Cepan

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cepan (Cepan) and other antibacterial drugs, Cepan (Cepan) 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Treatment

Cepan (Cepan) is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms:

Urinary Tract Infections caused by E. coli, Klebsiella spp (including K. pneumoniae), Proteus mirabilis and Proteus spp (which may include the organisms now called Proteus vulgaris, Providencia rettgeri, and Morganella morganii).

Lower Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella species (including K. pneumoniae), E. coli, Proteus mirabilis, and Serratia marcescens*.

Skin and Skin Structure Infections due to Staphylococcus aureus (penicillinase- and nonpenicillinase-producing strains),

Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus species (excluding enterococci), Escherichia coli, Klebsiella pneumoniae, Peptococcus niger*, Peptostreptococcus species.

Gynecologic Infections caused by Staphylococcus aureus, (including penicillinase- and nonpenicillinase-producing strains),

Staphylococcus epidermidis, Streptococcus species (excluding enterococci), Streptococcus agalactiae, E. coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides species (excluding B. distasonis, B. ovatus, B. thetaiotaomicron), Fusobacterium species*, and gram-positive anaerobic cocci (including

Peptococcus niger and Peptostreptococcus species).

Cepan, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

Intra-abdominal Infections caused by E. coli, Klebsiella species (including K. pneumoniae), Streptococcus species (excluding enterococci), Bacteroides species (excluding B. distasonis, B. ovatus, B. thetaiotaomicron) and Clostridium species*.

Bone and Joint Infections caused by Staphylococcus aureus.*

*Efficacy for this organism in this organ system was studied in fewer than ten infections.

Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to Cepan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.

In cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, it is possible to use Cepan concomitantly with an aminoglycoside. Cepan combinations with aminoglycosides have been shown to be synergistic in vitro against many Enterobacteriaceae and also some other gram-negative bacteria. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition.

NOTE: Increases in serum creatinine have occurred when Cepan (Cepan) was given alone. If Cepan (Cepan) and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.

Prophylaxis

The preoperative administration of Cepan (Cepan) may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures that are classified as clean contaminated or potentially contaminated (eg, cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, and gastrointestinal surgery).

If there are signs and symptoms of infection, specimens for culture should be obtained for identification of the causative organism so that appropriate therapeutic measures may be initiated.

Cepan injection is used to treat bacterial infections in many different parts of the body. Cepan is also given before certain types of surgery to prevent infections.

Cepan injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Cepan will not work for colds, flu, or other virus infections.

Cepan is available only with your doctor's prescription.

Treatment

Cepan injection in Galaxy® plastic container should not be used for intramuscular administration.

Cepan (Cepan) in the ADD-Vantage Vial is intended for intravenous infusion only, after dilution with the appropriate volume of ADD-Vantage diluent solution.

The usual adult dosage is 1 or 2 grams of Cepan (Cepan for injection) administered intravenously or intramuscularly or Cepan (Cepan injection) in the Galaxy® plastic container (PL 2040) administered intravenously every 12 hours for 5 to 10 days. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organism.

If Chlamydia trachomatis is a suspected pathogen in gynecologic infections, appropriate antichlamydial coverage should be added, since Cepan has no activity against this organism.

Prophylaxis:

To prevent postoperative infection in clean contaminated or potentially contaminated surgery in adults, the recommended dosage is 1 or 2 g of Cepan (Cepan) administered once, intravenously, 30 to 60 minutes prior to surgery. In patients undergoing cesarean section, the dose should be administered as soon as the umbilical cord is clamped.

Impaired Renal Function:

When renal function is impaired, a reduced dosage schedule must be employed. The following dosage guidelines may be used.

Alternatively, the dosing interval may remain constant at 12 hour intervals, but the dose reduced to one-half the usual recommended dose for patients with a creatinine clearance of 10-30 mL/min, and one-quarter the usual recommended dose for patients with a creatinine clearance of less than 10 mL/min.

When only serum creatinine levels are available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent a steady state of renal function.

Males: Weight (kg) x (140 - age)

Females: 0.9 x value for males

Cepan is dialyzable and it is recommended that for patients undergoing intermittent hemodialysis, one-quarter of the usual recommended dose be given every 24 hours on days between dialysis and one-half the usual recommended dose on the day of dialysis.

Cepan FOR INJECTION

Preparation of Solution From Cepan For Injection For

Intravenous Use

Infusion bottles (100 mL) may be reconstituted with 50 to 100 mL of Dextrose Injection 5% or Sodium Chloride Injection 0.9%.

NOTE: ADD-VANTAGE VIALS ARE NOT TO BE USED IN THIS MANNER

For ADD-Vantage Vials: ADD-Vantage Vials of Cepan (Cepan) are to be reconstituted only with Sodium Chloride Injection 0.9% or Dextrose Injection 5% in the 50 mL, 100 mL or 250 mL Flexible Diluent Containers. Cepan (Cepan) supplied in single-use ADD-Vantage Vials should be prepared as directed.

Directions for Use of Cepan (Cepan for injection) in ADD-Vantage Vials:

To Open Diluent Container: Peel overwrap from the corner and remove container. Some opacity of the plastic 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 ADD-Vantage 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:

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 1/2 turn (180°) after the first audible click. 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.

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.

3. Pull the inner cap from the drug vial. Verify that the rubber stopper has been pulled out and invert the system several times, allowing the drug and diluent to mix.

4. Mix 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.

6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two 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.

For

Intramuscular Use

Intravenous Administration:

The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

For intermittent intravenous administration, a solution containing 1 gram or 2 grams of Cepan (Cepan for injection) in Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, the solution may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. Butterfly® or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing Cepan (Cepan for injection), it is advisable to discontinue temporarily the administration of other solutions at the same site.

NOTE: Solutions of Cepan (Cepan) must not be admixed with solutions containing aminoglycosides. If Cepan (Cepan) and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection.

Intramuscular Administration:

As with all intramuscular preparations, Cepan (Cepan for injection) should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (ie, gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel.

Cepan INJECTION

Directions for Use of Cepan (Cepan injection) in Galaxy® Plastic Container (PL 2040)

Cepan (Cepan injection) in Galaxy® plastic container (PL 2040) is for intravenous administration only.

Storage: Store in a freezer capable of maintaining a temperature of -20°C/-4°F.

Thawing of Plastic Container: Thaw frozen container at room temperature (25°C/77°F) or in a refrigerator (5°C/41°F). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

PREPARATION OF INTRAVENOUS USE (USE ASEPTIC TECHNIQUE):

1. Suspend container from eyelet support.

2. Remove protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Intravenous Administration

The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

Using an infusion system, Cepan (Cepan injection) in Galaxy® plastic container (PL 2040) should be given over 20 to 60 minutes through the tubing system by which the patient may be receiving other intravenous solutions. Butterfly® or scalp vein-type needles are preferred for this type of infusion. However, during infusion of the solution containing Cepan (Cepan injection) in Galaxy® plastic container (PL 2040), it is advisable to discontinue temporarily the administration of other solutions at the same site.

Compatibility and Stability of Cepan (Cepan) Products

Frozen samples should be thawed at room temperature before use. After the periods mentioned below, any unused solutions or frozen material should be discarded. DO NOT REFREEZE.

NOTE: Solutions of Cepan (Cepan) must not be admixed with solutions containing aminoglycosides. If Cepan (Cepan) and aminoglycosides are to be administered to the same patient, they must be administered separately and not as a mixed injection. DO NOT ADD SUPPLEMENTARY MEDICATION.

Cepan FOR INJECTION

Cepan (Cepan for injection) reconstituted as described above (PREPARATION OF SOLUTION) maintains satisfactory potency for 24 hours at room temperature (25°C/77°F), for 96 hours under refrigeration (5°C/41°F), and for at least 1 week in the frozen state (-20°C/-4°F). After reconstitution and subsequent storage in disposable glass or plastic syringes, Cepan (Cepan for injection) is stable for 24 hours at room temperature and 96 hours under refrigeration.

ADD-Vantage Vials:

Ordinarily, ADD-Vantage Vials should be reconstituted only when it is certain that the patient is ready to receive the drug. However, ADD-Vantage Vials of Cepan (Cepan) reconstituted as described in Preparation of Solution, for ADD-Vantage Vials, maintains satisfactory potency for 24 hours at room temperature (25°C/77°F).

(DO NOT REFRIGERATE OR FREEZE Cepan IN ADD-VANTAGE VIALS.)

Cepan INJECTION

The thawed solution in Galaxy® plastic container (PL 2040) remains chemically stable for 48 hours at room temperature (25°C/77°F) or for 21 days under refrigeration (5°C/41°F).

NOTE:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

How supplied

Cepan (Cepan for injection) is a dry, white to pale yellow powder supplied in vials containing Cepan equivalent to 1 g and 2 g Cepan activity for intravenous and intramuscular administration. The vials should not be stored at temperatures above 22°C (72°F) and should be protected from light.

Cepan (Cepan) is also available as a 10 g pharmacy bulk package.

Cepan (Cepan injection) is supplied as a frozen, iso-osmotic, premixed solution in single dose Galaxy® plastic containers (PL 2040) as follows:

Store containers at or below -20°C/-4°F.

REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically -- Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA, December, 1993.

2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests -- Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

3. National Committee for Clinical Laboratory Standards. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria - Third Edition. Approved Standard NCCLS Document M11-A3, Vol 13, No. 26, NCCLS, Villanova, PA, December 1993.

*Galaxy® is a registered trademark of Baxter Healthcare Corporation. †ADD-Vantage is a registered trademark of Abbott Laboratories Inc. †Clinitest® is a registered trademark of Ames Division, Miles Laboratories, Inc. All other trademarks are the property of the AstraZeneca group ©AstraZeneca 2002

Cepan® (Cepan injection) in Galaxy® plastic container (PL 2040) is manufactured by Baxter Healthcare Corporation, Deerfield, Illinois 60015 USA for AstraZeneca Pharmaceuticals LP.

Cepan® (Cepan for injection) is manufactured by GlaxoSmithKline for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850

Rev 01/03 SIC 64173-03

See also:
What is the most important information I should know about Cepan?

You should not use this medication if you are allergic to Cepan, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, 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 medicine 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. Cepan 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 Cepan and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Use Cepan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cepan is usually given as an injection at your doctor's office, hospital, or clinic.
• Do not use Cepan if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• To clear up your infection completely, use Cepan for the full course of treatment. Keep using it even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Cepan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cepan.

Use: Labeled Indications

Bone and joint infections: Treatment of bone and joint infections caused by Staphylococcus aureus.

Gynecologic infections: Treatment of gynecologic infections caused by S. aureus, (including penicillinase- and non-penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus spp. (excluding enterococci), Streptococcus agalactiae, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae, Bacteroides spp. (excluding Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron), Fusobacterium spp., and gram-positive anaerobic cocci (including Peptococcus and Peptostreptococcus spp.).

Limitations of use: Cepan has no activity against Chlamydia (Chlamydophila) trachomatis. When treating pelvic inflammatory disease, add appropriate antichlamydial coverage.

Lower respiratory tract infections: Treatment of lower respiratory tract infections caused by Streptococcus pneumoniae, S. aureus (penicillinase- and non-penicillinase-producing strains), Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp. (including K. pneumoniae), E. coli, P. mirabilis, and Serratia marcescens.

Serious infections: Treatment of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections (often administered with concomitant aminoglycosides).

Skin and skin structure infections: Treatment of skin and skin structure infections due to S. aureus (penicillinase- and non-penicillinase-producing strains), Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus spp. (excluding enterococci), E. coli, K. pneumoniae, Peptococcus niger, Peptostreptococcus spp.

Surgical (perioperative) prophylaxis: Preoperative administration in surgical procedures that are classified as clean contaminated or potentially contaminated (eg, cesarean section, abdominal or vaginal hysterectomy, transurethral surgery, biliary tract surgery, GI surgery).

Urinary tract infections: Treatment of urinary tract infections caused by E. coli, Klebsiella spp. (including K. pneumoniae), P. mirabilis and Proteus spp. (which may include the organisms now called Proteus vulgaris, Providencia rettgeri, and Morganella morganii).

See also:
What other drugs will affect Cepan?

Increases in serum creatinine have occurred when Cepan (Cepan) was given alone. If Cepan (Cepan) and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.

Drug/Laboratory Test Interactions: The administration of Cepan (Cepan) may result in a false positive reaction for glucose in the urine using Clinitest®†, Benedict's solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase be used.

As with other cephalosporins, high concentrations of Cepan may interfere with measurement of serum and urine creatinine levels by Jaffe¢ reaction and produce false increases in the levels of creatinine reported.

See also:
What are the possible side effects of Cepan?

Applies to Cepan: injection powder for solution

In addition to its needed effects, some unwanted effects may be caused by Cepan (the active ingredient contained in Cepan). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking Cepan, check with your doctor or nurse immediately:

Less common:

• Abdominal or stomach cramps or tenderness
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• bloating
• chest pain
• chills
• cough
• dark urine
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing
• fever
• general body swelling
• headache
• increased thirst
• loss of appetite
• nausea or vomiting
• nosebleeds
• pain
• painful or difficult urination
• pale skin
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• yellowing of the eyes or skin

• Blood in the urine
• bluish color
• change in frequency of urination or amount of urine
• changes in skin color
• drowsiness
• increased thirst
• swelling of the feet or lower legs
• tenderness
• weakness

• Blistering, peeling, or loosening of the skin
• cough or hoarseness
• coughing up blood
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• increased menstrual flow or vaginal bleeding
• itching
• itching of the vagina or genital area
• joint or muscle pain
• lower back or side pain
• nosebleeds
• pain during sexual intercourse
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• red or black, tarry stools
• red or dark brown urine
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• skin rash
• sudden decrease in the amount of urine
• swollen or painful glands
• thick, white vaginal discharge with no odor or with a mild odor
• tightness in the chest
• unpleasant breath odor
• vomiting of blood
• wheezing

A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms. [PubChem]