prescribing information


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prescribing information

A detailed description of a drug's uses, dosage range, side effects, drug-drug interactions, and contraindications that is available to clinicians and is often included in pharmaceutical packaging instructions.
References in periodicals archive ?
The prescribing information includes information data from the ASCENT trial showing that TUDORZA PRESSAIR decreases exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.
In addition, the updated CroFab Prescribing Information approved by the US FDA removes all references to the product containing mercury and all warnings regarding mercury toxicity.
The document's background section references what is referred to as the physician labeling rule, established in a final rule in 2006, which requires that prescription labeling contain three sections: Highlights, Contents and Full Prescribing Information.
Currently, the prescribing information for oral, skin patch, and vaginal ring estrogen-based contraceptives lists hormone-sensitive tumors as a possible concern, but does not specify melanoma.
Parentheses refer to sections in the Full Prescribing Information.
The prescribing information for many of the medications used to treat bipolar disorder advise against breast feeding, although there is little evidence of harm.
Zohydro ER is an opioid agonist approved for the management of pain "severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate," according to the prescribing information.
The prescribing information and medication guide are located in the fifth panel of the package.
Currently, generic drug manufacturers must seek FDA approval before making any changes to drug prescribing information or package inserts.