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Betamethasone Sodium Phosphate & Betamethasone Acetate Injectable Suspension, USP*

*Betamethasone 6 mg/mL as 3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate. 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 (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: 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 systems: 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. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP should not be administered intravenously or used in systemic fungal infections. 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.

DOES YOUR PATIENT NEED TO WAIT DAYS FOR RELIEF? Betamethasone Sodium Phosphate & Betamethasone Acetate Injectable Suspension, USP

Depo-Medrol® is a registered trademark of Pfizer, Inc. Kenalog® is a registered trademark of Apothecon, Inc. †

Adapted from Garber, Targoff C, Paulus HE: Glucocorticoid preparations. In Paulus HE, Furst DE, Droomgoole SH (eds): Drugs for Rheumatic Diseases. New York, Churchill Livingstone, 1987, p 446.

Full prescribing information enclosed. BB021, Iss. 5/2011

One Luitpold Drive | PO Box 9001 | Shirley, NY 11967 | 800-645-1706 | www.americanregent.coM

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 (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.


Betamethasone Sodium Phosphate & Betamethasone Acetate Injectable Suspension, USP

Free Ester Glucocorticoid Preparations†

Benefits of a dual agent corticosteroid for painful inflammatory conditions1

1

Betamethasone has one of the highest anti-inflammatory potencies

Anti-Inflammatory Potency

Equivalent Dose (mg)

Sodium-Retaining Potency

Plasma Half-life (min)

Biologic Half-life (hr)

0.8

25

2+

30

8 – 12

Hydrocortisone

1

20

2+

90

8 – 12

Prednisone

4

5

1+

60

12 – 36

Prednisolone

4

5

1+

200

12 – 36

Methylprednisolone

5

4

0

180

12 – 36

Triamcinolone

5

4

0

300

12 – 36

Dexamethasone

20 – 30

0.75

0

100 – 300

36 – 54

Betamethasone

20 – 30

0.75

0

100 – 300

36 – 54

Cortisone

Knee joint with inflamed tissues immediately after injection

2

Within 1 – 2 hours after injection, the fast acting BSP begins to reduce pain and inflammation, while the less soluble BA rests in the intra-articular space

(Comparison of anti-inflammatory potency only; no suggestion of superior efficacy or safety intended) • High Anti-Inflammatory Potency

• Minimal Sodium-Retaining Potency

• Low Equivalent Dose

• Long Plasma & Biological Half-Life

Fast Acting and Long Lasting Formulation in 1 Product

3

3

Days after injection, as the fast acting BSP is converted into FEB, the long lasting BA solubilizes, and continues to reduce pain and inflammation

Betamethasone Sodium Phosphate & Betamethasone Acetate Injectable Suspension, USP

4

A week after injection, both the BSP and BA have converted into biologically active FEB for continuing pharmacological activity

Kenalog® (Triamcinolone Acetonide) Injectable Suspension, USP

Depo-Medrol® (Methylprednisolone Acetate Injectable Suspension, USP)

Dexamethasone Sodium Phosphate Injection, USP

Your patients don’t need to wait days for relief! • Fast acting - Begins to reduce inflammation in 1-2 hours • Long lasting - Provides sustained relief

LEGEND Betamethasone Sodium Phosphate (BSP) Betamethasone Acetate (BA) Free Ester Betamethasone (FEB)

1

Duration of relief varies among labeled indications.


Betamethasone Sodium Phosphate & Betamethasone Acetate Injectable Suspension, USP*

*Betamethasone 6 mg/mL as 3 mg/mL Betamethasone Sodium Phosphate and 3 mg/mL Betamethasone Acetate. 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 (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: 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 systems: 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. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP should not be administered intravenously or used in systemic fungal infections. 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.

DOES YOUR PATIENT NEED TO WAIT DAYS FOR RELIEF? Betamethasone Sodium Phosphate & Betamethasone Acetate Injectable Suspension, USP

Depo-Medrol® is a registered trademark of Pfizer, Inc. Kenalog® is a registered trademark of Apothecon, Inc. †

Adapted from Garber, Targoff C, Paulus HE: Glucocorticoid preparations. In Paulus HE, Furst DE, Droomgoole SH (eds): Drugs for Rheumatic Diseases. New York, Churchill Livingstone, 1987, p 446.

Full prescribing information enclosed. BB021, Iss. 5/2011

One Luitpold Drive | PO Box 9001 | Shirley, NY 11967 | 800-645-1706 | www.americanregent.coM

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 (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.

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