pharmacopeia

Sodium Succinate

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Indications

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  • 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 intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection is indicated as follows: Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).ICD-10: J45.909, L20.9

Contraindications

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  • Methylprednisolone Sodium Succinate Sterile Powder is contraindicated: in systemic fungal infections and patients with known hypersensitivity to the product and its constituents; The methylprednisolone sodium succinate for injection 40 mg presentation includes lactose monohydrate produced from cow’s milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients.contraindicated

Dosage & administration

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Note: Methylprednisolone sodium succinate injection when reconstituted with bacteriostatic water for injection contains benzyl alcohol (see DESCRIPTION , WARNINGS and PRECAUTIONS , Pediatric Use) Because of possible physical incompatibilities, methylprednisolone sodium succinate should not be diluted or mixed with other solutions. Use only Water for Injection or Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting methylprednisolone sodium succinate (see DESCRIPTION ). 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 methylprednisolone sodium succinate ( greater than 0.5 gram administered over a period of less than 10 minutes ). 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 sterile powder is 30 mg/kg administered intravenously over at least 30 minutes .

Warnings & precautions

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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 Reconstituted methylprednisolone sodium succinate sterile powder contains benzyl alcohol, which is potentially toxic when administered locally to neural tissue . Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known.

Adverse reactions

Sourced from openFDA

The following adverse reactions have been reported with methylprednisolone sodium succinate or other corticosteroids: Allergic reactions: Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema. Blood and lymphatic system disorders: Leukocytosis. 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 WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic: Acne, allergic dermatitis, burning or tingling (especially in the perineal area after intravenous injection), 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, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Use in specific populations

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Pregnancy: Teratogenic effects: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. This product when reconstituted with bacteriostatic water for injection contains benzyl alcohol as a preservative and the benzyl alcohol can cross the placenta. See PRECAUTIONS: Pediatric use .

Overdosage

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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.

Approval history

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  • Apr 27, 1955NDANDA009866Pharmacia And Upjohn
  • May 18, 1959NDANDA011856Pharmacia And Upjohn
  • Aug 25, 1982ANDAANDA062365Fresenius Kabi Usa
  • Jul 30, 2004ANDAANDA040583Fresenius Kabi Usa
  • Aug 12, 2004ANDAANDA040612Fresenius Kabi Usa
  • Dec 15, 2015ANDAANDA207667Eugia Pharma
  • Feb 16, 2016ANDAANDA202691Hikma
  • Apr 20, 2021ANDAANDA212396Tianjin Kingyork

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
53,219 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use9,17017%
  2. 2Fatigue5,0549.5%
  3. 3Drug Ineffective4,9129.2%
  4. 4Infusion Related Reaction4,7528.9%
  5. 5Headache4,6818.8%
  6. 6Pain4,5688.6%
  7. 7Pyrexia4,5288.5%
  8. 8Nausea4,4118.3%
  9. 9Dyspnoea4,3108.1%
  10. 10Rash3,7597.1%
  11. 11Diarrhoea3,5886.7%
  12. 12Arthralgia3,5826.7%
  13. 13Vomiting3,3966.4%
  14. 14Hypertension3,3926.4%
  15. 15Condition Aggravated3,3236.2%

Literature

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Recent PubMed references pinned to Sodium Succinate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 156 ClinicalTrials.gov registrations naming Sodium Succinate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Sodium Succinate used for?
According to FDA labeling, Sodium Succinate carries indications including: 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 intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection is indicated as follows: Allergic states Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for Sodium Succinate?
Sodium Succinate labeling lists contraindications including: Methylprednisolone Sodium Succinate Sterile Powder is contraindicated: in systemic fungal infections and patients with known hypersensitivity to the product and its constituents; The methylprednisolone sodium succinate for injection 40 mg presentation includes lactose monohydrate produced from cow’s milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow’s milk or its components or other dairy products because it may contain trace amounts of milk ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for sodium-succinate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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