Celestone Soluspan SUSP INJ 1ml, Betamethazone
THIS IS A BRAND MEDICATION
THERAPEUTIC INDICATIONS: Celestone ® is indicated for the treatment of various rheumatic diseases, connective tissue, skin, allergic, endocrine, eye, gastrointestinal, respiratory, hematologic and other types, which respond to corticosteroid treatment.
The corticosteroid hormone therapy is an adjunct and not replace conventional therapy.
This preparation is suitable when you need or want a rapid and intense corticosteroid effect.
Musculoskeletal disorders and soft tissue: Celestone ® can be administered as adjunctive therapy in the short term (to support the patient through an acute episode or exacerbation) in cases of adult rheumatoid arthritis and juvenile rheumatoid arthritis, osteoarthritis (after trauma or synovitis), psoriatic arthritis, ankylosing spondylitis, gouty arthritis, acute and subacute bursitis, acute rheumatic fever, fibrositis, tennis elbow, nonspecific tenosynovitis, acute myositis, heloma.
May also be useful in treating cystic tumors or fascia of a tendon (ganglion).
Connective tissue diseases: During an exacerbation or as maintenance therapy in certain cases of lupus erythematosus, acute rheumatic carditis, scleroderma, dermatomyositis and temporal arteritis.
Dermatologic Diseases: Pemphigus, bullous dermatitis herpetiformis, erythema multiforme (syndrome
Stevens-Johnson), exfoliative dermatitis, mycosis fungoides, severe psoriasis, allergic eczema (chronic dermatitis), severe seborrheic dermatitis.
Intralesional administration is indicated for the treatment of keloids, hypertrophic lesions located, infiltrated, inflammatory lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis), discoid lupus erythematosus, necrobiosis lipoid of diabetics, alopecia areata.
Allergic Diseases: Control of severe and incapacitating allergic conditions that do not respond to conventional treatment, such as seasonal or perennial allergic rhinitis, nasal polyps, bronchial asthma (including status asthmaticus), contact dermatitis, atopic dermatitis (neurodermatitis), hypersensitivity to drugs , transfusion reactions, laryngeal edema, acute, infectious, serum sickness.
Endocrine diseases: primary or secondary adrenocortical insufficiency (together with mineralocorticosteroides, if applicable), acute adrenal insufficiency, in the preoperative period, or if injury or serious illness in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful; shock not respond to conventional therapy if adrenocortical insufficiency or suspected, bilateral adrenalectomy, congenital adrenal hyperplasia, thyroiditis, acute suppurative thyroiditis and thyroid storm, and hypercalcemia associated with cancer.
Ophthalmic Diseases: Severe allergic and inflammatory processes, acute and chronic that affect the eye and its annexes such as allergic conjunctivitis, keratitis, marginal ulcers, corneal allergies, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, posterior uveitis diffuse choroiditis, optic neuritis, sympathetic ophthalmia.
Respiratory diseases: aspiration pneumonitis, sarcoidosis, symptomatic, Loeffler's syndrome not manageable by other means, berylliosis, disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy.
Hematologic Disorders: idiopathic and secondary thrombocytopenia in adults Acquired haemolytic anemia (autoimmune) erythroblastopenia (anemia erythrocyte) and hypoplastic anemia (erythroid) congenital.
Gastrointestinal Diseases: To tide the patient over critical periods of ulcerative colitis and regional enteritis (Crohn's disease).
Neoplastic Diseases: For palliative management of leukemias and lymphomas in adults Acute leukemia in children.
Renal diseases: To induce diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
Shock: The beginning of the adjuvant corticosteroid therapy in shock is rather based on the pharmacological effects in a physiological replacement.
Cerebral edema (increased intracranial pressure): The clinical benefits of adjunctive corticosteroid therapy in brain edema, probably resulting from the depression of the brain swelling.
Corticosteroids should not be considered as a replacement for neurosurgical procedures. Are of value to reduce or prevent the development of cerebral edema associated with surgical trauma or other brain injury, stroke, and primary or metastatic brain tumors.
Episodes of renal allograft rejection: Celestone ® has demonstrated efficacy in the treatment of primary acute rejection and late rejection classic, along with conventional treatment in preventing renal transplant rejection.
Use before delivery to prevent respiratory distress syndrome in preterm infants: Celestone ® is indicated as prophylactic treatment of hyaline membrane disease in preterm infants when administered to mothers (before the 32nd week of gestation).
Miscellaneous: tuberculous Meningovasculitis with subarachnoid block or impending block when concurrently accompanied the administration of appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.
Pharmacokinetics IN HUMAN synthetic corticosteroids such as betamethasone, have potent anti-inflammatory action with minimal mineralocorticoid effects.
In particular, the antiinflammatory effect of betamethasone 30 times higher than that of hydrocortisone and has no effect mineralocorticoids.
Your metabolism and excretion is similar to hydrocortisone, approximately 90% reversibly binds to plasma proteins, primarily albumin and globulins, is metabolized in the liver, where the induction of liver enzymes may increase the metabolic clearance of all glucocorticoids. About 1% of the dose was excreted daily in urine, renal clearance is increased when plasma levels are high.
Betamethasone has a plasma half-life of more than 300 minutes a dose of 0.6 mg of betamethasone equivalent to 5 mg of prednisone and 20 mg of hydrocortisone. Biological half-life is 36 to 54 hours, of the longest of corticosteroids, taking into account that hydrocortisone has a biological half life of 8 to 12 hours. This is the time that a dose equivalent to 40 mg of prednisone (5.8 mg betamethasone) inhibits the function of the hypothalamic-pituitary-adrenal, so it is considered a long-acting synthetic corticosteroid.
CONTRAINDICATIONS: Contraindicated in patients with systemic mycoses, in those with hypersensitivity reactions to betamethasone sodium phosphate, betamethasone acetate, other corticosteroids or any component of this product.
PRECAUTIONS: It is mandatory to use a strict aseptic technique during the administration of Celestone ®.
This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthma episodes or less severe in sensitive people.
Celestone ® should be administered with caution to patients with idiopathic thrombocytopenic purpura, when using the intramuscular route.
Intramuscular administration of corticosteroids should be deep in large muscle masses to avoid local tissue atrophy.
The soft tissue administration, intraarticular and intralesional corticosteroid may cause local and systemic effects.
We need to examine the joint fluid to exclude a septic process. Do not inject local
in a previously infected joint. The increased pain and local swelling, further restriction of joint movement, fever and malaise are suggestive of septic arthritis. If confirmed the diagnosis of sepsis should be instituted appropriate antimicrobial therapy.
Corticosteroids should not be injected into unstable joints, infected areas or intervertebral spaces. Repeated injections in osteoarthritic joints can increase the destruction of the joint. Avoid injecting corticosteroids directly into the substance of tendons because delayed rupture occurred tendon.
After intra-articular corticosteroid therapy, the patient should be careful not to overuse the joint in which symptomatic benefit has been obtained.
Because there have been rare cases of anaphylactic reactions in patients receiving parenteral corticosteroid therapy should be appropriate precautionary measures before administration, especially when the patient has a history of allergy to any medicine.
With the long-term corticosteroid therapy should be considered the transfer of parenteral to oral administration after evaluating the benefits and potential risks.
You may need to adjust the dose in the presence of remission or exacerbation of the disease, before the individual patient response to treatment and patient exposure to emotional or physical stress, as in the case of serious infection, surgery or trauma. You may need to remain vigilant until one year after discontinuation of long-term corticosteroid therapy or high doses.
Corticosteroids may mask some signs of infection may also develop new infections while in use. When corticosteroids are used, it may be a reduction of the resistance and inability to localize the infection.
Prolonged use of corticosteroids may cause posterior subcapsular cataracts (especially in children), glaucoma with possible damage to the optic nerves and may also promote secondary eye infections caused by fungi or viruses.
Normal and elevated doses of corticosteroids may increase blood pressure, salt and water retention and potassium excretion. Is less likely that these effects occur with the synthetic derivatives except when used at high doses. May be considered dietary salt restriction and potassium supplementation. All corticosteroids increase calcium excretion.
Patients who are receiving corticosteroid treatment should not be vaccinated against smallpox. Not be taken other immunization procedures
in patients receiving corticosteroids, especially at high doses, because of possible hazards of neurological complications and impaired humoral immune response. However, they can immunize patients receiving corticosteroids as replacement therapy for example in the case of Addison's disease.
It should be noted in patients receiving immunosuppressive doses of corticosteroids to avoid exposure to chickenpox or measles and, if so, consult a doctor. This is especially important in children.
Corticosteroid therapy in patients with active tuberculosis should be restricted to cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for combined treatment with appropriate antituberculous scheme.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reaction, it is necessary to observe closely, since it is possible reactivation of the disease. During prolonged corticosteroid therapy, patients should receive chemoprophylaxis.
If used in a program chemoprophylactic rifampicin, it should be noted that increases hepatic metabolic clearance of corticosteroids, may be necessary to adjust the dose of corticosteroid.
You must use the lowest possible dose of corticosteroid to control the condition being treated, where possible reduce the dose, it must be gradual.
The withdrawal of corticosteroids too quickly can induce secondary adrenal insufficiency, which can be minimized by gradual dose reduction. This condition may persist for months after discontinuation of treatment, therefore, if they occurred under stress during this period should reinstituted the steroids. If the patient is already receiving corticosteroids may be necessary to increase the dose. As can be impaired secretion of mineralocorticoids should be administered salt and / or a mineralocorticosteroide.
The corticosteroid effect is increased in patients with hypothyroidism or cirrhosis.
Caution is advised in patients with ocular herpes simplex, due to the possibility of corneal perforation.
With the steroids may develop psychiatric disorders. Emotional instability or psychotic tendencies may be aggravated by previous corticosteroids.
Corticosteroids should be used with caution in: nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer; strongyloides infestation or clinical suspicion, renal failure, hypertension , osteoporosis and myasthenia gravis.
Since complications of treatment with glucocorticoids are dependent on the dose and duration of treatment should consider the risks and potential benefits for each patient.
As administration of corticosteroids can modify the growth rates and inhibit the endogenous production of corticosteroids in infants and children, growth and development of these patients should be monitored carefully, especially when they have received prolonged treatment.
Corticosteroids may alter motility and sperm count in some patients.
Use in Pregnancy and Lactation: As there have been no controlled studies in human reproduction with the use of corticosteroids, the use of these medications during pregnancy or in women of childbearing age requires that the possible benefits of medication considered in terms of potential risks to mother and fetus.
Published data indicate that it is still unclear prophylactic corticosteroid use beyond the 32nd. week of gestation. Therefore, the physician should assess the benefits against the potential risks to both mother and baby when corticosteroids are used after the 32nd. week of gestation.
Corticosteroids are not indicated in the treatment of hyaline membrane syndrome after birth.
In the prophylactic treatment of hyaline membrane disease in preterm infants, corticosteroids should not be administered to pregnant patients presenting with symptoms of preeclampsia, eclampsia or evidence of placental damage.
Infants born to mothers who received high doses of corticosteroids during pregnancy should be observed carefully for signs of adrenal insufficiency. When mothers received betamethasone prenatally, infants showed transient decrease in the secretion of growth hormone and probably fetal pituitary hormones that regulate the production of corticosteroids by the fetal adrenal glands. However, the removal of hydrocortisone did not interfere with fetal pituitary and adrenal responses to stress after birth.
Corticosteroids cross the placental barrier and is secreted in breast milk.
Due to the transplacental passage of corticosteroids, infants of mothers who were administered corticosteroids during all or part of pregnancy, congenital cataract should be considered, this condition is possible but rare.
The patients who were administered corticosteroids during pregnancy should be monitored during and after labor for any symptoms of adrenal insufficiency secondary to stress associated with childbirth.
Corticosteroids administered during pregnancy did not produce delayed cognitive development in the infant.
Because of the potential of Celestone ® to produce unpleasant side effects in infants, should be considered to discontinue nursing or the drug, taking into account the importance to the mother.
ADVERSE REACTIONS: Adverse effects of Celestone ®, are the same as those reported for other corticosteroids, and are related to dose and duration of treatment.
Normally these effects can be reversed or minimized by reducing the dose, which is generally preferable to treatment discontinuation.
Fluid and electrolyte disturbances: sodium retention, potassium loss, hypokalemic alkalosis, fluid retention.
Cardiovascular: Congestive heart failure in susceptible patients and hypertension.
Musculoskeletal: Muscle weakness, corticosteroid myopathy, muscular hypotrophy, progression of symptoms in myasthenia gravis, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fractures of long bones, tendon rupture, joint instability by Repeated intra-articular administration.
Gastrointestinal: peptic ulcer with possible subsequent perforation and hemorrhage, pancreatitis, abdominal distention, esophageal ulcers.
Dermatologic Disorders of wound healing, skin atrophy, fragile and thin skin, stretch marks, acne, petechiae and ecchymoses, facial flushing, diaphoresis, altered in the reaction of skin tests, allergic dermatitis, urticaria, angioneurotic edema.
Neurological: convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache.
Psychiatric: euphoria, mood changes, major depression with frank psychotic manifestations, personality changes, mania, hallucinations and insomnia.
Endocrine: menstrual irregularities, development of Cushing syndrome, decreased fetal intrauterine growth or childhood, lack of adrenal and pituitary secondary response, particularly in periods of stress, as in trauma, surgery or illness, reduced tolerance carbohydrates, manifestations of diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetic patients, dyslipidemia with raised triglycerides, total cholesterol and low density lipoproteins, may precipitate porphyria.
Ophthalmic: posterior subcapsular cataract, increased intraocular pressure, glaucoma, exophthalmos.
Metabolic: negative nitrogen balance due to protein catabolism.
Other: hypersensitivity or anaphylactic reactions and hypotension similar to shock, infections in general.
Other adverse reactions related to parenteral corticosteroid therapy include rare instances of blindness associated with intralesional therapy around the face and head, hyperpigmentation or hypopigmentation, subcutaneous and cutaneous atrophy, sterile abscess, swelling at the injection site (after intra-articular use) and Charcot arthropathy.
DRUG INTERACTIONS AND OTHER GENDER: Concurrent use of phenobarbital, phenytoin, rifampicin, ephedrine, carbamazepine, may increase the metabolism of corticosteroids, reducing their therapeutic effects.
By combining corticosteroids with neuromuscular blocking agents, decreasing the effectiveness of the latter and increases the risk of acute flaccid paralysis when used for prolonged periods with neuromuscular blockers.
Patients receiving a corticosteroid and estrogen should be observed for the presence of excessive corticosteroid effects.
Concurrent use of corticosteroids with diuretics remove potassium, hypokalemia may increase. Concurrent use of corticosteroids with cardiac glycosides may increase the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may promote the elimination of potassium causing amphotericin B. All patients who were administered any of these combination therapies, they should make determinations of serum electrolytes, especially potassium levels and should be closely monitored.
Concurrent use of corticosteroids with coumarin anticoagulants may increase or decrease the anticoagulant effects, may need a dose adjustment.
The combined effects of non-steroidal antiinflammatory drugs, acetylsalicylic acid or alcohol with glucocorticoids can lead to an increase in the occurrence or severity of gastrointestinal ulcers.
Corticosteroids may reduce blood levels of salicylate. Aspirin should be used with caution when given concurrently with corticosteroids in hypoprothrombinemia cases.
When corticosteroids are administered to diabetic patients may need to adjust the dose of hypoglycemic medication and / or insulin dose.
Concomitant treatment with glucocorticoids may inhibit the response to somatotropin.
CHANGES IN THE LABORATORY TEST RESULTS: Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and give false-negative results.
DOSAGE AND ADMINISTRATION: Celestone ® can be used for administration IV, IM, intraarticular, intralesional or soft tissue.
Doses are variable and must be individualized based on the specific disease, its severity and patient response.
The initial dose of Celestone ® for adults can reach up to 8.0 mg of betamethasone per day, depending on the specific disease being treated. In less serious situations are generally satisfied with the lower doses, while in some patients may require higher initial doses.
The initial dose should be maintained or adjusted until a satisfactory response observed. If after a reasonable period does not occur, discontinue treatment with Celestone ® and transfer the patient to other appropriate treatment.
The dose I.M. usual initial pediatric varies from 0.02 to 0125 mg per kg of body weight per day. At the doses for infants and children should be seen the same considerations as in the case of adults, with the same proportions indicated by age or body weight.
Although Celestone ® can be administered by various routes, in emergency situations is recommended to use the IV
Celestone ® can also be administered by IV drip together with isotonic saline or dextrose solution in the desired amount of solution. In these cases, add CELESTONE ® to the solution at the time of administration. Unused solutions should be refrigerated immediately and administered within 24 hours of preparation.
When looking at a favorable clinical response, you must determine the appropriate dosage of maintenance by reducing the initial drug dosage in small amounts at appropriate intervals to reach the minimum effective dose.
The patient's exposure to situations that cause stress, not related to the disease being treated, may require increased doses of Celestone ®. If the drug is stopped after prolonged treatment, the dose should be gradually reduced.
Dosage recommendations according to the disease:
Cerebral Edema: Can occur subjective and objective evidence of improvement within the first hours after administration of Celestone ® at doses of 2 to 4 mg of betamethasone. Patients with impaired awake state can receive conventional doses ranging from 2 to 4 mg four times daily.
Renal allograft rejection: The first evidence and diagnosis of acute rejection or late Celestone ® should be administered intravenously constant trickle-shaped, the initial dose is 60 mg of betamethasone during the first 24 hours. There may be minor variations in the dose according to individual circumstances of each patient.
Use before delivery to prevent respiratory distress syndrome in preterm infants: When necessary to induce labor before 32 a. week of gestation or when delivery is premature before the 32nd. week of gestation and is unavoidable due to obstetric complications, it is recommended Celestone ® 4 to 6 mg of betamethasone intramuscularly every 12 hours for 24 to 48 hours (2 to 4 doses) before the expected time of delivery.
The need to initiate treatment at least 24 hours (and preferably 48 to 72 hours) before delivery, lies in giving sufficient time for the corticosteroid exert its action and produce clinically observable effects.
Celestone ® should also be considered for prophylactic treatment if it is known that the product has low lecithin sphingomyelin ratio in amniotic fluid.
In this situation it is recommended to use the same therapeutic regimen, including dose interval before delivery, as suggested above.
Musculoskeletal conditions: The recommended dose depends on the size of the joint or site to be discussed:
Large joints (hip)
2.0 to 4.0 mg
0.8 to 2.0 mg
2.0 to 3.0 mg
0.4 to 1.0 mg
A1.0 0.4 mg
2.0 to 6.0 mg
1.0 to 2.0 mg
Transfusion reactions: For the prevention of transfusion reactions should be administered 1 or 2 ml of Celestone ® (4 to 8 mg of betamethasone) IV immediately before starting the blood transfusion. Corticosteroids should not be mixed with blood. With repeated transfusions, the same dose of CELESTONE ® can be administered again until a total of four times during 24 hours, if necessary.
Subconjunctival administration: Corticosteroids are frequently administered soluble via subconjunctival many eye conditions that respond to corticosteroids.
The usual dose of CELESTONE ® is 0.5 ml (2 mg of betamethasone).
REPRESENTATIONS AND MANAGEMENT Overdosage:
Symptoms: Not expected to acute overdosage with glucocorticosteroids, including betamethasone, leading to a potentially fatal. Except in extreme doses, it is unlikely that a few days of excessive administration of glucocorticoids result in damage if there are no specific contraindications, as in the case of patients with diabetes mellitus, glaucoma or active peptic ulcer, or patients taking drugs such as digital anticoagulants or diuretics that remove potassium.
Treatment: The complications that arise
by the metabolic effects of corticosteroids or the specific effects of the underlying disease or concomitant, or that result from drug interactions, should be managed appropriately.
It should maintain adequate fluid intake and monitor serum electrolytes and urine, with special attention to the balance of sodium and potassium. Electrolyte imbalance treated, if necessary.
Laboratorio : Schering-Plough, S. A. DE C.V.
Made in: Mexico