Methylprednisolone Sodium Succinate: Package Insert and Label Information (Page 3 of 3)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

NOTE: After mixing as directed, some of the methylprednisolone sodium succinate for injection, USP formulations contain benzyl alcohol (see DESCRIPTION, WARNINGS and PRECAUTIONS, Pediatric Use)

Because of possible physical incompatibilities, methylprednisolone sodium succinate for injection, USP 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 for injection, USP (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 for injection, USP (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 for injection, USP sterile powder is 30 mg/kg administered intravenously over at least 30 minutes. 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 patient’s 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. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation, it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Methylprednisolone sodium succinate for injection, USP 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. Ifdesired, the medication may be administered in diluted solutions by adding Water for Injection or other suitable diluent (see below) to the 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/m2 bsa/day).

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone, or methylprednisolone in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses. It is further recommended that short course, or “burst” 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 PRECAUTIONS, Neurologic-psychiatric).

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

Cortisone, 25 Triamcinolone, 4
Hydrocortisone, 20 Paramethasone, 2
Prednisolone, 5 Betamethasone, 0.75
Prednisone, 5 Dexamethasone, 0.75
Methylprednisolone, 4

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 controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Store reconstituted solution (not further diluted) at controlled room temperature 20° to 25°C (68° to 77°F) [see USP], and use it within 48 hours.

See section DOSAGE AND ADMINISTRATION for storage of further diluter solution.

HOW SUPPLIED

Methylprednisolone sodium succinate for injection, USP is a sterile, white or off-white lyophilized lumps or powder, available in the following packages:

NDC Methylprednisolone Sodium Succinate for Injection, USP Packaging Configuration
NDC 43598-127-25 40 mg Single- Dose Vial 25 vials per Carton
NDC 43598-129-25 125 mg Single- Dose Vial 25 vials per Carton
NDC 43598-128-11 500 mg Multi-Dose Vial 1 vial per Carton
NDC 43598-130-74 1 g Multi-Dose Vial 1 vial per Carton

Manufactured By

Tianjin Kingyork Pharmaceuticals

(Tianjin. China)

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540 USA

January 2022

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Methylprednisolone Sodium Succinate for Injection, USP 40 mg* per vial-Vial Label

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Methylprednisolone Sodium Succinate for Injection, USP 125 mg* per vial-Vial Label

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Methylprednisolone Sodium Succinate for Injection, USP 500

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Methylprednisolone Sodium Succinate for Injection, USP 1g* per vial-Vial Label

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Methylprednisolone Sodium Succinate for Injection, USP 40 mg* per vial — carton label

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Methylprednisolone Sodium Succinate for Injection, USP 125 mg* per vial — carton label

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Methylprednisolone Sodium Succinate for Injection, USP 500 mg* per vial — carton label

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Methylprednisolone Sodium Succinate for Injection, USP 500 mg* per vial — carton label

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METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-127
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.84 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 17.46 mg in 1 mL
LACTOSE MONOHYDRATE 25 mg in 1 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-127-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43598-127-45)
1 NDC:43598-127-45 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43598-127-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-129
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 125 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.84 mg in 2 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 17.4 mg in 2 mL
Product Characteristics
Color WHITE (white to offi-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-129-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43598-129-01)
1 NDC:43598-129-01 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43598-129-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-128
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 500 mg in 8 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 7.36 mg in 8 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 69.6 mg in 8 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-128-11 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 8 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (43598-128-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-130
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 1 g in 16 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 14.72 mL in 16 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 139.2 mg in 16 mL
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-130-74 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 16 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (43598-130-74)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212396 03/24/2022
Labeler — Dr. Reddy’s Laboratories Inc (802315887)
Registrant — Tianjin Kingyork Pharmaceuticals Co., Ltd (544518503)
Establishment
Name Address ID/FEI Operations
Tianjin Kingyork Pharmaceuticals Co., Ltd 544518503 analysis (43598-127), analysis (43598-128), analysis (43598-129), analysis (43598-130), manufacture (43598-127), manufacture (43598-128), manufacture (43598-129), manufacture (43598-130)

Revised: 05/2022 Dr. Reddy’s Laboratories Inc

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