Ceftaroline Fosamil Injection for Intravenous

Teflaro is a sterile, semi-synthetic, prodrug antibacterial drug of the cephalosporin class of beta-lactams (βlactams). Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O.

Figure 1: Chemical structure of ceftaroline fosamil

Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil. The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see DOSAGE AND ADMINISTRATION].

Each vial of Teflaro contains ceftaroline fosamil and L-arginine, which results in a constituted solution at pH 4.8 to 6.5.

Dosage Forms And Strengths

For Injection: Teflaro is supplied as 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-use, 20 mL clear glass vials. The powder is constituted and further diluted for intravenous injection.

Storage And Handling

Teflaro (ceftaroline fosamil) for injection is supplied in single-use, clear glass vials containing:

600 mg -individual vial (NDC 0456-0600-01) and carton containing 10 vials (NDC 0456-0600-10)

400 mg -individual vial (NDC 0456-0400-01) and carton containing 10 vials (NDC 0456-0400-10)

Unreconstituted Teflaro vials should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC. Manufactured by: Facta Farmaceutici S.p.A. Nucleo Industriale S. Atto–S. Nicolò a Tordino 64020 Teramo, Italy. Revised: Aug 2015

Included as part of the PRECAUTIONS section.

You should not use this medication if you are allergic to ceftaroline, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ceftaroline will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using ceftaroline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

You should not use this medication if you are allergic to ceftaroline or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);
• cefadroxil (Duricef);
• cefazolin (Ancef);
• cefdinir (Omnicef);
• cefditoren (Spectracef);
• cefpodoxime (Vantin);
• cefprozil (Cefzil);
• ceftibuten (Cedax);
• cefuroxime (Ceftin);
• cephalexin (Keflex); or
• cephradine (Velosef); and others.

To make sure you can safely use ceftaroline, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• a history of intestinal problems, such as colitis; or
• if you are allergic to any drugs (especially penicillin antibiotics).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ceftaroline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• E. coli (0157:H7) (Symptoms, Treatment, Prevention)
• MRSA
• Staph Infection (Staphylococcus Aureus)