CEFEPIME HYDROCHLORIDE AND DEXTROSE

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Overview

What is CEFEPIME HYDROCHLORIDE AND DEXTROSE?

Cefepime hydrochloride, USP is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6,7)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 7-()-(-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula:

Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of CHClNOS•HCl•HO.

Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (CHNOS) per mg, calculated on an anhydrous basis. It is highly soluble in water.

Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® dual chamber container is supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection USP and Dextrose Injection USP is supplied as a sterile, nonpyrogenic, single-use packaged combination of cefepime hydrochloride with L-arginine (drug chamber) and 50 mL of 5% dextrose injection (diluent) in the DUPLEX® sterile container.

The powder chamber of the DUPLEX® container contains a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefepime (CHNOS). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the reconstituted solution at 4.0 – 6.0.

The DUPLEX® container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. Each 50 mL contains cefepime hydrochloride equivalent to either 1 gram or 2 grams of cefepime. Reconstituted solutions of Cefepime for Injection USP and Dextrose Injection USP range in color from colorless to amber.

Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).

The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container is supported by USP biological evaluation procedures.

What does CEFEPIME HYDROCHLORIDE AND DEXTROSE look like?

What are the available doses of CEFEPIME HYDROCHLORIDE AND DEXTROSE?

Dual-chamber, single-use container:

What should I talk to my health care provider before I take CEFEPIME HYDROCHLORIDE AND DEXTROSE?

How should I use CEFEPIME HYDROCHLORIDE AND DEXTROSE?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefepime for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended adult and pediatric dosages and routes of administration are outlined in Table 1. Cefepime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.

What interacts with CEFEPIME HYDROCHLORIDE AND DEXTROSE?

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What are the warnings of CEFEPIME HYDROCHLORIDE AND DEXTROSE?

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What are the precautions of CEFEPIME HYDROCHLORIDE AND DEXTROSE?

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What are the side effects of CEFEPIME HYDROCHLORIDE AND DEXTROSE?

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What should I look out for while using CEFEPIME HYDROCHLORIDE AND DEXTROSE?

Hypersensitivity to cefepime or other cephalosporin class antibiotics, penicillins, or other beta-lactam antibiotics ()

Hypersensitivity to corn products ()

What might happen if I take too much CEFEPIME HYDROCHLORIDE AND DEXTROSE?

Carefully observe patients who receive an overdose of cefepime, and give supportive treatment as appropriate. In the presence of renal impairment, hemodialysis, not peritoneal dialysis, is recommended to aid in the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, nonconvulsive status epilepticus, and neuromuscular excitability [see ].

How should I store and handle CEFEPIME HYDROCHLORIDE AND DEXTROSE?

Store the generator at 20-25°C (68-77°F) [See USP].Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection.Cefepime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Do not freeze.As with other cephalosporins, reconstituted Cefepime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.Use only if prepared solution is clear and free from particulate matter.Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection.Cefepime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Do not freeze.As with other cephalosporins, reconstituted Cefepime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.Use only if prepared solution is clear and free from particulate matter.Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection.Cefepime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Do not freeze.As with other cephalosporins, reconstituted Cefepime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.Use only if prepared solution is clear and free from particulate matter.Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection.Cefepime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Do not freeze.As with other cephalosporins, reconstituted Cefepime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.Use only if prepared solution is clear and free from particulate matter.Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two strengths, 1 and 2 g cefepime. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection.Cefepime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.Store the unactivated unit at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Do not freeze.As with other cephalosporins, reconstituted Cefepime for Injection USP and Dextrose Injection USP tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected.Use only if prepared solution is clear and free from particulate matter.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Cefepime is an antibacterial drug [see ].

Non-Clinical Toxicology

Hypersensitivity to cefepime or other cephalosporin class antibiotics, penicillins, or other beta-lactam antibiotics ()

Hypersensitivity to corn products ()

Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with tretinoin. It also is advisable to "rest" a patient's skin until the effects of such preparations subside before use of tretinoin is begun.

Before therapy with Cefepime for Injection USP and Dextrose Injection USP is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other drugs. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefepime for Injection USP and Dextrose Injection USP occurs, discontinue the drug.

The following adverse reactions are discussed in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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