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P: 877-845-6371For Intramuscular Use. For intra-articular or soft tissue administration.
For intralesional administration. INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for specific diseases in the following categories:
Allergic States; Dermatologic Diseases; Endocrine Disorders; Gastrointestinal Diseases; Hematologic Disorders; Neoplastic Diseases; Nervous System; Ophthalmic Diseases; Renal Diseases; Respiratory Diseases; Rheumatic Disorders Miscellaneous; Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. WARNINGS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension should not be administered intravenously. Serious Neurologic Adverse Reactions with Epidural Administration
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. General
Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Cardio-renal
Therapy with corticosteroids should be used with great caution in these patients. Endocrine
Corticosteroids can produce reversible hypothalamic pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Infections General
Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. Fungal Infections
Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions. Special Pathogens
Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens. Tuberculosis
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. Vaccination
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Viral Infections
Chickenpox and measles can have a more serious or even fatal course in patients on corticosteroids. Neurologic
Reports of severe medical events have been associated with the intrathecal route of administration. Ophthalmic
Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections. PRECAUTIONS General
The lowest possible dose of corticosteroid should be used to control the condition under treatment. A risk/benefit decision must be made in each individual case as to dose and duration of treatment.
Kaposi’s sarcoma has been reported in patients receiving corticosteroid therapy, most often for chronic conditions. Cardio-renal
These agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine
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. Gastrointestinal
Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.
There is an enhanced effect of corticosteroids in patients with cirrhosis. Intra-Articular and Soft Tissue Administration
Intra-articular injected corticosteroids may be systemically absorbed.
Appropriate examination of any joint fluid present is necessary to exclude a septic process.
Injection of a steroid into an infected site is to be avoided. Local injection of a steroid into a previously injected joint is not usually recommended. Corticosteroid injection into unstable joints is generally not recommended. Intra-articular injection may result in damage to joint tissues. Musculoskeletal
Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation and inhibition of osteoblast function. Neuro-psychiatric
An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission, or in patients receiving concomitant therapy with neuromuscular blocking drugs. Psychic derangements may appear when corticosteroids are used or be aggravated by corticosteroids. Ophthalmic
Intraocular pressure may become elevated. Drug Interactions
Drug interactions could occur with the following:
Aminoglutethimide; Amphotericin B Injection and Potassium-Depleting Agents; Macrolide Antibiotics; Anticholinesterases; Warfarin; Antidiabetics; Isoniazid; Cholestyramine; Cyclosporine; Digitalis Glycosides; Estrogens, Including Oral Contraceptives; Hepatic Enzyme Inducers; Ketoconazole; Nonsteroidal Anti-inflammatory Agents; Skin Tests; Vaccines Pregnancy: Teratogenic Effects: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Nursing Mothers: Use caution when corticosteroids are administered to a nursing woman.
Pediatric Patients: In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose. ADVERSE REACTIONS Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness, suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels, hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis. Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intraarticular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration. Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections. Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. OVERDOSAGE
Treatment of acute overdose is by supportive and symptomatic therapy. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236
or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.