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Cefdinir (Oral Route) Proper Use - Mayo Clinic.
Concomitantly administered iron-fortified infant formula 2. 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. A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide.
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. 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. Following administration of single mg doses, cefdinir was not detected in human breast milk. 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.
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.
In clinical trials, pediatric patients U. Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 0. In the U. NOTE: In both cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.
The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:. Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis.
If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Information on cefdinir overdosage in humans is not available. Toxic signs and symptoms following overdosage with other beta-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.
Once-daily dosing for 10 days is as effective as twice daily dosing. Once-daily dosing has not been studied in skin infections; therefore, cefdinir for oral suspension should be administered twice daily in this infection. Cefdinir for oral suspension may be administered without regard to meals. Creatinine clearance is difficult to measure in outpatients. However, the following formula may be used to estimate creatinine clearance CL cr in adult patients.
For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function. Tap bottle to loosen powder, then add water in 2 portions. Shake well after each aliquot. The container should be kept tightly closed, and the suspension should be shaken well before each administration.
The suspension may be used for 10 days, after which any unused portion must be discarded. The reconstituted suspensions have a cream color and strawberry flavor. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.
In a controlled, double-blind study in adults and adolescents conducted in the U. Using strict evaluability and clinical response criteria 6 to 14 days post-therapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:.
In four controlled studies conducted in the United States, cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Multiple Dosing Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function. Distribution The mean volume of distribution Vd area of cefdinir in adult subjects is 0. Skin Blister In adult subjects, median range maximal blister fluid cefdinir concentrations of 0.
Tonsil Tissue In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single and mg doses were 0. Lung Tissue In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single and mg doses were 0.
CSF Data on cefdinir penetration into human cerebrospinal fluid are not available. Metabolism and Excretion Cefdinir is not appreciably metabolized. Cefdinir is classified in FDA pregnancy risk category B. Animal data show that there are no teratogenic effects of cefdinir in rats.
There are, however, no adequate and well-controlled studies in pregnant women, Because animal reproduction studies are not always predictive of human response, cefdinir should be used during pregnancy only if clearly needed. Cefdinir may be administered to breast-feeding women. Cefdinir was not detected in human breast milk following single mg oral doses. Dose adjustment of cefdinir is not necessary in the geriatric patient unless renal function is markedly compromised.
Clinical trial data and clinical experience suggests similar efficacy toin geriatric and younger adult patients. According to OBRA, use of antibiotics should be limited to confirmed or suspected bacterial infections. Antibiotics are non-selective and may result in the eradication of beneficial microorganisms while promoting the emergence of undesired ones, causing secondary infections such as oral thrush, colitis, or vaginitis.
Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, and hypersensitivity reactions. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium salicylate. Cefdinir absorption may be reduced. Antacids: Moderate Antacids containing magnesium or aluminum can interfere with the absorption of cefdinir.
If aluminum or magnesium containing antacids are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid. Choline Salicylate; Magnesium Salicylate: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium salicylate.
Desogestrel; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported.
It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs.
Antituberculous drugs e. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives.
These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified.
During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries e.
Dienogest; Estradiol valerate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Drospirenone: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Drospirenone; Estetrol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Drospirenone; Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Drospirenone; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Drospirenone; Ethinyl Estradiol; Levomefolate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Elagolix; Estradiol; Norethindrone acetate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Estradiol; Levonorgestrel: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Estradiol; Norethindrone: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Estradiol; Norgestimate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethinyl Estradiol; Norelgestromin: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethinyl Estradiol; Norethindrone Acetate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Ethinyl Estradiol; Norgestrel: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethynodiol Diacetate; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Etonogestrel; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ferric Maltol: Moderate Administer cefdinir at least 2 hours before or 2 hours after iron supplements. Iron Salts: Moderate Administer cefdinir at least 2 hours before or 2 hours after iron supplements. Iron: Moderate Administer cefdinir at least 2 hours before or 2 hours after iron supplements. Lanthanum Carbonate: Moderate To limit absorption problems, cefdinir should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like cefdinir, may be bound by lanthanum carbonate.
Separate the times of administration appropriately. Monitor the patient to ensure the appropriate response to cefdinir is obtained. Leuprolide; Norethindrone: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Levonorgestrel: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Levonorgestrel; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Loop diuretics: Minor Nephrotoxicity associated with cephalosporins may be potentiated by concomitant therapy with loop diuretics. Clinicians should be aware that this may occur even in patients with minor or transient renal impairment. Magnesium Salicylate: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium salicylate.
Magnesium Salts: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium chloride. Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium gluconate. Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium sulfate. Drug information provided by: IBM Micromedex. Take this medicine only as directed by your doctor.
Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. If you are taking aluminum or magnesium-containing antacids, iron supplements, or multivitamins, do not take them at the same time that you take this medicine.
It is best to take these medicines at least 2 hours before or after taking cefdinir. These medicines may keep cefdinir from working properly. Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
Your infection may not clear up if you stop using the medicine too soon. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Oral extended-spectrum, semisynthetic, third generation cephalosporin. It is not active against methicillin-resistant staphylococci or Pseudomonas aeruginosa. Cefdinir is used for skin infections and a variety of upper respiratory infections. Guidelines recommend cefdinir as an alternative to high-dose amoxicillin or high-dose amoxicillin; clavulanate in penicillin allergic patients.
Third-generation oral cephalosporins, such as cefdinir, are not recommended by the Infectious Disease Society of America IDSA for empiric monotherapy of acute bacterial sinusitis due to variable rates of S. Guidelines recommend cefdinir as an alternative to amoxicillin or amoxicillin; clavulanate for infections due to H.
Guidelines do not recommend cefdinir for Group A Streptococcal pharyngitis to prevent rheumatic fever. Guidelines do not recommend cefdinir Group A Streptococcal pharyngitis to prevent rheumatic fever. A 3- to 7-day course of cefidinir may be an alternative in patients with uncomplicated cystitis when other recommended agents cannot be used. Cefdinir has been shown to be statistically equivalent to cefaclor for microbiologic response rates and clinical cure rates in adults with uncomplicated urinary tract infection UTI.
A treatment course of 7 to 14 days is recommended by the American Academy of Pediatrics AAP for the treatment of initial UTI in febrile infants and young children 2 to 24 months of age. Shorter courses 2 to 4 days may be used in older children with uncomplicated cystitis.
In a retrospective in vitro antimicrobial susceptibility study in children, This rate was comparable or superior to rates for other antibiotics i. Intermittent hemodialysis Hemodialysis removes cefdinir from the body. If antacids or iron supplements are necessary during cefdinir therapy, cefdinir should be given at least 2 hours before or after the antacid or iron supplement. Iron-fortified infant formulas do not significantly alter the absorption of cefdinir.
Cefdinir oral suspension may be administered without regard to meals. Shake well prior to each use. For accurate dosage, measure using a calibrated oral syringe, spoon or cup. Suspension Reconstitution: Tap the bottle to loosen the powder. The water will be added in 2 portions; shake well after each aliquot. See manufacturer's specific instructions regarding reconstitution volumes needed. After mixing, the suspension can be stored at controlled room temperature. The container should be kept tightly closed when not in use.
The suspension may be used for 10 days, after which any unused portion must be discarded. Omnicef: - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F - Store in original container.
A false-positive reaction for glucose in the urine has been observed in patients receiving cephalosporins, such as cefdinir, and using Benedict's solution, Fehling's solution, or Clinitest tablets for urine glucose testing. However, this reaction has not been observed with glucose oxidase tests e. Patients with diabetes mellitus who test their urine for glucose should use glucose tests based on enzymatic glucose oxidase reactions while on cefdinir treatment.
A positive direct Coombs test may develop in some patients. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs test of newborns whose mothers received cefdinir before delivery, clinicians should keep in mind that a positive Coombs test may be due to the drug. Cefdinir does not treat viral infection e.
Prescribing 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 antimicrobial resistance.
Patients should be told to complete the full course of treatment, even if they feel better earlier. Cefdinir is contraindicated in patients with a known history of cephalosporin hypersensitivity or cephamycin hypersensitivity. Cefdinir should be used cautiously in patients with hypersensitivity to penicillin.
The structural similarity between cefdinir and penicillin means cross-reactivity can occur. Penicillins can cause a variety of hypersensitivity reactions ranging from mild rash to fatal anaphylaxis. Patients who have experienced severe penicillin hypersensitivity should not receive cefdinir. Cefdinir should be used with caution in patients who have had a delayed-type reaction to penicillin or related drugs.
Serum sickness-like reactions have occurred following a second course of therapy. Because hemodialysis removes cefdinir from the body, additional dosage adjustments are needed to ensure therapeutic effect if a patient receives dialysis.
Consider pseudomembranous colitis in patients presenting with diarrhea after antibacterial use. Careful medical history is necessary as pseudomembranous colitis has been reported to occur over 2 months after the administration of antibacterial agents. Almost all antibacterial agents, including cefdinir, have been associated with pseudomembranous colitis or C.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. All cephalosporins, including cefdinir, can rarely cause hypoprothrombinemia and have the potential to cause bleeding.
Cephalosporins, which contain the methylthiotetrazole MTT side chain e. Cephalosporins should be used cautiously in patients with a preexisting coagulopathy e. In patients with diabetes mellitus, it should be noted that cefdinir oral suspension contains sucrose 1. Safety and efficacy of cefdinir in neonates and infants less than 6 months of age have not been established. Cefdinir is classified in FDA pregnancy risk category B.
Animal data show that there are no teratogenic effects of cefdinir in rats. There are, however, no adequate and well-controlled studies in pregnant women, Because animal reproduction studies are not always predictive of human response, cefdinir should be used during pregnancy only if clearly needed. Cefdinir may be administered to breast-feeding women. Cefdinir was not detected in human breast milk following single mg oral doses.
Dose adjustment of cefdinir is not necessary in the geriatric patient unless renal function is markedly compromised. Clinical trial data and clinical experience suggests similar efficacy toin geriatric and younger adult patients. According to OBRA, use of antibiotics should be limited to confirmed or suspected bacterial infections. Antibiotics are non-selective and may result in the eradication of beneficial microorganisms while promoting the emergence of undesired ones, causing secondary infections such as oral thrush, colitis, or vaginitis.
Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, and hypersensitivity reactions. Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium salicylate.
Cefdinir absorption may be reduced. Antacids: Moderate Antacids containing magnesium or aluminum can interfere with the absorption of cefdinir. If aluminum or magnesium containing antacids are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid. Choline Salicylate; Magnesium Salicylate: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium salicylate.
Desogestrel; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora.
One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs.
Antituberculous drugs e. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives.
These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified.
During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries e. Dienogest; Estradiol valerate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Drospirenone: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Drospirenone; Estetrol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Drospirenone; Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Drospirenone; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Drospirenone; Ethinyl Estradiol; Levomefolate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Elagolix; Estradiol; Norethindrone acetate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Estradiol; Levonorgestrel: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Estradiol; Norethindrone: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Estradiol; Norgestimate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethinyl Estradiol; Norelgestromin: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethinyl Estradiol; Norethindrone Acetate: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Ethinyl Estradiol; Norgestrel: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.
Ethynodiol Diacetate; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Etonogestrel; Ethinyl Estradiol: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics. Ferric Maltol: Moderate Administer cefdinir at least 2 hours before or 2 hours after iron supplements.
Iron Salts: Moderate Administer cefdinir at least 2 hours before or 2 hours after iron supplements. Iron: Moderate Administer cefdinir at least 2 hours before or 2 hours after iron supplements.
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all. Powder for Oral Suspension ; Acute Maxillary Sinusitis, 7 mg/kg q12h or 14 mg/kg q24h, 10 days 10 days ; Pharyngitis/Tonsillitis, 7 mg/kg q12h or. prevent infections that are proven or strongly suspected to be caused by administration of single and mg oral doses of cefdinir to adult. Clinical trials with cefdinir have demonstrated that QD dosing is as effective as BID dosing against respiratory tract infections, excluding community-acquired. 6months–12yrs: Otitis media, pharyngitis/tonsillitis: 7mg/kg every 12hrs for 5–10 days, or 14mg/kg every 24hrs for 10 days. Sinusitis: 7mg/kg every 12hrs, or. Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days. Sodium Sulfate; Magnesium Sulfate; Potassium Chloride: Moderate Administer cefdinir at least 2 hours before or 2 hours after magnesium sulfate. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Hepatic Disease Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted. Drospirenone: Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Cefdinir for oral suspension contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Cefdinir is a white to slightly brownish-yellow solid.
It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0. Cefdinir has the structural formula shown below:. Cefdinir for oral suspension, after reconstitution, contains mg cefdinir per 5 mL or mg cefdinir per 5 mL and the following inactive ingredients: citric acid anhydrous, colloidal silicone dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate, strawberry flavoring, sucrose, and xanthan gum.
Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. The magnitude of these reductions is not likely to be clinically significant because the safety and efficacy studies of oral suspension in pediatric patients were conducted without regard to food intake.
Therefore, cefdinir may be taken without regard to food. Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single and mg oral doses of cefdinir to adult subjects are presented in the following table:. Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function. The mean volume of distribution Vd area of cefdinir in adult subjects is 0.
In adult subjects, median range maximal blister fluid cefdinir concentrations of 0. In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single and mg doses were 0. In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single and mg doses were 0.
Respective median epithelial lining fluid concentrations were 0. Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. In healthy subjects with normal renal function, renal clearance is 2. Mean percent of dose recovered unchanged in the urine following and mg doses is Cefdinir clearance is reduced in patients with renal dysfunction see Special Populations: Patients with Renal Insufficiency.
Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function. As a result, plasma cefdinir concentrations were higher and persisted longer in subjects with renal impairment than in those without renal impairment.
Cefdinir pharmacokinetics were studied in 8 adult subjects undergoing hemodialysis. Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted.
It is not expected that dosage adjustment will be required in this population. The effect of age on cefdinir pharmacokinetics after a single mg dose was evaluated in 32 subjects 19 to 91 years of age. This increase was due to a reduction in cefdinir clearance. As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis.
Cefdinir is stable in the presence of some, but not all, beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Resistance to cefdinir is primarily through hydrolysis by some beta-lactamases, alteration of penicillin-binding proteins PBPs and decreased permeability. Cefdinir is inactive against most strains of Enterobacter spp. The following in vitro data are available, but their clinical significance is unknown.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir 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. Cefdinir for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Caused by Haemophilus influenzae including beta-lactamase producing strains , Haemophilus parainfluenzae including beta-lactamase producing strains , Streptococcus pneumoniae penicillin-susceptible strains only , and Moraxella catarrhalis including beta-lactamase producing strains.
Caused by Haemophilus influenzae including beta-lactamase producing strains , Streptococcus pneumoniae penicillin-susceptible strains only , and Moraxella catarrhalis including beta-lactamase producing strains.
Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Caused by Staphylococcus aureus including beta-lactamase producing strains and Streptococcus pyogenes. Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
Clostridium difficile associated diarrhea CDAD has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Hypertoxin producing strains of C. CDAD must be considered in all patients who present with diarrhea following antibacterial use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. 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.
Patients should be counseled that antibacterial drugs including cefdinir should only be used to treat bacterial infections. They do not treat viral infections e. 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. 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. Time to reach C max 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. 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. 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. A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide.
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. 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.
Following administration of single mg doses, cefdinir was not detected in human breast milk. 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.
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.
In clinical trials, pediatric patients U. Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea. Five of 0. In the U. NOTE: In both cefdinir- and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients. The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the U.
The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:. Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis.
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