CEPIMAX 2000mg 

  Cefepime

Vial 2000 mg

Cepimax^® (Cefepime)

Description

Cepimax^® is a semi synthetic, broad spectrum, fourth generation cephalosporin antibiotic.

Clinical pharmacology

Cepimax^® is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cepimax^® has a broad spectrum of in vitro activity that encompasses a wide range of gram-positive and gram-negative bacteria. Cepimax^® has a low affinity for chromosomally-encoded beta-lactamases. Cepimax^® is highly resistant to hydrolysis by most beta –lactamases and exhibits rapid penetration into gram-negative bacterial cells. Within bacterial cells, the molecular targets of Cepimax^® are the penicillin binding proteins (PBP). Cepimax^® has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections:

Aerobic Gram-Negative Microorganisms:

(Enterobacter Escherichia coli, Klebsiella pneumoniae

Proteus mirabillis, seudomonas aeruginosa)

Aerobic Garm-Positive Microorganisms: Staphylococcus aureus (methicillin-susceptible strains only)

Streptococcus pneumoniae

Streptococcuus pyogenes (Lancefield's Group A streptococci Viridans group streptococci)

Pharmacokinetics

Oral absorption poor

Presystemic metabolism Nil

Plasma half – life Range 2-2.3h

Volume of distribution ~18±2.0 L

Plasma protein binding ~ 20%

Indication

1- Moderate to severe Pneumonia.

2- Empiric therapy for febrile neutropenic patients

3- Uncomplicated and complicated urinary Tract Infections (including pyelonephritris)

4- Uncomplicated skin and skin structure infections

5- Complicated intra-abdominal infections

Contraindication

Cepimax^® is contraindicated in patients who have shown immediate hypersensitivity reactions to Cepimax^® or the cephalosporin of antibiotics, penicillins or other beta-lactam antibiotics.

Precaution

· Prescribing Cepimax^® in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development drug-resistant bacteria.

· Cepimax^® should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

· Prolonged use of Cepimax^® may result overgrowth of nonsusceptible microorganisms.

· Cepimax^® has been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment.

· Before Cepimax^® administration, previous hypersensitivity reaction to cephalosporin, penicillins or other beta-lactam must be determined.

· Safety and effectiveness in pediatric patients below the age of 2 months have not been established.

· Cepimax^® should not be added to Ampicillin solutions of a strength greater then 40 mg per mL, or to Aminophylline, Gentamicin, Metronidazole, Netilmicin, Tobramycin, or Vancomycin solutions. If these medications are administered concurrently with Cepimax^®, they should be administered at separate sites.

Pregnancy

Pregnancy category B

There are, however, no adequate and well-controlled studies of Cepimax^® use in pregnant women; this drug should be used during pregnancy only if clearly needed.

Breast feeding

Cepimax^® is excreted in human breast milk in very low Concentration (0.5 ng/mL). Caution should be exercised when Cepimax^® is administered to a nursing woman.

Dosage

Usual adult and adolescent dose

· Complicated Intra-abdominal infections: Intravenous, 2 grams (base), in combination with metronidazole, every twelve hours for seven to ten days.

· Uncomplicated, moderate to severe Skin and soft tissue infections, or severe urinary tract infections: Intravenous, 2 grams (base) every twelve hours for ten days.

· Neutropenia, fabrile: Intravenous, 2 grams (base) every eight hours for seven days or until resolution of neutropenia.

Note: In patients whose fever resolves but who remain neutropenic for more than seven days, the need for continued antimicrobial therapy should be re-evaluated frequently.

· Moderate to severe Pneumonia: Intravenous, 1 to 2 grams (base) every twelve hours for ten, days.

· Mild to moderate Urinary tract infections: Intramuscular or intravenous, 500 mg to 1 gram (base) every twelve hours for seven to ten days.

· Sever urinary tract infections: intravenous, 2 grams every 12 hours for ten days.

Note: After an initial loading dose equal to that of patients with normal renal function, patients with renal function impairment may require a reduction in dose.

Usual pediatric dose

· moderate to severe Pneumonia or moderate to severe, uncomplicated Skin and skin structure infection, or mild to moderate uncomplicated or complicated Urinary tract infection: Infants and children 2 months to 16 years of age (up to 40 kg of body weight): Intravenous, 50 mg per kg of body weight every 12 hours for 10 days (7 to 10 days for urinary tract infection).

Severe, uncomplicated or complicated Urinary Tract infection: Infants and children 2 month to 16 years of age (up to 40 kg of body weight): Intravenous or Intramuscular, 50 mg per kg of body weight every 12 hours for 7 to 10 days.

Note: Intramuscular route of administration is indicated only for mild to moderate, uncomplicated or complicated urinary tract infections due to Escherichia coli in the event that intramuscular administration is determined to be the more appropriate drug administration route.

· Febrile neutropenia, empiric therapy: Infants and children 2 months to 16 years of age (up to 40 kg of body weight): Intravenous, 50 mg per kg of body weight every 8 hours for 7 days or until resolution of neutropenia.

Note: In patients whose fever resolves but who remain neutropenic for more than seven days, the need for continued antimicrobial therapy should be re-evaluated frequently.

Usual pediatric prescribing limits

The maximum pediatric dose should not exceed the dose recommended for adults.

Usual geriatric dose

Dosing the same as adult dose.

Administration

To prepare initial dilution for Intramuscular use. Use.

2mL of sterile water for injection, 0.9% sodium chloride injection, 5% dextrose injection, or 1% lidocaine hydrochloride (without epinephrine), should be added to each 500 mg vial, or 3mL of diluent should be added to each 1 gram vial.

To prepare initial dilution for intravenous administration.

5 mL of sterile water for injection should be added to each 500-mg vial, or 10 mL of diluent should be added to each 1 or 2 gram vial. The resulting solution should be further diluted in 50 to 100 mL of suitable diluents (, 0.9% sodium chloride injection, 5% dextrose injection) and administered over a period of 30 minutes.

Patient consultation

· Continue medicine for full time of treatment.

· Cepimax^®<