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CELESTONE SOLUSPAN is a brand name for Betamethasone, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Intramuscular injection CELESTONE® SOLUSPAN® (betamethasone sodium phosphate and betamethasone acetate injectable suspension) is indicated in allergic, dermatologic, rheumatic, and other conditions responsive to systemic corticosteroids, including bursitis. Injection directly into the affected tissues CELESTONE®…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosage must be adjusted according to the severity of the condition, the response obtained, and the patient's tolerance to the corticosteroid. The initial dose should be maintained or adjusted until a satisfactory response is observed.
If a satisfactory clinical response does not occur after a reasonable period of time, treatment with CELESTONE® SOLUSPAN® should be discontinued and other appropriate therapy initiated. 2 Recommended Dose and Dosage Adjustment For system effect Treatment is initiated with 1 mL intramuscular in most conditions and repeated weekly, or more often, if necessary.
In severe illness, 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, intramuscular 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, intramuscular dosage is usually 1 to 2 mL at weekly intervals. Bursitis may be treated with intramuscular injections of 1 mL repeated weekly if necessary.
For local effect In acute bursitis (subdeltoid, subacromial and prepatellar), one intrabursal injection of 1 ml relieves pain and restores the 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 exacerbations of chronic bursitis.
Partial relief of pain and some increase in mobility may be expected in both conditions after 1 or 2 injections. In tendonitis, myositis, fibrositis, tenosynovitis, peritendonitis, and periarticular inflammatory conditions, 3 or 4 local 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 periarticular inflammatory conditions, the painful area should be infiltrated. 5 ml is injected directly 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.
1 Adverse Reaction Overview 05/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment.....................................................
4 Administration................................................................................................... 5 Missed Dose ......................................................................................................
6 5 OVERDOSAGE ............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS ..................................................................................
, Endocrine and Metabolism 05/2022
CELESTONE® SOLUSPAN® is contraindicated in patients: who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
with herpes simplex of the eye with systemic fungal infections with vaccinia CELESTONE® SOLUSPAN® (Betamethasone Sodium Phosphate and Betamethasone Acetate) Page 5 of 25 with cerebral malaria in idiopathic thrombocytopenia purpura when administered intramuscularly 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 corticosteroid regionally.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Using sterile technique, a 20 to 24 gauge needle on an empty 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 the syringe containing CELESTONE® SOLUSPAN® and the injection is then made into the joint (see Table 1).
0 CELESTONE® SOLUSPAN® (Betamethasone Sodium Phosphate and Betamethasone Acetate) Page 6 of 25 Pain with intra-articular injection of CELESTONE® SOLUSPAN® has not been a problem. However, should the physician want to administer it with a local anaesthetic, it can be mixed in the syringe with an equal volume of 1% or 2% lidocaine hydrochloride, procaine hydrochloride, or similar local anesthetics using formulations which do not contain parabens.
Anesthetics containing methylparaben, propylparaben, phenol, etc. should be avoided. 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 is shaken briefly.
Do not inject local anaesthetic 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.
) per cm2 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. 5 mL are recommended. 5 to 1 mL are recommended. 4 Administration Suspension for injection. Shake well before using. Intramuscular injections of corticosteroids should be given deep into large muscle masses to avoid local tissue atrophy.
5 Missed Dose If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
5 CELESTONE® SOLUSPAN® (Betamethasone Sodium Phosphate and Betamethasone Acetate) Page 7 of 25
1 Special Populations .......................................................................................... 1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................
3 Pediatrics ................................................................................................... 12 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview.............................................................................. 12 9 DRUG INTERACTIONS................................................................................................ 3 Drug-Behavioural Interactions..........................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 16 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics....................................................................................... 16 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
16 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 16 PART II: SCIENTIFIC INFORMATION ......................................................................................
17 13 PHARMACEUTICAL INFORMATION............................................................................ 17 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication.......................................................................... 17 15 MICROBIOLOGY ........................................................................................................ 17 16 NON-CLINICAL TOXICOLOGY .....................................................................................
17 PATIENT MEDICATION INFORMATION ................................................................................. 18 CELESTONE® SOLUSPAN® (Betamethasone Sodium Phosphate and Betamethasone Acetate) Page 4 of 25 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Intramuscular injection CELESTONE® SOLUSPAN® (betamethasone sodium phosphate and betamethasone acetate injectable suspension) is indicated in allergic, dermatologic, rheumatic, and other conditions responsive to systemic corticosteroids, including bursitis.
Injection directly into the affected tissues CELESTONE® SOLUSPAN® (betamethasone sodium phosphate and betamethasone acetate injectable suspension) is indicated in bursitis and associated inflammatory disorders of tendons such as tenosynovitis, and inflammatory disorders of muscle such as fibrosis and myositis.
Intra-articular and periarticular injection CELESTONE® SOLUSPAN® (betamethasone sodium phosphate and betamethasone acetate injectable suspension) is indicated in rheumatoid arthritis and osteoarthritis. Intralesional injection CELESTONE® SOLUSPAN® (betamethasone sodium phosphate and betamethasone acetate injectable suspension) is indicated in various dermatologic conditions.
Local injection CELESTONE® […]