Ceftriaxone Sodium 500 mg/1
Ceftriaxone Sodium · INJECTION, POWDER, FOR SOLUTION · Sandoz Inc
Ceftriaxone Sodium is a injection, powder, for solution containing ceftriaxone sodium at 500 mg/1, taken intramuscular. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Ceftriaxone Sodium
- Generic Name
- Ceftriaxone Sodium
- NDC Code (Product)
0781-3207- Manufacturer
- Sandoz Inc
- Strength
- 500 mg/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA065169
- Marketing Start
- 05/09/2005
Recall History
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lupin Pharmaceuticals Inc.
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone for injection, USP and other antibacterial drugs, ceftriaxone for injection, USP should be used only to treat or prevent 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. Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms: Lower Respiratory Tract Infections Caused by Streptococcus pneumoniae , Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Prot…
Dosage & Administration
DOSAGE AND ADMINISTRATION Ceftriaxone may be administered intravenously or intramuscularly. Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS ). 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). Neonates Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone for injection. Ceftri…
Warnings
WARNINGS Hypersensitivity Reactions Before therapy with ceftriaxone for injection is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam agents or other drugs. This product should be given cautiously to penicillin and other beta-lactam agent-sensitive patients. Antibacterial drugs should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures. As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions (i.e., anaphylaxis) have been reported. In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Interaction with Calcium-Containing Products Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can f…
Contraindications
CONTRAINDICATIONS Hypersensitivity Ceftriaxone for injection is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to ceftriaxone (see Warnings – Hypersensitivity Reactions ). Neonates Premature neonates : Ceftriaxone for injection is contraindicated in premature neonates up to a post-menstrual age of 41 weeks (gestational age + chronological age). Hyperbilirubinemic neonates : Hyperbilirubinemic neonates should not be treated with ceftriaxone for injection. Ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients. Neonates Requiring Calcium Containing IV Solutions Ceftriaxone for injection is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium (see CLINICAL PHARMACOLOGY…
Adverse Reactions
ADVERSE REACTIONS Ceftriaxone is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to ceftriaxone therapy or of uncertain etiology, were observed: Local Reactions Pain, induration and tenderness was 1% overall. Phlebitis was reported in <1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL. General Disorders and Administration Site Conditions Injection site pain (0.6%) Hypersensitivity Rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills. Infections and Infestations Genital fungal infection (0.1%) Hematologic Eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time. Blood and Lymphatic Disorders Granulocytopenia (0.9%), coagulopathy (0.4%) Gastrointestinal Diarrhea/loose stools (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or …
Frequently Asked Questions
What is Ceftriaxone Sodium used for?
Ceftriaxone Sodium contains Ceftriaxone Sodium. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is Ceftriaxone Sodium a controlled substance?
Ceftriaxone Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Ceftriaxone Sodium?
The generic name for Ceftriaxone Sodium is Ceftriaxone Sodium. There are 2 other brand versions of Ceftriaxone Sodium.
What is the NDC code for Ceftriaxone Sodium 500 mg/1?
The NDC (National Drug Code) for Ceftriaxone Sodium 500 mg/1 is 0781-3207, listed by Sandoz Inc.
Other Ceftriaxone Sodium Dosages
- Ceftriaxone Sodium1 g/185766-069
- Ceftriaxone Sodium500 mg/185766-128
- Ceftriaxone Sodium250 mg/150090-1875
- Ceftriaxone Sodium2 g/160505-6149
- Ceftriaxone Sodium2 g/167184-1008
- Ceftriaxone Sodium250 mg/10781-3206
- Ceftriaxone Sodium250 mg/160505-6151
- Ceftriaxone Sodium2 g/10409-7336
- Ceftriaxone Sodium250 mg/150090-2444
Other Ceftriaxone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)