DEXAKEL 02 (Dexamethasone) injection solution (50 ml) Kela
I. General information
Name of the drug: Dexakel 02 (Dexakelum 02).
1.0 cm3 of the drug contains 2.64 mg of dexamethasone sodium phosphate (equivalent to 2 mg of dexamethasone); sodium EDTA, sodium citrate, sodium methyl parahydroxybenzoate, N-methylpyrrolidone, hydrochloric acid, water for injection.
The drug is a clear, colorless, odorless solution.
Dexakel 02 is produced in dark glass bottles with a nominal volume of 50.0 cm3.
The drug is stored with caution (list B) at temperatures from 2 ° C to 8 ° C in dry, protected from sunlight, out of reach of children.
Shelf life 4 years from the date of manufacture.
II. Pharmacological properties
Dexamethasone is a synthetic analogue of the glucocorticosteroid hormone of the adrenal cortex – cortisol (hydrocortisone). It has anti-inflammatory, anti-allergic, desensitizing, immunosuppressive, anti-shock and anti-toxic effects. Mineralocorticoid effect is negligible.
Dexamethasone inhibits all phases of inflammation. It inhibits phospholipase-A2, thereby disrupting the formation of prostaglandins and leukotrienes. In addition, dexamethasone stabilizes cell membranes, lysosomal membranes, reduces capillary permeability, inhibits the migration of neutrophils and macrophages to the inflammatory focus and their phagocytic activity, inhibits the proliferation of fibroblasts and the formation of collagen and cytokines. It also inhibits the synthesis and disrupts the kinetics of T-lymphocytes, reduces their cytotoxic activity. Dexamethasone has a counterinsular effect (stimulates gluconeogenesis in the liver, reduces membrane permeability for glucose, causes hyperglycemia and glucosuria).
Aqueous solutions of dexamethasone are rapidly absorbed when administered intramuscularly or subcutaneously. Its maximum plasma concentrations are reached 30 minutes after administration. Dexamethasone is well distributed throughout the body. The pharmacological action lasts for 2-4 days.
Dexamethasone is metabolized in the liver, partially forming conjugates with glucuronic acid. It is excreted in the urine, in small quantities – with feces.
III. The procedure for using the drug
Dexakel 02 is used for non-infectious acute inflammatory processes in the musculoskeletal system (for arthritis, periarthritis, tendovaginitis, bursitis, dislocations, myositis, bruises); acute infectious diseases (in addition to etiotropic therapy); allergic conditions (asthma, allergic skin lesions, snake bites); metabolic disorders (ketosis in cattle and toxemia of pregnant women in sheep); for the artificial induction of labor in ruminants in the last stages of pregnancy; in shock and stress conditions (collapse, anaphylaxis, trauma).
Dexakel 02 is administered intramuscularly, intraarticularly; Subcutaneous administration is allowed in dogs. Intravenous administration of the drug is used in the treatment of shock conditions.
Dexakel dosages
As an anti-inflammatory and antiallergic agent:
dogs: 0.25-0.5 ml of the drug / 5 kg of body weight (0.1-0.2 mg of dexamethasone / kg of body weight);
horses, cattle: 5-10 ml of the drug / 400 kg of body weight (2.5-5 mg of dexamethasone / 100 kg of body weight);
calves, sheep, goats: 1-2 ml of the drug / 50 kg of body weight (2-4 mg of dexamethasone / 50 kg of body weight).
If necessary, the introduction can be repeated after 2 days in dogs, after 3-4 days in other animals.
Artificial induction of labor in cows (applied within one week before delivery): 2.5 ml of the drug / 100 kg of body weight (5 mg of dexamethasone / 100 kg of body weight).
Postpartum toxemia and induced labor in sheep and goats: 6 ml of the drug / 50 kg of body weight (2.5 mg of dexamethasone / 10 kg of body weight).
In case of shock: slow intravenous administration of a tenfold anti-inflammatory dose; can be repeated after 8-12 hours.
Intra-articular administration: based on the affected area and the weight of the animal – 0.25-4 ml.
Side effects of Dexakel: immunosuppression, when used in the last trimester of pregnancy – premature birth, accompanied by retention of the placenta, stillbirth, low birth weight; with intra-articular administration – degenerative changes in cartilage and synovial fluid. In ruminants, skin reactions, hemorrhages, decreased milk production are possible; in dogs (rarely), colon perforation. With prolonged use of the drug, symptoms of hypercortisolism (Cushing’s syndrome) may occur; with an abrupt cessation of therapy – symptoms of hypocorticism.
Measures to prevent unwanted effects: long-term use of the drug, if possible, should be interrupted by periods of rest. Discontinue therapy gradually. Before intra-articular injection, it is necessary to remove synovial fluid from the joint in a volume equal to the volume of the injected drug.
If side effects occur, if possible, a gradual reduction in the dose of the drug is carried out and its use is stopped. The use of the drug can be continued with a mild manifestation of side effects with the simultaneous appointment of symptomatic therapy (antihypertensive or sedative drugs, potassium and calcium preparations, diuretics, antibiotics). With a more severe manifestation of side effects, the appointment of the drug is canceled.
Contraindications: diabetes, hyperadrenocorticism (Cushing’s syndrome), osteoporosis, renal and heart failure, pregnancy (except in cases of desired induction of labor in ruminants), viral diseases, epilepsy. Simultaneous administration of the drug with vaccines is prohibited.
Interaction with other drugs: antihistamines and barbiturates reduce the activity of dexamethasone; estrogens – prolong its action; interaction with furosemide enhances hypokalemia. Dexamethasone reduces the concentration of salicylates in the blood, reduces the time of anesthesia caused by barbiturates.
It is forbidden to use milk for food purposes during the period of treatment with the drug and within 2 days (6 milking) after its last use.
Slaughter of animals for meat is allowed no earlier than 14 days after the last injection of the drug. In the case of forced slaughter before the expiry of the waiting period, animal meat can be used as feed for carnivores.
IV. Personal precautions
When working with the drug, you should follow the generally accepted rules of personal hygiene and safety precautions.
In case of complications after using the drug, its use is stopped, and the consumer contacts the state veterinary institution in the territory of which he is located. Veterinary specialists of this institution are studying compliance with all rules for the use of the drug in accordance with the instructions. Upon confirmation of the detection of a negative effect of the drug on the animal’s body, veterinary specialists take samples in the required amount (at least 3 unopened vials of the drug from the batch that caused complications) for laboratory tests, a sampling report is written and sent to the State Institution “Belarusian State Veterinary center “for confirmation of compliance with regulatory documents.