Teflaro (ceftaroline fosamil acetate)

Ceftaroline fosamil is commercially available as ceftaroline fosamil monoacetate monohydrate; dosage is expressed in terms of anhydrous ceftaroline fosamil.

Dosage of ceftaroline fosamil should be selected with caution in geriatric patients. Dosage adjustments are not required based on age, but may be required based on age-related changes in renal function. (See Dosage and Administration: Dosage in Renal and Hepatic Impairment.)

Dosage of ceftaroline fosamil must be modified according to the degree of renal impairment in adults with creatinine clearances of 50 mL/minute or less, including those undergoing hemodialysis. (See Table 1.)

Table 1. Ceftaroline Fosamil Dosage for Adults with Renal Impairment

Estimated Creatinine Clearance Recommended Dosage (mL/minute) 31-50 400 mg every 12 hours 15-30 300 mg every 12 hours <15 or receiving hemodialysis 200 mg every 12 hours; on hemodialysis days, give dose after hemodialysis

Dosage adjustments are not necessary if ceftaroline fosamil is used in pediatric patients with creatinine clearances greater than 50 mL/minute per 1.73 m2. Data are insufficient to make dosage recommendations for pediatric patients with creatinine clearances less than 50 mL/minute per 1.73 m2.

Pharmacokinetics of ceftaroline fosamil have not been studied in patients with impaired hepatic function, but hepatic impairment is not expected to have a clinically important effect on systemic clearance of the drug.

Ceftaroline fosamil is administered by IV infusion.

Ceftaroline fosamil solutions should not be admixed with or added to solutions containing other drugs.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date using ceftaroline fosamil. Interactions are unlikely between ceftaroline fosamil and drugs that are cytochrome P-450 (CYP) substrates, inhibitors, or inducers or drugs that undergo active renal secretion or alter renal blood flow.

In vitro, ceftaroline does not inhibit CYP isoenzymes 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4 and does not induce CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, or 3A4/5. Therefore, pharmacokinetic interactions with drugs metabolized by these isoenzymes are unlikely.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Adequate data are not available regarding use of ceftaroline fosamil in pregnant women.

Animal studies in rats using ceftaroline fosamil dosages up to 4 times the maximum recommended human dosage (MRHD) or in rabbits using dosages up to approximately equal to the MRHD have not revealed evidence of fetal harm.

It is not known whether ceftaroline is distributed into human milk; possible effects of the drug on a breast-fed infant or on milk production are unknown.

Benefits of breast-feeding and the importance of ceftaroline fosamil to the woman should be considered along with the potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

No enhanced messaging available.