THERAPEUTIC INDICATIONS: Corticosteroids are hormones secreted by the adrenal cortex or synthetic analogs of these hormones. Exhibit glucocorticoid activity and / or mineralocorticoid and affect almost all body systems, but are used primarily for anti-inflammatory and immunosuppressive effects and powerful replacement. Betamethasone and its derivatives are mainly used as anti-inflammatory or immunosuppressive agents. Because CELESBITAN has only minimal mineralocorticoid properties, it is inappropriate only for the management of adrenocortical insufficiency. If used in the treatment of this condition is also required concomitant therapy with a mineralocorticoid.
Hypercalcemia: In dosages moderate CELESBITAN promotes a reduction in serum calcium concentrations and is effective in the treatment of hypercalcemia resulting from sarcoidosis intoxication or vitamin D. Hypercalcemia associated with bone involvement in multiple myeloma can be improved generally, and these are the long-term treatment more effective for hypercalcemia associated with breast cancer in postmenopausal women. Although glucocorticoids may occasionally be of value in the treatment of hypercalcaemia associated with other malignancies, no good results are always obtained and the drug must be reserved for patients refractory to other therapy. Glucocorticoids are effective in hypercalcemia caused by hyperparathyroidism.
Thyroiditis: The anti-inflammatory action CELESBITAN dramatically relieve symptoms such as fever, acute pain and swelling of the thyroid in thyroiditis (subacute, nonsuppurative) and granulomatous thyroiditis.
Indicated in medium to high dosages for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones. CELESBITAN can also be effective in reducing orbital edema in endocrine exophthalmos (thyroid ophthalmopathy). Changes in thyroid status may necessitate adjustment of the dosage glucocorticoid.
Collagen and rheumatic diseases: In rheumatic and collagen CELESBITAN relieves inflammation and suppresses the symptoms but does not affect the progression of the disease, is rarely indicated except for palliative treatment, short-term acute exacerbations and systemic complications in patients refractory to more conservative therapy. The dosage in life threatening situations is often high and decreases rapidly after the crisis is more serious. The CELESBITAN maintenance therapy is rarely indicated in rheumatoid arthritis, acute gouty arthritis or lupus erythematosus, but can be used as part of an overall treatment program in selected patients when more conservative therapies have proven ineffective.
In the symptomatic treatment of rheumatoid arthritis involving only some persistent swollen joints or in the treatment of inflammation of tendons or bursa, CELESBITAN local injections can be beneficial. Patients usually experience relief amática initially. Although the inflammation tends to recur and is often more intense after discontinuation of therapy, the drugs can prevent joint movement invalidismo providing they could get to be different still. CELESBITAN, systemically administered, controlled acute manifestations of rheumatic carditis more rapidly than salicylates and may be lifesaving in certain conditions, but both CELESBITAN, such as salicylates, can not prevent valve damage and no better than salicylates for long-term treatment . Salicylates used concomitantly can reduce rebound when removed inflammatory steroids.
CELESBITAN is the treatment of choice in Wegener's granulomatosis, but can be used herewith for severe systemic complications. CELESBITAN and other glucocorticoids are still the primary treatment to control symptoms and prevent severe complications, often life-threatening in patients with dermatomyositis and polymyositis, polyarteritis nodosa, relapsing polychondritis, polymyalgia rheumatica and arteritis (temporal) of the giant cells, or mixed syndrome of connective tissue disease. High doses may be needed for acute situations, after it has obtained a response, glucocorticoids should be continued for long periods often in low dosage.
Polymyositis associated with malignancy and childhood dermatomyositis may not respond well to glucocorticoids. CELESBITAN is rarely indicated in psoriatic arthritis, diffuse scleroderma (systemic sclerosis), acute and subacute bursitis, and osteoarthritis. The risks outweigh the benefits received, and a more conservative therapy should be used. In osteoarthritis, intra-articular injections may be beneficial CELESBITAN, but should be limited in number as joint damage can occur.
Dermatologic Diseases: In dermatological diseases such as pemphigus and pemphigoid, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), eczema uncontrollable, cutaneous sarcoidosis, mycosis fungoides and lichen planus, systemic CELESBITAN should generally be reserved for exacerbations Acute insensitive to conservative therapy. In all these skin diseases, may be required a high dosage of glucocorticoids. Early initiation of systemic therapy can be lifesaving CELESBITAN in Penfigus vulgaris and pemphigoid, and high or massive doses may be required. The dosage should be reduced gradually to a lower effective level, but discontinuation may not be possible alternate day therapy may be used and is often beneficial. Although chronic skin disorders are rarely an indication for systemic glucocorticoids. Or sublesionales intralesional injections can be indicated from time to time to localized chronic conditions (including keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus and granuloma annular) unresponsive to topical therapy. CELESBITAN, is rarely indicated for psoriasis or alopecia areata, totalis, universalis or. When systemic corticosteroids are used in the treatment of psoriasis, exacerbation of the disease can occur when drugs are isolated or decrease the dosage. Although CELESBITAN can stimulate hair growth in patients with alopecia, hair loss returns when the drugs are taken up.
Allergic conditions: CELESBITAN is used to control severe allergic conditions or disabling, unresponsive to adequate trials of conventional therapy in patients with bronchial asthma, seasonal allergic rhinitis or perennial, atopic dermatitis, urticaria associated with transfusions, or Acute noninfectious laryngeal edema (although epinephrine is the drug of choice). CELESBITAN also be used in acute manifestations of angioedema, serum sickness, contact dermatitis, drug hypersensitivity and allergic symptoms of trichinosis.
In acute conditions, CELESBITAN can be used for short periods in high dosage with other therapies such as antihistamines and sympathomimetics. In the symptomatic treatment of chronic allergic conditions, CELESBITAN generally should be reserved for acute conditions and severe exacerbations.
Prolonged treatment of chronic allergic conditions should be reserved for patients with disabling conditions to patients unresponsive to more conservative therapy and for whom the risks of long-term glucocorticoid therapy are justified.
Optic neuritis: CELESBITAN systemic, has been used for the treatment of acute optic neuritis.
Other eye disorders: CELESBITAN, can be used to suppress a variety of ocular allergic inflammation and biogenic, and to reduce scarring in ocular lesions. The dosage is used initially moderate and continue quickly after the acute condition is controlled.
Some disorders may relapse upon discontinuation of therapy and maintenance therapy of low doses may be required. Glucocorticoids are of no value in the treatment of degenerative eye diseases like cataracts. Topical glucocorticoids applied, seem to be as effective as systemic steroids for the treatment of most anterior ocular inflammation. Systemic CELESBITAN may be required, but in stubborn cases of disease of the anterior segment of the eye is required when deeper ocular structures are involved.
Sarcoidosis: In the management of sarcoidosis, CELESBITAN is indicated for the management of ocular complications, pulmonary, CNS, glandular, myocardial, or severe hypercalcemia or severe skin lesions unresponsive to intralesional injections of corticosteroids or sublesionales. The long-term therapy may be required.
Advanced pulmonary and extrapulmonary tuberculosis: CELESBITAN has been used as adjunctive therapy in some patients with severe pulmonary tuberculosis or extrapulmonary, in an attempt to suppress demonstrations related to the host's inflammatory response to Mycobacterium tuberculosis bacilli and improve the complications of the disease. While the evidence of infection studies of M. tuberculosis in both animals and humans, indicating that glucocorticoids may have deleterious effects (eg increased virulence of the organism) in the absence of appropriate antituberculosis therapy, such effects appear to generally be prevented by coadministration of antimicobacteriales effective agents (eg, streptomycin, isoniazid).
Advanced pulmonary tuberculosis: CELESBITAN has been used to treat severe respiratory and systemic manifestations in patients with advanced pulmonary tuberculosis.
Although the benefit to the patient is confused, obvious abnormalities (except cavities) are resolved faster radiographically glucocorticoid therapy. There has been no improvement in long-term outcomes (death or chronic respiratory disease). In patients receiving adequate antituberculosis therapy (2 or more agents), glucocorticoid use does not appear to delay the time to conversion of sputum culture negative or cups affect long-term cure.
Tuberculous Pericarditis: Limited data suggest that adjunctive therapy with CELESBITAN, to be effective in the management of acute tuberculous pericarditis, rapidly reducing the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably controlled hemodynamically threatening effusion .)
However, glucocorticoid therapy does not appear to alter the incidence of disease progression constrictive when used to treat acute or intermediate stage of pericarditis.
Other complications of tuberculosis: Limited data suggest that intrathoracic lymphadenopathy associated with primary tuberculosis can be resolved faster with the use of systemic CELESBITAN attached.
Lipid pneumonitis: pneumonitis in lipid CELESBITAN seems to promote the disruption or dissolution of lung lesions and remove lipids in the sputum.
Pneumocystis carinii Pneumonia: Using CELESBITAN as adjunctive therapy for Pneumocystis P. carinii in patients with acquired immunodeficiency syndrome (AIDS) can decrease the likelihood of deteriorating oxygenation, respiratory failure, and / or death in those with moderate to severe pneumonia. Current data suggest that CELESBITAN can prevent early deterioration in oxygenation associated with antipneumocistis therapy, and it is recommended that therapy be initiated glucocorticoid attached as early as possible in patients with Pneumocystis pneumonia.
The advantage in controlled studies have not been shown with the start of glucocorticoid therapy over 72 hours after initiation of the specific therapy antipneumocistis. Therefore, therapy may be initiated CELESBITAN in patients with acute pneumonia presumably associated pneumonia, whether these patients meet criteria recommended by oxygenation of the expert diagnosis. Of HIV infection and Pneumocystis pneumonia, confirmed promptly to minimize the likelihood of masking and / or exacerbate other treatable diseases (eg tuberculosis) and to prevent harmful effects of unnecessary drugs.
Other respiratory diseases: CELESBITAN can be used for symptomatic relief of acute manifestations of respiratory diseases including symptomatic idiopathic eosinophilic pneumonias (eg Löffler syndrome) not manageable by other means, idiopathic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organization pneumonia, aspiration pneumonitis, hypersensitivity pneumonitis and berylliosis. CELESBITAN also used in fulminating or disseminated tuberculosis in conjunction with appropriate antituberculosis therapy.
High dosage may be required for several days. Glucocorticoids are not indicated for simple chronic respiratory diseases.
Complications of prematurity:
Prenatal use in preterm labor: The IM short course therapy with CELESBITAN, is used in selected women with preterm labor to accelerate fetal maturation (eg, lungs, brain blood vessels), including women with premature rupture of membranes, preeclampsia or third trimester bleeding. Antenatal CELESBITAN seems generally reduce the incidence and / or severity of respiratory distress syndrome (SSR) as indicated by reduced requirements for neonatal ventilatory support therapy or surfactant, and the beneficial effects are additive with of surfactant. Prenatal glucocorticoid therapy can also improve neonatal circulatory stability and reduce the incidence or severity of intraventricular hemorrhage. The combined effects on multiple organ maturation during glucocorticoid therapy reduced the incidence of neonatal mortality, and the beneficial effects extend to a wide range of gestational ages (ie, 24-34 weeks) and are not limited by gender or race. The conflicting data concerning the effects of prenatal glucocorticoids on the incidence of necrotizing enterocolitis, bronchopulmonary dysplasia, and patent ductus arteriosus in neonates, and the efficacy and safety of prenatal therapy with drugs before or after 24 weeks 34 weeks of gestation have not been established. The short-term adverse effects of prenatal glucocorticoid administration include neonatal and maternal adrenal suppression and transient increased risk of infection.
Myasthenia gravis: CELESBITAN is used in the management of myasthenia gravis, usually in patients who have had an inadequate response to anticholinesterase therapy. Have also been administered parenterally in the treatment of myasthenic crisis.
Organ Transplants: In massive dosage, CELESBITAN can be used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs. Because the incidence of secondary infections is high in patients receiving these drugs, such therapy should be administered by physicians experienced in its use.
Nephrotic syndrome: CELESBITAN can induce diuresis and remission of proteinuria in children and adults with nephrotic syndrome secondary to primary renal disease, especially when there is minimal renal histologic change. Lupus nephritis can also respond to glucocorticoids. It may require a high dosage for prolonged periods, and alternate day therapy should be used to reduce harmful effects. Nephrotic syndrome secondary to diabetes mellitus, renal amyloidosis, glomerulonephritis, or other diseases is generally refractory to glucocorticoids.
Shock: Although intravenous CELESBITAN can be lifesaving in shock secondary to adrenocortical insufficiency, the value of the drug in the treatment of shock resulting from other causes is controversial. The management of shock should be based on the specific treatment of the primary cause and secondary abnormalities, and if used glucocorticoids should be used only as supportive deputy. CELESBITAN value in the treatment of septic shock has been particularly controversial. Although few controlled studies have shown beneficial effects of high-dose regimens on morbidity and mortality in septic shock, many studies do not.
Pericarditis: CELESBITAN has been used to reduce pain, fever and inflammation of pericarditis, including that associated with myocardial infarction. The most common cardiac causes of recurrent chest pain following an acute myocardial infarction are acute pericarditis and ischemia, being the most common and potentially serious. Recurrent pain that occurs during the initial 12 hours after onset of infarction is generally considered related to the original attack itself. Pericarditis is probably responsible for clinically significant chest pain during the first 24 hours after infarction and may not become apparent until several weeks after pericarditis or myocardial infarction. Acute myocardial infarction, occurs to the extent of myocardial necrosis through the epicardial wall. The multicenter research study of the limitation of infarct size (MILIS) found that pericarditis (defined as the presence of pericardial friction rub) occurred in about 20% of patients who were acute myocardial infarction.
While CELESBITAN can provide effective symptomatic relief, there is evidence that drugs can cause alterations of the scar that forms and myocardial rupture. In addition, the utility and effectiveness in handling gluococorticoides pericarditis associated with acute myocardial infarction are less established by evidence and opinion that the acetylsalicylic acid, and thus aspirin is considered the treatment of choice for postinfarction pericarditis myocardium. CELESBITAN also been used in the management of tuberculous pericarditis.
Chronic fatigue syndrome: Due to evidence that chronic fatigue syndrome is associated with subnormal cortisol secretion secondary to impaired activation of the hypothalamic-pituitary-adrenal (HPA), glucocorticoid supplementation has been studied in patients with this condition . In a study in patients 18 to 55 years of age who met the United States centers.
Anthrax: CELESBITAN has been used as an adjunct to anti-infective therapy in the treatment of Anthrax in an attempt to enhance the effects mediated by toxins associated with Bacillus anthracis. Some experts suggest that glucocorticoids may be indicated in the treatment of cutaneous Anthrax if there is evidence of systemic involvement or extensive edema involving the neck and thoracic region.
CELESBITAN also been used as an adjunct in the treatment of meningitis Anthrax. United States Centers for Disease Control and Prevention (CDC) suggest that glucocorticoid use attachments are considered in the treatment of inhalational Anthrax occurs as a result of exposure to Anthrax spores in the context of biological warfare or bioterrorism if edema is extensive, there is respiratory compromise, or meningitis is present.
Other applications in miscellaneous inflammatory reactions, such as those resulting from dental procedures, therapy with short-term CELESBITAN can reduce swelling and can relieve the pain associated with such inflammations.
Local injection of CELESBITAN in the soft tissue around the carpal tunnel has been used in a limited number of patients to relieve symptoms (eg pain, edema, sensory deficit) of carpal tunnel syndrome.
In clinical studies, short-term response was observed in most patients, but the improvement in symptoms decreased during the 11-24 months. Limited evidence suggests that the technique of injection can influence the duration of effect.
Pharmacokinetics in Humans: CELESBITAN is readily absorbed by the gastrointestinal tract. The water-soluble forms, are given by intravenous injection for rapid response; more prolonged effects are achieved using lipid-soluble forms of corticosteroids by intramuscular injection. CELESBITAN is rapidly distributed to all the soft tissues of the body. Cross the placenta to the degree that vary and can be distributed in small amounts in breast milk. Most of corticosteroids in the circulation is limited extensively to plasma proteins, mainly to globulin, albumin less. Corticosteroid binding globulin (transcortin) has high affinity but low binding capacity, whereas albumin has low affinity but large capacity link. Synthetic corticosteroids are less limited to proteins than hydrocortisone (cortisol). They also tend to have longer periods. Corticosteroids are metabolized primarily in the liver but also in other soft tissues, and excreted in the urine. The slower metabolism of synthetic corticosteroids binding affinity lower protein may explain its increased potency compared with natural corticosteroids.
Absorption After intramuscular administration, the absorption of sodium phosphate and water soluble salts of sodium succinate is fast, the rate of absorption of lipid-soluble esters of acetate and the acetonide is slower. When you want a faster onset of action, a water soluble ester glucocorticoid should be administered IV Thus, systemic absorption occurs following the slow administration intraarticular, intrabursal, intrasynovial, intradermal, or injections mild soft tissue in most of glucocorticoids.
Distribution: Animal studies suggest that distribution of most glucocorticoids are eliminated rapidly from the blood and distributed to the muscles, liver, skin, intestine and kidneys. Glucocorticoids vary in the degree to which are bound to plasma proteins. CELESBITAN has a high affinity for transcortin and competes with cortisol for this binding protein.
Elimination: The pharmacologically active glucocorticoids are metabolized in most soft tissues, but mainly in the liver, to biologically inactive compounds. Changes in thyroid status may necessitate adjustment of the dosage glucocorticoid. The metabolic separation of prednisolone is impaired in geriatric patients (as evidenced by reduced fractional separation of urinary 68-hydroxyprednisolone) compared with younger adults.
Prenatal use of twitch, to reduce morbidity and mortality in women with premature rupture of membranes is controversial, since the magnitude of the advantage neonatal SSR seems to be lower and the risk of neonatal infection is higher than women with intact membranes. However, even in the presence of premature rupture of membranes, the incidence of intraventricular hemorrhage and neonatal mortality is reduced by prenatal glucocorticoid therapy. Furthermore, the magnitude of increased risk of neonatal infection associated with such therapy appears to be small. Therefore, because of the advantage in mortality and hemorrhage in fetuses of less than 30-32 weeks of gestation, the risk seems small, maternal antenatal glucocorticoid therapy is considered appropriate in the absence of important clinical chorioamnionitis.
CELESBITAN prenatal therapy (12 mg once daily for 2 days) has been studied most extensively, and some experts indicate that this drug is generally preferred for use in preterm labor because of similarities in power, efficiency and its ability to easily cross the placenta, and the relative absence of mineralocorticoid activity and relatively weak immunosuppressive effects. Also preferred due to their longer duration of action compared to hydrocortisone or methylprednisolone. The beneficial effects I.M. in the maturation of fetal CELESBITAN are beneficial after the first 24 hours after initiation of therapy and extending until at least 7 days, however, the significant improvement in neonatal outcomes has also been clinically observed in women receiving a course incomplete therapy (ie, less than 24 hours), and prenatal administration of a uniform partial course of glucocorticoids should be attempted unless immediate delivery is anticipated.
Some experts recommend a single course of treatment for all pregnant women between 24-34 weeks gestation who are at risk of preterm labor within 7 days, indicating that repeat courses of antenatal glucocorticoids should not be routinely used because the data evaluating the risks and benefits of such therapy are scarce. Maternal use of tocolytic agents in conjunction with glucocorticoids may delay delivery in patients with preterm labor long enough for the fetus derives the benefit of accelerated fetal maturation glucocorticoid-inducida.El combined use of drugs has been shown to reduce the risk SSR neonatal, and women between 24-34 weeks gestation at risk of preterm delivery are candidates for prenatal glucocorticoid therapy regardless of race, gender or availability fetal surfactant. Because ß-adrenergic tocolytic monotherapy may be associated with an increased risk of intraventricular hemorrhage, the addition of prenatal glucocorticoid therapy may have a secondary benefit of reducing this risk. Prenatal glucocorticoid therapy appears to have an additive effect with postnatal prophylactic therapy of lung surfactant in reducing the incidence of SSR and neonatal mortality. Further, prenatal glucocorticoids may reduce the incidence and / or severity of intraventricular hemorrhage, which surfactant therapy alone does not seem to benefit. However, data are limited regarding the prophylactic use of combination therapy for respiratory distress syndrome in women less than 28 weeks gestation.
Postnatal Use for Bronchopulmonary dysplasia: CELESBITAN therapy can provide short-term pulmonary benefits (eg reduced incidence of bronchopulmonary dysplasia, facilitation of weaning from mechanical ventilation) but does not reduce total mortality and may be associated to short-term adverse effects (eg, hyperglycemia, hypertension, gastrointestinal bleeding or intestinal perforation, hypertrophic obstructive cardiomyopathy, poor weight gain, poor growth of head circumference) and long-term sequelae.
Hematological disorders: CELESBITAN used in the management of hemolytic anemia (autoimmune) acquired, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia (erythroid) hypoplastic anemia congenital (Diamond-Blackfan syndrome) and pure red cell aplasia . Although there is evidence that glucocorticoids affect the course or duration of hematologic disorders, or even the high-dose mass drug is often used to decrease bleeding tendencies and normalize blood counts. When treatment is indicated in adults or children with idiopathic thrombocytopenic purpura moderate to severe (PTI), CELESBITAN, IV immune globulin (IVIG) or splenectomy, are considered first-line therapies depending on the extent of bleeding involved. Other methods of treatment such as splenectomy should be considered if CELESBITAN should be continued for prolonged periods (over several months), especially in patients with idiopathic or secondary thrombocytopenia, hemolytic anemia (autoimmune) acquired erythroblastopenia (RBC anemia), or ( erythroid) hypoplastic anemia congenital. Cytotoxic agents produce better results in erythroblastopenia, but CELESBITAN can enhance the response. CELESBITAN may affect or prevent renal complications in Henoch-Schoenlein. It has also been widely used in aplastic anemia in children, but there is no evidence to prove its effectiveness.
Digestive Diseases: In ulcerative colitis, regional enteritis, and celiac disease, CELESBITAN in medium to high dosages may be useful as short-term palliative therapy for acute exacerbations and systemic complications of these chronic conditions. CELESBITAN should not be used if there is a probability of impending perforation, abscess or other pyogenic infection.
Trichinosis: CELESBITAN is used in the treatment of trichinosis with neurological involvement or the myocardium.
Drug Name: CELESBITAN
Comparable Patent Medicines: Diprospan
Active ingredient: Betamethasone
Presentation: Solution for Injection
Extended-release tablets: No
Laboratory Grupo Bruluart
Box with a vial of 2ml
Made in: Mexico