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Cefepime Hydrochloride for Injection

Basic Info

Model No.:  PI0017

Product Description

Model NO.: PI0017 Pharmaceutical Technology: Chemical Synthesis Specification: OEM/GMP Type: Organic Chemicals Trademark: aoshun Origin: China Mainland Normal renal function in elderly patients is generally recommended dose, its efficacy and safety similar to other adult patients; elderly patients with renal insufficiency the FDA, dosing schedules should be adjusted based on renal function

Product:

Cefepime Hydrochloride for Injection

Ingredients

The main ingredients of cefepime hydrochloride, its chemical name: 1 - [[(6R, 7R) -7- [2- (2- amino-4-thiazolyl) - acetaldehyde amido] -2- - carboxy-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-en-3-yl] methyl] -1-methyl-pyrrolidin chloride, 72- (Z ) - (O- methyloxime), hydrochloric acid, monohydrate

Formula

C19H25ClN6O5S2 ? HCl ? H2O

Molecular Weight

571.5

Properties

white to pale yellow powder.

Indications

It can be used to treat adults and children aged 2 months to 16 above-sensitive bacteria that cause moderate to severe infections, including lower respiratory tract infections (pneumonia and bronchitis), urinary tract infections and SIMPLE complicated urinary tract infections (including pyelonephritis nephritis), uncomplicated skin and skin and soft tissue infections, complicated intra-abdominal infections (including peritonitis and biliary tract infections), obstetrics and gynecology infections, sepsis, and neutropenia with experience in the treatment of fever patients. It can also be used in children with bacterial meningitis.
Bacterial infection should be suspected bacterial culture and sensitivity test, but because Cefepime is a Gram-positive and Gram-negative bacteria broad-spectrum fungicide, it can start cefepime monotherapy before susceptibility test results were announced treatment. Suspected anaerobic mixed infection, it is recommended combined with other anti-anaerobic drugs such as metronidazole for initial treatment. Once the bacterial culture and sensitivity test results were announced, should be timely adjustment of treatment.

Adverse reactions

This product is generally well tolerated, side effects are mostly mild and transient, discontinuation of treatment rare. Common adverse reactions associated with the product can mainly diarrhea, rash, and injection site reactions, such as phlebitis, injection site pain and inflammation. Other adverse effects include nausea, vomiting, allergies, itching, fever, paresthesia and headache. When adjusted in patients with renal insufficiency without cefepime dosage, can cause encephalopathy, muscle spasms, seizures. In case of treatment-related epilepsy, medication should be stopped, if necessary, should be carried out anticonvulsant therapy. The treatment of children with meningitis product, occasional convulsions, drowsiness, nervousness and headaches, mainly meningitis caused no significant relationship with the product.
Occasionally bowel disease (including pseudomembranous colitis), oral candidiasis report. Related to this product laboratory abnormalities mostly transient, withdrawal can be restored, including the increase or decrease in serum phosphorus, transaminases (ALT and / or AST) increased, increased eosinophils, partial thromboplastin time and prolonged prothrombin time. Alkaline phosphatase, blood urea nitrogen, creatinine, potassium, total bilirubin, blood calcium decreased, hematocrit decreased. Like other cephalosporins, there leukopenia, neutropenia, thrombocytopenia reported.
Cephalosporins can cause Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, bleeding, liver dysfunction (cholestasis) and blood cells cut back.

Taboo

The product is contraindicated in cefepime or L- arginine, cephalosporins, penicillins, or other β- lactam antibiotics, patients with immediate allergic reactions.

NOTES

Before using, you should determine whether the patient has cefepime, other cephalosporins, penicillins other β- lactam antibiotics or allergies. For any allergies, especially in patients with a history of drug allergy should be cautious.
Broad-spectrum antibiotics can induce pseudomembranous colitis. During using this treatment in patients with diarrhea should consider the possibility of pseudomembranous colitis happen. Mild cases of enteritis, only stopping the drug can be; in severe cases require special treatment. Gastrointestinal disorders, especially colitis patients should be prescribed with caution cefepime. Like other cephalosporins, cefepime may cause prothrombin activity decreased. Cause for the existence of prothrombin activity decreased in patients with risk factors, such as liver, kidney dysfunction, malnutrition and prolonged antibiotic therapy the patient should be monitored for prothrombin time, if necessary administration of exogenous vitamin K.
This product contains arginine at the dose of 33 times the maximum recommended dose can cause when glucose metabolism disorders and a transient increase in serum potassium. When low doses of arginine effect is not clear.
Renal insufficiency (creatinine clearance ≤60ml / min) patients should be administered dose of this product or intermittent time adjustment based on renal function. The goods and aminoglycosides or potent diuretics should strengthen clinical observation and monitoring of renal function, to avoid triggering aminoglycosides nephrotoxicity or ototoxicity.

Pregnant and lactating women

Although animal reproductive toxicity and teratogenicity tests showed no teratogenic cefepime and embryo toxicity, but no clinical data for this product is adequate and well-controlled pregnant women and women in childbirth. Therefore, this product should be used with caution in pregnant women.
Cefepime in human milk have a very small amount of discharge (concentration of about 0.5μg / ml). Cefepime for lactating women should be cautious.

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