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FAST-ACTING & LONG-LASTING Sodium Phosphate & Betamethasone * Injectable Suspension, USP

Product Name Fast-Acting Long-Lasting

Betamethasone Sodium Phosphate & Betamethasone Acetate* P P Injectable Suspension, USP Dual- Kenalog® Agent ( Acetonide) X Injectable Suspension, USP P

Depo-Medrol® ( Acetate X Injectable Suspension, USP) P

Kenalog® is a registered trademark of Bristol-Myers Squibb. Depo-Medrol® is a registered trademark of Pfizer Inc.

® Please see reverse side for Important Safety Information A Dual-Agent Corticosteroid for Betamethasone Has One of the Highest Painful Inflammatory Conditions Anti-Inflammatory Potencies per mg†

Your patients don’t need to wait hours for relief! • Begins to reduce inflammation in 1-2 hours • Provides sustained relief • High anti-inflammatory potency† † • Minimal sodium-retaining potency Free Ester Preparations Anti-Inflammatory Equivalent Dose Sodium-Retaining Plasma Half-life Biologic Half-life • Long plasma & biological half-life Potency (mg)** Potency (min) (hr) 0.8 25 2+ 30 8 – 12 1 20 2+ 90 8 – 12 Recommended Doses for Intra-articular injection of Betamethasone 4 5 1+ 60 12 – 36 Sodium Phosphate & Betamethasone Acetate* Methylprednisolone 5 4 0 180 12 – 36 Size of Joint Location Dose (mL) Triamcinolone 5 4 0 300 12 – 36 Very Large Hip 1 –­ 2 Large Knee, Ankle, Shoulder 1 Betamethasone 20 – 30 0.75 0 100 – 300 36 – 54 Medium Elbow, Wrist 0.5 –­ 1 Small Hand, Chest 0.25 –­ 0.5 †Comparison of anti-inflammatory potency only; no suggestion of superior efficacy or safety intended (metacarpophalangeal, interphalangeal, **These dose relationships apply only to oral or intravenous administration of these compounds. When these substances sternoclavicular) are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate* Injectable Suspension is absorbed systemically following intra-articular injection. In patients being treated concomitantly with oral or parenteral cort- McKesson Cardinal Amerisource- costeroids, especially those receiving large doses, the systemic absorption of the drug should be considered in determining Strength Size Shelf Pack intra-articular dosage. For additional dosing information please refer to package insert. Item # Item # Bergen Item # 6 mg/mL 5 mL The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate* Injectable (3 mg/mL Betamethasone 1 1973130 4299483 080061 Suspension, USP is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or Sodium Phosphate and 3 mg/mL Multiple exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, Betamethasone Acetate*) Dose Vial rheumatoid arthritis, synovitis of osteoarthritis.

Please see reverse side for Important Safety Information and Full Prescribing Information enclosed in pocket. NDC 0517- 0720-01 HCPCS “J” Code: J0702 • First and only AB-rated, therapeutically-equivalent generic to Celestone® Soluspan® • NDC 0517-0720-01 • J Code 0702

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

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

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

Serious neurologic events, some resulting in death, have been reported with epidural injection of . 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.

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, ophthalmic and other. 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.

Please see Full Prescribing Information enclosed in pocket ®

BB033 Rev. 8/2014

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