Hydrocortisone Sodium Succinate (Solu-Cortef)

Trade Name : Solu-Cortef

Pharmacia and Upjohn Company LLC

INJECTION, POWDER, FOR SOLUTION

Strength 1000 mg/8mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydrocortisone Sodium Succinate (Solu-Cortef) which is also known as Solu-Cortef and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 1000 mg/8mL per ml. Read more

Hydrocortisone Sodium Succinate (Solu-Cortef) 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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • For Intravenous or Intramuscular Administration
  • SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.
  • Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. SOLU-CORTEF 100 mg plain does not contain diluent (see ).
  • The diluent, as part of the packaging presentation for the ACT-O-VIAL system, is comprised of Water for Injection only, and does not contain any preservative.
  • 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.
  • The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11u03b2)- and its molecular weight is 484.52.
  • The structural formula is represented below:
  • Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform.
  • 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.
  • Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. The highly water-soluble sodium succinate ester of hydrocortisone permits the immediate intravenous administration of high doses of hydrocortisone in a small volume of diluent and is particularly useful where high blood levels of hydrocortisone are required rapidly. Following the intravenous injection of hydrocortisone 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.
  • Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli.
  • 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 SOLU-CORTEF Sterile Powder is indicated as follows:
  • SOLU-CORTEF Sterile Powder is contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
  • Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
  • SOLU-CORTEF Sterile Powder is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
  • No data
  • No data
  • The following adverse reactions have been reported with SOLU-CORTEF 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 ), 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.
  • 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, 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 ), epidural lipomatosis.
  • Ophthalmic: Central serous chorioretinopathy, exophthalmoses, 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, injection site infections following non-sterile administration (see ), malaise, moon face, weight gain.
  • 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, SOLU-CORTEF should not be diluted or mixed with other solutions.
  • 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.
  • Therapy is initiated by administering SOLU-CORTEF Sterile Powder intravenously over a period of 30 seconds (e.g., 100 mg) to 10 minutes (e.g., 500 mg or more). In general, high dose corticosteroid therapy should be continued only until the patient's condition has stabilized, usually not beyond 48 to 72 hours. When high dose hydrocortisone therapy must be continued beyond 48u201372 hours, hypernatremia may occur. Under such circumstances, it may be desirable to replace SOLU-CORTEF with a corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention.
  • The initial dose of SOLU-CORTEF Sterile Powder is 100 mg to 500 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.
  • This dose may be repeated at intervals of 2, 4, or 6 hours as indicated by the patient's response and clinical condition.
  • 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 pediatric patients, the initial dose of hydrocortisone may vary depending on the specific disease entity being treated. The range of initial doses is 0.56 to 8 mg/kg/day in three or four divided doses (20 to 240 mg/mbsa/day). 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.
  • SOLU-CORTEF Sterile Powder is available in the following packages:
  • Store unreconstituted product at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).
  • Store solution at controlled room temperature 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) and protect from light. Use solution only if it is clear. Unused solution should be discarded after 3 days.
  • This product's label may have been updated. For current full prescribing information please visit www.pfizer.com
  • LAB-0424-10.0Revised November 2019
  • NDC 0009-0825-01
  • Solu-Cortef
  • (hydrocortisone sodium succinate for injection, USP)
  • 100 mg*
  • For IM or IV use Preservative-Free
  • Rx only
  • NDC 0009-0825-01
  • 1 Vial
  • Solu-Cortefn
  • (hydrocortisonesodium succinatefor injection, USP)
  • 100 mg*
  • For intramuscular orintravenous use
  • Preservative-Free
  • Rx only
  • Pfizer Injectables
  • 2 mL Act-O-Vialn
  • Solu-Cortef
  • (hydrocortisone sodium succinate for injection, USP)
  • 100 mg*
  • For IM or IV use Preservative-Free Rx only
  • NDC 0009-0011-04Contains 25 of NDC 0009-0011-03
  • 25u20132 mL Act-O-Vial SystemsSingle-Dose Vials
  • Solu-Cortefn
  • (hydrocortisone sodiumsuccinate for injection, USP)
  • 100 mg*
  • For intramuscular or intravenous use
  • Preservative-Free
  • Pfizer Injectablesn- Rx only
  • Single-Dose Vial2 mL Act-O-Vialn
  • Solu-Cortef
  • (hydrocortisone sodium succinate for injection, USP)
  • 250 mg*
  • For IM or IV use Preservative-FreeRx only
  • NDC 0009-0013-05
  • Single-Dose Vial2 mL Act-O-Vialn
  • Solu-Cortefn
  • (hydrocortisonesodium succinatefor injection, USP)
  • 250 mg*
  • For intramuscular orintravenous use
  • Preservative-Free
  • Rx only
  • Pfizer Injectables
  • Single-Dose Vial4 mL Act-O-Vialn
  • Solu-Cortef
  • (hydrocortisone sodium succinate for injection, USP)
  • 500 mg*
  • For intramuscular or intravenous use
  • Preservative-Free Rx only
  • NDC 0009-0016-12
  • Single-Dose Vial4 mL Act-O-Vialn
  • Solu-Cortef
  • (hydrocortisonesodium succinatefor injection, USP)
  • 500 mg*
  • For intramuscular orintravenous use
  • Preservative-Free
  • Rx only
  • Pfizer Injectables
  • Single-Dose Vial8 mL Act-O-Vialn
  • Solu-Cortef
  • (hydrocortisone sodium succinate for injection, USP)
  • 1000 mg*
  • For IM or IV use Preservative-Free Rx only
  • NDC 0009-0005-01
  • Single-Dose Vial8 mL Act-O-Vialn
  • Solu-Cortef
  • (hydrocortisonesodium succinatefor injection, USP)
  • 1000 mg*
  • For intramuscular orintravenous use
  • Preservative-Free
  • Rx only
  • Pfizer Injectables

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