Celestone Soluspan (Betamethasone Sodium Phosphate – Betamethasone Acetate)



Betamethasone Sodium Phosphate – Betamethasone Acetate

Injectable Glucocorticoid

Indications And Clinical Uses: (1) I.M. injection in allergic, dermatologic, rheumatic, and other conditions responsive to systemic corticosteroids, including bursitis; (2) injection directly into the affected tissues in bursitis and associated inflammatory disorders of tendons such as tenosynovitis, and inflammatory disorders of muscle such as fibrositis and myositis; (3) intra-articular and periarticular injection in rheumatoid arthritis and osteoarthritis; (4) intralesional injection in various dermatologic conditions; and (5) local injection in certain inflammatory and cystic disorders of the foot.

Contra-Indications: Herpes simplex of the eye. Regional corticosteroid therapy is contraindicated in areas that are locally infected, although infection elsewhere in the body is not a contraindication to the use of corticosteroids regionally.

Precautions: See Celestone oral preparations. Following intra-articular injection, a portion of the administered dose of Celestone Soluspan is absorbed systemically. In patients being treated concomitantly with peroral or parenteral corticosteroids, especially those receiving large doses, the systemic absorption of the drug should be considered in determining intra-articular dosage.

Adverse Reactions: See Celestone oral preparations. There have been a few cases of crystal deposition but no reports of dimpling of the skin after intradermal injection. Nevertheless, because dimpling of the skin is attributable to atrophy of subcutaneous fat and is seen with other injectable corticosteroids, s.c. injection should be avoided. Gastrointestinal side effects have not been reported, nor has pain or the “secondary flare” which sometimes occur after intra-articular injection of corticosteroids.

Dosage And Administration: Shake well before using. Dosage must be adjusted according to the severity of the condition, the response obtained, and the patient’s tolerance of the corticosteroid. For systemic effect, treatment is initiated with 1 mL i.m. in most conditions and repeated weekly, or more often, if necessary. In severe illnesses such as status asthmaticus or disseminated lupus erythematosus, 2 mL might be required initially. In dermatologic disorders, including neurodermatitis, psoriasis, hypertrophic lichen planus, lichen simplex, eczema, contact dermatitis, and dermatitis medicamentosa, i.m. dosage is usually 1 mL at intervals of 3 days to a week. In respiratory tract disorders, including bronchial asthma, hay fever, allergic bronchitis, and perennial allergic rhinitis, i.m. dosage is usually 1 to 2 mL at weekly intervals. Bursitis may be treated with i.m. injections of 1 mL repeated weekly if necessary.

For local effect, in acute bursitis, 1 intrabursal injection of 1 mL may relieve pain and restore full range of movement in a few hours. Several intrabursal injections at intervals of 1 to 2 weeks are usually required in recurrent acute bursitis and in acute bursitis superimposed on chronic bursitis. Partial relief of pain and some increase in mobility may be expected in both conditions after 1 or 2 injections. In tenosynovitis and tendinitis, 3 or 4 injections of 1 mL each at intervals of 1 to 2 weeks between injections are given in most cases. Injection should be made into the affected tendon sheaths rather than into the tendons themselves. In ganglions of joint capsules and tendon sheaths, 0.5 mL is injected into the ganglion cysts. In rheumatoid arthritis and osteoarthritis, relief of pain, soreness, and stiffness may be experienced in 2 to 4 hours after intra-articular injection. Using sterile technique, a 20 to 24 gauge needle on a syringe for aspiration is inserted into the synovial cavity, and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint. The aspirating syringe is replaced by a syringe containing Celestone Soluspan, and injection is then made into the joint.

Pain with intra-articular injection of Celestone Soluspan has not been a problem. However, should the physician want to administer it with a local anesthetic, it can be mixed in the syringe with an equal volume of 1% procaine HCl or of 1% lidocaine HCl before injection. The required dose of Celestone Soluspan is first withdrawn from the vial into the syringe. The local anesthetic is then drawn in, and the syringe shaken briefly. Do not inject local anesthetics into the vial of Celestone Soluspan.

Dermatologic conditions that have responded to intralesional treatment with Celestone Soluspan include: localized neurodermatitis, psoriasis, nummular eczema, alopecia areata, hypertrophic lichen planus, circumscribed lichen simplex, keloids, and chronic discoid lupus erythematosus. In intralesional treatment, 0.2 mL of Celestone Soluspan is injected intradermally (not s.c.) per square centimeter of lesion using a tuberculin syringe with a 25 gauge, 13 mm needle. Care should be taken to deposit a uniform depot of medication intradermally. A total of no more than 1 mL at weekly intervals is recommended.

Disorders of the foot responsive to corticosteroids injected locally: For most injections into the foot, a tuberculin syringe with a 25 gauge, 2 cm needle is used. Treatment is given at intervals of 3 days to a week. In bursitis under heloma durum (hard corn), bursitis under heloma molle (soft corn), synovial cysts, and Morton’s neuralgia (metatarsalgia) 0.25 to 0.5 mL are recommended. For bursitis under calcaneal spurs, bursitis over hallux rigidis (flexion deformity of the great toe), bursitis over digiti quinti varus (inward deviation of the fifth toe), tenosynovitis, and periostitis of the cuboid, 0.5 mL is recommended; in acute gouty arthritis, 0.5 to 1 mL are recommended.

Availability And Storage: Each mL of aqueous suspension contains: betamethasone acetate USP 3 mg and betamethasone sodium phosphate USP equivalent to 3 mg betamethasone USP. Nonmedicinal ingredients: benzalkonium chloride, disodium edetate, sodium phosphate dibasic and sodium phosphate monobasic. Vials of 1 mL. Boxes of 10 and multiple dose vials of 5 mL. Store between 2 and 25°C. Protect from light.

CELESTONE® SOLUSPAN®Schering Betamethasone Sodium Phosphate – Betamethasone Acetate Injectable Glucocorticoid

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