| This activity is part of an ongoing CME/CE initiative to | | | | displace bilirubin from binding to serum albumin, |
| provide information on label changes reported by the | | | | potentially leading to bilirubin encephalopathy, the FDA |
| FDA. Activities of this nature will be posted on | | | | said. Use of ceftriaxone is therefore contraindicated in |
| Medscape on a weekly basis. | | | | neonates with hyperbilirubinemia, especially those who |
| August 16, 2007 — The US Food and Drug | | | | are premature. |
| Administration (FDA) has approved safety labeling | | | | Because of the risk for particulate precipitation, |
| revisions to advise of drug interactions that increase | | | | ceftriaxone should not be mixed with |
| the risk for myopathy/rhabdomyolysis associated with | | | | calcium-containing solutions/products or reconstituted |
| the lovastatin component of niacin extended-release | | | | with calcium-containing diluents such as Ringer's or |
| lovastatin tablets, the risks associated with | | | | Hartmann's solution. |
| concomitant use of calcium or calcium-containing | | | | Concomitant administration of ceftriaxone with |
| solutions/products and ceftriaxone sodium | | | | calcium-containing solutions or products is also |
| manufacturer injection, drug interactions with tinidazole | | | | contraindicated, even via different infusion lines; 48 |
| tablets, and the risk for Candida vaginitis in patients | | | | hours should elapse between the last dose of |
| with bacterial vaginosis receiving a course of | | | | ceftriaxone and their use. |
| treatment with tinidazole. | | | | Ceftriaxone injection is indicated for the treatment of |
| Lovastatin Component of Advicor Linked to Drug | | | | lower respiratory tract infections, urinary tract |
| Interactions That Increase Risk for Myopathy | | | | infections, bacterial septicemia, skin and skin structure |
| On April 6, the FDA approved safety labeling revisions | | | | infections, bone and joint infections, pelvic inflammatory |
| for niacin extended-release/lovastatin tablets ( Advicor; | | | | disease, uncomplicated gonorrhea, intra-abdominal |
| KOS Pharmaceuticals, Inc) to advise of certain drug | | | | infections, acute bacterial otitis media, and meningitis |
| interactions that increase the risk for myopathy | | | | caused by susceptible microorganisms. It also is |
| rhabdomyolysis associated with the lovastatin | | | | approved for surgical prophylaxis in patients undergoing |
| component. | | | | certain procedures classified as contaminated or |
| As with other 3-hydroxy-3-methylglutaryl coenzyme A | | | | potentially contaminated. |
| reductase inhibitors, lovastatin may cause myopathy | | | | Tinidazole ( Tindamax) Linked to Drug Interactions, Risk |
| that presents as muscle pain, tenderness, or | | | | for Candida Vaginitis |
| weakness with creatine kinase levels greater than 10 | | | | On May 21, the FDA approved revisions to the safety |
| times the upper limit of normal. Myopathy may also | | | | labeling for tinidazole tablets ( Tindamax; Mission |
| take the form of rhabdomyolysis with or without acute | | | | Pharmacal Co) to advise of drug interactions, the risk |
| renal failure secondary to myoglobinuria, and rare | | | | for Candida vaginitis in patients with bacterial vaginosis, |
| fatalities have occurred. | | | | and certain contraindications. ceftriaxone sodium |
| Because lovastatin is metabolized by the cytochrome | | | | manufacturer |
| P-450 isoform 3A4 (CYP 3A4) enzyme, concomitant | | | | According to clinical study data, patients receiving |
| administration of potent CYP 3A4 inhibitors results in | | | | tinidazole for the treatment of bacterial vaginosis may |
| elevated 3-hydroxy-3-methylglutaryl coenzyme A | | | | be at risk for Candida vaginitis. In the study, 11 (4.7%) of |
| plasma activity levels and may increase the risk for | | | | 235 women developed a vaginal fungal infection. |
| myopathy. According to the FDA, serious skeletal | | | | Because tinidazole is biotransformed mainly by the |
| muscle disorders (eg, rhabdomyolysis) have been | | | | cytochrome P-450 isoform 3A4 (CYP 3A4) enzyme, |
| reported during concomitant use of these drugs. | | | | simultaneous administration with CYP 3A4 inducers |
| Drugs considered to be potent CYP 3A4 inhibitors | | | | (eg, phenobarbital, rifampin, phenytoin, and fosphenytoin) |
| include cyclosporine, itraconazole, ketoconazole, and | | | | can accelerate its elimination and decrease plasma |
| other antifungal azoles; the macrolide antibiotics | | | | levels. Similarly, administration of CYP 3A4 inhibitors |
| erythromycin and clarithromycin; the ketolide antibiotic | | | | (eg, cimetidine and ketoconazole) may prolong |
| telithromycin; HIV protease inhibitors; and nefazodone. | | | | tinidazole half-life and decrease plasma clearance, |
| Large quantities of grapefruit juice (> 1 quart daily) | | | | thereby increasing plasma levels. |
| may also exert this effect. | | | | Use of tinidazole is contraindicated in patients with a |
| Because of the additive effect on the risk for | | | | previous history of having a reaction to tinidazole or |
| myopathy, the dose of niacin/lovastatin should | | | | other nitroimidazole derivatives, the FDA warned, |
| generally not exceed 1000 mg/20 mg in patients | | | | noting that reported reactions have ranged in severity |
| receiving concomitant therapy with cyclosporine, | | | | from urticaria to Stevens-Johnson syndrome. |
| danazol, or fibrates. Interruption of treatment should be | | | | Because tinidazole is excreted in breast milk at serum |
| considered during use of a systemic antifungal azole, | | | | concentrations and can be detected in breast milk for |
| macrolide antibiotic, or ketolide antibiotic. | | | | up to 72 hours after administration, interruption of |
| Niacin/lovastatin tablets are indicated for the treatment | | | | breast-feeding during therapy and for 3 days after the |
| of hypercholesterolemia when use of both | | | | last dose is advised. ceftriaxone sodium manufacturer |
| components is appropriate. | | | | The FDA also warned that carcinogenicity has been |
| Ceftriaxone Sodium Injection ( Rocephin) Plus Calcium | | | | observed in mice and rats treated long term with |
| Linked to Neonate Fatalities | | | | metronidazole, another nitroimidazole antimicrobial. |
| On May 11, the FDA approved revisions to the safety | | | | Although similar data have not been reported with |
| labeling for ceftriaxone sodium injection ( Rocephin; | | | | tinidazole, its use should be limited to approved |
| Roche Pharmaceuticals, Inc) to advise of the potential | | | | indications because of the similar nature of these |
| risks associated with concomitant use of calcium or | | | | drugs. |
| calcium-containing solutions and products. | | | | As with other antimicrobials, prescribing tinidazole in the |
| | | | | absence of a proven or strongly suspected bacterial |
| Cases of fatal reactions with calcium-ceftriaxone | | | | infection or a prophylactic indication is unlikely to |
| precipitates in the lungs and kidneys of both term and | | | | provide benefit to the patient and increases the risk for |
| premature neonates have been reported, some of | | | | the development of drug-resistant bacteria. |
| which occurred when ceftriaxone and the | | | | Tinidazole is a nitroimidazole antimicrobial indicated for |
| calcium-containing products were administered by | | | | the treatment of trichomoniasis; giardiasis and |
| different routes at different times. | | | | amebiasis in patients aged 3 years and older; and |
| In vitro studies have shown that ceftriaxone can | | | | bacterial vaginosis in nonpregnant adult women. |