Cefadroxil 100 MG/ML Oral Suspension
Generic Name: CEFADROXIL
Brand Name: Cefadroxil
- Substance Name(s):
- CEFADROXIL
WARNINGS
BEFORE THERAPY WITH CEFADROXIL MONOHYDRATE IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS.
IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-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 CEFADROXIL MONOHYDRATE OCCURS, DISCONTINUE THE DRUG.
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 cefadroxil monohydrate, 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.
OVERDOSAGE
A study of children under six years of age suggested that ingestion of less than 250 mg/ kg of cephalosporins is not associated with significant outcomes.
No action is required other than general support and observation.
For amounts greater than 250 mg/kg, induce gastric emptying.
In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6 to 8 hour hemodialysis session.
DESCRIPTION
Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic intended for oral administration.
It is a white to yellowish-white crystalline powder.
It is soluble in water and it is acid-stable.
It is chemically designated as 5-Thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino (4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate, [6R-[6 α (,7β (R*)]]-.
It has the formula C 16 H 17 N 3 O 5 S•H 2 O and the molecular weight of 381.40.
It has the following structural formula: Cefadroxil for oral suspension, USP contains cefadroxil monohydrate, USP.
After reconstitution, each 5 mL contains Cefadroxil monohydrate, USP equivalent to 250 mg or 500 mg of cefadroxil.
In addition, cefadroxil for oral suspension, USP contains the following inactive ingredients: FD&C Yellow No.
6, orange powder flavor, pineapple powder flavor, polysorbate 80, sodium benzoate, sugar (sucrose), and xanthan gum.
Cefadroxil for oral suspension, USP is off-white yellow powder, forming an orange colored suspension on constitution.
Chemical Structure
HOW SUPPLIED
Cefadroxil for oral suspension, USP is an off-white to yellow powder with orange and pineapple flavor, and is supplied as follows: 250 mg/5 mL 50 mL Bottle with child-resistant closure 100 mL Bottle with child-resistant closure 500 mg/5 mL 75 mL Bottle with child-resistant closure 100 mL Bottle with child-resistant closure Prior to reconstitution: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
After reconstitution: Store in refrigerator.
Shake well before using.
Keep container tightly closed.
Discard unused portion after 14 days.
Distributed By: West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724 USA.
Manufactured By: Jazeera Pharmaceutical Industries (JPI) AL-Kharj Road P.O Box 106229 Riyadh 11666 Saudi Arabia.
An Affiliate of: Hikma Pharmaceuticals P.O Box 182400 Amman 11118-Jordan Revised: October 2020
GERIATRIC USE
Geriatric Use Of approximately 650 patients who received cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older.
Of approximately 1000 patients who received cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over.
No overall differences in safety were observed between the elderly patients in these studies and younger patients.
Clinical studies of cefadroxil for the treatment of pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients.
Other reported clinical experience with cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment (see DOSAGE AND ADMINISTRATION: Renal Impairment ).
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
INDICATIONS AND USAGE
Cefadroxil for oral suspension is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E.
coli , P.
mirabilis , and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever.
Cefadroxil monohydrate is generally effective in the eradication of streptococci from the oropharynx.
However, data establishing the efficacy of cefadroxil monohydrate for the prophylaxis of subsequent rheumatic fever are not available.
Note: Culture and susceptibility tests should be initiated prior to and during therapy.
Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil for oral suspension and other antibacterial drugs, cefadroxil for oral suspension 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.
PEDIATRIC USE
Pediatric Use (See DOSAGE AND ADMINISTRATION ).
PREGNANCY
Pregnancy Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil monohydrate.
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.
NUSRING MOTHERS
Nursing Mothers Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.
INFORMATION FOR PATIENTS
Information for Patients Patients should be counseled that antibacterial drugs including cefadroxil for oral suspension should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold).
When cefadroxil for oral suspension 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 cefadroxil for oral suspension or other antibacterial drugs in the future.
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.
DOSAGE AND ADMINISTRATION
Cefadroxil for oral suspension is acid-stable and may be administered orally without regard to meals.
Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
Adults Urinary Tract Infections For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).
For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).
Skin and Skin Structure Infections For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).
Pharyngitis and Tonsillitis Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis— 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.
Children For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours.
For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours.
For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours.
In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil for oral suspension should be administered for at least 10 days.
See chart for total daily dosage for children.
DAILY DOSAGE OF CEFADROXIL FOR ORAL SUSPENSION Child’s Weight 250 mg/5 mL 500 mg/5 mL lbs kg 10 4.5 ½ tsp – 20 9.1 1 tsp – 30 13.6 1½ tsp – 40 18.2 2 tsp 1 tsp 50 22.7 2½ tsp 1¼ tsp 60 27.3 3 tsp 1½ tsp 70 & Above 31.8+ — 2 tsp Renal Impairment In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation.
The following schedule is suggested.
In adults, the initial dose is 1000 mg of cefadroxil monohydrate and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m 2 ]) is 500 mg at the time intervals listed below.
Creatinine Clearances Dosage Interval 0 to 10 mL/min 36 hours 10 to 25 mL/min 24 hours 25 to 50 mL/min 12 hours Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.
Reconstitution Directions for Oral Suspension Bottle Size Reconstitution Directions 100 mL Suspend in a total of 67 mL water.
Method: Tap bottle lightly to loosen powder.
Add 67 mL of water in two portions.
Shake well after each addition.
75 mL Suspend in a total of 51 mL water Method: Tap bottle lightly to loosen powder.
Add 51 mL of water in two portions.
Shake well after each addition.
50 mL Suspend in a total of 34 mL water Method: Tap bottle lightly to loosen powder.
Add 34 mL of water in two portions.
Shake well after each addition.
After reconstitution, store in refrigerator.
Shake well before using.
Keep container tightly closed.
Discard unused portion after 14 days.