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Cefadroxil 1000 mg Tablet, 50-count — NDC 00093-4059-53 package photo

Cefadroxil 1000 mg Tablet, 50-count

by Teva Pharmaceuticals USA, Inc. · 50 TABLET in 1 BOTTLE (0093-4059-53)
NDC 00093-4059-53
🏷️ FDA NDC (as labeled) 0093-4059-53 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0093-4059-53
Product NDC 0093-4059
11-digit billing NDC 00093405953
NCPDP billing unit EA — each (per item)
RxCUI 309047
UNII 280111G160
Application # ANDA062774
SPL Set ID 4674a05c-fdef-4737-a4b8-e3229bdada9d
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-01-31
Route ORAL
Dosage form TABLET
Substance CEFADROXIL
GPI-14 02100010000305
GPI class Cefadroxil
GCN Seq No 048266
GCN 45345
HICL code 022796
Ingredient (HICL) Cefadroxil
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1W
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 1St Generation
AHFS code 08:12.06.04
AHFS class 1St Generation Cephalosporin Antibiotics
FDB label name CEFADROXIL 1 GM TABLET
FDB brand name Cefadroxil
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0093-4059-53 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00093-4059-53. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) First-generation cephalosporins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.
Application holderTEVA PHARMACEUTICALS USA
FDA applicationANDA062774 (ANDA)
Labeler code00093
First marketedJan 2007
Product typeHuman Prescription Drug
Portfolio504 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CEFADROXIL 1 GM TABLET Ingredient Cefadroxil
📖 What it is MedlinePlus · NLM

Cefadroxil is used to treat certain infections caused by bacteria. Cefadroxil is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as cefadroxil will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Cefadroxil is used to treat three main types of bacterial infections: urinary tract infections (UTIs), skin and skin structure infections, and strep throat or tonsillitis caused by...
  • What kind of infections does cefadroxil actually treat?
  • You can take it with or without food — it's absorbed fine either way. That said, if you notice any nausea or stomach upset, taking it with a meal or snack can help settle things do...
  • This is really important to flag with your doctor before you start. Cefadroxil and penicillin belong to related antibiotic families, and up to about 1 in 10 people with a penicilli...
📖 Read our full Cefadroxil guide →
7
Nutrient depletion considerations

Cefadroxil may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeOval
Imprint9;3;4059
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $3.375 $168.76 / 50 tablets
Medicaid paysCMS SDUD · 12 mo $4.74 $237.18 / 50 tablets
Medicare drug plans payPart D · Q2 2026 $5.84 $291.92 / 50 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 Apr 2026 Aug 2026 $4.194 $3.315
▲ Up 2% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cefadroxil 1000 mgthis 00093-4059-53 Teva 50 tablets $3.375 Availability likely
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Jan 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00093-4059-53, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.6K
Units reimbursed last 4 qtrs
69.5K
Gross reimbursed last 4 qtrs
$329.7K
Avg / prescription
$91.04
Avg / unit
$4.7435
Latest quarter Q4 2025
915Rx
Medicaid pays / ea
$4.7435
gross reimbursed
vs
NADAC / ea
$3.3751
acquisition cost
=
Spread
+$1.3684
+41% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
70% FFS 30% MCO
Fee-for-service · 2,552 Rx Managed care · 1,070 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,231 units · 88.2 per 100k residents ME Washington: 1,831 units · 23.4 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 30,507 units · 156 per 100k residents NY Vermont: no data reported VT New Hampshire: 335 units · 23.9 per 100k residents NH Oregon: 1,562 units · 36.9 per 100k residents OR Nevada: 218 units · 6.8 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 3,590 units · 28.6 per 100k residents IL Indiana: 3,379 units · 49.2 per 100k residents IN Ohio: 4,018 units · 34.1 per 100k residents OH Pennsylvania: 213 units · 1.6 per 100k residents PA New Jersey: 2,677 units · 28.8 per 100k residents NJ Massachusetts: no data reported MA California: 7,072 units · 18.1 per 100k residents CA Utah: no data reported UT Colorado: 2,569 units · 43.7 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: 3,123 units · 176 per 100k residents WV Virginia: no data reported VA Maryland: 2,976 units · 48.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,626 units · 21.9 per 100k residents AZ New Mexico: 1,442 units · 68.2 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 278 units · 2.5 per 100k residents GA D.C.: 500 units · 73.6 per 100k residents DC Hawaii: no data reported HI Texas: 366 units · 1.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.2176
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 176 /100k
2 New York 156 /100k
3 Maine 88.2 /100k
4 D.C. 73.6 /100k
5 New Mexico 68.2 /100k
6 Indiana 49.2 /100k
7 Maryland 48.2 /100k
8 Colorado 43.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cefadroxil — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cefadroxil. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.21M
Claims incl. refills
149.5K
Beneficiaries
130.4K
Spend / beneficiary
$16.92
Spend / claim
$14.76
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00093-4059-53 You're viewing this 50 TABLET in 1 BOTTLE (0093-4059-53) 2007-01-31 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 209 words

INDICATIONS AND USAGE Cefadroxil tablets are 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 is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil 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 tablets and other antibacterial drugs, cefadroxil tablets 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.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION Cefadroxil tablets are 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 tablets should be administered for at least 10 days. 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 tablets 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.

Contraindications 16 words

CONTRAINDICATIONS Cefadroxil tablets are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

⚠️ Warnings ~1 min read

WARNINGS BEFORE THERAPY WITH CEFADROXIL 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 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, 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.

🤒 Adverse Reactions 219 words

ADVERSE REACTIONS Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS ). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred.

Hypersensitivity Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported.

Other Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported. In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.

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.

🔄 Drug / Laboratory Test Interactions 62 words

Drug/Laboratory Test Interactions Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs’ testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs’ test may be due to the drug.

🤰 Pregnancy 75 words

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.

🧒 Pediatric Use 7 words

Pediatric Use (See DOSAGE AND ADMINISTRATION .)

🧓 Geriatric Use 194 words

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 1,000 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.

🆘 Overdosage 76 words

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.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Cefadroxil is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 mcg/mL, respectively. Measurable levels were present 12 hours after administration.

Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 mcg/mL during the period following a single 500 mg oral dose. Increases in dosage generally produce a proportionate increase in cefadroxil urinary concentration.

The urine antibiotic concentration, following a 1 g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours. Microbiology In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both in vitro and in clinical infections (see INDICATIONS AND USAGE ): Beta-hemolytic streptococci Staphylococci , including penicillinase-producing strains Streptococcus (Diplococcus) pneumoniae Escherichia coli Proteus mirabilis Klebsiella species Moraxella (Branhamella) catarrhalis Note: Most strains of Enterococcus faecalis (formerly Streptococcus faecalis ) and Enterococcus faecium (formerly Streptococcus faecium ) are resistant to cefadroxil.

It is not active against most strains of Enterobacter species, Morganella morganii (formerly Proteus morganii ), and P. vulgaris. It has no activity against Pseudomonas species and Acinetobacter calcoaceticus (formerly Mima and Herellea species). Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 92 words

HOW SUPPLIED Cefadroxil tablets USP, 1,000 mg are available as white to off-white, oval-shaped, scored tablets, debossed “93” on one side (with a bisect cut between the 9 and 3) and “4059” on the other side, containing cefadroxil monohydrate equivalent to 1,000 mg of cefadroxil, packaged in bottles of 50 tablets (NDC 0093-4059-53). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Use child-resistant closure (as required). Keep this and all medications out of the reach of children.

📋 Description 93 words

DESCRIPTION Cefadroxil, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to off-white crystalline powder. It is soluble in water and it is acid-stable.

It is chemically designated as (6 R ,7 R )-7-[( R )-2-amino-2-( p -hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. It has the following structural formula: C 16 H 17 N 3 O 5 S•H 2 O M.W. 381.40 Cefadroxil tablets, USP are available in a 1,000 mg strength and contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

Cefadroxil chemical structure

💬 Information for Patients 176 words

Information for Patients Patients should be counseled that antibacterial drugs including cefadroxil tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefadroxil tablets are 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 tablets 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.