Dexamethasone storage after opening

Indications for use

The use of Dexamethasone is indicated for replacement therapy of adrenal insufficiency, including acute or relative, primary and secondary, as well as those that developed after withdrawal of glucocorticosteroids (GCS).

According to the instructions, Dexamethasone can also be included in the regimen of pathogenetic and symptomatic therapy for:

• Diseases of an allergic nature;
• Systemic connective tissue diseases;
• Lung diseases (including sarcoidosis, aspiration pneumonitis, etc.);
• Hematological diseases (including idiopathic thrombocytopenic purpura in adults and acute leukemia in children);
• Joint diseases (including osteoarthritis or rheumatoid arthritis);
• Dermatological diseases (including neutrophilic, contact, exfoliative dermatitis; erythema multiforme, toxic epidermal necrolysis, etc.);
• Diseases of the digestive tract (including Crohn's disease, ulcerative colitis);
• Edema syndrome;
• Ophthalmological diseases;
• Metabolic disorders (including hyperkalemia caused by a malignant tumor);
• Infantile spasms.

As part of combination therapy, Dexamethasone is used for shock of various origins.

In combination with antimicrobial agents, the drug is often used for infectious diseases.

Systemic use of Dexamethasone is also indicated for premedication before surgery, as well as as a maintenance agent after surgery if adrenal insufficiency is suspected.

DEXAMETHASONE (Solution for injection)

Drug: DEXAMETHASONE

Active substance: dexamethasone ATC code: H02AB02 CG: GCS for injection ICD-10 codes (indications): D59, D69.3, D70, E06, E25, E27.1, E27.2, E27.4, G93.6, H01 .0, H10, H10.1, H10.5, H15.0, H15.1, H16, H16.2, H20.0, H20.1, H30, H44.1, J44, J45, J46, L20.8 , L21, L40, L50, L51.1, L51.2, L91.0, L93.0, M05, M07, M08, M30, M31, M32, M33, M34, M35, R57, R57.0, R57.8 , T78.2, T78.3, T79.4, Z51.5 Reg. number: P N014442/01-2002 Registration date: 11/18/08 Owner reg. credential: SHREYA LIFE SCIENCES (India)

DOSAGE FORM, COMPOSITION AND PACKAGING

The solution for injection is clear, colorless or pale yellow.

Excipients: methylparaben, propylparaben, sodium metabisulfite, disodium edetate, sodium hydroxide, water for injection.

1 ml - dark glass ampoules (25) - cardboard boxes.

1 ml - dark glass bottles (25) - cardboard boxes.

The solution for injection is clear, colorless or pale yellow.

Excipients: methylparaben, propylparaben, sodium metabisulfite, disodium edetate, sodium hydroxide, water for injection.

2 ml - dark glass ampoules (25) - cardboard boxes.

2 ml - dark glass bottles (25) - cardboard boxes.
INSTRUCTIONS FOR USE FOR SPECIALISTS.
The description of the drug was approved by the manufacturer in 2009. PHARMACOLOGICAL ACTION

Synthetic glucocorticoid (GCS), a methylated derivative of fluoroprednisolone. It has anti-inflammatory, antiallergic, immunosuppressive effects, increases the sensitivity of beta-adrenergic receptors to endogenous catecholamines.

Interacts with specific cytoplasmic receptors (receptors for GCS are present in all tissues, especially in the liver) to form a complex that induces the formation of proteins (including enzymes that regulate vital processes in cells.)

Protein metabolism: reduces the amount of globulins in plasma, increases albumin synthesis in the liver and kidneys (with an increase in the albumin/globulin ratio), reduces synthesis and increases protein catabolism in muscle tissue.

Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (fat accumulation occurs mainly in the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase (increasing the flow of glucose from the liver into the blood); increases the activity of phosphoenolpyruvate carboxylase and the synthesis of aminotransferases (activation of gluconeogenesis); promotes the development of hyperglycemia.

Water-electrolyte metabolism: retains Na+ and water in the body, stimulates the excretion of K+ (mineralocorticoid activity), reduces the absorption of Ca+ from the gastrointestinal tract, reduces bone mineralization.

The anti-inflammatory effect is associated with inhibition of the release of inflammatory mediators by eosinophils and mast cells; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in capillary permeability; stabilization of cell membranes (especially lysosomal) and organelle membranes. Acts on all stages of the inflammatory process: inhibits the synthesis of prostaglandins (Pg) at the level of arachidonic acid (lipocortin inhibits phospholipase A2, suppresses the liberation of arachidonic acid and inhibits the biosynthesis of endoperoxides, leukotrienes, which contribute to inflammation, allergies, etc.), the synthesis of “proinflammatory cytokines” ( interleukin 1, tumor necrosis factor alpha, etc.); increases the resistance of the cell membrane to the action of various damaging factors.

The immunosuppressive effect is caused by the involution of lymphoid tissue, inhibition of the proliferation of lymphocytes (especially T-lymphocytes), suppression of the migration of B cells and the interaction of T and B lymphocytes, inhibition of the release of cytokines (interleukin-1, 2; interferon gamma) from lymphocytes and macrophages and decreased antibody formation.

The antiallergic effect develops as a result of a decrease in the synthesis and secretion of allergy mediators, inhibition of the release of histamine and other biologically active substances from sensitized mast cells and basophils, a decrease in the number of circulating basophils, T- and B-lymphocytes, mast cells; suppressing the development of lymphoid and connective tissue, reducing the sensitivity of effector cells to allergy mediators, inhibiting antibody formation, changing the body's immune response.

In obstructive diseases of the respiratory tract, the effect is due mainly to inhibition of inflammatory processes, prevention or reduction of the severity of swelling of the mucous membranes, reduction of eosinophilic infiltration of the submucosal layer of the bronchial epithelium and deposition of circulating immune complexes in the bronchial mucosa, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of beta-adrenergic receptors of small and medium-sized bronchi to endogenous catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus by reducing its production.

Suppresses the synthesis and secretion of ACTH and, secondarily, the synthesis of endogenous corticosteroids.

Inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

The peculiarity of the action is significant inhibition of pituitary function and the almost complete absence of mineralocorticosteroid activity.

Doses of 1-1.5 mg/day inhibit the function of the adrenal cortex; biological half-life is 32-72 hours (duration of inhibition of the hypothalamus-pituitary-adrenal cortex system).

In terms of the strength of glucocorticoid activity, 0.5 mg of dexamethasone corresponds to approximately 3.5 mg of prednisone (or prednisolone), 15 mg of hydrocortisone or 17.5 mg of cortisone.

PHARMACOKINETICS

Dexamethasone in the blood binds (60-70%) to a specific carrier protein - transcortin. Easily passes through histohematic barriers (including blood-brain and placental barriers).

Metabolized in the liver (mainly by conjugation with glucuronic and sulfuric acids) to inactive metabolites.

Excreted by the kidneys (a small part by the lactating glands). T1/2 of dexamethasone from plasma - 3-5 hours.

INDICATIONS

Diseases requiring the administration of fast-acting corticosteroids, as well as cases when oral administration of the drug is impossible:

- endocrine diseases: acute adrenal insufficiency, primary or secondary adrenal insufficiency, congenital adrenal hyperplasia, subacute thyroiditis;

— shock (burn, traumatic, surgical, toxic) — in case of ineffectiveness of vasoconstrictors, plasma replacement drugs and other symptomatic therapy;

- cerebral edema (with a brain tumor, traumatic brain injury, neurosurgical intervention, cerebral hemorrhage, encephalitis, meningitis, radiation injury);

— asthmatic status; severe bronchospasm (exacerbation of bronchial asthma, chronic obstructive bronchitis);

- severe allergic reactions, anaphylactic shock;

- rheumatic diseases;

- systemic connective tissue diseases;

- acute severe dermatoses;

— malignant diseases: palliative treatment of leukemia and lymphoma in adult patients; acute leukemia in children; hypercalcemia in patients suffering from malignant tumors when oral treatment is not possible;

- blood diseases: acute hemolytic anemia, agranulocytosis, idiopathic thrombocytopenic purpura in adults;

- severe infectious diseases (in combination with antibiotics);

- in ophthalmological practice (subconjunctival, retrobulbar or parabulbar administration): allergic conjunctivitis, keratitis, keratoconjunctivitis without damage to the epithelium, iritis, iridocyclitis, blepharitis, blepharoconjunctivitis, scleritis, episcleritis, inflammatory process after eye injuries and surgical interventions, sympathetic ophthalmia, immunosuppressive treatment after corneal transplantation;

— local application (in the area of ​​pathological formation): keloids, discoid lupus erythematosus, granuloma annulare.

DOSING REGIME

The dosage regimen is individual and depends on the indications, the patient’s condition and his response to therapy. The drug is administered intravenously in a slow stream or drip (for acute and emergency conditions); i/m; local (into the pathological formation) administration is also possible. To prepare a solution for intravenous drip infusion, you should use an isotonic sodium chloride solution or a 5% dextrose solution.

In the acute period for various diseases and at the beginning of therapy, Dexamethasone is used in higher doses. During the day, you can administer from 4 to 20 mg of Dexamethasone 3-4 times.

Doses of Dexamethasone for children (i.m.):

The dose of the drug during replacement therapy (for adrenal insufficiency) is 0.0233 mg/kg body weight or 0.67 mg/m2 body surface area, divided into 3 doses, every 3rd day or 0.00776 - 0.01165 mg/kg body weight or 0.233 - 0.335 mg/m2 body surface area daily. For other indications, the recommended dose is from 0.02776 to 0.16665 mg/kg body weight or 0.833 to 5 mg/m2 body surface area every 12-24 hours.

When the effect is achieved, the dose is reduced to maintenance or until treatment is stopped. The duration of parenteral use is usually 3-4 days, then they switch to maintenance therapy with dexamethasone tablets.

Long-term use of high doses of the drug requires a gradual dose reduction in order to prevent the development of acute adrenal insufficiency.

SIDE EFFECTS of Dexamethasone

Dexamethasone is usually well tolerated. It has low mineralocorticoid activity, i.e. its effect on water-electrolyte metabolism is small. As a rule, low and medium doses of Dexamethasone do not cause sodium and water retention in the body or increased potassium excretion. The following side effects are described:

From the endocrine system: decreased glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing syndrome (moon-shaped face, pituitary-type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, muscle weakness, stretch marks) , delayed sexual development in children.

From the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenum, erosive esophagitis, gastrointestinal bleeding and perforation of the wall of the gastrointestinal tract, increased or decreased appetite, indigestion, flatulence, hiccups. In rare cases, increased activity of liver transaminases and alkaline phosphatase.

From the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed patients) or increased severity of heart failure, changes in the electrocardiogram characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle.

From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor of the cerebellum, headache, convulsions.

From the senses: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos, sudden loss of vision (with parenteral administration in the head, neck, nasal shells, scalp, deposition of drug crystals in the vessels of the eye is possible).

From the metabolic side: increased excretion of calcium, hypocalcemia, increased body weight, negative nitrogen balance (increased breakdown of proteins), increased sweating.

Caused by mineralocorticoid activity - fluid and sodium retention (peripheral edema), hypsarnatremia, hypokalemia syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the musculoskeletal system: slowing of growth and ossification processes in children (premature closure of the epiphyseal growth plates), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), rupture of muscle tendons, steroid myopathy, decreased muscle mass (atrophy).

From the skin and mucous membranes: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to develop pyoderma and candidiasis.

Allergic reactions: skin rash, itching, anaphylactic shock, local allergic reactions.

Local for parenteral administration: burning, numbness, pain, tingling at the injection site, infection at the injection site, rarely - necrosis of surrounding tissues, scarring at the injection site; atrophy of the skin and subcutaneous tissue with intramuscular injection (injection into the deltoid muscle is especially dangerous).

Other: development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, “flushing” of blood to the face, syndrome of “slow” acetylators), which leads to a decrease in their plasma concentrations.

Carbonic anhydrase inhibitors and loop diuretics may increase the risk of osteoporosis.

Indomethacin, displacing dexamethasone from its association with albumin, increases the risk of developing its side effects.

ACTH enhances the effect of dexamethasone.

Ergocalciferol and parathyroid hormone prevent the development of osteopathy caused by dexamethasone.

Cyclosporine and ketoconazole, by slowing down the metabolism of dexamethasone, can in some cases increase its toxicity.

The simultaneous administration of androgens and steroidal anabolic drugs with dexamethasone promotes the development of peripheral edema and hirsutism, and the appearance of acne.

Estrogens and oral contraceptives containing estrogen reduce the clearance of dexamethasone, which may be accompanied by an increase in the severity of its action.

Mitotane and other inhibitors of adrenal function may necessitate an increase in the dose of dexamethasone.

When used simultaneously with live antiviral vaccines and against the background of other types of immunization, it increases the risk of viral activation and the development of infections.

Antipsychotics (neuroleptics) and azathioprine increase the risk of developing cataracts when dexamethasone is prescribed.

When used simultaneously with antithyroid drugs, the clearance of dexamethasone decreases and with thyroid hormones increases.

CONDITIONS OF VACATION FROM PHARMACIES

The drug is available with a prescription.

Price - 107 rubles BUY

CONDITIONS AND DURATION OF STORAGE

List B. Store at a temperature not exceeding 25°C out of the reach of children. Do not freeze. Shelf life: 3 years. Do not use after the expiration date stated on the package.

Contraindications

If the drug is used for a short period of time and for health reasons, the only contraindication to the use of Dexamethasone is hypersensitivity to its components.

Dexamethasone should be prescribed with caution:

• In case of infectious and parasitic diseases caused by viruses, fungi or bacteria (current or recently suffered, including recent contacts with a sick person);
• In the period before vaccination (8 weeks before vaccination), as well as in the post-vaccination period (14 days after immunization);
• For lymphadenitis that developed due to the administration of the BCG vaccine;
• Patients with immunodeficiency conditions, including AIDS and HIV infection;
• For diseases of the digestive tract;
• People with heart and vascular diseases, including recent myocardial infarction, decompensated chronic heart failure, hyperlipidemia, arterial hypertension;
• For endocrine diseases, including thyrotoxicosis, hypothyroidism, impaired glucose tolerance, diabetes mellitus, Itsenko-Cushing's disease;
• Patients with nephrourolithiasis;
• In severe forms of functional failure of the kidneys and/or liver;
• With hypoalbuminemia, as well as with conditions predisposing to its development.

Other conditions that require careful use of Dexamethasone include acute psychosis, systemic osteoporosis, grade 3 and 4 obesity, myasthenia gravis, poliomyelitis, glaucoma (both open-angle and closed-angle), and lactation.

Special monitoring is necessary for patients with heart failure, arterial hypertension, tuberculosis, osteoporosis, liver/renal failure, active peptic ulcers, diabetes mellitus, and epilepsy.

In children and adolescents, Dexamethasone is used only for health reasons under strict control of their growth and development.

Is it possible to use an expired drug?

This medication maintains its quality for the entire time indicated on the package. If the storage rules are followed, it can be used without fear even 2 - 3 days before the expiration of the time specified by the manufacturer.

If medications have been stored incorrectly, are past their expiration date, or have been damaged in packaging, their continued use may be hazardous. Or, at a minimum, ineffective in cases where urgent help is required (for example, with pulmonary edema).

Do not use an injection solution in which a precipitate has formed, cloudiness or a change in odor has occurred.

If the storage of deximethasone tablets was incorrect or the protective shells were damaged, they cannot be used for treatment.

The doctor must make all appointments and calculate the dosage of the drug. Self-medication or uncontrolled use of medications can cause serious harm to health. Especially in the presence of concomitant chronic diseases.

Directions for use and dosage

According to the instructions for Dexamethasone, the dose of the drug is selected individually depending on the characteristics of the clinical situation. For children, the dosage is calculated based on their weight. The method of use of the drug depends on the patient’s condition and indications.

In the acute period of disease development, as well as in the initial stages of treatment, the use of increased doses of Dexamethasone is indicated. After the therapeutic effect is achieved, the dose is gradually (usually 0.5 mg every 3 days) reduced to an effective maintenance dosage or until the drug is completely discontinued.

The duration of treatment is determined by the nature of the pathological process and the effectiveness of therapy. It can range from several days to several months. The course of therapy is stopped gradually, at the end it is recommended to give the patient several injections of corticotropin.

Dexamethasone tablets are taken orally, the daily dose is divided into 2-4 doses. The solution is administered slowly intravenously (drip or jet) or intramuscularly. Before IV infusion, Dexamethasone is diluted with 0.9% NaCl solution or 5% dextrose solution. The daily dose is divided into 3-4 injections.

Gastrointestinal tract and respiratory system

According to the instructions for use, the Dexamethasone solution shows a good effect in ulcerative colitis in the acute phase of the disease. The drug is prescribed to relieve attacks of Crohn's disease and, if necessary, to select components of a complex course for autoimmune hepatitis in the form of a chronicle. If a person has undergone a liver transplant, Dexamethasone is indicated as a means of preventing organ rejection.

For symptomatic treatment, Dexamethasone is used for sarcoidosis and acute bronchiolitis, accompanied by manifestations of poisoning. The drug is indicated for asthmatics and people with chronic bronchitis - it is prescribed during an exacerbation. Instructions for use Dexamethasone solution is recommended to combat pulmonary tuberculosis if the disease has caused exceptional weakness of the patient. The drug is combined with the classical course of treatment of the disease. It is allowed to use "Dexamethasone" in the treatment of granulomatous inflammatory processes and in case of pneumonitis of radiation nature, aspiration type.

Release form

Composition of Dexamethasone in ampoules: Dexamethasone sodium phosphate (4 mg/ml), glycerin, propylene glycol, disodium edetate, phosphate buffer solution (7.5 pH), methyl and propyl parahydroxybenzoate, water for injection.

Dexamethasone tablets contain 0.5 mg of the active substance, as well as lactose in the form of monohydrate, MCC, colloidal anhydrous silicon dioxide, magnesium stearate, croscarmellose sodium.

Dexamethasone eye drops: Dexamethasone sodium phosphate (1 mg/ml), boric acid, benzalkonium chloride (preservative), sodium tetraborate, Trilon B, water d/i.

• Dexamethasone eye drops 0.1% (ATC code S01BA01; 5 and 10 ml bottles).
• Tablets 0.5 mg (package No. 50).
• Injection solution 0.4% (ampoules 1 and 2 ml).

Dexamethasone is produced in different forms:

1. Pills. The concentration of the active substance is 0.5 mg. Additionally, the composition includes magnesium stearate, anhydrous colloidal silicon dioxide, MCC, lactose monohydrate, croscarmellose sodium. The shape is round and flat, the color is white, the surface is scored and chamfered. Packaging: one package contains 10 tablets.
2. Injection. The active substance content in 1 ml is 4 mg, auxiliary components: disodium edetate, glycerin, water, phosphate buffer solution, propylene glycol, methyl, propyl parahydroxybenzoate. Packaging: in one package of 5, 25 ampoules.
3. Eye drops (additionally used for ears). 1 ml of liquid contains 1 mg of active substance. Other ingredients: boric acid, Trilon B, sodium tetraborate, benzalkonium chloride, water.
4. Eye ointment. Ingredients: dexamethasone – 0.1%, liquid anhydrous lanolin, petroleum jelly, propyl parahydroxybenzoate, methyl parahydroxybenzoate. The ointment is white in color without a specific odor, packaged in aluminum tubes of 3.5 grams.