Tetracef IV/IM 2gm Injection
Cefepime
2gm/vial
Beximco Pharmaceuticals Ltd.
| Pack size | 2gm vial with water |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1100.00 AED |
Available as:
Indications
Tetracef IV/IM 2gm Injection is used for:
Skin and skin structure infections, Urinary tract infection, Nosocomial pneumonia, Multiple drug resistant pneumonia, Neutropenia
Adult Dose
Adult:
Pneumonia
Treatment of moderate-to-severe pneumonia
1-2 g IV q8-12hr for 7-10 days (if not caused by Pseudomonas) or for up to 21 days (if caused by Pseudomonas)
Febrile Neutropenia
Empiric therapy in febrile neutropenic patients
2 g IV q8hr for 7 days or until neutropenia resolves
Urinary Tract Infections
Treatment of uncomplicated and complicated urinary tract infections (UTIs), including pyelonephritis
0.5-1 g IV or IM q12hr for 7-10 days
Severe UTIs due to Escherichia coli or Klebsiella pneumonia:
2 g IV q12hr for 10 days
Skin/Skin Structure Infections
Treatment of uncomplicated skin and skin structure infections
2 g IV q12hr for 10 days
Intra-abdominal Infections
Treatment of complicated intra-abdominal infections; use in combination with metronidazole
2 g IV q12hr for 7-10 days
Child Dose
Child:
Febrile Neutropenia
Empiric therapy in febrile neutropenic patients
>2 months, <40 kg: 50 mg/kg IV q8hr for 7 days or until neutropenia resolves; not to exceed 2 g q8hr
Pneumonia
Treatment of moderate-to-severe pneumonia
50 mg/kg IV q12hr for 10 days; not to exceed 2 g q12hr
Skin/Skin Structure Infections
Treatment of uncomplicated skin and skin structure infections
50 mg/kg IV q12hr for 10 days; not to exceed 2 g q12hr
Urinary Tract Infections
Treatment of uncomplicated and complicated UTIs, including pyelonephritis
50 mg/kg IV/IM q12hr for 7-10 days; not to exceed 2 g q12hr
Renal Dose
Renal impairment:
Adjust recommended maintenance dosages according to CrCl
Recommended maintenance dosage 500 mg q12hr
CrCl >60 mL/min: 500 mg q12hr
CrCl 30-60 mL/min: 500 mg q24hr
CrCl 11-29 mL/min: 500 q24hr
CrCl <11 mL/min: 250 q24hr
Continuous ambulatory peritoneal dialysis (CAPD): 500 mg q48hr
Hemodialysis: 1 g on day 1, then 500-1000 mg q24hr thereafter (on hemodialysis days, administer after hemodialysis)
Recommended maintenance dosage 1 g q12hr
CrCl >60 mL/min: 1 g q12hr
CrCl 30-60 mL/min: 1 g q24hr
CrCl 11-29 mL/min: 500 mg q24hr
CrCl <11 mL/min: 250 mg q24hr
CAPD: 1 g q48hr
Hemodialysis: 1 g on day 1, then 500 mg q24hr thereafter (on hemodialysis days, administer after hemodialysis)
Recommended maintenance dosage 2 g q12hr
CrCl >60 mL/min: 2 g q12hr
CrCl 30-60 mL/min: 2 g q24hr
CrCl 11-29 mL/min: 1 g q24hr
CrCl <11 mL/min: 500 mg q24hr
CAPD: 2 g q48hr
Hemodialysis: 1 g on day 1, then 500 mg q24hr thereafter (on hemodialysis days, administer after hemodialysis)
Recommended maintenance dosage 2 g q8hr
CrCl >60 mL/min: 2 g q8hr
CrCl 30-60 mL/min: 2 g q12hr
CrCl 11-29 mL/min: 2 g q24hr
CrCl <11 mL/min: 1 g q24hr
CAPD: 2 g q48hr
Hemodialysis: 1 g q24hr (on hemodialysis days, administer after hemodialysis)
Administration
Reconstitution: IV infusion: Add 5 mL, 10 mL, or 10 mL of a compatible IV soln to a vial labeled as containing 500 mg, 1 g, or 2 g, respectively, to provide soln containing approx 100 mg/mL, 100 mg/mL, or 160 mg/mL of the drug, respectively. The appropriate dose of the drug should then be added to a compatible IV soln. IM inj: Add 1.3 mL or 2.4 mL of an appropriate diluent (e.g. sterile water for inj, NaCl 0.9%) to a vial labeled as containing 500 mg or 1 g respectively, to provide a soln containing approx 280 mg/mL.
IV Preparation
Reconstitute with 50-100 mL of NS, D5W, D10W, LR, D5/LR, or other compatible fluid
Thaw infusion solution at room temperature or in refrigerator, not in water bath or microwave oven
IV Administration
Infuse intermittently over 30 minutes
Do not administer other drugs through Y-site
IM Preparation
Add 2.4 mL of appropriate diluent (SWI, NS, D5W etc) to 1 g vial to yield solution containing approximately 280 mg/mL
IM Administration
Inject deeply
Give IM only in mild-to-moderate UTI due to E coli
Contra Indications
Hypersensitivity to cefepime or other cephalosporins.
Precautions
Hypersensitivity reactions: Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug.
Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime for Injection and Dextrose Injection occurs, discontinue the drug.
Clostridioides difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs.
IM is recommended only for mild-to-moderate complicated or uncomplicated UTI due to E coli
Pregnancy-Lactation
Pregnancy
There are no cases of drug exposure during pregnancy reported from postmarketing experience or from clinical trials; available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during period of organogenesis; the doses used in these studies were 1.6 times (rats), approximately equal to (mice) and 0.3 times (rabbits) the maximum recommended clinical dose
Lactation
Drug is present in human milk at low concentration (0.5 mcg/mL); a nursing infant consuming approximately 1000 mL of human milk per day would receive approximately 0.5 mg of cefepime per day
There is no information regarding effects on milk production or on breastfed infant
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for cefepime and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
Aminoglycosides: Increased potential of nephrotoxicity and ototoxicity. (7.2)
Diuretics: Nephrotoxicity has been reported with concomitant administration of cephalosporins with potent diuretics such as furosemide.
Monitor renal function.
Contraindicated (0)
Serious (5)
BCG intravesical live
BCG vaccine live
cholera vaccine
microbiota oral
typhoid vaccine live
Adverse Effects
Side effects of Cefepime :
>10%
Positive Coombs test result without hemolysis (16%)
1-10%
Rash (1-4%),Elevated alanine aminotransferase (3%),Hypophosphatemia (3%),Diarrhea (<3%),Eosinophilia (2%),Erythema at injection site (2%),Normal partial thromboplastin time (PTT) (2%),Nausea or vomiting (<2%),Fever (1%),Headache (1%),Pain (1%),Pruritus (1%)
<1%
Agranulocytosis,Anaphylactic shock,Anaphylaxis,Coma,Encephalopathy,Hallucinations,Leukopenia,Myoclonus,Neuromuscular excitability,Neutropenia,Seizures,Thrombocytopenia
Mechanism of Action
Cefepime is a 4th generation cephalosporin which inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall by binding to one or more of the penicillin-binding proteins (PBPs).
Note
Tetracef IV/IM 2gm 2gm/vial Injection manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Cefepime. Tetracef IV/IM 2gm is availble in Bangladesh.
Farmaco BD drug index information on Tetracef IV/IM 2gm Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.