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Ceftriaxone

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Overview

What is Ceftriaxone?

Ceftriaxone for injection is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (,)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo--triazin-3-yl)thio]methyl]-5-thia-l-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid, 7-(Z)-(), disodium salt, sesquaterhydrate.

The molecular formula of ceftriaxone sodium is CHNNaOS . 3.5 HO. It has a calculated molecular weight of 661.60 and the following structural formula:

Ceftriaxone for injection 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 for injection solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used.

Ceftriaxone for injection contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.



What does Ceftriaxone look like?



What are the available doses of Ceftriaxone?

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What should I talk to my health care provider before I take Ceftriaxone?

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How should I use Ceftriaxone?

Before instituting treatment with ceftriaxone for injection, 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 and other antibacterial drugs, ceftriaxone for injection 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 is indicated for the treatment of the following infections when caused by susceptible organisms:

LOWER RESPIRATORY TRACT INFECTIONS

Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis

Serratia marcescens.

ACUTE BACTERIAL OTITIS MEDIA

Streptococcus pneumoniae, Haemophilus influenzae

Moraxella catarrhalis

NOTE: In one study lower clinical cure rates were observed with a single dose of ceftriaxone for injection compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose ceftriaxone for injection and the comparator. The potentially lower clinical cure rate of ceftriaxone for injection should be balanced against the potential advantages of parenteral therapy (see     ).

SKIN AND SKIN STRUCTURE INFECTIONS

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes,

Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii*, *Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis*

Peptostreptococcus

URINARY TRACT INFECTIONS (complicated and uncomplicated)

Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii

Klebsiella pneumoniae.

UNCOMPLICATED GONORRHEA (cervical/urethral and rectal)

Neisseria gonorrhoeae

Neisseria gonorrhoeae.

PELVIC INFLAMMATORY DISEASE

Neisseria gonorrhoeae

Chlamydia trachomatis

Chlamydia trachomatis

BACTERIAL SEPTICEMIA

Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae

Klebsiella pneumoniae.

BONE AND JOINT INFECTIONS

Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae

Enterobacter

INTRA-ABDOMINAL INFECTIONS

Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium

Clostridium difficile

Peptostreptococcus

MENINGITIS

Haemophilus influenzae, Neisseria meningitidis

Streptococcus pneumoniae.

Staphylococcus epidermidis

Escherichia coli.

*Efficacy for this organism in this organ system was studied in fewer than ten infections.

SURGICAL PROPHYLAXIS:

When administered prior to surgical procedures for which it is indicated, a single 1 g dose of ceftriaxone for injection provides protection from most infections due to susceptible organisms throughout the course of the procedure.

Ceftriaxone for injection may be administered intravenously or intramuscularly.

Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute ceftriaxone for injection. Particulate formation can result. ceftriaxone for injection and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites

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What interacts with Ceftriaxone?

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What are the warnings of Ceftriaxone?

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What are the precautions of Ceftriaxone?

Sorry No Records found


What are the side effects of Ceftriaxone?

Ceftriaxone for injection is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to ceftriaxone for injection therapy or of uncertain etiology, were observed:

LOCAL REACTIONS -

HYPERSENSITIVITY -

HEMATOLOGIC –

GASTROINTESTINAL -

HEPATIC -

RENAL -

CENTRAL NERVOUS SYSTEM -

GENITOURINARY -

MISCELLANEOUS -

Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed (see   ).


What should I look out for while using Ceftriaxone?

Ceftriaxone for injection is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.


What might happen if I take too much Ceftriaxone?

In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.


How should I store and handle Ceftriaxone?

Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Ceftriaxone for injection is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing 1 g equivalent of ceftriaxone. Box of 10 (NDC 10019-098-01).Ceftriaxone for injection is supplied as a sterile crystalline powder in glass vials. The following packages are available: Vials containing 1 g equivalent of ceftriaxone. Box of 10 (NDC 10019-098-01).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

 In one study, total ceftriaxone concentrations (bound and unbound) were measured in middle ear fluid obtained during the insertion of tympanostomy tubes in 42 pediatric patients with otitis media. Sampling times were from 1 to 50 hours after a single intramuscular injection of 50 mg/kg of ceftriaxone. Mean (± SD) ceftriaxone levels in the middle ear reached a peak of 35 (± 12) mcg/mL at 24 hours, and remained at 19 (± 7) mcg/mL at 48 hours. Based on middle ear fluid ceftriaxone concentrations in the 23 to 25 hour and the 46 to 50 hour sampling time intervals, a half-life of 25 hours was calculated. Ceftriaxone is highly bound to plasma proteins. The extent of binding to proteins in the middle ear fluid is unknown.

Non-Clinical Toxicology
Ceftriaxone for injection is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

Few systemic data have been collected on the metabolism of bupropion following concomitant administration with other drugs or, alternatively, the effect of concomitant administration of bupropion on the metabolism of other drugs.

Because bupropion is extensively metabolized, the coadministration of other drugs may affect its clinical activity. studies indicate that bupropion is primarily metabolized to hydroxybupropion by the CYP2B6 isoenzyme. Therefore, the potential exists for a drug interaction between bupropion hydrochloride tablets and drugs that are substrates or inhibitors of the CYP2B6 isoenzyme (e.g., orphenadrine, thiotepa, and cyclophosphamide). In addition, studies suggest that paroxetine, sertraline, norfluoxetine, and fluvoxamine as well as nelfinavir, ritonavir, and efavirenz inhibit the hydroxylation of bupropion. No clinical studies have been performed to evaluate this finding. The threohydrobupropion metabolite of bupropion does not appear to be produced by the cytochrome P450 isoenzymes. The effects of concomitant administration of cimetidine on the pharmacokinetics of bupropion and its active metabolites were studied in 24 healthy young male volunteers. Following oral administration of two 150 mg sustained-release tablets with and without 800 mg of cimetidine, the pharmacokinetics of bupropion and hydroxybupropion were unaffected. However, there were 16% and 32% increases in the AUC and C, respectively, of the combined moieties of threohydrobupropion and erythrohydrobupropion.

While not systematically studied, certain drugs may induce the metabolism of bupropion (e.g., carbamazepine, phenobarbital, phenytoin).

Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 healthy volunteers.

Animal data indicated that bupropion may be an inducer of drug-metabolizing enzymes in humans. In one study, following chronic administration of bupropion, 100 mg 3 times daily to 8 healthy male volunteers for 14 days, there was no evidence of induction of its own metabolism. Nevertheless, there may be the potential for clinically important alterations of blood levels of coadministered drugs.

Prescribing ceftriaxone for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Although transient elevations of BUN and serum creatinine have been observed, at the recommended dosages, the nephrotoxic potential of ceftriaxone for injection is similar to that of other cephalosporins.

Ceftriaxone is excreted via both biliary and renal excretion (see   ). Therefore, patients with renal failure normally require no adjustment in dosage when usual doses of ceftriaxone for injection are administered, but concentrations of drug in the serum should be monitored periodically. If evidence of accumulation exists, dosage should be decreased accordingly.

Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, ceftriaxone for injection dosage should not exceed 2 g daily without close monitoring of serum concentrations.

Alterations in prothrombin times have occurred rarely in patients treated with ceftriaxone for injection. Patients with impaired vitamin K synthesis or low vitamin K stores (e.g., chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during ceftriaxone for injection treatment. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.

Prolonged use of ceftriaxone for injection may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Ceftriaxone should be prescribed with caution in individuals with a history of gastrointestinal disease, especially colitis.

There have been reports of sonographic abnormalities in the gallbladder of patients treated with ceftriaxone for injection; some of these patients also had symptoms of gallbladder disease.

The condition appears to be transient and reversible upon discontinuation of ceftriaxone for injection and institution of conservative management.

Ceftriaxone for injection is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to ceftriaxone for injection therapy or of uncertain etiology, were observed:

LOCAL REACTIONS -

HYPERSENSITIVITY -

HEMATOLOGIC –

GASTROINTESTINAL -

HEPATIC -

RENAL -

CENTRAL NERVOUS SYSTEM -

GENITOURINARY -

MISCELLANEOUS -

Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed (see   ).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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