nephritis.
APPLICATION FOR CHILDREN
Kenalog 40 mg / ml should not be used in / m in children under 12 years of age and in adolescents under 16 years.
SPECIAL INSTRUCTIONS
At systemic treatment by a preparation it is recommended to appoint or nominate the diet enriched with fibers and vitamins.
For intramuscular administration in the treatment of tendons, inflammation of the tendon sheath and "tennis elbow," it is recommended to use Kenalog 10 mg / ml.
When re-applying the drug, the intervals between injections should be observed and, if necessary, the intervals between injections should be increased.
DRUG INTERACTION
In systemic or repeated local application, it is necessary to take into account the interactions characteristic of systemic therapy with glucocorticoids, which can weaken the hypoglycemic effect of antidiabetic drugs and the anticoagulant effect of coumarin derivatives.
With the simultaneous use of the drug with cardiac glycosides, there may be an intensification of their action; when combined with saluretics, the release of potassium from the body may increase.
Simultaneous use with NSAIDs or antirheumatic drugs may contribute to the development of gastrointestinal bleeding.
With simultaneous administration with rifampicin, the corticoid effect of the drug may be weakened.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Keep in a dark place. Do not freeze. Keep out of the reach of children. The drug should not be used after the expiry date indicated on the package.
