Presentation and Status in Health Basket
1 X 1 ml
1 X 2 ml
DOSING REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE SPECIFIC DISEASE, THE SEVERITY OF THE CONDITION AND THE RESPONSE OF THE PATIENT.
The initial dose should be maintained or adjusted until a satisfactory response is observed. If a satisfactory clinical response does not occur after a reasonable period of time, treatment should be discontinued and other appropriate therapy initiated. Systemic Administration: For systemic therapy, treatment is initiated with 1 to 2 ml in most conditions and repeated as necessary. Administration is by deep intramuscular (IM) injection in the gluteal region. Dosage and frequency of administration will depend on the severity of the patient’s condition and the therapeutic response. In a severe illness, such as lupus erythematosus or status asthmaticus which has been resolved by appropriate life-saving procedures, 2 ml might be required initially. A wide variety of dermatologic conditions respond to IM injections of corticosteroids. An IM injection of 1 ml, repeated according to the response of the condition, has been found to be effective. In respiratory tract disorders, onset of relief of symptoms has occurred within a few hours after IM injection. Effective control of symptoms with 1 to 2 ml is obtained in bronchial asthma, hay fever, allergic bronchitis and allergic rhinitis. In the treatment of acute or chronic bursitis, excellent results are obtained with 1 to 2 ml IM injection, repeated as necessary. Local Administration: Concomitant use of local anesthetic is rarely necessary. If coadministration of a local anesthetic is desired, this product may be mixed (in the syringe) with 1% or 2% procaine hydrochloride or lidocaine, using formulations which do not contain parabens. Similar local anesthetics may also be used. Anesthetics containing methylparaben, propylparaben, phenol, etc. should be avoided. The required dose is first withdrawn into the syringe. The local anesthetic is then drawn in, and the syringe is shaken briefly. In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, an intrabursal injection of 1 to 2 ml may relieve pain and restore full range of movement within a few hours. Chronic bursitis may be treated with reduced dosage once acute symptoms are controlled. In acute tenosynovitis, tendinitis, and peritendinitis, one injection of should alleviate the condition. In chronic forms of these conditions, it may be necessary to repeat the injections as the patient’s condition requires. Following 0.5 to 2 ml intra-articular administration, relief of pain, soreness, and stiffness associated with rheumatoid arthritis and osteoarthritis may be experienced within two to four hours. Duration of relief, which varies widely in both diseases, is four or more weeks in the majority of cases. An intra-articular injection is well tolerated in the joint and peri-articular tissues. Recommended doses for intra-articular injection are: large joints (knee, hip, shoulder), 1 – 2 ml; medium joints (elbow, wrist, ankle), 0.5 – 1 ml; small joints (foot, hand, chest), 0.25 – 0.5 ml. Dermatologic conditions may respond to intralesional administration. An intradermal dosage of 0.2 ml/cm2 evenly injected with a tuberculin syringe and a 26-gauge needle is recommended. The total amount injected at all sites each week should not exceed 1 ml. This product may be used effectively in disorders of the foot that are responsive to corticosteroids. Bursitis under heloma durum may be controlled with two successive injections of 0.25 ml each. In some conditions such as hallux rigidus, digiti quinti varus and acute gouty arthritis, onset of relief may be rapid. A tuberculin syringe with a 25-gauge needle is suitable for most injections. Recommended doses at intervals of approximately one week: bursitis under heloma durum or molle, 0.25 – 0.5 ml; bursitis under calcaneal spur, 0.5 ml; bursitis over hallux rigidus, 0.5 ml; bursitis over digiti quinti varus, 0.5 ml; synovial cyst, 0.25 – 0.5 ml; Morton’s neuralgia (metatarsalgia), 0.25 – 0.5 ml; tenosynovitis, 0.5 ml; periostitis of cuboid, 0.5 ml; acute gouty arthritis, 0.5 – 1 ml. After a favorable response is obtained, the proper maintenance dosage should be determined by decreasing the initial dose in small decrements at appropriate time intervals until the lowest dose which will maintain an adequate clinical response is determined. Exposure of the patient to stressful situations unrelated to the existing disease may necessitate an increased dose. If the drug is to be discontinued after long-term therapy, the dose should be decreased gradually.
This product is indicated for the treatment of acute and chronic corticosteroid-responsive disorders such as the following conditions:
Musculoskeletal and Soft Tissue Conditions: Rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccydynia, torticollis, sciatica, lumbago, ganglion cyst, exostosis, fasciitis.
Allergic Conditions: Chronic bronchial asthma (including adjunctive therapy for status asthmaticus), hay fever, angioneurotic edema, allergic bronchitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness, insect bites.
Dermatologic Conditions: Atopic dermatitis (nummular eczema), neurodermatitis (circumscribed lichen simplex), necrobiosis lipoidica diabeticorum, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus, dermatitis herpetiformis, urticaria, hypertrophic lichen planus, contact dermatitis, severe solar dermatitis, cystic acne.
Collagen Diseases: Disseminated lupus erythematosus, scleroderma, dermatomyositis, polyarteritis nodosa.
Neoplastic Diseases: For palliative management of leukemias and lymphomas in adults; acute leukemia of childhood.
Other Conditions: Adrenogenital syndrome, ulcerative colitis, regional ileitis, sprue, podiatric conditions (bursitis under heloma durum, hallux rigidus, digiti quinti varus), disorders requiring subconjunctival injection, corticosteroid-responsive blood dyscrasias, nephritis and nephrotic syndrome. Primary or secondary adrenocortical insufficiency may be treated with this product but should be supplemented with mineralocorticoids. This product is recommended for: Intramuscular injection in conditions responsive to systemic corticosteroids, Injection directly into the affected soft tissues where indicated, Intra-articular and peri-articular injection in arthritis, Intralesional injection in various dermatologic conditions, Local injection in certain inflammatory and cystic disorders of the foot and soft tissue.
As with other corticosteroids, this product is contra-indicated in patients with systemic fungal infections, in patients hypersensitive to betamethasone dipropionate, betamethasone sodium phosphate, other corticosteroids, or to any component of this product. This product is not to be administered intramuscularly to patients with idiopathic thrombocytopenic purpura.
This product is not for intravenous or subcutaneous use. Strict aseptic technique is mandatory in use of this product. Dosage adjustments may be required for remissions or exacerbations of the disease process, the patient’s individual response to therapy and exposure of the patient to stress, e.g. serious infection, surgery or injury. Following cessation of long-term or high-dose corticosteroid therapy, monitoring may be necessary for up to one year. Drug-induced secondary adrenocortical insufficiency may result from too rapid corticosteroid withdrawal and may be minimized by gradual dose reduction. The lowest possible dose of corticosteroid should be used to control the condition under treatment. When dose reduction is possible, the reduction should be gradual. This product contains two betamethasone esters, one of which, betamethasone sodium phosphate, disappears rapidly from the injection site. The potential for systemic effect produced by this soluble portion of DIPROSPAN Suspension should therefore be taken into account by the physician when using this preparation. Corticosteroid effect is enhanced in patients with hypothyroidism and in those with cirrhosis. Cautious use of 5 corticosteroids is advised in patients with ocular herpes simplex. Corticosteroids may aggravate existing emotional instability or psychotic tendencies. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. 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; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Since complications of glucocorticoid treatment are dependent on dose size and duration of treatment, a risk/benefit decision must be made in each individual case. Corticosteroids may mask signs of infection. Prolonged corticosteroid use may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Elevation of blood pressure, and salt and fluid retention and increased potassium excretion are less likely to occur with the synthetic derivatives, except when used in large doses. While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients receiving corticosteroids, especially high doses. Corticosteroid therapy in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis, close observation is necessary. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Growth and development of infants and children on prolonged corticosteroid therapy should be followed carefully. Corticosteroid therapy may alter the motility and number of spermatozoa.
For full details see prescribing information.
Adverse reactions can usually be reversed or minimized by a reduction in dosage; this is generally preferable to withdrawal of drug treatment. Although the incidence of adverse reactions to this product has been low, the possible occurrence of the known side effects with corticosteroid use should be considered: fluid and electrolyte, musculoskeletal, gastrointestinal, dermatologic, neurologic, endocrine, ophthalmic, metabolic and psychiatric disturbances. Adverse reactions relate both to dose and to duration of therapy. 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; post-injection flare (following intra-articular use); Charcot-like arthropathy.
For full details see prescribing information.
Concurrent use of phenobarbital, rifampin, phenytoin or ephedrine may enhance corticosteroid metabolism, thus reducing therapeutic effects. Excessive corticosteroid effects may occur in patients receiving both a corticosteroid and an estrogen. Concurrent use of corticosteroids with potassium-depleting diuretics may enhance hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B. Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects, possibly requiring adjustment in dosage. Combined effects of nonsteroidal anti-inflammatory drugs or alcohol with glucocorticoids may result in an increased occurrence or increased severity of gastrointestinal ulceration. Corticosteroids may decrease blood salicylate concentrations. When corticosteroids are given to diabetics, dosage adjustments of the antidiabetic drug may be necessary. Concomitant glucocorticoid therapy may inhibit the response to somatotropin.
For full details see prescribing information.
Pregnancy and Lactation
The use of corticosteroids during pregnancy, in nursing mothers, or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and fetus or infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. 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.