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Betamethasone Sodium Phosphate and Betamethasone Acetate
Overview
What is ReadySharp Betamethasone?
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is a sterile aqueous suspension containing betamethasone 3 mg per milliliter as betamethasone sodium phosphate, and betamethasone acetate 3 mg per milliliter. Inactive ingredients per mL: dibasic sodium phosphate 7.1 mg; monobasic sodium phosphate 3.4 mg; edetate disodium 0.1 mg; and benzalkonium chloride 0.2 mg as a preservative. The pH is adjusted to between 6.8 and 7.2.
The formula for betamethasone sodium phosphate is C
H
FNa
O
P and it has a molecular weight of 516.40. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate).
The formula for betamethasone acetate is C
H
FO
and it has a molecular weight of 434.50. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-acetate.
The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows:
Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic. It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.
Betamethasone acetate is a white to creamy white, odorless powder that sinters and resolidifies at about 165ºC, and remelts at about 200ºC to 220ºC with decomposition. It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform.
What does ReadySharp Betamethasone look like?
What are the available doses of ReadySharp Betamethasone?
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What should I talk to my health care provider before I take ReadySharp Betamethasone?
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How should I use ReadySharp Betamethasone?
When oral therapy is not feasible, the
of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows:
Allergic States
Dermatologic Diseases
Endocrine Disorders
Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance.
Gastrointestinal Diseases
Hematologic Disorders
Miscellaneous
Neoplastic Diseases
Nervous System
Ophthalmic Diseases
Renal Diseases
Respiratory Diseases
Rheumatic Disorders
The
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.
The
of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum.
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Benzyl alcohol as a preservative has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight. Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant. The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9 mg per day depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.
It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient.
In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended (see
section).
In pediatric patients, the initial dose of betamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m
bsa/day).
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.
If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens. Similar local anesthetics may also be used. Diluents containing methylparaben, propylparaben, phenol, etc., should be avoided, since these compounds may cause flocculation of the steroid. The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe. The local anesthetic is then drawn in, and the syringe shaken briefly.
What interacts with ReadySharp Betamethasone?
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What are the warnings of ReadySharp Betamethasone?
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What are the precautions of ReadySharp Betamethasone?
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What are the side effects of ReadySharp Betamethasone?
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What should I look out for while using ReadySharp Betamethasone?
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product.
Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
What might happen if I take too much ReadySharp Betamethasone?
Treatment of acute overdose is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
How should I store and handle ReadySharp Betamethasone?
Store in the closed original carton to protect from light until ready for injection. Store in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Discard if frozen. Once removed from the refrigerator, PLEGRIDY should be allowed to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm PLEGRIDY. If refrigeration is unavailable, PLEGRIDY may be stored between 2°C to 25°C (36°F to 77°F) for a period up to 30 days, protected from light. PLEGRIDY can be removed from, and returned to, a refrigerator if necessary. The total combined time out of refrigeration, within a temperature range of 2°C to 25°C (36°F to 77°F), should not exceed 30 days. Store in the closed original carton to protect from light until ready for injection. Store in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Discard if frozen. Once removed from the refrigerator, PLEGRIDY should be allowed to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm PLEGRIDY. If refrigeration is unavailable, PLEGRIDY may be stored between 2°C to 25°C (36°F to 77°F) for a period up to 30 days, protected from light. PLEGRIDY can be removed from, and returned to, a refrigerator if necessary. The total combined time out of refrigeration, within a temperature range of 2°C to 25°C (36°F to 77°F), should not exceed 30 days. Store in the closed original carton to protect from light until ready for injection. Store in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Discard if frozen. Once removed from the refrigerator, PLEGRIDY should be allowed to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm PLEGRIDY. If refrigeration is unavailable, PLEGRIDY may be stored between 2°C to 25°C (36°F to 77°F) for a period up to 30 days, protected from light. PLEGRIDY can be removed from, and returned to, a refrigerator if necessary. The total combined time out of refrigeration, within a temperature range of 2°C to 25°C (36°F to 77°F), should not exceed 30 days. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, 5 mL multiple dose vial; box of one: NDC 0517-0720-01SHAKE WELL BEFORE USING.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Rx onlyAMERICANREGENT, INC.SHIRLEY, NY 11967Revised September 2015
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems. A derivative of prednisolone, betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium- and water-retaining properties of the fluorine atom bound at carbon 9.
Betamethasone sodium phosphate, a soluble ester, provides prompt activity, while betamethasone acetate is only slightly soluble and affords sustained activity.
Non-Clinical Toxicology
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.
The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.
Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.
(listed alphabetically, under each subsection)
Allergic Reactions
Anaphylactoid reaction, anaphylaxis, angioedema.
Cardiovascular
Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic
Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.
Endocrine
Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.
Fluid and Electrolyte Disturbances
Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.
Gastrointestinal
Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.
Metabolic
Negative nitrogen balance due to protein catabolism.
Musculoskeletal
Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.
Neurologic/Psychiatric
Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration (see section).
Ophthalmic
Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections.
Other
Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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