Ceftriaxone

DRUG DESCRIPTION

Ceftriaxone for Injection and Dextrose Injection (ceftriaxone sodium and dextrose injection ) 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 intravenous administration. Ceftriaxone (ceftriaxone sodium and dextrose injection ) 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-carboxylicacid,72-(Z)-(0-methyloxime), disodium salt, sesquaterhydrate.

Ceftriaxone Sodium has the following structural formula:

Ceftriaxone Sodium structural formula illustration

The chemical formula of ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium is C18H16N8Na207S33.5H20, representing a molecular weight of 661.60.

Ceftriaxone (ceftriaxone sodium and dextrose injection ) Sodium is supplied as a dry powder form equivalent to either..1 g or 2 g of ceftriaxone. Ceftriaxone Sodium 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 (ceftriaxone sodium and dextrose injection ) 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.

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

Hydrous Dextrose structural formula illustration

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 intravenous use. When reconstituted, the approximate osmolality for the reconstituted solution for Ceftriaxone for Injection and Dextrose Injection (ceftriaxone (ceftriaxone sodium and dextrose injection ) sodium and dextrose injection ) 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.

What are the precautions when taking ceftriaxone sodium and dextrose injection (Ceftriaxone)?

Before using ceftriaxone, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gallbladder disease, kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Avoid giving any products by vein that contain calcium (including solutions such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN) to a newborn less than 1 month old who is receiving this medication. Doing so can cause serious problems in the vital...

Read All Potential Precautions of Ceftriaxone


Ceftriaxone Consumer (continued)

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, or headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, seizures, unusual weakness/tiredness, yellowing eyes/skin, change in the amount of urine, chest pain, trouble breathing, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ceftriaxone, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gallbladder disease, kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).

Avoid giving any products by vein that contain calcium (including solutions such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN) to a newborn less than 1 month old who is receiving this medication. Doing so can cause serious problems in the vital organs.

Ceftriaxone is not recommended for use in newborns with high blood bilirubin levels.

Tell your doctor if you are pregnant before using this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.



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