Celestone Chronodose

/ MSD

The initial dosage may vary from 0.5 to 9.0 mg per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, lifethreatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, this product should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. If coadministration of a local anesthetic is desired, this product may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens. Similar local anesthetics may also be used. Diluents containing methylparaben, propylparaben, phenol, etc., should be avoided since these compounds may cause flocculation of the steroid. The required dose is first withdrawn from the vial into the syringe. The local anesthetic is then drawn in, and the syringe shaken briefly. Do not inject local anesthetics into vial of this product. Bursitis. Tenosynovitis, Peritendinitis. In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 ml can relieve pain and restore full range of movement. Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis. Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections. Chronic bursitis may be treated with reduced dosage once the acute condition is controlled. In tenosynovitis and tendonitis, three or four local injections at intervals of one to two weeks between injections are given in most cases. Injections should be made into the affected tendon sheaths rather than into tendons themselves. In ganglions of joint capsules and tendon sheaths, injections of 0.5 ml directly into the ganglion cysts has produced marked reduction in the size of the lesions. Rheumatoid arthritis and osteoarthritis. Following intra-articular administration of 0.5 to 2.0 ml of this product, relief of pain, soreness, and stiffness may be experienced. Duration of relief varies widely in both diseases. Intra-articular Injection – is well tolerated in joints and periarticular tissues. There is virtually no pain on injection, and the “secondary flare” that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with this product. Using sterile technique, a 20- to 24- gauge needle on an empty syringe is inserted into the synovial cavity, and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint. The aspirating syringe is replaced by a syringe containing this product and injection is then made into the joint.

When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, for intramuscular use is indicated as follows:
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance).  Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer.
Rheumatic disorders: As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis; synovitis of osteoarthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); acute and subacute bursitis; epicondylitis; acute nonspecific tenosynovitis; acute gouty arthritis; psoriatic arthritis; ankylosing spondylitis.
Collagen disease: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus; acute rheumatic carditis.
Dermatologic diseases: Pemphigus: severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; bullous dermatitis herpetiformis; severe seborrheic dermatitis; severe psoriasis; mycosis fungoides.
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; seasonal or perennial allergic rhinitis; drug hypersensitivity reactions; urticarial transfusion reactions; acute noninfectious laryngeal edema (epinephrine is the drug of first choice). Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus; iritis, iridocyclitis; chorioretinitis; diffuse posterior uveitis and choroiditis; optic neuritis; sympathetic ophthalmia; anterior segment inflammation; allergic conjunctivitis; allergic corneal marginal ulcer; keratitis.
Gastrointestinal diseases: To tide the patient over a critical period of disease in: ulcerative colitis – (systemic therapy); regional enteritis – (systemic therapy).
Respiratory diseases: Symptomatic sarcoidosis; berylliosis; fulminating or disseminated pulmonary tuberculosis, when used concurrently with appropriate antituberculous chemotherapy; Loeffler’s syndrome not manageable by other means; aspiration pneumonitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia. Secondary thrombocytopenia in adults. Erythro-blastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia.
Neoplastic diseases: For palliative management of: leukemias and lymphomas in adults; acute leukemia of childhood.
Edematous state: To induce diuresis or remission of proteinuria in the nephritic syndrome, without uremia of the idiopathic type or that due to lupus erythematosus.
Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic myocardial involvement. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, the intra-articular or soft tissue administration is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis; rheumatoid arthritis; acute and subacute bursitis; acute gouty arthritis; epicondylitis; acute nonspecific tenosynovitis; post-traumatic osteoarthritis. When the strength and dosage form of the drug lend the preparation to the treatment of the condition, the intra-lesional administration is indicated for: keloids, localized hypertrophic, inflammatory lesions of lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis); discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata. this product may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

This product is contraindicated in systemic fungal infections. Patients hypersensitive to betamethasone sodium phosphate, betamethasone acetate, other corticosteroids, or to any component of this product.

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction must be gradual. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability, agitation or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. Corticosteroids should be used with caution in: nonspecific ulcerative colitis as there may be a risk of impending perforation, abscess or other pyogenic infection diverticulitis; fresh intestinal anastomoses; active or latent gastrointestinal ulcer; erosive esophagitis; renal insufficiency; hypertension; osteoporosis and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully followed. Corticosteroids should be used with caution in patients with diabetes mellitus. Corticosteroids increase glucose levels and may require modification of dosing for insulin and other antihyperglycemic medications. The following additional precautions also apply for parenteral corticosteroids. Intraarticular injection of a corticosteroid may produce systemic as well as local effects. Appropriate examination of any joint fluid present is necessary to exclude a septic process. A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted. Local injection of a steroid into a previously infected joint is to be avoided. The slower rate of absorption by intramuscular administration should be recognized.  Strict aseptic technique is mandatory in the use of this product. This product should be administered intramuscularly with caution to patients with idiopathic thrombocytopenic purpura. Intramuscular injections of corticosteroids should be given deep into large muscle masses to avoid local tissue atrophy. Corticosteroids should not be injected into unstable joints, infected areas or intervertebral spaces. Repeated injections into joints of osteoarthritis may increase joint destruction. Avoid injecting corticosteroids directly into the substance of tendons because delayed appearance of tendon rupture has resulted. Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice. This is of particular importance in children. Corticosteroids may alter the mobility and number of spermatozoa in some patients. Results from a single, multicenter, randomized, controlled study with another corticosteroid, methylprednisolone hemisuccinate, showed an increase of early mortality (at 2 weeks) and late mortality (at 6 months) in patients with cranial trauma who had received methylprednisolone, compared to placebo. The causes of mortality in the methylprednisolone group have not been established. Of note, this study excluded patients who were felt to have a clear indication for corticosteroids.

Depending on steroid, dose and length of treatment, glucocorticoid and mineralocorticoid side effects may be seen. These include suppression of growth in children, hypertension, sodium retention, GI effects, CNS disturbances, water retention, potassium loss, muscle weakness, aseptic necrosis of femoral and humeral heads, cushingoid changes, hyperglycemia, osteoporosis, depression, euphoria, peptic ulceration, posterior subcapsular cataracts, impaired wound healing, glaucoma with optical nerve damage, altered sperm motility, skin thinning, other skin reactions.
For full details see prescribing information.

Phenytoin, barbiturates, carbamazepine, aminoglutethimide, rifampicin. Thiazide and loop diuretics, cardiac glycosides, acetazolamide. Oral hypoglycemics, insulin. Antihypertensives, anabolic steroids, ophthalmic idoxuridine, NSAIDs, aspirin, other salicylates, coumarin anticoagulants, vaccines, estrogens.

Usage during pregnancy, lactation or in women of child-bearing potential: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Treatment of acute overdose is administration of symptomatic therapy, as appropriate.