Omnicef


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cefdinir

Omnicef

Pharmacologic class: Third-generation cephalosporin

Therapeutic class: Anti-infective

Pregnancy risk category B

Action

Interferes with bacterial cell-wall synthesis and division by binding to cell wall, causing cell to die. Active against gram-negative and gram-positive bacteria, with expanded activity against gram-negative bacteria. Exhibits minimal immunosuppressant activity.

Availability

Capsules: 300 mg

Oral suspension: 125 mg/5 ml in 60-and 100-ml bottles

Indications and dosages

Acute bacterial otitis media caused by Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella catarrhalis

Adults and children ages 13 and older: 300 mg P.O. q 12 hours or 600 mg P.O. q 24 hours for 10 days

Children ages 6 months to 12 years: 7 mg/kg P.O. q 12 hours for 5 to 10 days or 14 mg/kg P.O. q 24 hours for 10 days

Uncomplicated skin and soft-tissue infections caused by Staphylococcus aureus and Streptococcus pyogenes

Adults and children ages 13 and older: 300 mg P.O. q 12 hours for 10 days. Maximum dosage is 600 mg/day.

Acute maxillary sinusitis caused by H. influenzae, S. pneumoniae, and M. catarrhalis

Adults and children ages 13 and older: 300 mg P.O. q 12 hours or 600 mg P.O. q 24 hours for 10 days. Maximum dosage is 600 mg/day.

Children ages 6 months to 12 years: 7 mg/kg P.O. q 12 hours or 14 mg/kg P.O. q 24 hours for 10 days

Pharyngitis or tonsillitis caused by S. pyogenes, chronic bronchitis caused by H. influenzae, S. pneumoniae, and M. catarrhalis

Adults and children ages 13 and older: 300 mg P.O. q 12 hours for 5 to 10 days or 600 mg P.O. q 24 hours for 10 days. Maximum dosage is 600 mg/day.

Community-acquired pneumonia caused by H. influenzae, Haemophilus parainfluenzae, S. pneumoniae, and M. catarrhalis

Adults and children ages 13 and older: 300 mg P.O. q 12 hours for 10 days. Maximum dosage is 600 mg/day.

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to cephalosporins or penicillins

Precautions

Use cautiously in:
• renal impairment, phenylketonuria
• history of GI disease (especially colitis)
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

• Obtain specimens for culture and sensitivity tests as necessary before starting therapy.
• Give with or without food.
• Administer 2 hours before or after iron supplements or antacids containing aluminum or magnesium.
• Give capsules, if possible, to diabetic patients (oral suspension contains 2.86 g of sucrose per teaspoon).

Adverse reactions

CNS: headache, lethargy, paresthesia, syncope, seizures

CV: hypotension, palpitations, chest pain, vasodilation

EENT: hearing loss

GI: nausea, vomiting, diarrhea, abdominal cramps, oral candidiasis,

pseudomembranous colitis

GU: vaginal candidiasis, nephrotoxicity

Hematologic: lymphocytosis, eosinophilia, bleeding tendency, hemolytic anemia, hypoprothrombinemia, neutropenia, thrombocytopenia, agranulocytosis, bone marrow depression

Hepatic: hepatomegaly, hepatic failure

Musculoskeletal: arthralgia

Respiratory: dyspnea

Skin: chills, fever, urticaria, maculopapular or erythematous rash

Other: superinfection, anaphylaxis, serum sickness

Interactions

Drug-drug.Aminoglycosides, loop diuretics: increased risk of nephrotoxicity

Antacids, iron-containing preparations: decreased cefdinir absorption

Probenecid: decreased excretion and increased blood level of cefdinir

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, eosinophils, gamma-glutamyltransferase, lactate dehydrogenase: increased levels
Coombs' test, urinary 17-ketosteroids, nonenzyme-based urine glucose tests (such as Clinitest): false-positive results

Hemoglobin, platelets, white blood cells: decreased values

Drug-herbs.Angelica, anise, arnica, asafetida, bogbean, boldo, celery, chamomile, clove, danshen, fenugreek, feverfew, garlic, ginger, ginkgo, horse chestnut, horseradish, licorice, meadowsweet, onion, ginseng, papain, passionflower, poplar, prickly ash, quassia, red clover, turmeric, wild carrot, wild lettuce, willow: increased risk of bleeding

Patient monitoring

• Monitor CBC and kidney and liver function test results.
• Monitor for signs and symptoms of superinfection and other serious adverse reactions.

Patient teaching

• Tell patient he may take drug with or without food.
• Instruct patient to report persistent diarrhea (more than four episodes daily) and other adverse effects.
• If patient uses antacids or iron-containing preparations (such as iron supplements), tell him to take these 2 hours before or after cefdinir.
• Inform patient that drug may temporarily discolor stools.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and herbs mentioned above.

cefdinir

(sef-di-nir) ,

Omnicef

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: third generation cephalosporins
Pregnancy Category: B

Indications

Treatment of the following infections caused by susceptible organisms:
  • Community-acquired pneumonia (adults only),
  • Acute exacerbations of chronic bronchitis (adults only),
  • Acute maxillary sinusitis,
  • Pharyngitis and tonsillitis,
  • Uncomplicated skin and skin structure infections,
  • Acute bacterial otitis media (children only).

Action

Binds to bacterial cell wall membrane, causing cell death.

Therapeutic effects

Bactericidal action against susceptible bacteria.
Active against the following gram-positive organisms: :
  • Staphylococcus aureus,
  • Streptococcus pneumoniae,
  • Streptococcus pyogenes.
Active against the following gram-negative organisms:
  • Haemophilus influenzae(including β-lactamase-producing strains),
  • Haemophilus parainfluenzae(including β-lactamase-producing strains),
  • Moraxella catarrhalis (including β-lactamase-producing strains).
Not active against methicillin-resistant staphylococci or enterococci.

Pharmacokinetics

Absorption: 16–25% absorbed after oral administration.
Distribution: Widely distributed.
Protein Binding: 60–70%.
Metabolism and Excretion: Mostly excreted unchanged in urine.
Half-life: 1.7 hr (↑ in renal impairment).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POrapid2–4 hr12–24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to cephalosporins; Serious hypersensitivity to penicillins.
Use Cautiously in: Renal impairment (dose ↓ recommended if CCr <30 mL/min); Diabetes (suspension contains sucrose); History of GI disease, especially colitis; Geriatric: Dose adjustment due to age-related ↓ in renal function may be necessary; Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <6 mo (safety not established). Suspension contains sodium benzoate, avoid use in neonates.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea (most frequent)
  • vomiting (most frequent)
  • abdominal pain
  • nausea

Genitourinary

  • vaginal moniliasis
  • vaginitis

Dermatologic

  • rash (most frequent)
  • pruritus

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Antacids and iron supplements ↓ absorption (administer at least 2 hr before or 2 hr after).Probenecid ↓ excretion and ↑ blood levels.

Route/Dosage

Oral (Adults and Children ≥13 yr) 300 mg every 12 hr or 600 mg every 24 hr (twice daily dosing must be used for community-acquired pneumonia or uncomplicated skin and skin structure infections).

Renal Impairment

(Adults and Children ≥13 yr) CCr <30 mL/min—300 mg every 24 hr.
Oral (Children 6 mo–12 yr) 7 mg/kg every 12 hr or 14 mg/kg every 24 hr (not to exceed 600 mg/day). Twice daily dosing must be used for uncomplicated skin and skin structure infections.

Renal Impairment

(Children 6 mo-12 yr) CCr <30 mL/min—7 mg/kg every 24 hr.

Availability (generic available)

Oral suspensionstrawberry flavor: 125 mg/5 mL, 250 mg/5 mL
Capsules: 300 mg

Nursing implications

Nursing assessment

  • Assess patient for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
  • Before initiating therapy, obtain a history to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
  • Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
  • Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify physician or other health care professional immediately if these symptoms occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Lab Test Considerations: May cause positive results for Coombs’ test.
    • May cause increased serum AST, ALT, alkaline phosphatase, bilirubin, LDH, and BUN.
    • May rarely cause leukopenia, eosinophilia, lymphocytosis, and thrombocytosis.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)
Diarrhea (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Oral: Administer around the clock. May be administered without regard to food. Shake oral suspension well before administering. Suspension can be stored at room temperature for up to 10 days.
    • Do not administer within 2 hr before or after antacids or iron supplements.

Patient/Family Teaching

  • Instruct patient to take medication around the clock at evenly spaced times and to finish the medication completely as directed, even if feeling better. Take missed doses as soon as possible unless almost time for next dose; do not double doses. Instruct patient to use calibrated measuring device with suspension. Advise patient that sharing this medication may be dangerous.
  • Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
  • Instruct patient to notify health care professional if fever and diarrhea develop, especially if diarrhea contains blood, mucus, or pus. Advise patient not to treat diarrhea without consulting health care professional.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.

Omnicef

(ōm′nĭ-sĕf′)
A trademark for the drug cefdinir.

Omnicef®

Cefdinir Infectious disease A cephalosporin used for community-acquired pneumonia, exacerbation of chronic bronchitis, bacterial sinusitis, pharyngitis and tonsillitis related to strep throat, uncomplicated skin infections; in children, for acute bacterial otitis media. See Cephalosporin.
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Abbott lost an appeals court case last year seeking to stop sales of Sandoz's generic version of Omnicef until a trial is held.
6 percent was impacted by the expected decline in Omnicef sales, as generic competition for the product began in May 2007.
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0 percent was led by double-digit increases in HUMIRA, Depakote, TriCor, Kaletra and Omnicef.
In the quarter, five additional products posted double-digit growth in the United States including TriCor, Omnicef and Kaletra.
Abbott sales representatives promoting Omnicef were cited by panel pediatricians discussing Omnicef's "five day dosing for bronchitis" as well as the benefits of providing "once-a-day dosing for sinusitis".
Other products contributing to growth in the United States included TriCor, Omnicef, Kaletra and Mobic.
4) * Abbott's global anti-infectives franchise, which includes Biaxin (clarithromycin) and Omnicef, grew 10.
pharmaceutical sales, which increased nearly 20 percent, were led by double-digit growth in HUMIRA, Ultane, Mobic, Depakote and our antibiotic franchise of Biaxin and Omnicef, which grew more than 45 percent in the first quarter on the strength of the late flu season.