Ceftazidime and Dextrose

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Overview

What is Ceftazidime and Dextrose?

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial 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]pyridinium hydroxide, inner salt, 7-()-[-(1-carboxy-1-methylethyl)oxime], pentahydrate. It has the following structure:

The molecular formula is CHNOS•5HO, representing a molecular weight of 636.6.

Ceftazidime for Injection USP is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity.

Ceftazidime for Injection USP in sterile crystalline form is supplied in the DUPLEX® Container equivalent to 1 g or 2 g of anhydrous ceftazidime. The pH of freshly constituted solutions usually ranges from 5 to 7.5.

The diluent chamber contains 50 mL of 5% Dextrose Injection USP.

Solutions of Ceftazidime for Injection USP and Dextrose Injection USP range in color from light yellow to amber. The solution is intended for intravenous (IV) use only. The pH of solutions ranges from 5 to 7.5. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.

Hydrous Dextrose USP has the following structural (molecular) formula:

After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the osmolality of the reconstituted solution of Ceftazidime for Injection USP and Dextrose Injection USP is approximately 340 mOsmol/kg for the 1 g dose and approximately 400 mOsmol/kg for the 2 g dose.

Not made with natural rubber latex, PVC, or 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 system is supported by USP biological evaluation procedures.

What does Ceftazidime and Dextrose look like?

What are the available doses of Ceftazidime and Dextrose?

Dual-chamber, single-use container:

What should I talk to my health care provider before I take Ceftazidime and Dextrose?

How should I use Ceftazidime and Dextrose?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftazidime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Ceftazidime for Injection USP and Dextrose Injection USP should be used only to treat 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.

Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible bacteria.

Ceftazidime 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. Ceftazidime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.

The guidelines for dosage of Ceftazidime for Injection USP and Dextrose Injection USP are listed in Table 1. The following dosage schedule is recommended.

* Use this formulation of ceftazidime only in patients who require the entire 1 or 2 gram dose and not any fraction thereof.

What interacts with Ceftazidime and Dextrose?

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What are the warnings of Ceftazidime and Dextrose?

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What are the precautions of Ceftazidime and Dextrose?

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What are the side effects of Ceftazidime and Dextrose?

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What should I look out for while using Ceftazidime and Dextrose?

Hypersensitivity Reactions to Ceftazidime or the Cephalosporin Class of Antibiotics, Penicillins, or Other Beta-lactam Antibiotics

Ceftazidime for Injection USP and Dextrose Injection USP is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to ceftazidime or the cephalosporin class of antibiotics, penicillins, or other beta-lactam antibiotics. [see]

What might happen if I take too much Ceftazidime and Dextrose?

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma [see ]. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of ceftazidime from the body.

How should I store and handle Ceftazidime and Dextrose?

Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection. After reconstitution, the concentrations are equivalent to 1g and 2g ceftazidime.Ceftazidime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 5% Dextrose Injection. After reconstitution, the concentrations are equivalent to 1g and 2g ceftazidime.Ceftazidime for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Ceftazidime is an antibacterial drug. [see]

Non-Clinical Toxicology

Hypersensitivity Reactions to Ceftazidime or the Cephalosporin Class of Antibiotics, Penicillins, or Other Beta-lactam Antibiotics

Ceftazidime for Injection USP and Dextrose Injection USP is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to ceftazidime or the cephalosporin class of antibiotics, penicillins, or other beta-lactam antibiotics. [see]

NSAIDs may diminish the antihypertensive effect of ACE-inhibitors, ARBs, or beta-blockers (including propanolol).

Monitor patients taking NSAIDs concomitantly with ACE-inhibitors, ARBs, or beta-blockers for changes in blood pressure.

In addition, in patients who are elderly, volume-depleted (including those on diuretic therapy), or have compromised renal function, co-administration of NSAIDs with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. Monitor these patients closely for signs of worsening renal function.

Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.

When naproxen as naproxen tablets is administered with aspirin, its protein binding is reduced, although the clearance of free naproxen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects.

As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen.

Clinical studies, as well as postmarketing observations, have shown that naproxen tablets can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Naproxen and other nonsteroidal anti-inflammatory drugs have been reported to reduce the tubular secretion of methotrexate in an animal model. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. No significant interactions have been observed in clinical studies with naproxen and coumarin-type anticoagulants. However, caution is advised since interactions have been seen with other nonsteroidal agents of this class. The free fraction of warfarin may increase substantially in some subjects and naproxen interferes with platelet function.

There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Caution should be used when NSAIDs are administered concomitantly with SSRIs.

Other Information Concerning Drug Interactions

Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.

Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.

Drug/Laboratory Test Interaction

Naproxen may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined.

The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.

Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).

Carcinogenesis

A 2-year study was performed in rats to evaluate the carcinogenic potential of naproxen at rat doses of 8, 16, and 24 mg/kg/day (50, 100, and 150 mg/m). The maximum dose used was 0.28 times the systemic exposure to humans at the recommended dose. No evidence of tumorigenicity was found.

Immediate hypersensitivity reactions to ceftazidime have been reported. Careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions with cephalosporins or penicillins. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterials has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Ceftazidime for Injection USP and Dextrose Injection USP occurs, discontinue the drug.

The following serious adverse reactions to ceftazidime are described below and elsewhere in 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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