Trade Name: Methylprednisolone Sodium Succinate

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Manufacturer: Amneal Biosciences LLC

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 125 mg/2mL

Storage and handling

METHYLPREDNISOLONE SODIUM SUCCINATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • After mixing as directed, contains Benzyl Alcohol.
  • Not for use in neonates.
  • For Intravenous or Intramuscular Administration
  • Methylprednisolone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate, USP as the active ingredient. Methylprednisolone sodium succinate, USP, is the sodium succinate ester of methylprednisolone, and it occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone.
  • The chemical name for methylprednisolone sodium succinate is pregna-1,4-diene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium salt, (6u03b1, 11u03b2), and the molecular weight is 496.53. The structural formula is represented below:
  • Methylprednisolone sodium succinate, USP is soluble in water; it may be administered in a small volume of diluent and is well suited for intravenous use in situations where high blood levels of methylprednisolone are required rapidly.
  • Methylprednisolone sodium succinate for injection, USP is available in below formulations:
  • IMPORTANT
  • Use within 48 hours after mixing.
  • When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL solution, 0.40 osmolar. (Isotonic saline = 0.28 osmolar.)
  • 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 potent anti-inflammatory effects in disorders of many organ systems.
  • Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
  • Methylprednisolone is a potent anti-inflammatory steroid with greater anti-inflammatory potency than prednisolone and even less tendency than prednisolone to induce sodium and water retention.
  • Methylprednisolone sodium succinate has the same metabolic and anti-inflammatory actions as methylprednisolone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. Following the intravenous injection of methylprednisolone sodium succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.
  • 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 of methylprednisolone sodium succinate for injection 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:
  • Methylprednisolone sodium succinate is contraindicated:
  • Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
  • After mixing as directed, methylprednisolone contains benzyl alcohol. The use of methylprednisolone, reconstituted with benzyl alcohol, is contraindicated for use in premature infants (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
  • After mixing as directed, methylprednisolone (n- Arrayn- Array
  • Injection of methylprednisolone sodium succinate 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. Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy.
  • Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ).
  • In patients receiving the 40 mg presentation of methylprednisolone sodium succinate during the treatment for acute allergic conditions and where these symptoms worsen or any new allergic symptoms occur, consideration should be given to the potential for hypersensitivity reactions to cowu2019s milk ingredients (see ). If appropriate, administration of methylprednisolone sodium succinate should be stopped, and the patientu2019s condition should be treated accordingly. Alternative treatments, including the use of corticosteroid formulations that do not contain ingredients produced from cowu2019s milk, should be considered for acute allergy management, where appropriate.
  • Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy who are subjected to any unusual stress before, during, and after the stressful situation.
  • Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, anu00a0intravenous 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 u00a0methylprednisolone sodium succinate, 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 the synthetic derivatives except 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 the 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.
  • Drug-Induced Liver Injury
  • Rarely, high doses of cyclically pulsed intravenous methylprednisolone (usually for the treatment of exacerbations of multiple sclerosis at doses of 1 gram/day) can induce a toxic form of acute hepatitis. The time to onset of this form of steroid-induced liver injury can be several weeks or longer. Resolution has been observed after discontinuation of treatment. However, serious liver injury can occur, sometimes resulting in acute liver failure and death. Discontinue intravenous methylprednisolone if toxic hepatitis occurs. Since recurrence has occurred after re-challenge, avoid use of high dose intravenous methylprednisolone in patients with a history of toxic hepatitis caused by methylprednisolone.
  • Infections
  • Arrayn- General
  • Patients 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. Corticosteroids may also mask some signs of current infection. Do not use intra-articularly, intrabursally or for intratendinous administration for local effect in the presence of acute local infection.
  • A study has failed to establish the efficacy of methylprednisolone sodium succinate in the treatment of sepsis syndrome and septic shock. The study also suggests that treatment of these conditions with methylprednisolone sodium succinate may increase the risk of mortality in certain patients (i.e., patients with elevated serum creatinine levels or patients who develop secondary infections after methylprednisolone sodium succinate).
  • 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 reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (seeu00a0 and , ).
  • Arrayn- Special pathogens
  • Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by .
  • 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 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- Vaccination
  • 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.
  • Neurologic
  • Reports of severe medical events have been associated with the intrathecal route of administration (see , n ).
  • 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 oral 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 sodium succinate or other corticosteroids:
  • Allergic reactions:
  • Blood and lymphatic system disorders:
  • Cardiovascular:n- Array
  • Dermatologic:
  • Endocrine:
  • Fluid and electrolyte disturbances:
  • Gastrointestinal:
  • Hepatobiliary:n- Array
  • Metabolic:
  • Musculoskeletal:
  • Neurologic/Psychiatric:n- Array
  • Ophthalmic:
  • Other:n- Array
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or 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.
  • NOTE: After mixing as directed, methylprednisolone contains benzyl alcohol (see ,u00a0 and )
  • Because of possible physical incompatibilities, methylprednisolone sodium succinate for injection n- should not be diluted or mixed with other solutions.
  • Use only Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate for injection (see ). Use within 48 hours after mixing.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • This preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation.
  • There are reports of cardiac arrhythmias and/or cardiac arrest following the rapid administration of large intravenous doses of u00a0methylprednisolone sodium succinate for injection (). Bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate, and may be unrelated to the speed or duration of infusion. When high dose therapy is desired, the recommended dose of methylprednisolone sodium succinate for injection is 30 mg/kg . This dose may be repeated every 4 to 6 hours for 48 hours.
  • In general, high dose corticosteroid therapy should be continued only until the patientu2019s condition has stabilized; usually not beyond 48 to 72 hours.
  • In other indications, initial dosage will vary from 10 to 40 mg of methylprednisolone 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.
  • Methylprednisolone sodium succinate for injection may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer by intravenous (or intramuscular) injection, prepare solution as directed. The desired dose may be administered intravenously over a period of several minutes. If desired, the medication may be administered in diluted solutions by adding Water for Injection or other suitable diluent (see below) to the single-dose vial and withdrawing the indicated dose.
  • To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic saline solution.
  • In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/mbsa/day).
  • The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1 to 2 mg/kg/day in single or divided doses. It is further recommended that short course, or u201cburstu201d therapy, be continued until the patient achieves a peak expiratory flow rate of 80% of his or her personal best or until symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.
  • Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg per kg every 24 hours.
  • Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.
  • 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 (see ).
  • For the purpose of comparison, the following is the equivalent milligram dosage 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.
  • STORAGE CONDITIONS
  • Protect from light.
  • Store unreconstituted product at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Store solution at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Use solution within 48 hours after mixing.
  • Methylprednisolone sodium succinate for injection, USP is supplied as a white to off-white lyophilized cake or powder, available in the following packages:
  • 40 mg/vial (1 mL) (Single-Dose Vial):u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0 u00a0u00a0u00a0u00a0u00a0
  • 25 vials in 1 carton: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1000-5
  • 125 mg/vial (2 mL) (Single-Dose Vial): u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0 u00a0u00a0 u00a0u00a0
  • 25 vials in 1 carton: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1001-5
  • This productu2019s label may have been updated. For current full prescribing information, please visit www.amneal.com.
  • Manufactured by:
  • Amneal Pharmaceuticals Pvt. Ltd.Parenteral Unit
  • Distributed by:n n Bridgewater, NJ 08807
  • Rev. 05-2020-03
  • NDC 70121-1000-1 Methylprednisolone Sodium Succinate for Injection USP, 40 mg/vial 1 mL Single-Dose Vial Vial Label Rx only Amneal Pharmaceuticals LLC
  • NDC 70121-1000-5 Methylprednisolone Sodium Succinate for Injection USP, 40 mg/vial 1 mL Single-Dose Vial Carton Label Rx only Amneal Pharmaceuticals LLC
  • NDC 70121-1001-1 Methylprednisolone Sodium Succinate for Injection USP, 125 mg/vial 2 mL Single-Dose Vial Vial Label Rx only Amneal Pharmaceuticals LLC
  • NDC 70121-1001-5 Methylprednisolone Sodium Succinate for Injection USP, 125 mg/vial 2 mL Single-Dose Vial Carton Label Rx only Amneal Pharmaceuticals LLC
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