This requires Flash to play. Click here to download.

Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections caused by P aeruginosa, bacterial eradication may not necessarily be achieved.

As with other beta-lactam antibiotics, some strains of P aeruginosa may develop resistance fairly rapidly during treatment with PRIMAXIN I.V. During therapy of P aeruginosa infections, periodic susceptibility testing should be done when clinically appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.V. and other antibacterial drugs, PRIMAXIN I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Important Safety Information

PRIMAXIN I.V. is contraindicated in patients who have shown hypersensitivity to any component of this product.

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN PERSONS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

BEFORE INITIATING THERAPY WITH PRIMAXIN I.V., CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER BETA-LACTAMS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION TO PRIMAXIN I.V. OCCURS, DISCONTINUE THE DRUG. SEIZURES AND OTHER CNS ADVERSE EVENTS HAVE BEEN REPORTED DURING TREATMENT WITH PRIMAXIN I.V.

Co-administration of carbapenems, including PRIMAXIN I.V., to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations, which may drop below the therapeutic range and increase the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient. Concomitant use of PRIMAXIN I.V. and valproic acid/divalproex sodium is generally not recommended. Consider other anti-bacterials in patients whose seizures are well controlled on valproic acid or divalproex sodium. If PRIMAXIN I.V. is necessary, consider supplemental anticonvulsant therapy.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including PRIMAXIN I.V., and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued.

Central nervous system (CNS) adverse experiences such as confusional states, myoclonic activity, and seizures have been reported during treatment with PRIMAXIN I.V., especially when recommended dosages were exceeded. These experiences have occurred most commonly in patients with CNS disorders (eg, brain lesions or history of seizures) and/or compromised renal function. However, there have been reports of CNS adverse experiences in patients who had no recognized or documented underlying CNS disorder or compromised renal function.

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. were nausea (2.0%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), seizures (0.4%), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), and somnolence (0.2%).

Prescribing PRIMAXIN I.V. in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than 3 months of age, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluents containing benzyl alcohol should not be used when PRIMAXIN I.V. is constituted for administration to pediatric patients in this age range.

Before prescribing PRIMAXIN I.V., please read the Prescribing Information.

^a Efficacy for this organism in this organ system was studied in fewer than 10 infections.

¹ AMR/Arlington Medical Resources, Inc., The Hospital Antibiotic Market Guide. 1994–2006.

This site is intended only for health care professionals of the United States, its territories, and Puerto Rico.

PPRIMAXIN I.V., MerckServices, MerckSource, and MerckMedicus are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

21050755(1)-04/10-PRI