Amupime IM/IV Injection
Amupime Hydrochloride is a preparation of Amupime. It is a fourth generation broad-spectrum cephalosporin antibiotic. Amupime acts by inhibition of bacterial cell wall synthesis. It is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram-negative bacterial cells.
Amupime has been shown to be active against most strains of the following microorganisms:
Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Viridans group streptococci, Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus hominis, Streptococcus agalactiae.
Enterobacter, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Acinetobacter calcoaceticus, Citrobacter diversus, Citrobacter freundii, Enterobacter spp., Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (including beta-lactamase producing strains), Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Neisseria meningitidis.
Clostridium perfringens, Mobiluncus spp.
Amupime Hydrochloride is used for the treatment of the following infections:
• Pneumonia (moderate to severe)
• Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis)
• Uncomplicated Skin and Skin Structure Infections
• Complicated Intra-abdominal Infections
• Empiric Therapy for Febrile Neutropenic Patients.
Amupime is also used to associated treatment for these conditions: Bacterial Infections, Complicated Intra-Abdominal Infections, Complicated Urinary Tract Infection, Febrile Neutropenia, Meningitis, Bacterial, Pyelonephritis, Severe Pneumonia, Uncomplicated Urinary Tract Infections, Moderate Pneumonia, Uncomplicated skin and subcutaneous tissue bacterial infections
|Other Names||Cefepima, Cefepime, Cefepimum|
The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum.
|Therapeutic Class||Fourth generation Cephalosporins|
|Manufacturer||Amulet Pharmaceuticals Ltd|
|Last Updated:||June 23, 2021 at 11:17 am|
Table Of contents
Recommended dosage schedule for adults with normal renal function
Type of Infection Dose Frequency Duration (Days)
Moderate to severe Pneumonia 1-2 g IV q12h 10
Empiric Therapy for Febrile Neutropenic Patients 2 g IV q8h 7
Mild to moderate Uncomplicated or Complicated Urinary 0.5-1 g IV/IM q12h 7-10
Tract Infections (including pyelonephritis)
Severe Uncomplicated or Complicated Urinary 2 g IV q12h 10
Tract Infections (including pyelonephritis)
Moderate to severe Uncomplicated Skin and Skin Structure 2 g IV q12h 10
Complicated Intra-abdominal Infections 2 g IV q12h 7-10
Pediatric Patients (2 months up to 16 years)
The maximum dose for pediatric patients should not exceed the recommended adult dose.
Type of Infection Pediatric patients up to 40 kg in weight
Dose Frequency Duration
Uncomplicated and Complicated Urinary Tract Infections 50 mg/kg q12h 7-10
Uncomplicated Skin and Skin Structure Infections 50 mg/kg q12h 10
Pneumonia 50 mg/kg q12h 10
Febrile Neutropenic Patients 50 mg/kg q8h 7
Impaired Hepatic Function - No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function - In patients with impaired renal function (creatinine clearance <60 ml/min), the dose of Amupime should be adjusted. The recommended initial dose of Amupime should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of Amupime in patients with renal insufficiency are presented in the following table:
Creatinine Clearance Recommended Maintenance Schedule
>60 500 mg q12h 1g q12h 2g q12h 2g q8h
30-60 500 mg q24h 1g q24h 2g q24h 2g q12h
11-29 500 mg q24h 500 mg q24h 1g q24h 2g q24h
<11 250 mg q24h 250 mg q24h 500 mg q24h 1g q24h
CAPD 500 mg q48h 1g q48h 2g q48h 2g q48h
Hemodialysis 1g on day 1, then 500 mg q24h thereafter 1g q24h
Preparation of Solutions of Amupime Hydrochloride
Single-dose vial Administration Amount of diluent to be added
500 mg IM 1.3 ml
500 mg IV 5 ml
1 gm IM 2.4 ml
1 gm IV 10 ml
These solutions may be stored up to 24 hours at room temperature or 7 days in a refrigerator.
Amupime Hydrochloride is compatible at concentrations between 1 and 40 mg/ml with the following IV infusion fluids: (1) 0.9% Sodium chloride, (2) 5% and 10% Dextrose.
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.
Generally Amupime is well tolerated. However, few side-effects including rash, pruritus, urticaria, fever, headache, nausea, vomiting, diarrhea, dizziness, oral moniliasis may occur.
In patients with impaired renal function (creatinine clearance <60 ml/min), the dose of Amupime should be adjusted. Amupime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis.
Increased potential for nephrotoxicity and ototoxicity of aminoglycosides. Increased risk of nephrotoxicity with potent diuretics (e.g. furosemide).
Food InteractionNo interactions found.
Volume of Distribution
- 18.0 ±2.0 L
- 0.3 ±0.1 L/kg [Pediatric]
2.0 (± 0.3) hours in normal patients. The average half-life in patients requiring hemodialysis was 13.5 (± 2.7) hours and in patients requiring continuous peritoneal dialysis was 19.0 (± 2.0) hours.
- 120 mL/min [Healthy adult male receiving a single 30-minute IV infusions of cefepime]
- 3.3 +/-1.0 mL/min/kg [Petriatic patients (2 months – 11 years of age) receiving a single IV dose]
Pregnancy & Breastfeeding use
Pregnancy: There are no adequate and well-controlled studies of Amupime use in pregnant women. Amupime should be used during pregnancy only if clearly needed.
Lactation: Amupime is excreted in human breast milk in very low concentrations. Caution should be exercised when Amupime is administered to a nursing woman.
Hypersensitivity to cefepime or other cephalosporins.
Patients who receive an overdose should be carefully observed and given supportive treatment. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
Interaction with other Medicine
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Amupime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Amupime Hydrochloride should be stored in a cool & dry place and protected from light.