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Ertapenem for injection

Function and Efficacy

Biapenem is an injectable 1β-methylcarbapenem antibiotic developed by Japan's Lederle Company and the American Cyanamid Company. It was approved for marketing in Japan in March 2002 and is currently undergoing Phase II clinical trials in the United States. Like meropenem, this product has the characteristics of a broad antibacterial spectrum and strong antibacterial activity. Biapenem has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria (including drug-resistant Pseudomonas aeruginosa), anaerobic bacteria, etc.; it is stable to β-lactamase; and its stability to DHP-1 is stronger than that of imipenem. Compared with other carbapenems on the market, biapenem has almost zero nephrotoxicity and can be administered alone; it also has no central nervous system toxicity, will not induce epileptic seizures, and can be used to treat bacterial meningitis. This product has inhibitory effects on

Ingredients

Not yet clear.

Name Description Content CAS NO. Manufacturer
BiapenemIngredients

Biapenem is an injectable 1β-methylcarbapenem antibiotic developed by Japan's Lederle Company and the American Cyanamid Company. It has the characteristics of a broad antibacterial spectrum and strong antibacterial activity. It has strong antibacterial activity against Gram-positive bacteria, Gram-negative bacteria (including drug-resistant Pseudomonas aeruginosa), anaerobic bacteria, etc.; it is stable to β-lactamase; and it is more stable to DHP-1 than imipenem. It has almost zero nephrotoxicity and can be administered alone; it has no central nervous system toxicity, will not induce epileptic seizures, and can be used to treat bacterial meningitis.

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120410-24-4 8

Indication

Carbapenem antibiotics are clinically used to treat secondary infections of chronic bronchitis, pneumonia, pulmonary suppuration, pyelonephritis, complicated cystitis, peritonitis and adnexitis.

Usage and Dosage

The usual dose of this product in adults is 1g once a day. This product can be administered by intravenous infusion for up to 14 days; or by intramuscular injection for up to 7 days. When administered by intravenous infusion, the infusion time should be more than 30 minutes. For those infections that are suitable for treatment by intramuscular injection, intramuscular injection of this product can be used as an alternative to intravenous infusion.

Adverse Reactions

1. About 3% of patients with cardiovascular system had edema, and 2% of patients had chest pain, hypertension or hypotension, and tachycardia. 2. Respiratory system: Less than 3% of patients had dyspnea (including respiratory distress), cough, and pharyngitis, but the causal relationship between these reactions and this drug has not been determined. 3. Urogenital system: Less than 3% of patients had increased serum creatinine, urine red blood cells, and urine white blood cells, but the causal relationship between these reactions and this drug has not been determined. In addition, 1%-3% of female patients had reports of vaginitis. 4. Nervous system: Headache (6%), mental status changes (4%, such as confusion, disorientation, drowsiness), and epileptic seizures [about 0.5%, mainly in patients with renal insufficiency and/or central nervous system diseases (such as brain damage or history of epileptic seizures)]. There have been individual reports of systemic convulsive epilepsy, without the use of antiepileptic drugs, and no sequelae were found in follow-up neurological examinations. Anxiety, weakness, dizziness, and insomnia are less common. 5. Liver During treatment, serum aminotransferase (about 8%), alkaline phosphatase (4%-6%), and bilirubin (about 1%) may be increased, but many changes may be related to the patient's underlying symptoms. 6. The most common gastrointestinal symptoms are nausea (9%-10%) and vomiting (6%-9%). 7. Blood It has been reported that about 4% of patients have decreased hemoglobin or hematocrit, less than 2% of patients have decreased platelet count, eosinophilia, and prolonged prothrombin time, and about 5% of patients have increased platelet count, but the causal relationship between these hematological reactions and this drug has not yet been clarified. 8. Skin Less than 2.5% of patients have erythema, itching, and rash. Drug extravasation (2%), phlebitis or thrombophlebitis (2%), etc. can also be seen. 9. Other fever (about 3%) is related to the treatment of this drug, but it may also be related to the patient's underlying symptoms.

Precautions

Ertapenem is contraindicated for patients who are allergic to any ingredient in this drug or to other drugs of the same class. Since lidocaine hydrochloride is used as a diluent, patients who are allergic to amide local anesthetics, patients with severe shock or heart block are contraindicated for intramuscular injection of this drug.

Drug Interactions

When ertapenem is co-administered with probenecid, probenecid competes with ertapenem for active tubular secretion, thereby inhibiting the latter's renal excretion. This results in a small but statistically significant increase in elimination half-life (19%) and increased systemic drug exposure (25%). No dose adjustment of ertapenem is required when co-administered with probenecid. Due to the small effect on half-life, it is not recommended to prolong the half-life of ertapenem with co-administration of probenecid. In vitro studies have shown that ertapenem has no inhibitory effect on the P-glycoprotein-mediated transport of digoxin or vinblastine, and ertapenem is not a substrate for P-glycoprotein-mediated transport. In vitro studies in human liver microsomes have shown that ertapenem inhibits the six major cytochrome P450 (CYP) isoenzymes (1

Storage

Keep away from light and store in a sealed place.

Packaging Specification

1 gram (calculated as Ertapenem)

Validity Period

24 months

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