"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
- Patients should be counseled that antibacterial drugs including MERREM I.V. should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When MERREM I.V. 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 MERREM I.V. or other antibacterial drugs in the future.
- Patients should be counseled that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop 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. If this occurs, patients should contact their physician as soon as possible [see WARNINGS AND PRECAUTIONS].
- Patients should be counseled to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with MERREM I.V. If treatment with MERREM I.V. is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed [see WARNINGS AND PRECAUTIONS].
- Patients receiving MERREM I.V. on an outpatient basis may develop adverse events such as seizures, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that MERREM I.V. is well tolerated, patients should not operate machinery or motorized vehicles [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
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