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Administration with Food: Patients should be informed that SIVEXTRO tablets may be taken with or without food and without any dietary restrictions [see Recommended Dosage under Dosage & Administration and Pharmacology under Actions].
Usage Safeguards: Patients should be advised that antibacterial drugs including SIVEXTRO should only be used to treat bacterial infections. SIVEXTRO does not treat viral infections (e.g., the common cold). When SIVEXTRO is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by SIVEXTRO or other antibacterial drugs in the future [see Usage under Indications].
Patients should be informed that if they miss a dose, they should take the dose as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remains before the next dose, then they should wait until their next scheduled dose. Patients should take the prescribed number of doses [see Recommended Dosage under Dosage & Administration].
Potentially Serious Adverse Reactions: Patients should be advised that diarrhea is a common problem caused by antibacterial drugs including SIVEXTRO and usually resolves when the drug is discontinued. Sometimes after starting treatment with antibiotics, patients can develop frequent watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic and may be a sign of a more serious intestinal infection [see Clostridium difficile-Associated Diarrhea under Precautions and Clinical Trials Experience under Adverse Reactions]. If this occurs, patients should contact their healthcare provider as soon as possible.
