OMNIFAL

Cefdinir for oral suspension, USP contains the active ingredient cefdinir USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration.

Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

USP is a white to slightly brownish-yellow solid.

It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer.

The molecular formula is

C 14 H 13 N 5 O 5 S and the molecular weight is 395.42.

Cefdinir has the structural formula shown below: Cefdinir for oral suspension, USP after reconstitution, contains 125 mg cefdinir USP per 5 mL or 250 mg cefdinir USP per 5 mL and the following inactive ingredients: sucrose, sodium benzoate, colloidal silicone dioxide, xanthan gum, guar gum, citric acid (anhydrous), sodium citrate (dihydrate), strawberry flavour, fresh cream flavour and magnesium stearate.

Antibiotics used in the treatment of various types of bacterial infections, especially negative gs: pneumonia or pneumonia (unacquired or hospital-related).

Acute upper jaw attack, lymphocytic infection, almonditis in cases of chronic reed infection (increased severity, or symptoms), acute mediocre ear infection, various skin infections, etc.

The doctor must be informed that if there are disorders or diseases in the kidneys, some cases may require special precautionary procedures or modified doses.

If the patient is sensitive to penicillin, the doctor must be informed before treatment begins.

The antibiotics are treated for long periods that may cause further infection (re-infection/infection by introducing organisms of the same type that cause the existing infection), which may not respond to the old treatment.

Stop taking treatment before the doctor's period of care ends, increases the likelihood of re-entry/infection and development of resistance to treatment (not responding to treatment).

Pharmacokinetics and Drug Metabolism Absorption Oral Bioavailability Maximal plasma cefdinir concentrations occur to 4 hours postdose following capsule or suspension administration.

Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg).

Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules.

Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose.

Estimated absolute bioavailability of cefdinir suspension is 25%.

Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions.

Effect of Food The C max and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when given with a high-fat meal.

In adults given the 250 mg/5 mL oral suspension with a high-fat meal, the C max and AUC of cefdinir are reduced by 44% and 33%, respectively.

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 600 mg oral doses of cefdinir to adult subjects are presented in the following table: Mean (±SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Capsules to Adult Subjects Dose C max (mcg/mL) t max (hr) AUC (mcg•hr/mL) 300 mg 1.6 2.9 7.05 600 mg 2.87 3 11.1 Cefdinir Suspension Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single and 14 mg/kg oral doses of cefdinir to pediatric subjects (age 6 months to 12 years) are presented in the following table: Mean (±SD) Plasma Cefdinir Pharmacokinetic Parameter Values Following Administration of Suspension to Pediatric Subjects Dose C max (mcg/mL) t max (hr) AUC (mcg•hr/mL) 7 mg/kg 2.3 2.2 8.31 14 mg/kg 3.86 1.8 13.4 Multiple Dosing 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 0.35 L/kg (±0.29); in pediatric subjects (age 6 months to 12 years), cefdinir Vd area is 0.67 L/kg (±0.38).

Cefdinir is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.

In adult subjects, median (range) maximal blister fluid cefdinir concentrations of 0.65 (0.33 to 1.1) and 1.1 (0.49 to 1.9) mcg/mL were observed to 5 hours following administration of and 600 mg doses, respectively.

Mean (±SD) blister C max and AUC (0-∞) values were 48% (±13) and 91% (±18) of corresponding plasma values.

In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single and 600 mg doses were 0.25 (0.22 to 0.46) and 0.36 (0.22 to 0.8) mcg/g.

Mean tonsil tissue concentrations were 24% (±8) of corresponding plasma concentrations.

In adult patients undergoing elective maxillary and ethmoid sinus surgery, respective median sinus tissue cefdinir concentrations 4 hours after administration of single and 600 mg doses were <0.12 (<0.12 to 0.46) and 0.21 (<0.12 to 2) mcg/g.

Mean sinus tissue concentrations were 16% (±20) of corresponding plasma concentrations.

In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single and 600 mg doses were 0.78 (<0.06 to 1.33) and 1.14 (<0.06 to 1.92) mcg/mL, and were 31% (±18) of corresponding plasma concentrations.

Respective median epithelial lining fluid concentrations were 0.29 (<0.3 to 4.73) and 0.49 (<0.3 to 0.59) mcg/mL, and were 35% (±83) of corresponding plasma concentrations.

In 14 pediatric patients with acute bacterial otitis media, respective median middle ear fluid cefdinir concentrations 3 hours after administration of single and 14 mg/kg doses were 0.21 (<0.09 to 0.94) and 0.72 (0.14 to 1.42) mcg/mL.

Mean middle ear fluid concentrations were 15% (±15) of corresponding plasma concentrations.

Data on cefdinir penetration into human cerebrospinal fluid are not available.

Cefdinir is not appreciably metabolized.

Activity is primarily due to parent drug.

Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t ½ ) of 1.7 (±0.6) hours.

In healthy subjects with normal renal function, renal clearance is 2 (±1) mL/min/kg, and apparent oral clearance is 11.6 (±6) and 15.5 (±5.4) mL/min/kg following doses of and 600 mg, respectively.

Mean percent of dose recovered unchanged in the urine following and 600 mg doses is 18.4% (±6.4) and 11.6% (±4.6), respectively.

Cefdinir clearance is reduced in patients with renal dysfunction.

Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis See DOSAGE AND ADMINISTRATION.

Special Populations Patients with Renal Insufficiency

Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function.

Decreases in cefdinir elimination rate, apparent oral clearance (CL/F), and renal clearance were approximately proportional to the reduction in creatinine clearance (CL cr ).

As a result, plasma cefdinir concentrations were higher and persisted longer in subjects with renal impairment than in those without renal impairment.

In subjects with

CL cr between and 60 mL/min, C max and t ½ increased by approximately 2-fold and AUC by approximately 3-fold.

CL cr <30 mL/min, C max increased by approximately 2-fold, t ½ by approximately 5-fold, and AUC by approximately 6-fold.

Dosage adjustment is recommended in patients with markedly compromised renal function (creatinine clearance <30 mL/min; see DOSAGE AND ADMINISTRATION ).

Cefdinir pharmacokinetics were studied in 8 adult subjects undergoing hemodialysis.

Dialysis (4 hours duration) removed 63% of cefdinir from the body and reduced apparent elimination t ½ from 16 (±3.5) to 3.2 (±1.2) hours.

Dosage adjustment is recommended in this patient population See DOSAGE AND ADMINISTRATION.

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 300 mg dose was evaluated in 32 subjects to 91 years of age.

Systemic exposure to cefdinir was substantially increased in older subjects (N=16), C max by 44% and AUC by 86%.

This increase was due to a reduction in cefdinir clearance.

The apparent volume of distribution was also reduced, thus no appreciable alterations in apparent elimination t ½ were observed (elderly: 2.2 ± 0.6 hours vs young: 1.8 ± 0.4 hours).

Since cefdinir clearance has been shown to be primarily related to changes in renal function rather than age, elderly patients do not require dosage adjustment unless they have markedly compromised renal function (creatinine clearance <30 mL/min, see Patients with Renal Insufficiency, above).

The results of a meta-analysis of clinical pharmacokinetics (N=217) indicated no significant impact of either gender or race on cefdinir pharmacokinetics.

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, β-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 β-lactamases, alteration of penicillin-binding proteins (PBPs) and decreased permeability.

Cefdinir is inactive against most strains of Enterobacter spp., Pseudomonas spp., Enterococcus spp., penicillin-resistant streptococci, and methicillin-resistant staphylococci. β-lactamase negative, ampicillin-resistant (BLNAR) H. influenzae strains are typically non-susceptible to cefdinir.

Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in INDICATIONS AND USAGE.

Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes Gram-Negative Bacteria Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis The following in vitro data are available, but their clinical significance is unknown.

Cefdinir exhibits in vitro minimum inhibitory concentrations (MICs) of 1 mcg/mL or less against (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of cefdinir in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Capsol, OMNICEF 300 mg is an extensive antibiotic anti-bacterial field and a few pulse, because it contains active substance Sevdenir.

Omnesev's method is made available as an amnesive capsule and powder for oral solution and drinking, to fit the doses of children, the distilled water bag accompanying Omnesef must be added to the mark on the bottle, the bottle is well worn to the full of melting, and the pregnant person is well worn before each dose.

Omnesf must not use antibiotics, except in the narrower limits and under medical supervision.

For more: what is the antibiotic damage?: rxlist.

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• Cefdinir Capsules (Adult and Adolescent Patients) In clinical trials, 5093 adult and adolescent patients (3841 U.S. and 1252 non-U.S). were treated with the recommended dose of cefdinir capsules (600 mg/day).

Most adverse events were mild and self-limiting.

No deaths or permanent disabilities were attributed to cefdinir.

One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefdinir therapy.

The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea.

Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to cefdinir administration.

In the

U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir capsules in multiple-dose clinical trials (N = 3841 cefdinir-treated patients): ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES U.S. TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) a a 1733 males, 2108 females Incidence ≥1% Diarrhea 15% Vaginal moniliasis 4% of women Nausea 3% Headache 2% Abdominal pain 1% Vaginitis 1% of women Incidence <1% but >0.1% Rash 0.9% Dyspepsia 0.7% Flatulence 0.7% Vomiting 0.7% Abnormal stools 0.3% Anorexia 0.3% Constipation 0.3% Dizziness 0.3% Dry mouth 0.3% Asthenia 0.2% Insomnia 0.2% Leukorrhea 0.2% of women Moniliasis 0.2% Pruritus 0.2% Somnolence 0.2% 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.S.: LABORATORY VALUE CHANGES OBSERVED WITH CEFDINIR CAPSULES U.S. TRIALS IN ADULT AND ADOLESCENT PATIENTS (N = 3841) a N <3841 for these parameters Incidence ≥1% ↑Urine leukocytes 2% ↑Urine protein 2% ↑Gamma-glutamyltransferase a 1% ↓Lymphocytes, ↑Lymphocytes 1%, 0.2% ↑Microhematuria 1% Incidence <1% but >0.1% ↑Glucose a 0.9% ↑Urine glucose 0.9% ↑White blood cells, ↓White blood cells 0.9%, 0.7% ↑Alanine aminotransferase (ALT) 0.7% ↑Eosinophils 0.7% ↑Urine specific gravity, ↓Urine specific gravity a 0.6%, 0.2% ↓Bicarbonate a 0.6% ↑Phosphorus, ↓Phosphorus a 0.6%, 0.3% ↑Aspartate aminotransferase (AST) 0.4% ↑Alkaline phosphatase 0.3% ↑Blood urea nitrogen (BUN) 0.3% ↓Hemoglobin 0.3% ↑Polymorphonuclear neutrophils (PMNs), ↓PMNs 0.3%, 0.2% ↑Bilirubin 0.2% ↑Lactate dehydrogenase a 0.2% ↑Platelets 0.2% ↑Potassium a 0.2% ↑Urine pH a 0.2% Clinical Trials.

• Cefdinir for Oral Suspension (Pediatric Patients) In clinical trials, 2289 pediatric patients (1783 U.S. and 506 non-U.S). were treated with the recommended dose of cefdinir suspension (14 mg/kg/day).

Forty of 2289 (2%) patients discontinued medication due to adverse events considered by the investigators to be possibly, probably, or definitely associated with cefdinir therapy.

Discontinuations were primarily for gastrointestinal disturbances, usually diarrhea.

Five of 2289 (0.2%) patients were discontinued due to rash thought related to cefdinir administration.

U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir suspension in multiple-dose clinical trials (N = 1783 cefdinir-treated patients): ADVERSE EVENTS ASSOCIATED WITH CEFDINIR SUSPENSION U.S. TRIALS IN PEDIATRIC PATIENTS (N = 1783) a a 977 males, 806 females b Laboratory changes were occasionally reported as adverse events.

Incidence ≥ 1% Diarrhea 8% Rash 3% Vomiting 1% Incidence <1% but >0.1% Cutaneous moniliasis 0.9% Abdominal pain 0.8% Leukopenia b 0.3% Vaginal moniliasis 0.3% of girls Vaginitis 0.3% of girls Abnormal stools 0.2% Dyspepsia 0.2% Hyperkinesia 0.2% Increased AST b 0.2% Maculopapular rash 0.2% Nausea 0.2% NOTE: In both cefdinir.

• and control-treated patients, rates of diarrhea and rash were higher in the youngest pediatric patients.

The incidence of diarrhea in cefdinir-treated patients ≤2 years of age was 17% (95/557) compared with 4% (51/1226) in those >2 years old.

The incidence of rash (primarily diaper rash in the younger patients) was 8% (43/557) in patients ≤2 years of age compared with 1% (8/1226) in those >2 years old.

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.S.: LABORATORY VALUE CHANGES OF POSSIBLE CLINICAL SIGNIFICANCE OBSERVED WITH CEFDINIR SUSPENSION U.S. TRIALS IN PEDIATRIC PATIENTS (N = 1783) a N = 1387 for these parameters Incidence ≥1% ↑Lymphocytes, ↓Lymphocytes 2%, 0.8% ↑Alkaline phosphatase 1% ↓Bicarbonate a 1% ↑Eosinophils 1% ↑Lactate dehydrogenase 1% ↑Platelets 1% ↑PMNs, ↓PMNs 1%, 1% ↑Urine protein 1% Incidence <1% but >0.1% ↑Phosphorus, ↓Phosphorus 0.9%, 0.4% ↑Urine pH 0.8% ↓White blood cells, ↑White blood cells 0.7%, 0.3% ↓Calcium a 0.5% ↓Hemoglobin 0.5% ↑Urine leukocytes 0.5% ↑Monocytes 0.4% ↑AST 0.3% ↑Potassium a 0.3% ↑Urine specific gravity, ↓Urine specific gravity 0.3%, 0.1% ↓Hematocrit a 0.2% Postmarketing Experience The following adverse experiences and altered laboratory tests, regardless of their relationship to cefdinir, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1991: shock, anaphylaxis with rare cases of fatality, facial and laryngeal edema, feeling of suffocation, serum sickness-like reactions, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestasis, fulminant hepatitis, hepatic failure, jaundice, increased amylase, acute enterocolitis, bloody diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthmatic attack, drug.

• induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, coagulation disorder, disseminated intravascular coagulation, upper GI bleed, peptic ulcer, ileus, loss of consciousness, allergic vasculitis, possible cefdinir-diclofenac interaction, cardiac failure, chest pain, myocardial infarction, hypertension, involuntary movements, and rhabdomyolysis.

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.

Pseudomembranous colitis symptoms may begin during or after antibiotic treatment See WARNINGS.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced See DOSAGE AND ADMINISTRATION and OVERDOSAGE.

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.

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.

β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.

SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

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. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of

C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

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.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

See INDICATIONS AND USAGE for Indicated Pathogens The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID 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.

Patients (Age 6 Months Through 12 Years) Type of Infection Dosage Duration Acute Bacterial Otitis Media 7 mg/kg q12h or 14 mg/kg q24h to 10 days 10 days Acute Maxillary Sinusitis 7 mg/kg q12h or 14 mg/kg q24h 10 days 10 days Pharyngitis/Tonsillitis 7 mg/kg q12h or 14 mg/kg q24h to 10 days 10 days Uncomplicated Skin and Skin Structure.

Infections 7 mg/kg q12h 10 days CEFDINIR FOR ORAL SUSPENSION PEDIATRIC DOSAGE CHART a Pediatric patients who weigh ≥ 43 kg should receive the maximum daily dose of 600 mg. Weight 125 mg/5 mL 250 mg/5 mL 9 kg/20 lbs 2.5 mL q12h or 5 mL q24h Use 125 mg/5 mL product 18 kg/40 lbs 5 mL q12h or 10 mL q24h 2.5 mL q12h or 5 mL q24h 27 kg/60 lbs 7.5 mL q12h or 15 mL q24h 3.75 mL q12h or 7.5 mL q24h 36 kg/80 lbs 10 mL q12h or 20 mL q24h 5 mL q12h or 10 mL q24h ≥ 43 kg a /95 lbs 12 mL q12h or 24 mL q24h 6 mL q12h or 12 mL q24h Patients With Renal Insufficiency For adult patients with creatinine clearance <30 mL/min, the dose of cefdinir should be 300 mg given once daily.

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.

CL cr = (weight) (140 – age) (serum creatinine) Females: CL cr = 0.85 x above value where creatinine clearance is in mL/min, age is in years, weight is in kilograms, and serum creatinine is in mg/dL.

The following formula may be used to estimate creatinine clearance in pediatric patients: CL cr = K x body length or height serum creatinine where K=0.55 for pediatric patients older than 1 year and 0.45 for infants (up to 1 year) 3.

In the above equation, creatinine clearance is in mL/min/1.73 m 2, body length or height is in centimeters, and serum creatinine is in mg/dL.

For pediatric patients with a creatinine clearance of <30 mL/min/1.73 m 2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

Hemodialysis removes cefdinir from the body.

In patients maintained on chronic hemodialysis, the recommended initial dosage regimen is a 300 mg or 7 mg/kg dose every other day. At the conclusion of each hemodialysis session, 300 mg (or 7 mg/kg) should be given.

Subsequent doses (300 mg or 7 mg/kg) are then administered every other day. Directions for Mixing Cefdinir for Oral Suspension Final Concentration Final Volume (mL) Amount of Water Directions 125 mg/5 mL 60 100 38 mL 63 mL Tap bottle to loosen powder, then add water in 2 portions.

Shake well after each aliquot. 250 mg/5 mL 60 100 38 mL 63 mL Tap bottle to loosen powder, then add water in 2 portions.

Shake well after each aliquot.

After mixing, the suspension can be stored at room temperature (25°C/77°F).

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.

Suspension, USP 125 mg/5 mL is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored suspension with strawberry and cream flavors. 60 mL Bottle NDC 65862-218-60 100 mL Bottle NDC 65862-218-01 Cefdinir for Oral Suspension, USP 250 mg/5 mL is a off-white to yellowish — white colored granular powder, on constitution with water, forming an off-white to yellowish-white colored suspension with strawberry and cream flavors. 60 mL Bottle NDC 65862-219-60 100 mL Bottle NDC 65862-219-01 Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Once reconstituted, the oral suspension can be stored at controlled room temperature for 10 days.

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/m 2 /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/m 2 /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.

Following administration of single 600 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.

Dose adjustment in elderly patients is not necessary unless renal function is markedly compromised See DOSAGE AND ADMINISTRATION.