What is Opeceftri?
Opeceftri (ceftriaxone) is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.
Opeceftri is used to treat many kinds of bacterial infections, including severe or life-threatening forms such as meningitis.
Opeceftri may also be used for purposes not listed in this medication guide.
Opeceftri indications
Acute bacterial otitis media ( Opeceftri ); treatment of infections of lower respiratory tract, skin and skin structures, bone and joint, and urinary tract; treatment of pelvic inflammatory disease, intra-abdominal infections, gonorrhea ( Opeceftri ), meningitis, and septicemia caused by susceptible microorganisms; preoperative prophylaxis.
Unlabeled Uses
Neurologic complications, arthritis, and carditis associated with Lyme disease in patients refractory to penicillin G.
How should I use Opeceftri?
Use Opeceftri as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Opeceftri is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Opeceftri at home, a health care provider will teach you how to use it. Be sure you understand how to use Opeceftri. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Opeceftri is light yellow to amber in color. Do not use Opeceftri if it contains particles, is cloudy or discolored, or if the vial or container is cracked or damaged in any way.
- To clear up your infection completely, use Opeceftri for the full course of treatment. Keep using it even if you feel better in a few days.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Opeceftri, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Opeceftri.
Opeceftri description
Opeceftri is a sterile, nonpyrogenic, single use, packaged combination of ceftriaxone sodium and dextrose injection (diluent) in the Duplex sterile container. The Duplex container is a flexible dual chamber container.
The drug chamber is filled with ceftriaxone sodium, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for IV administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate.
Its chemical formula is C18H16N8Na2O7S3·3.5H2O. It has a calculated molecular weight of 661.6.
Ceftriaxone sodium is supplied as a dry powder form equivalent to either 1 or 2 g of ceftriaxone. It is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage and concentration.
Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.
The diluent chamber contains dextrose injection. The concentration of hydrous dextrose in water for injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). Dextrose injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.
The molecular weight of hydrous dextrose USP is 198.17.
After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single IV use. When reconstituted, the approximate osmolality for the reconstituted solution for Opeceftri is 290 mOsmol/kg.
The Duplex container is latex-free, PVC-free, and DEHP-free.
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.
Opeceftri dosage
Standard Dosage: Adults and Children >12 years: Usual
Dosage: 1-2 g administered once daily (every 24 hrs). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, administered once daily.
Duration of Therapy: The duration of therapy varies according to the course of the disease. As with antibiotics therapy in general, administration of Opeceftri should be continued for a minimum of 48-72 hrs after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Combination Therapy: Synergy between Opeceftri and aminoglycosides has been demonstrated with many gram-negative bacteria under experimental conditions. Although enhanced activity of such combinations is not always predictable, it should be considered in severe, life threatening infections due to mincroogranisms eg, Pseudomonoas aeruginosa. Due to chemical incompatibility between Opeceftri and aminoglycosides, the 2 drugs must be administered serpately at the recommended dosages. Chemical incompatibility with Opeceftri has also been observed with IV administration of amsacrine, vancomycin and fluconazole.
Neonates, Infants and Children up to 12 years: The following dosage schedules are recommended for once daily administration.
Neonates (up to 14 days): 20-50 mg/kg body weight once daily. The daily dose should not exceed 50 mg/kg. Opeceftri is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational + chronological age).
Opeceftri is contraindicated in neonates (≤28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing eg, parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium.
Neonates, Infants and Children (15 days-12 years): 20-80 mg/kg once daily.
Children >50 kg: Usual adult dose should be used.
IV doses of ≥50 mg/kg body weight should be given by infusion over at least 30 min. In neonates, IV doses should be >60 min to reduce the potential risk of bilirubin encephalopathy.
Neonates (up to 2 weeks): A daily dose of 20-50 mg/kg body weight once daily. The daily dose should not to exceed 50 mg/kg.
Meningitis: 100 mg/kg (not to exceed 4 g) once daily. As soon as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly. The best results have been found with the following duration of therapy.
Lyme borreliosis: 50 mg/kg to a maximum of 2 g in children and adults, once daily for 14 days.
Gonorrhea: For the treatment of gonorrhea (penicillinase-producing and nonpenicillinase-producing strains), a single 250 mg IM dose is recommended.
Perioperative Prophylaxis: 1-2 g single dose of Opeceftri administered 30-90 min prior to surgery. In colorectal surgery, concurrent (but separate) administration of Opeceftri and a 5-nitroimidazole eg, ornidazole has proven effective.
Elderly: The dosages recommended for adults require no modification in the case of geriatric patients, provided there is no severe renal and hepatic impairment
Hepatic Impairment: In patients with liver damage, there is no need for the dosage to be reduced provided renal function is not impaired.
Renal Impairment: In patients with impaired renal function, there is no need to reduce the dosage of Opeceftri provided that hepatic function is not impaired. Only in cases of preterminal renal failure [creatinine clearance (CrCl) <10 mL/min] should the Opeceftri dosage not exceed 2 g daily. Ceftriaxone is not removed by peritoneal or hemodialysis. In patients undergoing dialysis no additional supplementary dosing is required following the dialysis.
Renal and Hepatic Impairment: In patients with both severe renal and hepatic dysfunction, clinical monitoring for safety and efficacy is advised.
Administration: As a general rule, the solutions should be used immediately after preparation.
Reconstituted solutions retain their physical and chemical stability for 6 hrs at room temperature (or 24 hrs in the refrigerator at 2-8°C). The solutions range in colour from pale yellow to amber, depending on the concentration and length of storage. The coloration of the solutions is of no significance for the efficacy or tolerance of Opeceftri.
IM Injection: Opeceftri 250 mg or 500 mg is dissolved in 2 mL, and Opeceftri 1 g in 3.5 mL of lidocaine hydrochloride 1% solution and injected well within the body of a relatively large muscle. It is recommended that not >1 g be injected at one site.
The lidocaine solution should never be administered IV.
IV Injection: Opeceftri 250 mg or 500 mg is dissolved in 5 mL, and Opeceftri 1 g in 10 mL of sterile water for injections. The IV administration should be given over 2-4 min.
IV Infusion: The infusion should be given over at least 30 min. For IV infusion, 2 g Opeceftri are dissolved in 40 mL of one of the following calcium-free infusion solutions: Sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in 5% dextrose, hydroxyl ether starch 6-10%, water for injection. Opeceftri solutions should not be mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, owing to possible incompatibility.
Do not use diluents containing calcium eg, Ringer's solution or Hartmann's solution, to reconstitute Opeceftri vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when Opeceftri is mixed with calcium-containing solutions in the same IV administration line. Opeceftri must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions eg, parenteral nutrition via a Y-site. However, in patients other than neonates, Opeceftri and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.
There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).
Opeceftri interactions
See also:
What other drugs will affect Opeceftri?
Aminoglycosides
Increased risk of nephrotoxicity.
Anticoagulants (eg, heparin, warfarin)
Risk of bleeding may be increased.
Cyclosporine
Elevated cyclosporine levels with increased risk of toxicity may occur.
Incompatibility
Other antimicrobial drugs.
Laboratory Test Interactions
None well documented.
Opeceftri side effects
See also:
What are the possible side effects of Opeceftri?
GI
Diarrhea (2%).
Hematologic-Lymphatic
Eosinophilia (6%); thrombocytosis (5%); leukopenia (2%).
Lab Tests
Elevated ALT and AST (3%); elevated BUN (1%).
Local
Induration/tightness/warmth (17%); induration/pain/tenderness (1%).
Miscellaneous
Fatal ceftriaxone-calcium precipitates in lung and kidneys of neonates.
Opeceftri contraindications
See also:
What is the most important information I should know about Opeceftri?
Hypersensitivity to cephalosporins; neonates (28 days of age or younger); concomitant use with calcium-containing IV solutions, including continuous calcium-containing infusions, such as parenteral nutrition in neonates.
Active ingredient matches for Opeceftri:
Ceftriaxone disodium in Vietnam.
| Unit description / dosage (Manufacturer) | Price, USD |
| OpeCeftri IV 1 g x 1 Bottle in tube dung mobi 10 mL | |
List of Opeceftri substitutes (brand and generic names): | |
| Brospec 1000 (Indonesia) | |
| Brospec 1000 1000 mg x 1's | $ 15.50 |
| CEF-3 Powder for Injectable Solution 500 mg/5 mL (Singapore) | |
| Cefin Panbiotic (Taiwan) | |
| Cefin Panbiotic 1 g x 1's | |
| Cefin Panbiotic 250 mg x 1's | |
| Cefin Panbiotic 500 mg x 1's | |
| Cefin Panbiotic 2 g x 1's | |
| Ceft-s (Taiwan) | |
| Ceft-s 1 g x 1's | |
| Ceft-s 500 mg x 1's | |
| Ceftriaxone disodium (Indonesia) | |
| İesef | |
References
- DailyMed. "CEFTRIAXONE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "ceftriaxone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ceftriaxone". http://www.drugbank.ca/drugs/DB01212 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
