Rocephin

DRUG DESCRIPTION

Rocephin (ceftriaxone) is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3yl)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 661.59 and the following structural formula:

ROCEPHIN®
(ceftriaxone sodium) Structural Formula Illustration

Rocephin (ceftriaxone) 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 Rocephin (ceftriaxone) solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

Rocephin (ceftriaxone) contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.

What are the possible side effects of ceftriaxone injection (Rocephin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever or chills;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • blistering, peeling, and red skin rash;
  • white patches or sores inside your mouth or on your lips;
  • pale or...

Read All Potential Side Effects and See Pictures of Rocephin »

What are the precautions when taking ceftriaxone (Rocephin)?

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 Rocephin »


Rocephin 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.


Rocephin Patient Information Including Side Effects

Brand Names: Rocephin

Generic Name: ceftriaxone (Pronunciation: SEF trye AX one)

  • What is ceftriaxone injection (Rocephin)?
  • What are the possible side effects of ceftriaxone injection (Rocephin)?
  • What is the most important information I should know about ceftriaxone injection (Rocephin)?
  • What should I discuss with my health care provider before using ceftriaxone injection (Rocephin)?
  • How should I use ceftriaxone injection (Rocephin)?
  • What happens if I miss a dose (Rocephin)?
  • What happens if I overdose (Rocephin)?
  • What should I avoid while using ceftriaxone injection (Rocephin)?
  • What other drugs will affect ceftriaxone injection (Rocephin)?
  • Where can I get more information?

What is ceftriaxone injection (Rocephin)?

Ceftriaxone is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Ceftriaxone injection is used to treat many kinds of bacterial infections, including severe or life-threatening forms such as meningitis.

Ceftriaxone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ceftriaxone injection (Rocephin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever or chills;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • blistering, peeling, and red skin rash;
  • white patches or sores inside your mouth or on your lips;
  • pale or yellowed skin, dark colored urine, confusion or weakness;
  • urinating less than usual or not at all;
  • swelling, pain, or irritation where the injection was given; or
  • chalky-colored stools, stomach pain just after eating a meal, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • headache, dizziness;
  • pain or swelling in your tongue;
  • sweating; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ceftriaxone injection (Rocephin)?

Do not use this medication if you are allergic to ceftriaxone, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have liver or kidney disease, gallbladder problems, a stomach or intestinal disorder, or if you are malnourished.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ceftriaxone is usually continued for at least 2 days after symptoms disappear.

Ceftriaxone will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

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