Cefadroxil 500 mg Capsule, 100-count — NDC 68180-180-01 (Billing 68180-0180-01)
This is a package of 100 capsules of Cefadroxil 500 mg Capsule from Lupin Pharmaceuticals, Inc., marketed since Apr 2008 and currently FDA-listed; retail pharmacies pay about $0.2690 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048262
- GCN: 45341
- GPI-14 (Medi-Span): 02100010000105
- HICL (First Databank): 022796
- AHFS class code: 08:12.06.04
- RxCUI (RxNorm): 309049
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cephalosporin Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- It is an antibiotic for bacterial infections of the urinary tract, the skin, and the throat or tonsils (strep). It will not help colds, flu or other viral illnesses. Your prescribe...
- You can take it with or without food. If it upsets your stomach, taking it with a meal may help. Follow the directions on your pharmacy label for how often to take it.
- Take it for the full course your prescriber gave you. For strep throat or tonsillitis, treatment is at least 10 days. Stopping early can let the infection come back.
- Tell your prescriber first. Some people with a penicillin allergy also react to cephalosporins like cefadroxil, up to about 10% in those with a history of penicillin allergy. If yo...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cefadroxil — tap one for details:
Cefadroxil may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.269 | $26.90 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.6608 | $66.08 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.4938 | $49.38 / 100 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68180-0180-01 You're viewing this Main listing | 100 CAPSULE in 1 BOTTLE | $0.2690 / ea | $26.90 | 2008-04-23 | — | Active |
| 68180-0180-08 68180-180-08 | 50 CAPSULE in 1 BOTTLE | $0.2690 / ea | $13.45 | 2008-04-23 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2690 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 91% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 68180-0180-08?
What NDC number is used to bill for this package of Cefadroxil 500 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cefadroxil 500 mg 00093-3196-01 | Teva | 100 capsules | $0.269 | AB | Availability likely | — |
| Cefadroxil 500 mg 16714-0388-01 | NorthStar | 50 capsules | $0.269 | AB | Availability likely | — |
| Cefadroxil 500 mg 57237-0096-01 | Rising | 100 capsules | $0.269 | AB | Availability likely | — |
| Cefadroxil 500 mg 65862-0085-01 | Aurobindo | 100 capsules | $0.269 | AB | Availability likely | — |
| Cefadroxil 500 mgthis 68180-0180-01 | Lupin | 100 capsules | $0.269 | AB | Availability likely | — |
| Cefadroxil 500 mg 43063-0553-10 | PD-Rx | 10 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 43063-0595-20 | PD-Rx | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 50090-6050-00 | A-S | 10 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 63187-0883-06 | Proficient | 6 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 63629-7987-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 63629-7988-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 63629-8253-01 | Bryant | 14 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 63629-9456-01 | Bryant | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 67296-0491-01 | Redpharm | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 67296-1727-01 | RedPharm | 14 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 67296-2199-01 | Redpharm | 14 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 67296-2221-02 | Redpharm | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68071-3597-06 | NuCare | 6 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68071-4515-01 | NuCare | 10 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68071-4690-06 | NuCare | 6 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68071-4938-01 | NuCare | 10 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68071-5234-06 | NuCare | 6 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68788-8261-02 | Preferred | 50 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 68788-8479-02 | Preferred | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 70518-3580-00 | REMEDYREPACK | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 72189-0103-06 | DIRECT | 6 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 72189-0445-06 | Direct_Rx | 6 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 72189-0506-20 | Direct_Rx | 20 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 80425-0198-01 | Advanced | 10 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 80425-0400-01 | Advanced | 10 capsules | — | AB | FDA listed | — |
| Cefadroxil 500 mg 80425-0432-01 | Advanced | 10 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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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.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 767IP0Y5NH
A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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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.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cefadroxil Capsules USP 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 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 capsules and other antibacterial drugs, cefadroxil capsules 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 ▾
DOSAGE AND ADMINISTRATION Cefadroxil capsules 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 monohydrate 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 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 Clearance Dosage Interval 0-10 mL/min 36 hours 10-25 mL/min 24 hours 25-50 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 ▾
CONTRAINDICATIONS Cefadroxil monohydrate is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
⚠️ Warnings ▾
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.
🤒 Adverse Reactions ▾
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.
🧒 Pediatric Use ▾
Pediatric Use (See DOSAGE AND ADMINISTRATION .)
🧓 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.
🆘 Overdosage ▾
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 6–8 hour hemodialysis session.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Cefadroxil monohydrate 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 monohydrate 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 monohydrate.
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 tests: Diffusion techniques The use of antibiotic disk susceptibility test methods which measure zone diameter give an accurate estimation of antibiotic susceptibility.
One such standard procedure 1 which has been recommended for use with disks to test susceptibility of organisms to cefadroxil uses the cephalosporin class (cephalothin) disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefadroxil. Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 mcg cephalothin disk should be interpreted according to the following criteria: Zone diameter ( mm ) Interpretation ≥ 18 (S) Susceptible 15-17 (I) Intermediate ≤ 14 (R) Resistant A report of "Susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels.
A report of "Intermediate susceptible" suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of "Resistant'' indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected. Standardized procedures require the use of laboratory control organisms.
The 30 mcg cephalothin disk should give the following zone diameters: Organism Zone Diameter ( mm ) Staphylococcus aureus ATCC 25923 29–37 Escherichia coli ATCC 25922 17–22 Dilution Techniques When using the NCCLS agar dilution or broth dilution (including microdilution) method 2 or equivalent, a bacterial isolate may be considered susceptible if the MIC (minimum inhibitory concentration) value for cephalothin is 8 mcg/mL or less. Organisms are considered resistant if the MIC is 32 mcg/mL or greater. Organisms with an MIC value of less than 32 mcg/mL but greater than 8 mcg/mL are intermediate.
As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard cephalothin powder should give MIC values in the range of 0.12 mcg/mL and 0.5 mcg/mL for Staphylococcus aureus ATCC 29213. For Escherichia coli ATCC 25922, the MIC range should be between 4 mcg/mL and 16 mcg/mL.
For Streptococcus faecalis ATCC 29212, the MIC range should be between 8 and 3… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Cefadroxil Capsules USP, 500 mg are size '0' capsules with maroon cap and white body, imprinted with "LU" (in black edible ink) on cap and with "F11" (in black edible ink) on body, containing white to off-white powder supplied as follows: NDC 68180-180-08 Bottle of 50 NDC 68180-180-01 Bottle of 100 Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature].
📋 Description ▾
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-[6α,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: Each capsule contains cefadroxil monohydrate USP equivalent to 500 mg of cefadroxil.
In addition, each capsule also contains the following inactive ingredients: crospovidone, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No.
40, ferric oxide black, gelatin, magnesium stearate, microcrystalline cellulose, potassium hydroxide, propylene glycol, shellac and titanium dioxide. Molecular Structure
💬 Information for Patients ▾
Information for Patients Patients should be counseled that antibacterial drugs including cefadroxil capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefadroxil capsules 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 capsules 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.
⚠️ Precautions ▾
PRECAUTIONS General Cefadroxil monohydrate should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 M 2 ). (See DOSAGE AND ADMINISTRATION .) In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy. Prescribing cefadroxil monohydrate 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.
Prolonged use of cefadroxil monohydrate may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Cefadroxil monohydrate should be prescribed with caution in individuals with history of gastrointestinal disease particularly colitis. Information for Patients Patients should be counseled that antibacterial drugs including cefadroxil capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When cefadroxil capsules 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 capsules 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. 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. Carcinogenesis, Mutagenesis and Impairment of Fertility No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.
Pregnancy: 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.
Labor and Delivery Cefadroxil monohydrate has not been studied for use during labor and delivery. Treatment should only be given if clearly needed. Nursing Mothers Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.
Pediatric Use (See DOSAGE AND ADMINISTRATION .) 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 the… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.
📚 References ▾
REFERENCES National Committee for Clinical Laboratory Standards, Approved Standard, Performance Standards for Antimicrobial Disk Susceptibility Test , 4th Edition, Vol. 10 (7): M2-A4, Villanova, PA, April, 1990. National Committee for Clinical Laboratory Standards, Approved Standard: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically , 2nd Edition, Vol. 10 (8): M7-A2, Villanova, PA, April, 1990.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cefadroxil Capsules USP, 500 mg Rx Only Package Label – Bottle of 100s NDC 68180-180-01 Cefadroxil Capsules USP, 500 mg-100s Pack