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Patients should be instructed not to ingest any portion of the press-through package (PTP). (There have been reports that the sharp edges of the sheet can cut or penetrate the esophageal mucosa if accidentally ingested, resulting in mediastinitis or other serious complications).
Use in Pregnancy & Lactation: This drug should be administered to pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. (The safety of this drug in pregnant women has not been established).
Nursing should be interrupted when this drug is administered to a nursing woman.
Use in Children: The safety of this drug in children has not been established.
Use in the Elderly: Special care is required in elderly patients to minimize the risk of gastrointestinal disorders, because these patients may be physiologically more sensitive to this drug than younger patients.
