Celeston - description of the drug, instructions for use, reviews

Reviews: 0

Manufacturers: Schering-Plough Ltd (UK)

Active ingredients

• Betamethasone

Disease class

• Anemia due to enzyme disorders
• Acquired pure red cell aplasia (erythroblastopenia)
• Other anemias
• Thrombocytopenia, unspecified
• Thyroiditis
• Bacterial meningitis, not elsewhere classified
• Brain swelling
• Acute atopic conjunctivitis
• Keratitis
• Corneal ulcer
• Iridocyclitis
• Chorioretinal inflammation
• Optic neuritis
• Rheumatic diseases of the mitral valve
• Other and unspecified adrenal insufficiency
• Vasomotor and allergic rhinitis
• Chronic rhinitis, nasopharyngitis and pharyngitis
• Mycosis fungoides
• Other unspecified types of non-Hodgkin's lymphoma
• Emphysema
• Asthma
• Leukemia of unspecified cell type
• Ulcerative colitis
• Pemphigus [pemphigus]
• Atopic dermatitis
• Allergic contact dermatitis
• Pyogenic arthritis
• Exfoliative dermatitis
• Erythematous diaper rash
• Psoriasis
• Hives
• Erythema multiforme
• Seropositive rheumatoid arthritis
• Gout
• Systemic lupus erythematosus
• Dermatopolymyositis
• Systemic sclerosis
• Ankylosing spondylitis
• Synovitis and tenosynovitis
• Other bursopathies
• Enthesopathy, unspecified
• Rheumatism, unspecified
• Neuralgia and neuritis, unspecified
• Respiratory distress in the newborn [distress]
• Fever of unknown origin
• Shock, not elsewhere classified
• Other specified general symptoms and signs
• Meningococcal infection
• Shingles
• Shock during or after procedure, not elsewhere classified
• Death and rejection of transplanted organs and tissues
• Traumatic shock
• Allergy unspecified
• Calcium metabolism disorders

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Anti-inflammatory
• Antipruritic
• Antiallergic

Pharmacological group

• Glucocorticoids

Pharmacological properties of the drug Celeston

Pharmacodynamics. Betamethasone is a synthetic glucocorticoid drug for systemic use. Betamethasone, a synthetic derivative of prednisolone, has a pronounced anti-inflammatory, antirheumatic and antiallergic effect, modifies the body's immune responses in the treatment of diseases that respond to corticosteroid therapy. Betamethasone has high GCS activity and weak mineralocorticoid effect. Pharmacokinetics. Betamethasone is rapidly absorbed into the blood (detected in the blood 20 minutes after oral administration). The maximum concentration in blood plasma is achieved 1 hour after injection and 2 hours after oral administration, gradually decreasing over 24 hours. Biotransformed in the liver. The half-life after taking a single dose ranges from 180–220 minutes to 300 minutes or more. In patients with liver disease, the clearance of betamethasone is slower. According to studies, clinical effectiveness depends more on the level of the unbound fraction of the corticosteroid than on the total plasma concentration. There is no relationship between the level of GCS in the blood plasma and the duration of the therapeutic effect. The half-life is 36–54 hours. It penetrates the placental, blood-brain barrier and other histohematic barriers and is excreted in breast milk. Binding to plasma proteins is significant. Excreted by the kidneys. After parenteral administration, betamethasone is rapidly absorbed at the injection site. The maximum concentration in blood plasma is reached after 1 hour. Betamethasone is almost completely eliminated within 24 hours. Biotransformed in the liver. The half-life is ≥300 min. In patients with liver disease, the clearance of betamethasone is slow. Binding to plasma proteins is significant. As a result of studies, it has been established that clinical effectiveness depends more on the level of the unbound fraction of GCS than on the total plasma concentration. There is no connection between the level of corticosteroid in the blood plasma and the duration of the therapeutic effect.

Advantages

• The drugs dissolve very slowly, up to 12 months.
• They have a local effect on all joint tissues.
• Almost do not enter the systemic circulation and do not affect the functioning of internal organs.
• Thanks to the previous point, they can be used in patients with severe concomitant pathologies, when treatment with other methods is unacceptable.
• Intra-articular injections help avoid surgery.
• After the procedure, no rehabilitation is required; the doctor can only apply a tight bandage and warn against excessive physical exertion.

Indications for use of the drug Celeston

Use of Celeston in tablet form Diseases sensitive to GCS therapy. As a rule, as part of complex therapy for the following diseases. Endocrine disorders: primary or secondary adrenal insufficiency, congenital adrenal hyperplasia; non-purulent thyroiditis; hypercalcemia in cancer (associated with a tumor). Diseases of the musculoskeletal system: as an adjuvant therapy for short-term use in psoriatic arthritis, rheumatoid arthritis (in some cases), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tendovaginitis, gouty arthritis, acute rheumatic fever and synovitis. Collagenoses: during an exacerbation of the disease or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis, scleroderma or dermatomyositis. Dermatological diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), urticaria, exfoliative dermatitis, severe psoriasis, ringworm, allergic eczema (chronic dermatitis). Allergic conditions: severe allergic conditions that do not respond to adequate therapy, such as seasonal and perennial allergic rhinitis, nasal polyps, asthma (including status asthmaticus), contact dermatitis, atopic dermatitis (neurodermatitis), allergic reactions to drugs or serum transfusions blood. Ophthalmological diseases: severe acute and chronic allergic and inflammatory processes of the eyes, such as allergic conjunctivitis, keratitis, allergic marginal corneal ulcers, herpetic eye lesions, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, central retinitis and retrobulbar neuritis . Respiratory diseases: symptomatic sarcoidosis, Lefler's syndrome, berylliosis, pulmonary fibrosis, fulminant and disseminated pulmonary tuberculosis (as an additional therapy in the course of anti-tuberculosis therapy), pulmonary emphysema, pneumofibrosis. Hematological diseases: idiopathic or secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, erythroid hypoplastic anemia, transfusion reactions. Tumor diseases: palliative treatment of leukemia and lymphomas in adults and acute leukemia in children. Edema syndrome: to increase diuresis or eliminate proteinuria in nephrotic syndrome without idiopathic uremia or lupus erythematosus, angioedema. Other diseases: tuberculous meningitis with subarachnoid blockade due to the use of anti-tuberculosis chemotherapy, ulcerative colitis, Bell's palsy. Indications for the use of Celeston in the form of an injection solution: as a concomitant therapy for diseases and syndromes that require a rapid and pronounced therapeutic effect. Endocrine disorders: primary or secondary insufficiency of the adrenal cortex; acute adrenal insufficiency, preoperative supportive therapy (as well as in cases of injury or severe illness) in persons with known or suspected adrenal insufficiency; shock that is not amenable to standard effects, if adrenal insufficiency is suspected; bilateral adrenectomy; congenital adrenal hyperplasia; acute non-purulent thyroiditis and thyrotoxic crisis; hypercalcemia in malignant tumors. Diseases of the musculoskeletal system (for short-term use) : rheumatoid arthritis, osteoarthritis, psoriatic arthritis, ankylosing spondylitis, acute gouty arthritis, acute and subacute bursitis, acute rheumatic attack, fibrositis, acute nonspecific tenosynovitis, epicondylitis, myositis and calluses; treatment of tendon cysts and aponeuroses. Collagenoses: during exacerbations or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis, scleroderma, dermatomyositis. Dermatological diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, ringworm, severe psoriasis, allergic eczema (chronic dermatitis), severe seborrheic dermatitis. Administration into the affected area is indicated for keloid scars, localized hypertrophic inflammatory infiltrates in cases of diseases such as lichen planus, plaque form of psoriasis, granuloma annulare, chronic lichen simplex; discoid lupus erythematosus, necrobiosis lipoidica in diabetes mellitus, alopecia areata. Allergic diseases: control of severe allergic conditions not responding to adequate conventional therapy, such as seasonal or perennial allergic rhinitis, nasal polyposis, asthma (including status asthmaticus), contact dermatitis, atopic dermatitis (neurodermatitis), allergic reaction to a drug, or serum sickness, acute non-infectious laryngeal edema. Ophthalmological diseases: severe acute and chronic allergic and inflammatory processes of the eyes, such as allergic conjunctivitis, keratitis, allergic marginal corneal ulcers, herpetic eye lesions, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, optic neuritis, inflammation of the anterior segment, sympathophthalmia . Respiratory diseases: symptomatic sarcoidosis, intractable Lefler's syndrome, berylliosis, fulminant and disseminated pulmonary tuberculosis (in combination with specific anti-tuberculosis therapy), aspiration pneumonia. Hematological diseases: idiopathic or secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, erythroid hypoplastic anemia, transfusion reactions. Other diseases: cerebral edema; in case of renal allograft rejection reactions; prenatal prevention of distress syndrome in premature infants; gastrointestinal diseases (nonspecific ulcerative colitis, enteritis); oncological diseases (palliative treatment of leukemia and lymphomas in adults and acute leukemia in children); edema syndrome (in order to increase diuresis or achieve remission of proteinuria in nephrotic syndrome without idiopathic uremia or in systemic lupus erythematosus); tuberculous meningitis with subarachnoid blockade or its threat against the background of specific anti-tuberculosis therapy; trichinosis (with neurological and myocardial damage).

Use of the drug Celeston

Doses of the drug are selected individually, depending on the severity of the disease and the patient’s response to the treatment. Oral administration Dosage regimens of the drug should be individual and different depending on the characteristics of the disease, its severity and the effectiveness of the treatment. The initial dosage of Celeston in tablet form can vary from 0.25 to 8 mg daily, depending on the characteristics of the disease. For less serious cases, low doses may be sufficient. The initial dose should be maintained or adjusted until clinical effect is achieved. If after a certain period (in some cases even after 2-3 days) the effect of treatment is not noted, it is necessary to discontinue Celeston tablets and use other therapy. The usual starting oral dose for children can vary from 0.017 to 0.25 mg/kg of the child's body weight per day or from 0.5 to 7.5 mg per 1 m 2 of body surface per day. Dosing for younger and older children is carried out in the same way as for adults, following doses in accordance with age and body weight. After achieving a positive clinical effect, the initial dose is gradually reduced at certain intervals to the lowest maintenance dose that provides the required clinical effect. During the period of spontaneous remission in chronic diseases, treatment should be stopped. In stressful situations, patients taking Celeston may require an increase in the dose of Celeston. If treatment with Celeston is stopped after prolonged therapy, the dose of the drug should be reduced gradually by 0.25–0.5 mg, that is, by 1/2–1 tablet after 2–3 days.

For gouty arthritis, therapy should be continued for several days after the symptoms of exacerbation disappear. *After achieving the desired result, the initial dose is reduced daily.

The daily maintenance dose can be administered once early in the morning. Betamethasone is not recommended to be taken every other day. Use in the form of an injection solution Celeston for injection can be administered intravenously, intramuscularly, into the joint cavity, into the lesion, as well as into soft tissues. The dosage regimen is set individually, depending on the type of disease, the severity of the condition and the effectiveness of the treatment. The initial dose of betamethasone for adults is up to 8 mg/day. In less severe cases, lower doses may be used, but some patients may require higher initial doses. Initial dosage adjustments should be made until clinical response is achieved. If the clinical result is not achieved, after a certain period, you should stop using Celeston for injection and reconsider the therapy. For children, the average initial dose of betamethasone for intramuscular administration is 20–125 mcg/kg body weight per day. The dosage regimen for younger and older children should be established according to the same schemes as for adults. Celeston for injection can also be administered intravenously with isotonic sodium chloride solution or dextrose solution. Celeston for injection should be added to the solution for intravenous infusion immediately before infusion. Unused solutions can only be stored in the refrigerator and for no more than 24 hours. After achieving positive results of treatment, the patient should be transferred to the minimum maintenance dose, gradually reducing the daily dose of the drug. In patients undergoing treatment, stress may require an increase in the dose of the drug. Celeston should also be discontinued gradually after long-term therapy. With cerebral edema, improvement in the patient's condition may occur within several hours after administration of 0.5–1 ml of Celeston solution (2–4 mg of betamethasone). Patients in a comatose state are usually administered 2–4 mg of the drug 4 times a day. To prevent kidney transplant rejection, 60 mg of betamethasone is administered intravenously during the first 24 hours. Slight changes in the dose of Celeston are possible, taking into account the individual characteristics of the patient. To prevent transfusion reactions, it is necessary to inject 1–2 mg of Celeston (4–8 mg of betamethasone) into a vein immediately before blood transfusion. The corticosteroid drug should not be mixed with blood transfusion. For repeated blood transfusions, Celeston can be re-administered in the same doses, the total dose of the drug can reach 4 single doses within 24 hours. Musculoskeletal lesions, soft tissue diseases

Prenatal prevention of respiratory distress syndrome in premature infants. When labor is induced before the 32nd week of pregnancy or if it is impossible to avoid premature birth before the 32nd week of pregnancy due to obstetric complications, it is recommended to administer 4-6 mg of betamethasone intramuscularly every 12 hours for 24–48 hours before the expected delivery ( 2–4 doses). It is necessary that treatment be started at least 24 hours (preferably 48–72 hours) before delivery to allow sufficient time to achieve the effect of the corticosteroid and a reliable clinical result. Celeston for injection can also be used for prophylactic purposes if the lecithin/sphingomyelin ratio in the amniotic fluid is reduced (or the stability of the amniotic fluid “foam” test is reduced). When prescribing a dose of medication in such cases, it is necessary to be guided by the above recommendations, including recommendations regarding the timing of administration of the medication before childbirth. Subconjunctival injection. The average dose of Celeston is 0.5 ml (2 mg betamethasone).

Variability of release forms

The drug is presented in the pharmacy chain in different forms:

1. Celeston tablets (0.5 mg of active ingredient - betamethasone in 1 tablet, 10 pieces per blister, 3 blisters in a cardboard package);
2. Celeston injections (betamethasone 4.0 mg in 1 ml injection solution, 1 or 10 ampoules per box);
3. Celeston ointment (Celestoderm) contains 5.3 mg of betamethasone in the form of sodium phosphate per 1 ml of product, which is equal to 4 mg of betamethasone.

Side effects of the drug Celeston

The side effects observed with the use of Celeston were the same as with the use of other corticosteroids, and also depended on the dose and duration of treatment. Typically, these effects were reversible or could be minimized by dose reduction, which is preferable to drug withdrawal. Muscle weakness, corticosteroid myopathy, decreased muscle mass, increased symptoms of myasthenia gravis, vertebral compression fractures, aseptic necrosis of the femoral and humeral heads, pathological fractures of long bones, tendon hernias, joint instability (due to repeated intra-articular injections). Hiccups, peptic ulcer with possible perforation and bleeding, pancreatitis, bloating, ulcerative esophagitis. Deterioration of wound healing, allergic dermatitis, urticaria, angioedema, skin atrophy, petechiae and ecchymoses, facial erythema, sweating, decreased response to skin allergy tests. Convulsions, increased intracranial pressure with swelling of the optic discs, dizziness, headache. Menstrual irregularities, development of Cushingoid syndrome, fetal and child growth retardation. Secondary adrenocortical and pituitary insufficiency (especially in a stressful situation - trauma, surgery, serious illness); decreased tolerance to carbohydrates, manifestation of latent diabetes mellitus, increased need for insulin or oral hypoglycemic agents. With prolonged use, the development of subcapsular posterior cataracts, glaucoma, and exophthalmos is possible. Negative nitrogen balance due to protein catabolism. Psycho-emotional instability, euphoria. Depression, psychotic reactions, personality changes, irritability, insomnia. Hypersensitivity reactions, including anaphylaxis. With injections into the lesion in the face and head, isolated cases of blindness have been described. Pigmentation disorders, subcutaneous atrophy, sterile abscesses, post-injection inflammation (after intra-articular injection), Charcot-type arthropathy.

Special instructions for the use of Celeston

Preventive measures It is necessary to strictly adhere to asepsis! The drug contains sodium bisulfite, which may cause allergic reactions in people prone to allergies. In persons with a history of drug allergies, the necessary preventive measures should be taken before administering Celeston. Celeston should be prescribed intramuscularly with caution to patients with idiopathic thrombocytopenic purpura. Injections should be performed deep into large muscle masses to prevent local tissue atrophy. When administered into soft tissues, into lesions and intra-articularly, both local and systemic effects of GCS may occur. Injection into an infected joint should be avoided (to exclude a septic process, conduct a study of intra-articular fluid). Corticosteroids should not be injected into unstable joints, areas of inflammation and intervertebral space, or directly into the tendon. Repeated injections into joints for osteoarthritis can increase joint destruction. With long-term use of corticosteroid therapy, when switching from parenteral to oral use, the potential benefits and risks should be considered. Changing the dosage regimen is possible depending on the course of the disease (remission or exacerbation), the patient's response to therapy, negative changes in the patient's emotional and physical state (severe infection, surgery, trauma). After completing a long or intensive course of treatment with GCS, constant monitoring of the patient’s condition is necessary throughout the year. Corticosteroids can mask signs of an infectious disease, reduce the body's resistance and ability to localize the infection. With long-term use, posterior subcapsular cataracts (especially in children), glaucoma with possible damage to the optic nerve, and an increased risk of developing secondary fungal or viral eye infections are possible. The use of moderate and low doses of corticosteroids may cause increased blood pressure, salt and water retention in the body, and increased potassium excretion. These effects are less likely when using synthetic derivatives (but not in high doses). All corticosteroids increase calcium excretion. Patients receiving corticosteroids (especially high doses) should not be vaccinated (risk of developing neurological complications and decreased immune response), unless corticosteroids are used as replacement therapy (eg, Addison's disease). Patients receiving doses of GCS for the purpose of immunosuppression should avoid contact with patients with chickenpox and measles (especially important for children). For active tuberculosis, the drug is used only in combination with a course of anti-tuberculosis therapy. Patients with inactive tuberculosis receiving corticosteroids should be under medical supervision and receive specific chemoprophylaxis. The effects of corticosteroid therapy may be enhanced by hypothyroidism and liver cirrhosis. Prescribe the drug with caution for herpetic eye lesions due to the likelihood of corneal perforation. With corticosteroid therapy, mental disorders may occur or existing ones may intensify (including increased emotional instability, psychotic tendencies). In case of nonspecific ulcerative colitis with threat of perforation, abscess or other purulent infection, diverticulitis, fresh intestinal anastomosis, active or latent peptic ulcer, renal failure, hypertension (arterial hypertension), osteoporosis, myasthenia gravis, the drug should be used with caution. Long-term corticosteroid therapy can alter the motility and number of sperm in the ejaculate. Use in children. With prolonged use of Celeston in children, it is necessary to carefully monitor their growth and development (taking into account the possibility of growth inhibition and endogenous production of corticosteroids). During pregnancy and breastfeeding . The safety of the drug during pregnancy and lactation has not been established, therefore GCS should be used only if the benefit of their use for the mother outweighs the possible harm to the fetus/child. The advisability of prenatal prevention of distress syndrome after the 32nd week of pregnancy is not clear. Therefore, the physician should evaluate the benefit/risk ratio for the mother and fetus when using corticosteroids after 32 weeks of gestation. Corticosteroids are not prescribed to prevent postpartum distress. Celeston should not be administered to pregnant women with placental damage or the risk of preeclampsia or eclampsia. The drug passes into breast milk, so a choice must be made between stopping the drug or stopping breastfeeding. Infants whose mothers received significant doses of corticosteroids during pregnancy should be monitored for signs of adrenal insufficiency and, very rarely, congenital cataracts. Women who received corticosteroids during pregnancy should be monitored during and after childbirth due to the likelihood of adrenocortical insufficiency (due to stress during childbirth).

Contraindications

The main contraindication to the use of the drug is hypersensitivity to the active substance.

The use of Celeston is also not recommended for the following diseases:

1. Joint pathologies: periarticular infections, endogenous bleeding, previous arthroplasty, sepsis, inflammatory process in the joint, bone destruction, osteoporosis, joint deformation and joint instability, bone necrosis;
2. Parasitic and infectious diseases of various etiologies (viral, fungal and bacterial): herpes, strongyloidiasis, measles, smallpox, amebiasis, systemic mycosis and tuberculosis;
3. Immunodeficiency states;
4. Gastrointestinal pathologies: peptic ulcer, esophagitis, diverticulitis, nonspecific ulcerative colitis, gastritis;
5. Diseases of the cardiovascular system: history of myocardial infarction, arterial hypertension, decompensated CHF, hyperlipedemia;
6. Endocrine problems: hypothyroidism, diabetes mellitus, Itsenko-Cushing syndrome, thyrotoxicosis;
7. Severe liver and kidney dysfunction, nephrourolithiasis.

A warning to prescribing may also be a patient's history of systemic osteoporosis, acute psychosis, myasthenia gravis, obesity, glaucoma, or poliomyelitis.

Celeston is not prescribed in the post-vaccination period, during pregnancy and lactation.

Drug interactions Celeston

When administered simultaneously with phenobarbital, phenytoin, rifampicin or ephedrine, the metabolism of betamethasone is increased and its therapeutic effect is reduced. Strengthening the effect of corticosteroids is possible when they are used in combination with estrogens. When combined with potassium-sparing diuretics, hypokalemia increases. Corticosteroids may enhance potassium excretion due to the action of amphotericin B. The combined use of corticosteroids and cardiac glycosides increases the likelihood of developing arrhythmia or increasing the toxicity of glycosides. Concomitant use of corticosteroids and indirect anticoagulants (such as coumarin) may result in increased or decreased effects of the anticoagulants, which may require dose adjustment. The combination of NSAIDs or ethanol (and ethanol-containing drugs) with glucocorticoids increases the frequency or severity of erosive and ulcerative lesions of the digestive tract. When using corticosteroids, the concentration of salicylates in the blood decreases. When administering corticosteroids to patients with diabetes mellitus, dose adjustment of hypoglycemic agents may be required. Simultaneous treatment with glucocorticoids may weaken the effects of GH drugs.

Analogs

Overdose of the drug Celeston, symptoms and treatment

Acute overdose of corticosteroids, including betamethasone, does not lead to the development of a life-threatening condition. Except for taking very high doses, excessive use of corticosteroids does not lead to side effects, provided that the patient does not have diseases such as diabetes mellitus, active peptic ulcers, and also if the patient is not simultaneously taking drugs such as cardiac glycosides, coumarin anticoagulants and potassium-sparing diuretics. Treatment : symptomatic therapy is recommended.

Reviews

Mostly positive reviews about the drug Celeston Reviews about the drug Celeston are positive . In particular, they note the affordability of the drug, its effectiveness and ease of use.

Among the negative factors, the need to adhere to systematic treatment in case of severe illnesses and the visible effect after one to three weeks of use are mentioned.

Also, long-term use of the drug, according to users, can provoke hypertension and osteoporosis .

However, most reviews note a rapid positive effect after use and the absence of any complications.

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