Betamethasone Sodium Phosphate and
Betamethasone Acetate
Injectable Suspension, USP

  • AB-Rated to Celestone® Soluspan®*
  • Vial closure is not made with natural rubber latex




NDC Number
Strength
Size
Shelf Pack
Availability
Product Information
Arrow Up 0517-0720-01 6 mg/mL
(3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate)
5 mL*
Multiple Dose Vial
1 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Preserved with:
  • 0.01% Edetate Disodium
  • 0.02% Benzalkonium Chloride
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10009255 4299483 2324275 1973130 048793
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0517-0720-01 Varies 80 17 cases


*Celestone® and Soluspan® are registered trademarks of Schering Corp.


NDC Number
Arrow Up 0517-0720-01
Strength
6 mg/mL
(3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate)
Size
5 mL*
Multiple Dose Vial
Shelf Pack
1
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10009255 4299483 2324275 1973130 048793
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
- - - -


*Celestone® and Soluspan® are registered trademarks of Schering Corp.


Rx Only INDICATIONS The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. WARNINGS
Serious Neurologic Adverse Reactions with Epidural Administration
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP should not be administered intravenously or used in systemic 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. Vaccination administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infections. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles and to seek medical advice without delay if exposed. ADVERSE REACTIONS As with any potent corticosteroid, adverse events have been associated with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, including fluid and electrolyte disturbances, as well as adverse reactions involving the following: allergic reactions, cardiovascular, dermatologic, endocrine, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, and ophthalmic. Corticosteroids may also affect immune response. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.










Rx Only INDICATIONS The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. WARNINGS
Serious Neurologic Adverse Reactions with Epidural Administration
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP should not be administered intravenously or used in systemic 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. Vaccination administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids and to seek medical advice at once should they develop fever or other signs of infections. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles and to seek medical advice without delay if exposed. ADVERSE REACTIONS As with any potent corticosteroid, adverse events have been associated with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, including fluid and electrolyte disturbances, as well as adverse reactions involving the following: allergic reactions, cardiovascular, dermatologic, endocrine, gastrointestinal, metabolic, musculoskeletal, neurological/psychiatric, and ophthalmic. Corticosteroids may also affect immune response. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy.


© 2017, American Regent, Inc., A Luitpold Pharmaceuticals, Inc. Company
PP-AS-US-0014     4/2017