WARNINGS AND PRECAUTIONS

Hypersensitivity reactions

Before therapy with Vancoplus is instituted, careful inquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to ceftriaxone, any other cephalosporin, or to any penicillin or other beta lactam drug. This product should be given cutaneously to test penicillin-sensitive patients or to any patients who has demonstrated some form of allergy. If an allergic reaction occurs, Vancoplus should be discontinued and the appropriate therapy instituted.

Infusion related reactions

Rapid bolus administration of Vancoplus (e. g. over several minutes) may be associated with exaggerated hypotension, including shock and rarely cardiac arrest. Vancoplus should be administered over a period of not less than 60 minutes to avoid rapid-infusion-related reactions. Stopping the infusion usually results in prompt cessation of these reactions. Vancoplus should be used with caution in patients with renal insufficiency because the risk of toxicity is appreciably increased by high, prolonged blood concentrations of Vancomycin.

There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. Infusion-related events may be minimized by the administration of Vancoplus as a 60 minute infusion prior to anesthetic induction.

Administration site reactions

Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness, and necrosis occur with inadvertent extravasation. Thrombophlebitis may occur, the frequency and severity of which can be minimized by slow infusion of Vancoplus and by rotation of venous access sites. The safety and efficacy of Vancoplus administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not established.

Interaction with calcium-containing products

Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution to reconstitute Vancoplus vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when Vancoplus is mixed with calcium-containing solutions in the same IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, Vancoplus and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium.

Clostridium difficile associated diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, therefore it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use.

Hemolytic Anemia

An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class of antibacterials including ceftriaxone. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on Vancoplus, the diagnosis of a cephalosporin associated anemia should be considered and Vancoplus should be stopped until the etiology is determined.

Ototoxicity

Ototoxicity has occurred in patients receiving Vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity.

Alteration in prothrombin time

Alterations in prothrombin times have occurred rarely in patients treated with Ceftriaxone. Patients with impaired vitamin K synthesis or low vitamin K stores (e. g, chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during Vancoplus treatment. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.

Neutropenia

Reversible neutropenia has been reported in patients receiving Vancomycin. Patients who will undergo prolonged therapy or those who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.

Prolonged use of medicinal product

Prolonged use of Vancoplus may result in overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If super infection occurs during therapy, appropriate measures should be taken.

Hepatic effects

There have been reports of sonographic abnormalities in the gallbladder of patients treated with ceftriaxone; some of these patients also had symptoms of gallbladder disease. These abnormalities appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones. The chemical nature of the sonographically detected material has been determined to be predominantly a ceftriaxone-calcium salt. The condition appears to be transient and reversible upon discontinuation of Ceftriaxone and institution of conservative management. Therefore, Vancoplus should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above.

Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported rarely in patients treated with ceftriaxone. Most patients presented with risk factors for biliary stasis and biliary sludge (preceding major therapy, severe illness, and total parenteral nutrition). A cofactor role of ceftriaxone related biliary precipitation cannot be ruled out.


Vancoplus

Prescribing Information

Prescribing Information