Cefdinir

Dosage Form: powder for oral suspension
Cefdinir for Oral Suspension

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 Description

Cefdinir for oral suspension contains the active ingredient Cefdinir, 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. Cefdinir 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 empirical formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:

Cefdinir for oral suspension, after reconstitution, contains 125 mg Cefdinir per 5 mL or 250 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.

Cefdinir - Clinical Pharmacology

Pharmacokinetics and Drug Metabolism

Absorption

Oral Bioavailability

Maximal plasma Cefdinir concentrations occur 2 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 Cmax 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 Cmax 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 Capsules

Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 300 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	Cmax (mcg/mL)	tmax (hr)	AUC (mcg•hr/mL)
300 mg	1.60	2.9	7.05
	(0.55)	(0.89)	(2.17)
600 mg	2.87	3.0	11.1
	(1.01)	(0.66)	(3.87)

Cefdinir Suspension

Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 7 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	Cmax (mcg/mL)	tmax (hr)	AUC (mcg•hr/mL)
7 mg/kg	2.30 (0.65)	2.2 (0.6)	8.31 (2.50)
14 mg/kg	3.86 (0.62)	1.8 (0.4)	13.4 (2.64)

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 (Vdarea) of Cefdinir in adult subjects is 0.35 L/kg (±0.29); in pediatric subjects (age 6 months to 12 years), Cefdinir Vdarea 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.

Skin Blister

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 4 to 5 hours following administration of 300 and 600 mg doses, respectively. Mean (±SD) blister Cmax and AUC (0-∞) values were 48% (±13) and 91% (±18) of corresponding plasma values.

Tonsil Tissue

In adult patients undergoing elective tonsillectomy, respective median tonsil tissue Cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were 0.25 (0.22 to 0.46) and 0.36 (0.22 to 0.80) mcg/g. Mean tonsil tissue concentrations were 24% (±8) of corresponding plasma concentrations.

Sinus Tissue

In adult patients undergoing elective maxillary and ethmoid sinus surgery, respective median sinus tissue Cefdinir concentrations 4 hours after administration of single 300 and 600 mg doses were < 0.12 (< 0.12 to 0.46) and 0.21 (< 0.12 to 2.0) mcg/g. Mean sinus tissue concentrations were 16% (±20) of corresponding plasma concentrations.

Lung Tissue

In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa Cefdinir concentrations 4 hours after administration of single 300 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.

Middle Ear Fluid

In 14 pediatric patients with acute bacterial otitis media, respective median middle ear fluid Cefdinir concentrations 3 hours after administration of single 7 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.

CSF

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

Metabolism and Excretion

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 (t1/2) of 1.7 (±0.6) hours. In healthy subjects with normal renal function, renal clearance is 2.0 (±1.0) mL/min/kg, and apparent oral clearance is 11.6 (±6.0) and 15.5 (±5.4) mL/min/kg following doses of 300 and 600 mg, respectively. Mean percent of dose recovered unchanged in the urine following 300 and 600 mg doses is 18.4% (±6.4) and 11.6% (±4.6), respectively. Cefdinir clearance is reduced in patients with renal dysfunction (see Special Populations: Patients with Renal Insufficiency).

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 (CLcr). 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 CLcr between 30 and 60 mL/min, Cmax and t1/2 increased by approximately 2-fold and AUC by approximately 3-fold. In subjects with CLcr< 30 mL/min, Cmax increased by approximately 2-fold, t1/2 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).

Hemodialysis

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 t1/2 from 16 (±3.5) to 3.2 (±1.2) hours. Dosage adjustment is recommended in this patient population (see DOSAGE AND ADMINISTRATION).

Hepatic Disease

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.

Geriatric Patients

The effect of age on Cefdinir pharmacokinetics after a single 300 mg dose was evaluated in 32 subjects 19 to 91 years of age. Systemic exposure to Cefdinir was substantially increased in older subjects (N=16), Cmax 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 t1/2 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).

Gender and Race

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

Microbiology

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.

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.

Aerobic Gram-Positive Microorganisms

Staphylococcus aureus (including β-lactamase producing strains)

NOTE: Cefdinir is inactive against methicillin-resistant staphylococci.

Streptococcus pneumoniae (penicillin-susceptible strains only)

Streptococcus pyogenes

Aerobic Gram-Negative Microorganisms

Haemophilus influenzae (including β-lactamase producing strains)

Haemophilus parainfluenzae (including β-lactamase producing strains)

Moraxella catarrhalis (including β-lactamase producing strains)

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.

Aerobic Gram-Positive Microorganisms

Staphylococcus epidermidis (methicillin-susceptible strains only)

Streptococcus agalactiae

Viridans group streptococci

NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.

Aerobic Gram-Negative Microorganisms

Citrobacter diversus

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.

Susceptibility Tests

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method(1) (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of Cefdinir powder. The MIC values should be interpreted according to the following criteria:

For organisms other than Haemophilus spp. and Streptococcus spp:

MIC (mcg/mL)	Interpretation
≤ 1	Susceptible (S)
2	Intermediate (I)
≥ 4	Resistant (R)

For Haemophilus spp:*

* These interpretive standards are applicable only to broth microdilution susceptibility tests with Haemophilus spp. using Haemophilus Test Medium (HTM).(1) † The current absence of data on resistant strains precludes defining any results other than “Susceptible.” Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
MIC (mcg/mL)	Interpretation†
≤ 1	Susceptible (S)

For Streptococcus spp:

Streptococcus pneumoniae that are susceptible to penicillin (MIC ≤ 0.06 mcg/mL), or streptococci other than S. pneumoniae that are susceptible to penicillin (MIC ≤ 0.12 mcg/mL), can be considered susceptible to Cefdinir. Testing of Cefdinir against penicillin-intermediate or penicillin-resistant isolates is not recommended. Reliable interpretive criteria for Cefdinir are not available.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures. Standard Cefdinir powder should provide the following MIC values:

* This quality control range is applicable only to H. influenzae ATCC 49766 tested by a broth microdilution procedure using HTM.
Microorganism	MIC Range (mcg/mL)
Escherichia coli ATCC 25922	0.12-0.5
Haemophilus influenzae ATCC 49766*	0.12-0.5
Staphylococcus aureus ATCC 29213	0.12-0.5

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure(2) requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5 mcg Cefdinir to test the susceptibility of microorganisms to Cefdinir.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5 mcg Cefdinir disk should be interpreted according to the following criteria:

For organisms other than Haemophilus spp. and Streptococcus spp:*

* Because certain strains of Citrobacter, Providencia, and Enterobacter spp. have been reported to give false susceptible results with the Cefdinir disk, strains of these genera should not be tested and reported with this disk.
Zone Diameter (mm)	Interpretation
≥ 20	Susceptible (S)
17-19	Intermediate (I)
≤ 16	Resistant (R)

For Haemophilus spp:*

* These zone diameter standards are applicable only to tests with Haemophilus spp. using HTM.(2) † The current absence of data on resistant strains precludes defining any results other than “Susceptible.” Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
Zone Diameter (mm)	Interpretation†
≥ 20	Susceptible (S)

For Streptococcus spp:

Isolates of Streptococcus pneumoniae should be tested against a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes ≥ 20 mm are susceptible to penicillin and can be considered susceptible to Cefdinir. Streptococci other than S. pneumoniae should be tested with a 10-unit penicillin disk. Isolates with penicillin zone sizes ≥ 28 mm are susceptible to penicillin and can be considered susceptible to Cefdinir.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures. For the diffusion technique, the 5 mcg Cefdinir disk should provide the following zone diameters in these laboratory quality control strains:

* This quality control range is applicable only to testing of H. influenzae ATCC 49766 using HTM.
Organism	Zone Diameter (mm)
Escherichia coli ATCC 25922	24-28
Haemophilus influenzae ATCC 49766*	24-31
Staphylococcus aureus ATCC 25923	25-32

Indications and Usage for Cefdinir

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.

Adults and Adolescents

Community-Acquired Pneumonia

caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains) (see CLINICAL STUDIES).

Acute Exacerbations of Chronic Bronchitis

caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

Acute Maxillary Sinusitis

caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

NOTE: For information on use in pediatric patients, see Pediatric Use and DOSAGE AND ADMINISTRATION.

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes (see CLINICAL STUDIES).

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections

caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

Pediatric Patients

Acute Bacterial Otitis Media

caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains).

Pharyngitis/Tonsillitis

caused by Streptococcus pyogenes (see CLINICAL STUDIES).

NOTE: Cefdinir is effective in the eradication of S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.

Uncomplicated Skin and Skin Structure Infections

caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

Contraindications

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

Warnings

BEFORE THERAPY WITH Cefdinir IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Cefdinir, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF Cefdinir IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG β-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Cefdinir OCCURS, THE DRUG SHOULD BE DISCONTINUED. 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Precautions

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 2.86 g of sucrose per teaspoon.

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

Teratogenic Effects

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).

Adverse Reactions

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). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to Cefdinir. 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.

In the 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)*

* 977 males, 806 females † 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†	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†	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

Nurofen 200mg Liquicaps Pharmacy Only / Nurofen Express 200mg Liquid Capsules

1. Name Of The Medicinal Product

Nurofen 200mg Liquicaps Pharmacy Only

Nurofen Express 200mg Liquid Capsules

2. Qualitative And Quantitative Composition

Each capsule, soft contains Ibuprofen 200 mg.

Potassium hydroxide

Sorbitol

For a full list of excipients see 6.1

3. Pharmaceutical Form

Capsule, soft.

A clear red oval soft gelatin capsule printed with an identifying logo in white .

4. Clinical Particulars

4.1 Therapeutic Indications

Adults and children over 12 years:

Nurofen 200mg Liquicaps Pharmacy Only are indicated for the symptomatic relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness colds and influenza symptoms

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Take one or two capsules, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 capsules in any 24 hour period.

4.3 Contraindications

Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).

Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs. (See Section 4.4)

Patients with severe hepatic failure, severe renal failure or severe heart failure. See also Section 4.4

Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors – increased risk of adverse reactions (see section 4.5)”

During the last trimester of pregnancy as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6).

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory:

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

Other NSAIDs:

The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5)

SLE and mixed connective tissue disease:

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8).

Renal:

Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)

Hepatic:

Hepatic dysfunction (see Sections 4.3 and 4.8)

Cardiovascular and cerebrovascular effects:

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.

Impaired female fertility:

There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal:

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complaicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

The label will include:

Read the enclosed leaflet before taking this product

Do not take if you:

• have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding

• are allergic to ibuprofen, to any of the ingredients, or to aspirin or other painkillers

• are taking other NSAID pain killers or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

• Are a smoker

• Are pregnant

This medicine contains 14 mg of potassium per dose. To be taken into consideration by patients on a controlled potassium diet.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Contains 50.5 mg of sorbitol per dose, a source of 12.6 mg of fructose per dose.

If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen (like other NSAIDs) should be avoided in combination with:

• Aspirin: unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions (see Section 4.4).

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

• Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4)

Ibuprofen should be used with caution in combination with:

• Corticosteroids: as these may increase the risk of gastrointestinal ulceration or bleeding (see Section 4.4)

• Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

• Anticoagulants. NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section 4.4).

• Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).

• Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

• Lithium. There is evidence for potential increase in plasma levels of lithium.

• Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate.

• Ciclosporin: Increased risk of nephrotoxicity.

• Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

• Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

• Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

• Quinolone antibiotics:Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen 200 mg Liquicaps Pharmacy Only should, if possible, be avoided during the first 6 months of pregnancy.

During the 3^rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. (See section 4.3 Contraindications).

In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended dose and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported and these may consist of

a. non-specific allergic reactions and anaphylaxis

b. respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea

c. various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Gastrointestinal Disorders	Uncommon:	abdominal pain, dyspepsia and nausea.
	Rare:	diarrhoea, flatulence, constipation and vomiting
	Very rare:	Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis gastritis. Exacerbation of ulcerative colitis and Crohn's disease (See section 4.4) (see section 4.4)
Nervous System	Uncommon: Very rare	Headache Aseptic meningitis – single cases have been reported very rarely
Kidney	Very rare:	Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in long-term use, and increased serum urea concentrations have been reported.
Liver	Very rare:	Liver disorders, especially in long-term treatment.
Blood	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Skin	Uncommon Very rare:	Various skin rashes Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Immune System	Very rare:	In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4)
Hypersensitivity Reactions	Uncommon:	Hypersensitivity reactions with urticaria and pruritus.
	Very rare	severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm.

Cardiovascular and Cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.

Symptoms – Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management –

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: M01A E01 Propionic acid derivative.

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

Clinical evidence demonstrates that when 400mg of ibuprofen is taken the pain relieving effects can last for up to 8 hours.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no relevant effect is considered to be likely for occasional ibuprofen use.

5.2 Pharmacokinetic Properties

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.

Nurofen 200 mg Liquicaps Pharmacy Only consist of ibuprofen 200 mg dissolved in a hydrophilic solvent inside a gelatin shell. On ingestion, the gelatin shell disintegrates in the gastric juice releasing the solubilised ibuprofen immediately for absorption. The median peak plasma concentration is achieved approximately 30 minutes after administration.

The median peak plasma concentration for Nurofen tablets is achieved approximately 1-2 hours after administration.

Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.

Elimination half-life is approximately 2 hours.

No significant differences in pharmacokinetic profile are observed in the elderly.

5.3 Preclinical Safety Data

No relevant information, additional to that contained elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 600

Potassium hydroxide 50% solution (E525)

Gelatin

Sorbitol Liquid, Partially Dehydrated (E420)

Purified Water

Ponceau 4R (E124)

Lecithin (E322)

Triglycerides , medium chain

Ethanol

White ink*

The ink contains the following residual materials after application: Titanium Dioxide (E171), Polyvinyl Acetate Phthalate, Macrogol 400, Ammonium hydroxide (E527), Propylene Glycol.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Blisters formed from

Opaque Duplex PVC/PVdC 250µm/60gsm heat sealed to 20µm aluminium foil

or

opaque Tristar (Triplex) PVC/PE/PVdC 250µm/25µm/90gsm heat sealed to 20µm aluminium foil

packed into cartons

Each carton may contain 10, 12, 16, 18, 20, 24, 28, 30, 32, 36, 48, 96 in blister strips

Not all packs will be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 4AQ

8. Marketing Authorisation Number(S)

PL 00063/0654

9. Date Of First Authorisation/Renewal Of The Authorisation

24/05/2011

10. Date Of Revision Of The Text

24/05/2011

velaglucerase alfa Intravenous

vel-a-GLOO-ser-ase AL-fa

Commonly used brand name(s)

In the U.S.

• VPRIV

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Enzyme

Uses For velaglucerase alfa

Velaglucerase alfa injection is used to treat type 1 Gaucher's disease. This disease is caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if the enzyme is not present. Velaglucerase alfa replaces the missing enzyme to help the body process fats.

velaglucerase alfa is available only with your doctor's prescription.

Before Using velaglucerase alfa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For velaglucerase alfa, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to velaglucerase alfa or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of velaglucerase alfa injection in children 4 to 17 years of age. However, safety and efficacy have not been established in children younger than 4 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of velaglucerase alfa injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of velaglucerase alfa

A nurse or other trained health professional will give you or your child velaglucerase alfa in a hospital or clinic. velaglucerase alfa is given through a needle placed in one of your veins.

You or your child may also receive medicines to help prevent unwanted effects from the injection.

Precautions While Using velaglucerase alfa

It is very important that your doctor check the progress of you or your child at regular visits to make sure that velaglucerase alfa is working properly. Blood tests may be needed to check for unwanted effects.

If you or your child develop a skin rash, hives, or any allergic reaction to velaglucerase alfa, check with your doctor as soon as possible.

velaglucerase alfa may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a cough, difficulty with swallowing, dizziness, fast heartbeat, headaches, wheezing, trouble with breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, nausea, unusual tiredness or weakness, or lightheadedness or faintness while you are receiving velaglucerase alfa.

velaglucerase alfa Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Body aches or pain


• cough


• difficulty with breathing


• dizziness


• ear congestion


• facial swelling


• fever or chills


• headache


• loss of voice


• nasal congestion


• nausea or vomiting


• runny nose


• shortness of breath


• skin rash


• sneezing


• sore throat


• unusual tiredness or weakness

Less common

• Blurred vision


• bone pain


• confusion


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fast, pounding, or irregular heartbeat or pulse


• nervousness


• pain, itching, burning, swelling, or a lump under your skin where the needle is placed


• pounding in the ears


• slow or fast heartbeat


• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• back pain


• joint pain


• lack or loss of strength

Less common

• Feeling of warmth


• hives or welts


• itching


• redness of the skin


• redness of the face, neck, arms, and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: velaglucerase alfa Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More velaglucerase alfa Intravenous resources

• Velaglucerase alfa Intravenous Side Effects (in more detail)
• Velaglucerase alfa Intravenous Use in Pregnancy & Breastfeeding
• Velaglucerase alfa Intravenous Support Group
• 0 Reviews for Velaglucerase alfa Intravenous - Add your own review/rating

Compare velaglucerase alfa Intravenous with other medications

• Gaucher Disease

Infed

Pronunciation: EYE-urn DEX-tran
Generic Name: Iron Dextran
Brand Name: Examples include Dexferrum and Infed

Infed may cause serious and possibly fatal allergic reactions. Patients who have had an allergic reaction to another medicine or to several other medicines may have a greater risk of allergic reaction to Infed. Tell your doctor if you have ever had an allergic reaction to another medicine.

Only use Infed if oral iron therapy is not adequate or possible. Infed should be administered under close medical supervision where emergency treatment for a severe allergic reaction is available, if it should occur.

Infed is used for:

Treating iron deficiency in patients for whom oral iron therapy is not appropriate.

Infed is elemental iron as an injection. It works by replenishing body iron stores in patients with iron deficiency.

Do NOT use Infed if:

• you are allergic to any ingredient in Infed


• you have high levels of iron


• you have anemia not caused by a lack of iron


• you currently have a kidney infection


• the patient is a child younger than 4 months old

Contact your doctor or health care provider right away if any of these apply to you.

Before using Infed:

Some medical conditions may interact with Infed. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of allergies, blood problems, liver problems, heart problems, rheumatoid arthritis, or you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Infed. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Angiotensin-converting enzymes (ACE) inhibitors (eg, captopril) because they may increase the risk of Infed's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Infed may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Infed:

Use Infed as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Infed is usually administered as an injection at your doctor's office or clinic. Ask your doctor or pharmacist any questions you may have about Infed.


• Do not use Infed if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Infed, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Infed.

Important safety information:

• Infed may cause dizziness, lightheadedness, or fainting. To help prevent this, sit up or stand slowly. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Infed.


• Infed may interfere with certain lab tests, including blood bilirubin and blood calcium levels. Be sure your doctor and lab personnel know you are using Infed.


• Lab tests, such as hemoglobin, hematocrit, blood iron levels, total iron binding capacity (TIBC) levels, or percent saturation of transferrin levels, will be performed while you use Infed. These tests will be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Infed is should not be used in CHILDREN younger than 4 months old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Infed can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Infed while you are pregnant. Infed is found in breast milk. If you are or will be breast-feeding while you use Infed, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Infed:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cramps/leg cramps; diarrhea; dizziness; fatigue; headache; lightheadedness; mild swelling or pain at the injection site; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); backache; chest pain; chills; fainting; fever; seizures; severe dizziness; severe muscle pain; severe stomach pain; severe swelling or pain at the injection site; shortness of breath or wheezing; skin flushing; slow, fast, or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Infed side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal skin sensations; chest pain; dizziness; fainting; headache; joint aches; nausea; stomach or muscle pain; swelling, especially of the feet and ankles; vomiting.

Proper storage of Infed:

Infed is usually handled and stored by a health care provider. If you are using Infed at home, store Infed as directed by your pharmacist or health care provider. Keep Infed out of the reach of children and away from pets.

General information:

• If you have any questions about Infed, please talk with your doctor, pharmacist, or other health care provider.


• Infed is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Infed. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Infed resources

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• Infed Use in Pregnancy & Breastfeeding
• Infed Drug Interactions
• Infed Support Group
• 0 Reviews for Infed - Add your own review/rating

• Infed Prescribing Information (FDA)


• Infed Concise Consumer Information (Cerner Multum)


• Iron Dextran Monograph (AHFS DI)


• Iron Dextran Professional Patient Advice (Wolters Kluwer)

Compare Infed with other medications

• Anemia Associated with Chronic Renal Failure
• Iron Deficiency Anemia