Zinacef

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Probenecid (Benemid, Probalan)
• Vitamins
• Anticoagulants such as warfarin (Coumadin)
• Diuretics
• Other antibiotics
• Combined estrogen/progesterone contraceptives

This is not a complete list of cefuroxime drug interactions. Ask your doctor or pharmacist for more information.

If you take too much cefuroxime, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If cefuroxime is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Cefuroxime is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth.

This medicine is available only with your doctor's prescription.

• It is used to treat or prevent bacterial infections.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.
• It may be given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If you need to store Zinacef at home, talk with your doctor, nurse, or pharmacist about how to store it.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following chemical structure:

The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4.

Zinacef contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity.

Zinacef in sterile crystalline form is supplied in vials equivalent to 750 mg, 1.5 g, or 7.5 g of cefuroxime as cefuroxime sodium and in TwistVialTM vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Zinacef range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.

Zinacef is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution with 1.5 g of cefuroxime as cefuroxime sodium. Sodium Citrate Hydrous, USP has been added as a buffer (600 mg to the 1.5-g dose). Zinacef contains approximately 222 mg (9.7 mEq) of sodium in the 1.5-g dose. The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. Solutions of premixed Zinacef range in color from light yellow to amber. The solution is intended for intravenous (IV) use after thawing to room temperature. The osmolality of the solution is approximately 300 mOsmol/kg, and the pH of thawed solutions ranges from 5 to 7.5.

The plastic container for the frozen solution is fabricated from a specially designed multilayer plastic, PL 2040. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Intramuscular

When constituted as directed with Sterile Water for Injection, suspensions of Zinacef for IM injection maintain satisfactory potency for 24 hours at room temperature and for 48 hours under refrigeration (5°C).

After the periods mentioned above any unused suspensions should be discarded.

Intravenous

When the 750-mg, 1.5-g, and 7.5-g pharmacy bulk vials are constituted as directed with Sterile Water for Injection, the solutions of Zinacef for IV administration maintain satisfactory potency for 24 hours at room temperature and for 48 hours (750-mg and 1.5-g vials) or for 7 days (7.5-g pharmacy bulk vial) under refrigeration (5°C). More dilute solutions, such as 750 mg or 1.5 g plus 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, also maintain satisfactory potency for 24 hours at room temperature and for 7 days under refrigeration.

These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hours at room temperature or for at least 7 days under refrigeration: 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; Ringer's Injection, USP; Lactated Ringer's Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 10% Dextrose Injection; and 10% Invert Sugar in Water for Injection.

Unused solutions should be discarded after the time periods mentioned above.

Zinacef has also been found compatible for 24 hours at room temperature when admixed in IV infusion with heparin (10 and 50 U/mL) in 0.9% Sodium Chloride Injection and Potassium Chloride (10 and 40 mEq/L) in 0.9% Sodium Chloride Injection. Sodium Bicarbonate Injection, USP is not recommended for the dilution of Zinacef.

The 750-mg and 1.5-g Zinacef TwistVialTM vials, when diluted in 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 0.45% Sodium Chloride Injection, may be stored for up to 24 hours at room temperature or for 7 days under refrigeration.

Frozen Stability

Constitute the 750-mg, 1.5-g, or 7.5-g vial as directed for IV administration in Table 5. Immediately withdraw the total contents of the 750-mg or 1.5-g vial or 8 or 16 mL from the 7.5-g bulk vial and add to a compatible container containing 50 or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection and freeze. Frozen solutions are stable for 6 months when stored at -20°C. Frozen solutions should be thawed at room temperature and not refrozen. Do not force thaw by immersion in water baths or by microwave irradiation. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

As with other cephalosporins, Zinacef powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.

Directions for Dispensing

The pharmacy bulk package is for use in a pharmacy admixture service only under a laminar flow hood. Entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using aseptic technique. The use of syringe and needle is not recommended as it may cause leakage (see DOSAGE AND ADMINISTRATION). AFTER INITIAL WITHDRAWAL USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 24 HOURS.

Zinacef in the dry state should be stored between 15° and 30°C (59° and 86°F) and protected from light. Zinacef is a dry, white to off-white powder supplied in vials as follows:

(The above TwistVialTM vials are to be used only with compatible diluent containers.)

Zinacef frozen as a premixed solution of cefuroxime injection should not be stored above -20°C. Zinacef is supplied frozen in 50-mL, single-dose, plastic containers as follows:

*Equivalent to cefuroxime.

To Open Diluent Container

Peel the corner of the diluent overwrap and remove flexible diluent container. Some opacity of the plastic flexible container due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container (Use Aseptic Technique)

1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

Figure 1

Figure 2

2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately one-half turn (180°) after the first audible click (see Figure 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go.
Note: Once vial is seated, do not attempt to remove (see Figure 4).

Figure 3

Figure 4

3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

4. Label appropriately.

To Prepare Admixture

1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

2. With the other hand, push the drug vial down into the container, telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (see Figure 5).

3. Pull the inner cap from the drug vial (see Figure 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

Figure 5

Figure 6

4. Mix container contents thoroughly and use within the specified time.

Preparation for Administration (Use Aseptic Technique)

1. Confirm the activation and admixture of vial contents.

2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

3. Close flow control clamp of administration set.

4. Remove cover from outlet port at bottom of container.

5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. Note: See full directions on administration set carton.

6. Lift the free end of the hanger loop on the bottom of the vial, breaking the 2 tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

7. Squeeze and release drip chamber to establish proper fluid level in chamber.

8. Open flow control clamp and clear air from set. Close clamp.

9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

10. Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

Covis Pharmaceuticals, Inc.
Cary, NC 27511

©2013, Covis Pharmaceuticals, Inc. All rights reserved.