Cefdinir

Pregnancy category: B

Lactation: Unknown whether drug is excreted in milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Cefdinir comes as a capsule and suspension (liquid) to take by mouth. It is usually taken with or without food every 12 or 24 hours for 5 to 10 days, depending on the condition being treated. Take cefdinir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cefdinir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the suspension well before each use to mix the medication evenly.

You should begin to feel better during the first few days of treatment with cefdinir. If your symptoms do not improve or get worse, call your doctor.

Continue to take cefdinir even if you feel better. If you stop taking cefdinir too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Most Common Side Effects of Cefdinir:

• Diarrhea
• Vaginal yeast infections
• Nausea
• Headache, dizziness
• Stomach pain
• Vaginitis
• Gas
• Mild itching or skin rash

Diarrhea usually ends once you have completed your course of antibiotics. Call your doctor at once if your stools are watery or bloody, as that could signal a C. difficile infection. Know that you can develop watery and bloody stools, with or without stomach cramps and fever, two or more months after completing treatment.

Do not treat yourself with anti-diarrhea medications, as they can worsen your diarrhea.

Rates of diarrhea and rash have been found to be higher in pediatric patients younger than 2 years old.

If you're taking iron supplements, your stools may become reddish. This is nothing to worry about.

Serious Side Effects of Cefdinir:

The following side effects can indicate an allergic reaction to cefdinir, and you need to call your doctor immediately:

• Hives
• Difficulty breathing
• Swelled tongue, face, lips, or throat

Other Serious Side Effects of Cefdinir:

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

• Watery, bloody diarrhea
• Chest pain
• Fever, chills, body aches, cough, flu-like symptoms
• Upset stomach
• Unusual bleeding
• Shortness of breath
• Convulsions
• Pale or yellow skin or eyes (jaundice)
• Bloody, cloudy, or dark urine
• Sore throat
• Vomiting
• Thrush (comes with prolonged use)
• Confusion
• Blistering, peeling, red-skin rash
• Increased thirst, weakened appetite, shortness of breath
• Insomnia
• Increased glucose in urine if you have diabetes
• Lowered white blood cell count (leukopenia)
• Black, sticky ("tarry") stools
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Fatigue, weakness

If you have diabetes, be aware that the oral liquid form of cefdinir contains 2.86 grams of sucrose (table sugar) per teaspoon.

If you have kidney disease, be aware that side effects might be heightened because cefdinir will take longer to leave your body.

Cefdinir comes in 300 milligram (mg) capsules, and in a powder (125 or 250 mg) to be mixed with water.

The total daily dose for all infections, except pneumonia and skin infections, is 600 mg, which can be taken twice a day in 300 mg doses, or in one 600 mg dose.

The drug works best if taken at the same time every day.

• For pneumonia and skin infections, take cefdinir twice a day in 300 mg doses.
• For children 6 months to 12 years old taking cefdinir in liquid form, the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg a day, depending on the child's body weight.
• For skin infections, children should take cefdinir twice a day.
• The safety and effectiveness of cefdinir for children younger than 6 months has not been established.
• For adult patients with poor kidney function, cefdinir should be taken in a 300 mg daily dose. Patients on chronic dialysis should take a 300 mg dose or a 7 mg dose every other day. A 300 mg or 7 mg dose should also be given at the end of each dialysis session, with 300 mg or 7 mg doses administered every other day.

As with all antibiotics, keep taking cefdinir for the prescribed treatment time even if your symptoms disappear to ensure that bacteria do not grow back.

Cefdinir Overdose

Contact a poison control center or get to an emergency room immediately. Overdose symptoms can include nausea, severe vomiting, and seizures.

Missed Dose of Cefdinir

Take it as soon as you remember, unless it's almost time for your next dose. In that case, skip the missed dose of cefdinir and simply take your next regularly scheduled dose when it's time. Do not take a double dose to make up for the missed dose.

Serious side effects have been reported with cefdinir. See the “Cefdinir Precautions” section.

Common side effects of cefdinir include the following:

• Stomach upset
• Vomiting
• Decreased appetite
• Headache
• Fatigue

This is not a complete list of cefdinir side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not take this medication if you are allergic to cefdinir or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);
• cefadroxil (Duricef);
• cefazolin (Ancef);
• cefditoren (Spectracef);
• cefpodoxime (Vantin);
• cefprozil (Cefzil);
• ceftibuten (Cedax);
• cefuroxime (Ceftin);
• cephalexin (Keflex); or
• cephradine (Velosef); and others.

To make sure you can safely take cefdinir, tell your doctor if you have any of these other conditions:

• kidney disease (or if you are on dialysis);
• a history of intestinal problems, such as colitis; or
• if you are allergic to any drugs (especially penicillins).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cefdinir passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The cefdinir suspension (liquid) contains sucrose. Talk to your doctor before using this form of cefdinir if you have diabetes.

Antibacterial; β-lactam antibiotic; aminothiazolyl third generation cephalosporin.1 2 3 4 5 6 40

Storage

Oral

20–25°C (may be exposed to 15–30°C).1

20–25°C (may be exposed to 15–30°C).40 41 Following reconstitution, store suspension in tight container at controlled room temperature; discard after 10 days.40 41

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

General

Prescribing Cefdinir 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.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.

Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.

In patients with transient or persistent renal insufficiency (creatinine clearance <30 mL/min), the total daily dose of Cefdinir should be reduced because high and prolonged plasma concentrations of Cefdinir can result following recommended doses (see DOSAGE AND ADMINISTRATION).

Information for Patients

Patients should be counseled that antibacterial drugs including Cefdinir should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefdinir is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefdinir or other antibacterial drugs in the future.

Antacids containing magnesium or aluminum interfere with the absorption of Cefdinir. If this type of antacid is required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the antacid.

Iron supplements, including multivitamins that contain iron, interfere with the absorption of Cefdinir. If iron supplements are required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the supplement.

Iron-fortified infant formula does not significantly interfere with the absorption of Cefdinir. Therefore, Cefdinir for oral suspension can be administered with iron-fortified infant formula.

Diabetic patients and caregivers should be aware that the oral suspension contains 2.85 g of sucrose per teaspoon for 125 mg/5 mL suspension and 2.72 g of sucrose per teaspoon for 250 mg/5 mL suspension.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Antacids: (aluminum- or magnesium-containing)

Concomitant administration of 300 mg Cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on Cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after Cefdinir. If antacids are required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the antacid.

Probenecid

As with other β-lactam antibiotics, probenecid inhibits the renal excretion of Cefdinir, resulting in an approximate doubling in AUC, a 54% increase in peak Cefdinir plasma levels, and a 50% prolongation in the apparent elimination t1/2.

Iron Supplements and Foods Fortified With Iron

Concomitant administration of Cefdinir with a therapeutic iron supplement containing 60 mg of elemental iron (as FeSO4) or vitamins supplemented with 10 mg of elemental iron reduced extent of absorption by 80% and 31%, respectively. If iron supplements are required during Cefdinir therapy, Cefdinir should be taken at least 2 hours before or after the supplement.
The effect of foods highly fortified with elemental iron (primarily iron-fortified breakfast cereals) on Cefdinir absorption has not been studied.

Concomitantly administered iron-fortified infant formula (2.2 mg elemental iron/6 oz) has no significant effect on Cefdinir pharmacokinetics. Therefore, Cefdinir for oral suspension can be administered with iron-fortified infant formula.

There have been reports of reddish stools in patients receiving Cefdinir. In many cases, patients were also receiving iron-containing products. The reddish color is due to the formation of a nonabsorbable complex between Cefdinir or its breakdown products and iron in the gastrointestinal tract.

Drug/Laboratory Test Interactions

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide. The administration of Cefdinir may result in a false-positive reaction for glucose in urine using Clinitest®, Benedict’s solution, or Fehling's solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix® or Tes-Tape®) be used. Cephalosporins are known to occasionally induce a positive direct Coombs’ test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Cefdinir has not been evaluated. No mutagenic effects were seen in the bacterial reverse mutation assay (Ames) or point mutation assay at the hypoxanthine-guanine phosphoribosyltransferase locus (HGPRT) in V79 Chinese hamster lung cells. No clastogenic effects were observed in vitro in the structural chromosome aberration assay in V79 Chinese hamster lung cells or in vivo in the micronucleus assay in mouse bone marrow. In rats, fertility and reproductive performance were not affected by Cefdinir at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m2/day).

Pregnancy

Pregnancy Category B

Cefdinir was not teratogenic in rats at oral doses up to 1000 mg/kg/day (70 times the human dose based on mg/kg/day, 11 times based on mg/m2/day) or in rabbits at oral doses up to 10 mg/kg/day (0.7 times the human dose based on mg/kg/day, 0.23 times based on mg/m2/day). Maternal toxicity (decreased body weight gain) was observed in rabbits at the maximum tolerated dose of 10 mg/kg/day without adverse effects on offspring. Decreased body weight occurred in rat fetuses at ≥100 mg/kg/day, and in rat offspring at ≥32 mg/kg/day. No effects were observed on maternal reproductive parameters or offspring survival, development, behavior, or reproductive function.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Cefdinir has not been studied for use during labor and delivery.

Nursing Mothers

Following administration of single 600 mg doses, Cefdinir was not detected in human breast milk.

Pediatric Use

Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of Cefdinir for the treatment of acute maxillary sinusitis in pediatric patients (age 6 months through 12 years) is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.

Geriatric Use

Efficacy is comparable in geriatric patients and younger adults. While Cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised (see DOSAGE AND ADMINISTRATION).

Information on Cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600 mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes Cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Tenth Edition. CLSI Document M07-A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI Document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement, CLSI Document M100-S25 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
4. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
5. Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58:259-63.
6. Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984;104:849-54.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Orchid Healthcare.

Manufactured for : OrchidPharma, Inc.
Princeton NJ 08540, USA

Manufactured by : Hospira Healthcare India Pvt.Ltd.,
At Irungattukottai – 602 105, India

On behalf of : Orchid Healthcare
(A Division of Orchid Pharma Ltd.)
At Irungattukottai – 602 105, India

Revised: 2/2016

(SEF di ner)

Clearance is reduced.

Acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis: Oral: 300 mg twice daily for 5 to 10 days or 600 mg once daily for 10 days

Acute maxillary sinusitis: Oral: 300 mg twice daily or 600 mg once daily for 10 days. Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (Chow 2012).

Community-acquired pneumonia, skin and skin structure infections (uncomplicated): Oral: 300 mg twice daily for 10 days

Cystitis, acute uncomplicated (off-label use): Oral: 300 mg twice daily (Colgan 2011) for 3 to 7 days (IDSA [Gupta 2011])

Concerns related to adverse effects:

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Colitis: Use with caution in patients with a history of colitis.

• Renal impairment: Use with caution in patients with renal impairment (CrCl <30 mL/minute); dosage adjustment may be required.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Iron-containing products: Cases of reddish stools have been reported with concomitant use of cefdinir and iron-containing products due to the formation of a nonabsorbable complex in the GI tract.

Community acquired: 300 mg orally every 12 hours for 10 to 14 days

Uncomplicated: 300 mg orally every 12 hours for 10 days

Hemodialysis: 300 mg or 7 mg/kg orally given upon completion of dialysis and every 48 hours thereafter

• Effective for the treatment of mild-to-moderate infections caused by a number of susceptible gram-positive and gram-negative bacteria, such as Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae (penicillin-susceptible strains only), S. pyogenes, Haemophilus influenzae, H. parainfluenzae, and Moraxella catarrhalis.
• Stable in the presence of some (but not all) beta-lactamase enzymes.
• May be administered once or twice a day depending on the type of infection.
• Generic cefdinir is available.