"(Reuters) - Sanofi SA and Regeneron Pharmaceuticals Inc on Friday said U.S. regulators had declined to approve their experimental treatment for rheumatoid arthritis because of manufacturing deficiencies.
The companies, in a release, s"...
(methylprednisolone acetate) injectable suspension, USP
Each mL of these preparations contains:
|Methylprednisolone acetate||20 mg||40 mg||80 mg|
|Polyethylene glycol 3350||29.5 mg||29.1 mg||28.2 mg|
|Polysorbate 80||1.97 mg||1.94 mg||1.88 mg|
|Monobasic sodium phosphate||6.9 mg||6.8 mg||6.59 mg|
|Dibasic sodium phosphate USP||1.44 mg||1.42 mg||1.37 mg|
|Benzyl alcohol added as a preservative||9.3 mg||9.16 mg||8.88 mg|
Sodium Chloride was added to adjust tonicity.
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0).
The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)- 11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below:
DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6- methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.
What are the precautions when taking methylprednisolone acetate injectable suspension (Depo Medrol)?
Before using methylprednisolone, tell your doctor or pharmacist if you are allergic to it; or to prednisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood clots, brittle bones (osteoporosis), diabetes, eye diseases (such as cataracts, glaucoma, herpes infection of the eye), heart problems (such as congestive heart failure, recent heart attack), high blood pressure, current/ past infections (such as those caused by tuberculosis, threadworm, herpes, fungus), kidney disease, liver disease, mental/mood conditions (such as psychosis,...
Last reviewed on RxList: 9/26/2016
This monograph has been modified to include the generic and brand name in many instances.
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