For the use of Registered Medical Practitioner of Hospital of Laboratory Only.

(CEFEPIME & TAZOBACTAM FOR INJECTION 1.125GM)

Each vial Contains:

Sterlie Cefepime Hydrochloride IP eq.to  Cefepime...1000mg

Sterlie Tazobactam Sodium eq. to Tazobactam....125mg

INDICATION:

Cefepime and Tazobactum are indicated as parenteral therapy for the treatment of various moderate to severe forms of infections due to susceptible beta-lactamase microbial organisms.Cefepime and Tazobactum combination are particularly indicated if the Cefepime monotheraly is ineffective. Cefepime and Tazobactum are prescribed for the treatment of uncomplited skin structure infections, uncomplicated urinary tract infections (UTI) and complicated intra-abdominal infections in adluts and children. Cefepime is a 4th generation cephalosporin.

Pharmacodynamics

Cefepime prevents final transpeptidation process of bacterial cell wall peptidoglycan blosynthesis. Cefepime binds with one or more penicillin-biding proteins (PBPs)

Pharmacokinetics

After intramuscular administration, Cefepime and Tazobactum is rapidly completed absorbed into the blood cirlulation. About 16-19% of Cefepime and Tazobactum are bound to plasma proteins.The Vss is 14-20L. Cefepime and Tazobactum can pass through the blood brain barrier and inflammatory fluids. Cefepime and Tazobactum are mostly metabolized in the liver. The plasma half-life of Cefepime and Tazobactum is about 2 hours. The drug is mostly excreted in the urine as inchanged drug.

Side Effects of Cefepime + Tazobactum

Positive Coombs Test Without Haemolysis, Rash, Diarrhoea, Nausea, Vomiting, Fever, Headache, Pain And Erythema at Inj site, Agranulocytosis, Anaphylatic shock, Laucopenia, Neutropenia, Thrombocytopenia.

Precautions

Cefepime and Tazobactum are contraindicated in patients with cephalosporin allergy, pregnancy, GI diseases including colitis, renal impairment, Clostridium-difficle associated diarrhoea, hapatic disorders and convulsion.

Other Drug Interactions

Cefepime and Tazobactum may interact with aminoglycosides and high-dose Pronenecid.

Dosage

Intravenous

For Urinarytractinfections (Adluts)

Consider administration of 0.5-1.0 g every 12 hours for 7-10 days. The drug can be administered as slow IV injections over 5minutes or as infusion of 30 minutes.

Intramuscular

For Urinary tract infections ( pediatrics)

For children 2 months to 16 years (<40kg) consider administration of 50mg/kg of Cefepime + Tazobactum every 12  hours for 30 minutes. The injection can be given as deep intramuscular injection for mild to moderate forms of UTI.

Intravenous

As an empirical treatment for febrile neutropeenia (Adults)

Consider administration of 2g of Cefepime + Tazobactum every 8 hours for seven days as needed. Cefepime + Tazobactum can be injected as slow IV over five minutes or as an infusion over 30 minutes.

As an empirical treatment for febrile neutropenia (Pediatrics)

For the children 2 months to 16 years (<40kg) consider administration of 50mg/kg of Cefepime + Tazobactum every 8 hours for 7 days. Cefepime + Tazobactum can be injected as slow IV over 5 minutes or as an infusion over 30 minutes.

For treatment of moderate to severe pneumonia (Adults)

Consider administration of 1-2 g of Cefepime + Tazobactum every 12 hours  for ten days. Cefepime+Tazobactum  can be injected as slow IV over 5minutes or as an infusion over 30 minutes.

For the treatment of moderate to  severe pnemonia (Pediatrics)

For children 2 months to 16 years (<40kg)  consider administration of 50mg/kg of Cefepime+Tazobactum every 12 hours for 10 days. Cefepime+Tazobactum can be injected as slow IV over 5 minutes or as an infusion over 30 minutes.

For the treatment of complicated intra-abdominal infections (Adults)

Consider administraction of 2 g of Cefepime+Tazobactum every 12 hours for 7 to 10 days as a combined therapy with Metrodinazole. Cefepime+Tazobactum can be injected as slow IV over 5 minutes or as an infusion over 30 minutes.

For treatment of uncomplicated skin and skin structure infections (Adults)

Consider administration of 2 g of Cefepime + Tazobactum every 12 hours  for ten days. Cefepime+Tazobactum  can be injected as slow IV over 5minutes or as an infusion over 30 minutes.

For treatment of uncomplicated skin and skin structure infections (Pediatrics)

For children 2 months to 16 years (<40kg)  consider administration of 50mg/kg of Cefepime+Tazobactum every 12 hours for 10 days. Cefepime+Tazobactum can be injected as slow IV over 5 minutes or as an infusion over 30 minutes.

List of Contraindications

Cefepime+ Tazobactum and pregnancy

USFDA pregnancy category. Cefepime and Tazobactum may not cause harm to an unborn foetus. Before Cefepime and Tazobactum treatment the patient should discuss with the physician, if they are planning for a pregnancy.

Cefepime + Tazobactum and Lactation

It is not known whether Cefepime and Tazobactum  can pass through the breat milk or not, Breastfeeding mothers should avoid nursing while tacking Cefepime and Tazobactum.

Cefepime + Tazobactum and children

Should be given as per a Paediatricians's advice

Storage

Store in a cool and dry place. Protect  from moisture and light

Manufactured & Marketed by:

FIDULIS BIO INC

At: Dhandha, Idar Road, Himatnagar 383001

A Subsidiary of

FIDULIS BIO INC

Level 1,139 Macquarie St  Sydney, NSW 2000, PO Box R1784,

Royal Exchange, NSW 1225, Australia.