Solu-Medrol description, usages, side effects, indications, overdosage, supplying and lots more!

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Solu-Medrol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

SOLU-MEDROL DESCRIPTION




Solu-Medrol





















CLINICAL PHARMACOLOGY







INDICATIONS & USAGE



Allergic states


Dermatologic diseases


Endocrine disorders


Gastrointestinal diseases


Hematologic disorders


Miscellaneous


Neoplastic diseases


Nervous System


Ophthalmic diseases


Renal diseases


Respiratory diseases


Rheumatic disorders


SOLU-MEDROL CONTRAINDICATIONS


  • ●in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.
  • ●for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
  • ●Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

WARNINGSPRECAUTIONS, Pediatric Use

WARNINGS


General
Formulations with preservative (seeDESCRIPTION) contain benzyl alcohol, which is potentially toxic when administered locally to neural tissue.
PRECAUTIONS, Pediatric Use

ADVERSE REACTIONS



Cardio-renal


Endocrine


Infections

General




Fungal infections
CONTRAINDICATIONSPRECAUTIONS, Drug Interactions, Amphotericin B injection and potassium-depleting agents

Special pathogens





Tuberculosis



Vaccination


Viral infections


Neurologic
ADVERSE REACTIONS, GastrointestinalNeurologic/Psychiatric

Ophthalmic


PRECAUTIONS

General





Cardio-renal


Endocrine



Gastrointestinal



Musculoskeletal



Neurologic-psychiatric
DOSAGE AND ADMINISTRATION



Ophthalmic


INFORMATION FOR PATIENTS




DRUG INTERACTIONS

Aminoglutethimide


Amphotericin B injection and potassium-depleting agents


Antibiotics
Drug Interactions, Hepatic Enzyme Inhibitors

Anticholinesterases


Anticoagulants, oral


Antidiabetics


Antitubercular drugs


Cholestyramine


Cyclosporine


Digitalis glycosides


Estrogens, including oral contraceptives


Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin)


Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin)


Ketoconazole


Nonsteroidal anti-inflammatory agents (NSAIDs)


Skin tests


Vaccines
WARNINGS, Infections, Vaccination

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY

Teratogenic effects

Pregnancy Category C


NURSING MOTHERS



PEDIATRIC USE

DESCRIPTION


ADVERSE REACTIONS

GERIATRIC USE



SOLU-MEDROL ADVERSE REACTIONS



WARNINGS






WARNINGS, Neurologic

WARNINGS

OVERDOSAGE



DOSAGE & ADMINISTRATION

NOTE: Some of the SOLU-MEDROL formulations contain benzyl alcohol (seeDESCRIPTION,WARNINGSandPRECAUTIONS, Pediatric Use)
Because of possible physical incompatibilities, SOLU-MEDROL should not be diluted or mixed with other solutions.

DESCRIPTION


(greater than 0.5 gram administered over a period of less than 10 minutes).administered intravenously over at least 30 minutes.








PRECAUTIONS, Neurologic-psychiatric


DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM






STORAGE CONDITIONS





HOW SUPPLIED











PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION










Solu-Medrol

Solu-Medrol

Methylprednisolone Sodium Succinate POWDER, FOR SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-840(NDC:0009-0047)
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Methylprednisolone Sodium Succinate METHYLPREDNISOLONE 125 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
SODIUM PHOSPHATE, DIBASIC

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-840-41 1 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 2011-12-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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