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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 12.05.2022
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Deltone and other antibacterial drugs, Deltone 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.
Deltone is indicated for the treatment of the following infections when caused by susceptible organisms:
Respiratory Tract Infections caused by S. pneumoniae, H. influenzae, S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes* (Group A beta-hemolytic streptococci), P. aeruginosa, Klebsiella pneumoniae, E. coli, Proteus mirabilis, and Enterobacter species.
Peritonitis and Other Intra-abdominal Infections caused by E. coli, P. aeruginosa,* and anaerobic gram-negative bacilli (including Bacteroides fragilis).
Bacterial Septicemia caused by S. pneumoniae, S. agalactiae,* S. aureus, Pseudomonas aeruginosa,* E. coli, Klebsiella spp.,* Klebsiella pneumoniae,* Proteus species* (indole-positive and indole-negative), Clostridium spp.* and anaerobic gram-positive cocci.*
Infections of the Skin and Skin Structures caused by S. aureus (penicillinase and non-penicillinase producing strains), S. pyogenes,* and P. aeruginosa.
Pelvic Inflammatory Disease, Endometritis, and Other Infections of the Female Genital Tract caused by N. gonorrhoeae, S. epidermidis,* S. agalactiae, E. coli, Clostridium spp.,* Bacteroides species (including Bacteroides fragilis), and anaerobic gram-positive cocci.
Deltone® has no activity against Chlamydia trachomatis. Therefore, when Deltone is used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.
Urinary Tract Infections caused by Escherichia coli and Pseudomonas aeruginosa.
Enterococcal Infections: Although Deltone has been shown to be clinically effective in the treatment of infections caused by enterococci in cases of peritonitis and other intra-abdominal infections, infections of the skin and skin structures, pelvic inflammatory disease, endometritis and other infections of the female genital tract, and urinary tract infections,* the majority of clinical isolates of enterococci tested are not susceptible to Deltone but fall just at or in the intermediate zone of susceptibility, and are moderately resistant to Deltone. However, in vitro susceptibility testing may not correlate directly with in vivo results. Despite this, Deltone therapy has resulted in clinical cures of enterococcal infections, chiefly in polymicrobial infections. Deltone should be used in enterococcal infections with care and at doses that achieve satisfactory serum levels of Deltone.
* Efficacy against this organism in this organ system was studied in fewer than 10 infections.
Combination Therapy
Synergy between Deltone and aminoglycosides has been demonstrated with many gram-negative bacilli. However, such enhanced activity of these combinations is not predictable. If such therapy is considered, in vitro susceptibility tests should be performed to determine the activity of the drugs in combination, and renal function should be monitored carefully.
Deltone injection is used to treat bacterial infections in the different parts of the body.
Deltone injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Deltone will not work for colds, flu, or other virus infections.
Deltone is to be given only by or under the supervision of your doctor.
The usual adult daily dose of Deltone (sterile Deltone) is 2 to 4 grams per day administered in equally divided doses every 12 hours.
In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6–12 grams divided into 2, 3 or 4 administrations ranging from 1.5 to 4 grams per dose.
When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because Deltone has no activity against this organism.
Solutions of Deltone and aminoglycoside should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with Deltone and an aminoglycoside is contemplated this can be accomplished by sequential intermittent intravenous infusion provided that separate secondary intravenous tubing is used, and that the primary intravenous tubing is adequately irrigated with an approved diluent between doses. It is also suggested that Deltone be administered prior to the aminoglycoside. In vitro testing of the effectiveness of drug combination(s) is recommended.
Reconstitution
The following solutions may be used for the initial reconstitution of Deltone (sterile Deltone).
Table 1: Solutions for Initial Reconstitution
| 5% Dextrose Injection (USP) | 0.9% Sodium Chloride Injection (USP) |
| 5% Dextrose and 0.9% Sodium Chloride Injection (USP) | Normosol® M and 5% Dextrose Injection |
| 5% Dextrose and 0.2% Sodium Chloride Injection (USP) | Normosol® R |
| 10% Dextrose Injection (USP) | Sterile Water for Injection* |
| Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP)*† | |
| * Not to be used as a vehicle for intravenous infusion. † Preparations containing Benzyl Alcohol should not be used in neonates. |
General Reconstitution Procedures
Deltone (sterile Deltone) for intravenous or intramuscular use may be initially reconstituted with any compatible solution mentioned above in Table 1. Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization. Vigorous and prolonged agitation may be necessary to solubilize Deltone in higher concentrations (above 333 mg Deltone/mL). The maximum solubility of Deltone (sterile Deltone) is approximately 475 mg Deltone/mL of compatible diluent.
Preparation For
Intravenous Use
General: Deltone (sterile Deltone) concentrations between 2 mg/mL and 50 mg/mL are recommended for intravenous administration.
Preparation of Vials: Vials of Deltone (sterile Deltone) may be initially reconstituted with a minimum of 2.8 mL per gram of Deltone of any compatible reconstituting solution appropriate for intravenous administration listed above in Table 1. For ease of reconstitution the use of 5 mL of compatible solution per gram of Deltone is recommended. The entire quantity of the resulting solution should then be withdrawn for further dilution and administration using any of the following vehicles for intravenous infusion:
Table 2: Vehicles for
Intravenous Infusion
| 5% Dextrose Injection (USP) | Lactated Ringer’s Injection (USP) |
| 5% Dextrose and Lactated Ringer’s Injection | 0.9% Sodium Chloride Injection (USP) |
| 5% Dextrose and 0.9% Sodium Chloride Injection (USP) | Normosol® M and 5% Dextrose Injection |
| 5% Dextrose and 0.2% Sodium Chloride Injection (USP) | Normosol® R |
| 10% Dextrose Injection (USP) |
The resulting intravenous solution should be administered in one of the following manners:
Intermittent Infusion: Solutions of Deltone should be administered over a 15–30 minute time period.
Continuous Infusion: Deltone can be used for continuous infusion after dilution to a final concentration of between 2 and 25 mg Deltone per mL.
Preparation For
Intramuscular Injection
Any suitable solution listed above may be used to prepare Deltone (sterile Deltone) for intramuscular injection. When concentrations of 250 mg/mL or more are to be administered, a lidocaine solution should be used. These solutions should be prepared using a combination of Sterile Water for Injection and 2% Lidocaine Hydrochloride Injection (USP) that approximates a 0.5% Lidocaine Hydrochloride Solution. A two-step dilution process as follows is recommended: First, add the required amount of Sterile Water for Injection and agitate until Deltone powder is completely dissolved. Second, add the required amount of 2% lidocaine and mix.
| Final Deltone Concentration | Step 1 Volume of Sterile Water | Step 2 Volume of 2% Lidoeaine | Withdrawable Volume*† | |
| 1 g vial | 333 mg/mL | 2.0 mL | 0.6 mL | 3 mL |
| 250 mg/mL | 2.8 mL | 1.0 mL | 4 mL | |
| 2 g vial | 333 mg/mL | 3.8 mL | 1.2 mL | 6 mL |
| 250 mg/mL | 5.4 mL | 1.8 mL | 8 mL | |
| * There is sufficient excess present to allow for withdrawal of the stated volume. † Final lidocaine concentration will approximate that obtained if a 0.5% Lidocaine Hydrochloride Solution is used as diluent. |
When a diluent other than Lidocaine HCl Injection (USP) is used reconstitute as follows:
| Deltone Concentration | Volume of Diluent to be Added | Withdrawable Volume* | |
| 1 g vial | 333 mg/mL | 2.6 mL | 3 mL |
| 250 mg/mL | 3.8 mL | 4 mL | |
| 2 g vial | 333 mg/mL | 5.0 mL | 6 mL |
| 250 mg/mL | 7.2 mL | 8 mL | |
| * There is sufficient excess present to allow for withdrawal of the stated volume. |
Storage And Stability
Deltone (sterile Deltone) is to be stored at or below 25°C (77°F) and protected from light prior to reconstitution. After reconstitution, protection from light is not necessary.
The following parenteral diluents and approximate concentrations of Deltone provide stable solutions under the following conditions for the indicated time periods. (After the indicated time periods, unused portions of solutions should be discarded.)
Room Temperature (15°–25°C/59°–77°F)
| 24 Hours | Approximate Concentrations |
| Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) | 300 mg/mL |
| 5% Dextrose Injection (USP) | 2 mg to 50 mg/mL |
| 5% Dextrose and Lactated Ringer’s Injection | 2 mg to 50 mg/mL |
| 5% Dextrose and 0.9% Sodium Chloride Injection (USP) | 2 mg to 50 mg/mL |
| 5% Dextrose and 0.2% Sodium Chloride Injection (USP) | 2 mg to 50 mg/mL |
| 10% Dextrose Injection (USP) | 2 mg to 50 mg/mL |
| Lactated Ringer’s Injection (USP) | 2 mg/mL |
| 0.5% Lidocaine Hydrochloride Injection (USP) | 300 mg/mL |
| 0.9% Sodium Chloride Injection (USP) | 2 mg to 300 mg/mL |
| Normosol® M and 5% Dextrose Injection | 2 mg to 50 mg/mL |
| Normosol® R | 2 mg to 50 mg/mL |
| Sterile Water for Injection | 300 mg/mL |
| Reconstituted Deltone solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers. |
Refrigerator Temperature (2°–8°C/36°–46°F)
| 5 Days | Approximate Concentrations |
| Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) | 300 mg/mL |
| 5% Dextrose Injection (USP) | 2 mg to 50 mg/mL |
| 5% Dextrose and 0.9% Sodium Chloride Injection (USP) | 2 mg to 50 mg/mL |
| 5% Dextrose and 0.2% Sodium Chloride Injection (USP) | 2 mg to 50 mg/mL |
| Lactated Ringer’s Injection (USP) | 2 mg/mL |
| 0.5% Lidocaine Hydrochloride Injection (USP) | 300 mg/mL |
| 0.9% Sodium Chloride Injection (USP) | 2 mg to 300 mg/mL |
| Normosol® M and 5% Dextrose Injection | 2 mg to 50 mg/mL |
| Normosol® R | 2 mg to 50 mg/mL |
| Sterile Water for Injection | 300 mg/mL |
| Reconstituted Deltone solutions may be stored in glass or plastic syringes, or in plastic parenteral solution containers. | glass or flexible |
| Reconstituted Deltone solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers. |
Freezer Temperature (–20° to –10°C/–4° to 14°F)
| Freezer Temperature (-20° to -10°C/-4° to 14°F) 3 Weeks | Approximate Concentrations |
| 5% Dextrose Injection (USP) | 50 mg/mL |
| 5% Dextrose and 0.9% Sodium Chloride Injection (USP) | 2 mg/mL |
| 5% Dextrose and 0.2% Sodium Chloride Injection (USP) | 2 mg/mL |
| 5 Weeks | |
| 0.9% Sodium Chloride Injection (USP) | 300 mg/mL |
| Sterile Water for Injection | 300 mg/mL |
| Frozen samples should be thawed at room temperature before use. After thawing, unused portions should be discarded. Do not refreeze. |
How supplied
Deltone® (sterile Deltone) is available in vials containing Deltone sodium equivalent to 1 g Deltone x 10 (NDC 0049-1201-83) and 2 g Deltone x 10 (NDC 0049-1202-83) for intramuscular and intravenous administration.
Deltone® (sterile Deltone) is available in 10 g (NDC 0049-1219-28) Pharmacy Bulk Package for intravenous administration.
Distributed by: Roerig, Division of Pfizer Inc., NY, NY 10017. Revised March 2015
Deltone for Injection USP and Dextrose Injection USP is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Deltone is used to treat bacterial infection of the respiratory tract, the abdomen and abdominal wall (peritonitis), the urinary tract, the female genital tract (endometritis, pelvic inflammatory disease), the blood (septicemia), and the skin and soft tissues.
Drug/Laboratory Test Interactions: A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedictís or Fehlingís solution or with ClinitestÒ tablets) but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood plasma glucose levels in patients receiving cefuroxime.
Deltone does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
See also:
What are the possible side effects of Deltone?
In clinical studies the following adverse effects were observed and were considered to be related to Deltone therapy or of uncertain etiology:
Hypersensitivity
As with all cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs' test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.
Hematology
As with other beta-lactam antibiotics, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins (1 in 20) or hematocrits (1 in 20) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia has occurred in 1 patient in 10.
Hepatic
Of 1285 patients treated with Deltone in clinical trials, one patient with a history of liver disease developed significantly elevated liver function enzymes during Deltone therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After Deltone therapy was discontinued, the patient's enzymes returned to pre-treatment levels and the symptomatology resolved. As with other antibiotics that achieve high bile levels, mild transient elevations of liver function enzymes have been observed in 5–10% of the patients receiving Deltone therapy. The relevance of these findings, which were not accompanied by overt signs or symptoms of hepatic dysfunction, has not been established.
Gastrointestinal
Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences have been mild or moderate in severity and self-limiting in nature. In all cases, these symptoms responded to symptomatic therapy or ceased when Deltone therapy was stopped. Nausea and vomiting have been reported rarely.
Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibiotic therapy.
Renal Function Tests
Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted.
Local Reactions
Deltone is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When Deltone is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site.
A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Deltone is considered an antioxidant.