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The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Prednisone is a synthetic glucocorticoid used for its anti-inflammatory and immunosuppressive properties. [36] [37] Prednisone is a prodrug; it is metabolised in the liver by 11-β-HSD to prednisolone, the active drug. Prednisone has no substantial biological effects until converted via hepatic metabolism to prednisolone. [38]
Sodium fluoride drug preparations including liquid and tablet forms containing no more than 110 mg of sodium fluoride per package. Betamethasone tablets packaged in manufacturers' dispenser packages containing no more than 12.6 mg of betamethasone. Prednisone in tablet form, when dispensed in packages containing no more than 105 mg.
Methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol) is a synthetic glucocorticoid, primarily prescribed for its anti-inflammatory and immunosuppressive effects. [4] [5] [6] It is either used at low doses for chronic illnesses or used concomitantly at high doses during acute flares.
The term dosage form may also sometimes refer only to the pharmaceutical formulation of a drug product's constituent substances, without considering its final configuration as a consumable product (e.g., capsule, patch, etc.). Due to the somewhat ambiguous nature and overlap of these terms within the pharmaceutical industry, caution is ...
Initial treatment is usually with oral prednisone (50–150 mg/day) or high-dose intravenous methylprednisolone (1 g/day) for 3–7 days. Thyroid hormone treatment is also included if required. Thyroid hormone treatment is also included if required.
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Research on animal reproduction has indicated that there is a trace of teratogenicity when doses are reduced by 10 times the human recommended dose. [54] There is no sufficient information on human pregnancy at this moment. Use is only recommended when the potential benefits outweigh the potential risks for the pregnant mother and the fetus. [54]