Trade Name: Methylprednisolone acetate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 40 mg/mL

Storage and handling

METHYLPREDNISOLONE ACETATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Methylprednisolone acetate (Methylprednisolone acetate) which is also known as Methylprednisolone acetate and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 40 mg/mL.

Methylprednisolone acetate (Methylprednisolone acetate) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Methylprednisolone acetate injectable suspension, USP is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. It is available as single-dose vials in two strengths: 40 mg/mL, 80 mg/mL.
  • Each mL of these preparations contains:
  • Sodium chloride was added to adjust tonicity.
  • When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
  • The pH of the finished product remains within the USP specified range (e.g., 3.0 to 7.0).
  • The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6u03b1,11u03b2)- and the molecular weight is 416.51. The structural formula is represented below:
  • Methylprednisolone acetate injectable suspension, USP contains methylprednisolone acetate, USP which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate, USP is a white or almost white crystalline powder which melts at about 213u00b0 with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.
  • Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids.
  • Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogs are used primarily for their anti-inflammatory effects in disorders of many organ systems.
  • A. For Intramuscular Administration
  • When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows:
  • Allergic States
  • Dermatologic Diseases
  • Endocrine Disorders
  • Gastrointestinal Diseases
  • Hematologic Disorders
  • Miscellaneous
  • Neoplastic Diseases
  • Nervous System
  • Ophthalmic Diseases
  • Renal Diseases
  • Respiratory Diseases
  • Rheumatic Disorders
  • B. For Intra-articular Or Soft Tissue Administration
  • (n- Array
  • Methylprednisolone 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.
  • C. For Intralesional Administration
  • Methylprednisolone acetate injectable suspension is indicated for intralesional use in 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.
  • Methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
  • Methylprednisolone acetate injectable suspension is contraindicated in patients with known hypersensitivity to the product and its constituents.
  • Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.Methylprednisolone acetate injectable suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route.
  • Methylprednisolone acetate injectable suspension is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see ).
  • Serious Neurologic Adverse Reactions with Epidural Administration
  • Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. 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.
  • General
  • This product is not suitable for multi-dose use. Following administration of the desired dose, any remaining suspension should be discarded.
  • Injection of methylprednisolone acetate may result in dermal and/or subdermal changes forming depressions in the skin at the injection site.
  • In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intra-articular and intramuscular injection should include precautions against injection or leakage into the dermis. Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy.
  • It is critical that, during administration of methylprednisolone acetate, appropriate technique be used and care taken to ensure proper placement of drug.
  • Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ).
  • Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation.
  • Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including methylprednisolone acetate, should not be used for the treatment of traumatic brain injury.
  • Cardio-renal
  • Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with synthetic derivatives when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
  • Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.
  • Endocrine
  • Hypothalamic-pituitary adrenal (HPA) axis suppression. Cushingu2019s syndrome, and Hyperglycemia: Monitor patients for these conditions with chronic use.
  • Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
  • Infections
  • Arrayn- General
  • Persons who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infections with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents.
  • These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of an acute infection. Corticosteroids may mask some signs of infection and new infections may appear during their use.
  • Arrayn- Fungal Infections
  • Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug interactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see and n ).
  • Arrayn- Special Pathogens
  • Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by and n
  • It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.
  • Similarly, corticosteroids should be used with great care in patients with known or suspected (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
  • Corticosteroids should not be used in cerebral malaria. There is currently no evidence of benefit from steroids in this condition.
  • Arrayn- Tuberculosis
  • The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.
  • If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary, as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
  • Arrayn- Vaccinations
  • Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted.
  • Arrayn- Viral Infections
  • Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents should be considered.
  • Ophthalmic
  • Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of systemic corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.
  • No data
  • The following adverse reactions have been reported with methylprednisolone acetate or other corticosteroids:
  • Arrayn- :
  • Arrayn- Blood and lymphatic system disorders:
  • Arrayn- :n- WARNINGS
  • Arrayn- :
  • Arrayn- :
  • Arrayn- Fluid and electrolyte disturbances
  • Arrayn- Gastrointestinal
  • Arrayn- Metabolic
  • Arrayn- Musculoskeletal
  • Arrayn- Neurologic/Psychiatric
  • Arrayn- Ophthalmic
  • Arrayn- :n- Array
  • The following adverse reactions have been reported with the following routes of administration:
  • Arrayn- Intrathecal/Epidural
  • Arrayn- Intranasal
  • Arrayn- Ophthalmic
  • Arrayn- Miscellaneous injection sites
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Treatment of acute overdosage 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.
  • Because of possible physical incompatibilities, methylprednisolone acetate injectable suspension should not be diluted or mixed with other solutions.
  • The initial dosage of parenterally administered methylprednisolone acetate injectable suspension will vary from 4 mg to 120 mg, depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administration 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.
  • A. Administration for Local Effect
  • Therapy with methylprednisolone acetate injectable suspension does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation.
  • 1. Rheumatoid Arthritis and Osteoarthritis.
  • Procedure:n- The injection site for each joint is determined by that location where the synovial cavity is most superficial and most free of large vessels and nerves.
  • Suitable sites for intra-articular injection are the knee, ankle, wrist, elbow, shoulder, phalangeal, and hip joints. Since difficulty is not infrequently encountered in entering the hip joint, precautions should be taken to avoid any large blood vessels in the area. Joints not suitable for injection are those that are anatomically inaccessible such as the spinal joints and those like the sacroiliac joints that are devoid of synovial space. Treatment failures are most frequently the result of failure to enter the joint space. Little or no benefit follows injection into surrounding tissue. If failures occur when injections into the synovial spaces are certain, as determined by aspiration of fluid, repeated injections are usually futile.
  • If a local anesthetic is used prior to injection of methylprednisolone acetate injectable suspension, the anesthetic package insert should be read carefully and all the precautions observed.
  • 2. Bursitis
  • 3. Miscellaneous: Ganglion, Tendinitis, Epicondylitis.
  • The dose in the treatment of the various conditions of the tendinous or bursal structures listed above varies with the condition being treated and ranges from 4 mg to 30 mg. In recurrent or chronic conditions, repeated injections may be necessary.
  • 4. Injections for Local Effect in Dermatologic Conditions
  • B. Administration for Systemic Effect
  • The intramuscular dosage will vary with the condition being treated. When employed as a temporary substitute for oral therapy, a single injection during each 24-hour period of a dose of the suspension equal to the total daily oral dose of methylprednisolone tablets, USP is usually sufficient. When a prolonged effect is desired, the weekly dose may be calculated by multiplying the daily oral dose by 7 and given as a single intramuscular injection.
  • In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. Dosage must be individualized according to the severity of the disease and response of the patient. The recommended dosage may be reduced for pediatric patients, but dosage should be governed by the severity of the condition rather than by strict adherence to the ratio indicated by age or body weight.
  • In patients with the , a single intramuscular injection of 40 mg every two weeks may be adequate. For maintenance of patients with , the weekly intramuscular dose will vary from 40 mg to 120 mg. The usual dosage for patients with benefited by systemic corticoid therapy is 40 mg to 120 mg of methylprednisolone acetate administered intramuscularly at weekly intervals for one to four weeks. In acute severe dermatitis due to poison ivy, relief may result within 8 to 12 hours following intramuscular administration of a single-dose of 80 mg to 120 mg. In chronic contact dermatitis, repeated injections at 5 to 10 day intervals may be necessary. In seborrheic dermatitis, a weekly dose of 80 mg may be adequate to control the condition.
  • Following intramuscular administration of 80 mg to 120 mg to asthmatic patients, relief may result within 6 to 48 hours and persist for several days to two weeks. Similarly, in patients with allergic rhinitis (hay fever), an intramuscular dose of 80 mg to 120 mg may be followed by relief of coryzal symptoms within six hours persisting for several days to three weeks.
  • If signs of stress are associated with the condition being treated, the dosage of the suspension should be increased. If a rapid hormonal effect of maximum intensity is required, the intravenous administration of highly soluble methylprednisolone sodium succinate is indicated.
  • In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective.
  • For the purpose of comparison, the following is the equivalent milligram dose of the various glucocorticoids:
  • 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.
  • Methylprednisolone Acetate Injectable Suspension, USP is supplied as a white to off-white homogenous suspension in single-dose vial available in the following strengths and package sizes:
  • 40 mg/mL (1 mL)
  • Single vial in a carton: u00a0u00a0u00a0u00a0 u00a0 u00a0u00a0u00a0 NDC 70121-1573-1
  • 25 vials in a carton: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0 u00a0u00a0 NDC 70121-1573-5
  • u00a0
  • 80 mg/mL (1 mL)
  • Single vial in a carton: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1574-1
  • 25 vials in a carton:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1574-5
  • u00a0
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • This productu2019s label may have been updated. For current full prescribing information, please visit www.amneal.com.
  • Amneal Pharmaceuticals Pvt. Ltd.
  • Parenteral Unit
  • Ahmedabad 382213, INDIA
  • Amneal n- Pharmaceuticals LLC
  • Bridgewater, NJ 08807
  • Rev. 10-2020-03
  • NDC 70121-1573-1
  • Methylprednisolone Acetate Injectable Suspension USP, n
  • Rx Only
  • Vial Labeln
  • Amneal Pharmaceuticals LLCn
  • u00a0
  • NDC 70121-1573-1
  • Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL
  • Rx Only
  • 1 mL Single-Dose Vial's Carton Labeln
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array
  • NDC 70121-1573-5
  • Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL
  • Rx Only
  • 25 x 1 mL Single-Dose Vial's Carton Labeln
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array
  • NDC 70121-1574-1
  • Methylprednisolone Acetate Injectable Suspension USP, n
  • Rx Only
  • Vial Labeln
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array
  • u00a0
  • NDC 70121-1574-1
  • Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL
  • Rx Only
  • 1 mL Single-Dose Vial's Carton Labeln
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array
  • NDC 70121-1574-5
  • Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL
  • Rx Only
  • 25 x 1 mL Single-Dose Vial's Carton Label
  • Amneal Pharmaceuticals LLC
  • Arrayn- Array

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