METHYLPREDNISOLONE 4 mg/1
METHYLPREDNISOLONE · TABLET · Doc Rx
METHYLPREDNISOLONE is a tablet containing methylprednisolone at 4 mg/1, taken oral. Manufactured by Doc Rx.
Key Facts
- Brand Name
- METHYLPREDNISOLONE
- Generic Name
- METHYLPREDNISOLONE
- NDC Code (Product)
69306-400- Manufacturer
- Doc Rx
- Strength
- 4 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204072
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 05/14/2018
Recall History
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Lack of Assurance of Sterility
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
New England Compounding Center
Non-Sterility
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
New England Compounding Center
Non-Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme (…
Dosage & Administration
DOSAGE AND ADMINISTRATION The initial dosage of methylprednisolone tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, methylprednisolone tablets should be discontinued and the patient transferred to other appropriate therapy. 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. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are ch…
Warnings
WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids,…
Contraindications
CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.
Drug Interactions
DRUG INTERACTIONS The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone; therefore, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increases in methylprednisolone dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore, the dose of methylprednisolone should be titrated to avoid steroid toxicity. Methylprednisolone may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of methylpredniso…
Adverse Reactions
ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention Congestive heart failure in susceptible patients Hypertension Fluid retention Potassium loss Hypokalemic alkalosis Musculoskeletal 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 Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic Impaired wound healing Petechiae and ecchymoses May suppress reactions to skin tests Thin fragile skin Facial erythema Increased sweating Neurological Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Convulsions Vertigo Headache Endocrine Development of Cushingoid state Suppression of growth in childr…
Frequently Asked Questions
What is METHYLPREDNISOLONE used for?
METHYLPREDNISOLONE contains METHYLPREDNISOLONE. It is a tablet taken oral. Consult your doctor for specific uses.
Is METHYLPREDNISOLONE a controlled substance?
METHYLPREDNISOLONE is not classified as a controlled substance by the DEA.
What is the generic name for METHYLPREDNISOLONE?
The generic name for METHYLPREDNISOLONE is METHYLPREDNISOLONE. There are 10 other brand versions of METHYLPREDNISOLONE.
What is the NDC code for METHYLPREDNISOLONE 4 mg/1?
The NDC (National Drug Code) for METHYLPREDNISOLONE 4 mg/1 is 69306-400, listed by Doc Rx.
Other METHYLPREDNISOLONE Dosages
Other Methylprednisolone Brands
See all →- Physicians EZ Use M-pred76420-520
- Methylprednisolone Sodium Succinate125 mg/2mL82094-402
- METHYLPREDNISOLONE ACETATE40 mg/mL42023-239
- Methylprednisolone sodium succinate1 g/16mL43598-130
- Medrol2 mg/10009-0020
- Medrol16 mg/10009-0073
- Methylprednisolone Sodium Succinate500 mg/155150-264
- Methylprednisolone2 mg/162135-759
- MethylPREDNISolone4 mg/163629-2218
- MethylPREDNISolone4 mg/163629-2226
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)