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Medrol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

MEDROL DESCRIPTION



Medrol




ACTIONS



INDICATIONS & USAGE



1. Endocrine Disorders





2. Rheumatic Disorders











3. Collagen Diseases





4. Dermatologic Diseases








5. Allergic States








6. Ophthalmic Diseases












7. Respiratory Diseases






8. Hematologic Disorders






9. Neoplastic Diseases




10. Edematous States


11. Gastrointestinal Diseases




12. Nervous System


13. Miscellaneous



MEDROL CONTRAINDICATIONS



WARNINGS






Usage in pregnancy









PRECAUTIONS

General Precautions








DOSAGE AND ADMINISTRATION


DRUG INTERACTIONS





INFORMATION FOR PATIENTS



MEDROL ADVERSE REACTIONS


  • ●     Sodium retention
  • ●     Congestive heart failure in susceptible patients
  • ●     Hypertension
  • ●     Fluid retention
  • ●     Potassium loss
  • ●     Hypokalemic alkalosis

  • ●     Muscle weakness
  • ●     Loss of muscle mass
  • ●     Steroid myopathy
  • ●     Osteoporosis
  • ●     Tendon rupture, particularly of the Achilles tendon
  • ●     Vertebral compression fractures
  • ●     Aseptic necrosis of femoral and humeral heads
  • ●     Pathologic fracture of long bones

  • ●     Peptic ulcer with possible perforation and hemorrhage
  • ●     Pancreatitis
  • ●     Abdominal distention
  • ●     Ulcerative esophagitis


  • ●     Impaired wound healing
  • ●     Petechiae and ecchymoses
  • ●     May suppress reactions to skin tests
  • ●     Thin fragile skin
  • ●     Facial erythema
  • ●     Increased sweating

  • ●     Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
  • ●     Convulsions
  • ●     Vertigo
  • ●     Headache

  • ●     Development of Cushingoid state
  • ●     Suppression of growth in children
  • ●     Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
  • ●     Menstrual irregularities
  • ●     Decreased carbohydrate tolerance
  • ●     Manifestations of latent diabetes mellitus
  • ●     Increased requirements of insulin or oral hypoglycemic agents in diabetics

  • ●     Posterior subcapsular cataracts
  • ●     Increased intraocular pressure
  • ●     Glaucoma
  • ●     Exophthalmos

  • ●     Negative nitrogen balance due to protein catabolism


DOSAGE & ADMINISTRATION


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.
Multiple Sclerosis


ADT(Alternate Day Therapy)

















HOW SUPPLIED


2 mg

4 mg




8 mg

16 mg

32 mg


STORAGE AND HANDLING



REFERENCES




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Medrol

Medrol

Methylprednisolone TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-564(NDC:0009-0176)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE methylprednisolone 32 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM STEARATE
STARCH, CORN
FD&C YELLOW NO. 6
LACTOSE
Mineral Oil
sorbic acid
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
orange 12 mm MEDROL;32 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-564-16 50 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011153 2011-10-11


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Be sure to consult your doctor before taking any medication!
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