Ceftriaxone

Generic name: ceftriaxone (injection)
Brand names: Rocephin, Rocephin ADD-Vantage
Dosage forms: injectable powder for injection (1 g; 10 g; 2 g; 250 mg; 500 mg); intravenous solution (1 g/50 mL-iso-osmotic dextrose; 2 g/50 mL-iso-osmotic dextrose)
Drug class: Third generation cephalosporins

Medically reviewed by  A Ras MD.

What is ceftriaxone?

Ceftriaxone is a prescription medicine that is used to treat or prevent bacterial infections.

Description

Ceftriaxone for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose, 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 antibacterial for intravenous 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.

The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S3•3.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula:

Ceftriaxone 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 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:

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 is 290 mOsmol/kg.

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.

Before taking ceftriaxone, tell your doctor:

For all patients taking ceftriaxone:

• If you are allergic to ceftriaxone; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

Children:

• If your child is a premature newborn. This medicine is not for use in certain ages of premature newborns.
• If your child is a newborn. Do not give to a newborn whose skin or eyes are yellow or who has high bilirubin levels in the blood. Do not give to a newborn who is getting a drug with calcium in it through a vein.

This is not a list of all drugs or health problems that interact with ceftriaxone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ceftriaxone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take ceftriaxone?

• Tell all of your health care providers that you take ceftriaxone. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take ceftriaxone.
• If you have high blood sugar (diabetes), talk with the doctor. Some of these products have sugar.
• If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use.
• Do not use longer than you have been told. A second infection may happen.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is ceftriaxone best taken?

Use ceftriaxone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of ceftriaxone that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of gallstones like sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.
• Seizures.
• A very bad and sometimes deadly type of anemia called hemolytic anemia has happened with ceftriaxone. Call your doctor right away if you have pale skin, dizziness, fever or chills, very bad back or belly pain, dark urine, yellow skin or eyes, or you feel very tired or weak.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.

What are some other side effects of ceftriaxone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea.
• Irritation where ceftriaxone is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out ceftriaxone?

• If you need to store ceftriaxone at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL

• CefTRIaxONE for Injection
  and Dextrose Injection
• 2g
• REF 3155-11
  NDC 0264-3155-11
• DUPLEX®CONTAINER
• 50 mL
• Use only after mixing contents of both chambers.
  For IV Use Only      Iso-osmotic      Single-Dose      Sterile/Nonpyrogenic