What is Cefaclor?
Cefaclor is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.
Cefaclor is used to treat many different types of infections caused by bacteria.
Cefaclor may also be used for other purposes not listed in this medication guide.
Cefaclor indications
Cefaclor (Cefaclor) is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes
Note: (β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to Cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus pyogenes
Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to Cefaclor despite apparent in vitro susceptibility of some BLNAR strains.
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor (Cefaclor) is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cefaclor (Cefaclor) in the subsequent prevention of rheumatic fever are not available at present.
Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to Cefaclor.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor (Cefaclor) and other antibacterial drugs, Cefaclor (Cefaclor) 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.
How should I use Cefaclor?
Use Cefaclor extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Cefaclor extended-release tablets by mouth with meals or within 1 hour of eating.
- Swallow Cefaclor extended-release tablets whole. Do not break, crush, or chew before swallowing.
- To clear up your infection completely, use Cefaclor extended-release tablets for the full course of treatment. Keep using it even if you feel better in a few days.
- Cefaclor extended-release tablets works best if it is taken at the same time each day.
- Do not take an antacid that has aluminum or magnesium in it within 2 hours before or after you take Cefaclor extended-release tablets.
- If you miss a dose of Cefaclor extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Cefaclor extended-release tablets.
Uses of Cefaclor in details
Cefaclor is used to treat respiratory tract infections such as inflammation of tonsils (tonsillitis), nasopharynx (area of the upper throat that lies behind the nose), throat (pharyngitis) or air passages (bronchitis), lung (pneumonia); sinus infection (sinusitis), urinary tract infections such as urinary bladder infection (cystitis) or kidney infection (pyelonephritis); skin and soft tissue infections, and middle ear infections (otitis media).
Cefaclor description
Each 5 mL of suspension contains Cefaclor monohydrate equivalent to anhydrous Cefaclor 125 mg.
Cefaclor also contains sodium benzoate 0.03 g as preservative.
Cefaclor dosage
Cefaclor (Cefaclor) is administered orally.
Adults - The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled.
Pediatric patients - The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day.
| Cefaclor Suspension 20 mg/kg/day | ||
| Weight | 125 mo/5 mL | 250 mg/5 mL |
| 9 kg | 1/2 tsp t.i.d. | |
| 18 kg | 1 tsp t.i.d. | 1/2 tsp t.i.d. |
| 40 mg/kg/day | ||
| 9 kg | 1 tsp t.i.d. | 1/2 tsp t.i.d. |
| 18 kg | 1 tsp t.i.d. |
B.I.D. Treatment Option - For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.
| Cefaclor (Cefaclor) Suspension 20 mg/kg/day (Pharyngitis) | ||
| Weight | 187 ms/5 mL | 375 ms/5 mL |
| 9 kg | 1/2 tsp b.i.d. | |
| 18 kg | 1 tsp b.i.d. | 1/2 tsp b.i.d. |
| 40 mg/kg/day (Otitis Media) | ||
| 9 kg | 1 tsp b.i.d. | 1/2 tsp b.i.d. |
| 18 kg | 1 tsp b.i.d. |
Cefaclor (Cefaclor) may be administered in the presence of impaired renal function. Under such a condition, the dosage usually is unchanged.
In the treatment of p-hemolytic streptococcal infections, a therapeutic dosage of Cefaclor (Cefaclor) should be administered for at least 10 days.
How supplied
Pulvules:
250 mg, purple and white (No. 3061) - (RxPak* of 15)
NDC 0002-3061-15; (100s)
NDC 0002-3061-02; (ID After mixing, store in a refrigerator. Shake well before using. Keep tightly closed. The mixture may be kept for 14 days without significant loss of potency. Discard unused portion after 14 days.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Literature revised March 28, 2003. Manufactured by: Eli Lilly Italia, S.p. A. Sesto Florentino (Firenze), Italy for Eli Lilly and Company Indianapolis, IN 46285, USA. FDA Rev date: 3/17/2004
Cefaclor interactions
See also:
What other drugs will affect Cefaclor?
Patients receiving Cefaclor may show a false-positive reaction for glucose in the urine with tests that use Benedict's and Fehling's solutions and also with Clinitest tablets but not with Tes-Tape (Glucose enzymatic test strip, USP, Lilly).
There have been rare reports of increased anticoagulant effect when Cefaclor and oral anticoagulants were administered concomitantly.
As with other β-lactam antibiotics, the renal excretion of Cefaclor is inhibited by probenecid.
Cefaclor side effects
See also:
What are the possible side effects of Cefaclor?
Clinical Trials
There were 3272 patients treated with multiple doses of Cefaclor extended-release tablets in controlled clinical trials and an additional 211 subjects in pharmacology studies. There were no deaths in these trials thought to be related to toxicity from Cefaclor extended-release tablets. Treatment was discontinued in 1.7% of patients due to adverse events thought to be possibly or probably drug-related.
The following adverse clinical and laboratory events were reported during the Cefaclor extended-release tablets clinical trials conducted in North America at doses of 375 mg or 500 mg BID; however, relatedness of the adverse events to the drug was not assigned by clinical investigators during the trials.
Adverse reactions occurring during the clinical trials with Cefaclor extended-release tablets with an incidence of less than 1% but greater than 0.1% included the following (listed alphabetically):
Accidental injury, anorexia, anxiety, arthralgia, asthma, bronchitis, chest pain, chills, congestive heart failure, conjunctivitis, constipation, dizziness, dysmenorrhea, dyspepsia, dysuria, ear pain, edema, fever, flatulence, flu syndrome, gastritis, infection, insomnia, leukorrhea, lung disorder, maculopapular rash, malaise, menstrual disorder, myalgia, nausea and vomiting, neck pain, nervousness, nocturia, otitis media, pain, palpitation, peripheral edema, rash, respiratory disorder, sinusitis, somnolence, surgical procedure, sweating, tremor, urticaria, vomiting.
NOTE: One case of serum-sickness-like reaction was reported among the 3272 adult patients treated with Cefaclor extended-release tablets during the controlled clinical trials. These reactions have also been reported with the use of Cefaclor in other oral formulations and are seen more frequently in pediatric patients than in adults. These reactions are characterized by findings of erythema multiforme, rash, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes and no evidence to date of sequelae of the reaction. While further investigation is ongoing, serum-sickness-like reactions appear to be due to hypersensitivity and more often occur during or following a second (or subsequent) course of therapy with Cefaclor. Such reactions have been reported with overall occurrence ranging from 1 in 200 (0.5%) in one focused trial; to 2 in 8346 (0.024%) in overall clinical trials (with an incidence in pediatric patients in clinical trials of 0.055%); to 1 in 38,000 (0.003%) in spontaneous event reports. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy. Occasionally these reactions have resulted in hospitalization, usually of short duration (median hospitalization = 2 to 3 days, based on postmarketing surveillance studies). In those patients requiring hospitalization, the symptoms have ranged from mild to severe at the time of admission with more of the severe reactions occurring in pediatric patients.
In Postmarketing Experience
In addition to the events reported during clinical trials with Cefaclor extended-release tablets, the following adverse experiences are among those that have been reported during worldwide postmarketing surveillance: allergic reaction, anaphylactoid reaction, angioedema, face edema, hypotension, Stevens-Johnson syndrome, syncope, paresthesia, vasodilatation and vertigo.
Other Adverse Reactions Associated With Other Formulations of Cefaclor
In addition to the above, the following other adverse reactions and altered laboratory tests have been associated with Cefaclor in other oral formulations:
Clinical
Severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis, have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, edema (including face and limbs), paresthesias, syncope, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy. Rarely, hypersensitivity symptoms may persist for several months.
Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment.
Laboratory
Abnormal urinalysis, eosinophilia, leukopenia, neutropenia, transient elevations in AST, and transient thrombocytopenia have been reported.
Cephalosporin-Class Reactions
In addition to the adverse reactions listed above, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Clinical
Confusion, erythema multiforme, genital pruritus, hepatic dysfunction including cholestasis, hemolytic anemia, reversible hyperactivity, hypertonia, and reversible interstitial nephritis.
Laboratory
Positive direct Coombs’ test.
Cefaclor contraindications
See also:
What is the most important information I should know about Cefaclor?
Cefaclor extended-release tablets are contraindicated in patients with known hypersensitivity to Cefaclor and other cephalosporins.
Active ingredient matches for Cefaclor:
Cefaclor
| Unit description / dosage (Manufacturer) | Price, USD |
| Capsule; Oral; Cefaclor 250 mg | |
| Capsule; Oral; Cefaclor 500 mg | |
| Suspension; Oral; Cefaclor 125 mg / 5 ml | |
| Suspension; Oral; Cefaclor 250 mg / 5 ml | |
| Tablet; Oral; Cefaclor 250 mg | |
| Tablet; Oral; Cefaclor 500 mg | |
| Tablet, Extended Release; Oral; Cefaclor 375 mg | |
| Tablet, Extended Release; Oral; Cefaclor 500 mg | |
| Capsule; Oral; Cefaclor Monohydrate 250 mg | |
| Tablet, Film-Coated; Oral; Cefaclor 500 mg | |
| Capsule; Oral; Cefaclor | |
| Tablet, Effervescent; Oral; Cefaclor 1000 mg | |
| Tablet, Effervescent; Oral; Cefaclor 250 mg | |
| Tablet, Effervescent; Oral; Cefaclor 500 mg | |
| Suspension; Oral; Cefaclor 375 mg / 5 ml | |
| Ceclor 15 500 mg capsule Bottle | $ 70.00 |
| Ceclor 375 mg/5ml Suspension 100ml Bottle | $ 59.99 |
| Ceclor 250 mg/5ml Suspension 150ml Bottle | $ 58.98 |
| Cefaclor 250 mg/5ml Suspension 150ml Bottle | $ 53.87 |
| Cefaclor 375 mg/5ml Suspension 100ml Bottle | $ 53.87 |
| Ceclor 15 250 mg capsule Bottle | $ 38.00 |
| Ceclor 125 mg/5ml Suspension 150ml Bottle | $ 34.99 |
| Ceclor 187 mg/5ml Suspension 100ml Bottle | $ 34.99 |
| Ceclor 250 mg/5ml Suspension 75ml Bottle | $ 31.99 |
| Cefaclor 125 mg/5ml Suspension 150ml Bottle | $ 29.41 |
| Cefaclor 250 mg/5ml Suspension 75ml Bottle | $ 29.37 |
| Cefaclor 187 mg/5ml Suspension 100ml Bottle | $ 29.26 |
| Cefaclor 375 mg/5ml Suspension 50ml Bottle | $ 27.44 |
| Cefaclor 187 mg/5ml Suspension 50ml Bottle | $ 14.92 |
| Cefaclor 125 mg/5ml Suspension 75ml Bottle | $ 14.70 |
| Ceclor 500 mg pulvule | $ 5.69 |
| Cefaclor 500 mg capsule | $ 4.05 |
| Cefaclor CR 500 mg 12 Hour tablet | $ 3.79 |
| Ceclor 250 mg pulvule | $ 3.28 |
| Raniclor 375 mg chewable tablet | $ 2.98 |
| Cefaclor 250 mg capsule | $ 2.07 |
| Raniclor 250 mg chewable tablet | $ 1.99 |
| Cefaclor / Kingdom 250 mg x 500's | |
| Cefaclor / Kingdom 500 mg x 500's | |
| Cefaclor / Chin Teng 250 mg x 1000's | |
| Cefaclor / CCPC 250 mg x 1000's | |
| Cefaclor / CCPC 25 mg/1 mL x 1.5 g | |
| Cefaclor / Root 250 mg x 1000's | |
| Cefaclor suspension 125 mg (Mm Therapeutics Inc (Canada)) | |
| Cefaclor suspension 250 mg (Mm Therapeutics Inc (Canada)) | |
| Cefaclor capsule 250 mg (Mm Therapeutics Inc (Canada)) | |
| Cefaclor suspension 375 mg (Mm Therapeutics Inc (Canada)) | |
| Cefaclor capsule 500 mg (Mm Therapeutics Inc (Canada)) | |
| Cefaclor suspension 250 mg/5mL (PACK Pharmaceuticals, LLC (US)) | |
| Cefaclor capsule 250 mg/1 (bryant ranch prepack (US)) | |
| Cefaclor tablet, film coated, extended release 500 mg/1 (Teva Pharmaceuticals USA Inc (US)) | |
| Cefaclor capsule 500 mg/1 (A S Medication Solutions (US)) | |
| Cefaclor suspension 375 mg/5mL (PACK Pharmaceuticals, LLC (US)) | |
| Cefaclor suspension 125 mg/5mL (Carlsbad Technology, Inc. (US)) | |
| Cefaclor suspension 187 mg/5mL (Carlsbad Technology, Inc. (US)) | |
List of Cefaclor substitutes (brand and generic names): | |
| Cefaclin (Vietnam) | |
| Cefaclin 250 mg x 10 Blister x 10 Tablet | |
| Cefaclor - 1 A Pharma (Germany) | |
| Cefaclor - Fuda Pharm (China) | |
| Cefaclor 10% (Japan) | |
| Cefaclor 10% Nichi-iko (Japan) | |
| Cefaclor 20% (Japan) | |
| Cefaclor 20% Nichi-iko (Japan) | |
| Cefaclor 375 | |
| Cefaclor 500 | |
| Cefaclor ABC (Italy) | |
| Cefaclor acis (Germany) | |
| Cefaclor acis 1000mg (Germany) | |
| Cefaclor acis 125mg (Germany) | |
| Cefaclor acis 250mg (Germany) | |
| Cefaclor acis 500mg (Germany) | |
| Cefaclor Ahngook (South Korea) | |
| Cefaclor AL (Bulgaria, Germany) | |
| Cefaclor Alkaloid (Bosnia & Herzegowina, Bulgaria) | |
| Cefaclor Alkaloid 125mg (Bulgaria) | |
| Cefaclor Alkaloid 250mg (Bulgaria) | |
| Cefaclor Alkaloid 500mg (Bulgaria) | |
| Cefaclor Arena (Romania) | |
| Cefaclor Aristo (Germany) | |
| Cefaclor Arlico (South Korea) | |
| Cefaclor Asia (South Korea) | |
| Cefaclor Aurobindo (Brazil) | |
| Cefaclor Basics (Germany) | |
| Cefaclor beta (Germany) | |
| Cefaclor Beta T | |
| Tablet, Film-Coated; Oral; Cefaclor 500 mg | |
| Cefaclor Bexal (Spain) | |
| Cefaclor Bidiphar (Vietnam) | |
| Cefaclor Bidiphar 250 mg x 1 Blister x 10 Tablet | |
| Cefaclor Bidiphar 500 mg x 1 Blister x 10 Tablet | |
| Cefaclor Bidiphar 125 mg x 20 Packs x 3 g | |
| Cefaclor Brause | |
| Tablet, Effervescent; Oral; Cefaclor 1000 mg | |
| Tablet, Effervescent; Oral; Cefaclor 500 mg | |
| Cefaclor Capsules | |
| Cefaclor Capsules capsule 250 mg (Ivax Pharmaceuticals Incorporated (Canada)) | |
| Cefaclor Capsules capsule 500 mg (Ivax Pharmaceuticals Incorporated (Canada)) | |
| Cefaclor CCPC (Taiwan) | |
| Cefaclor Choongwae (South Korea) | |
| Cefaclor CKD (South Korea) | |
| Cefaclor Daewoo (South Korea) | |
| Cefaclor Daewoo 250 mg x 10 Tablet | |
| Cefaclor Daewoong (South Korea) | |
See 1229 substitutes for Cefaclor | |
References
- DailyMed. "CEFACLOR: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "cefaclor". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "cefaclor". http://www.drugbank.ca/drugs/DB00833 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Cefaclor are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Cefaclor. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yet2 consumers reported age
| Users | % | ||
|---|---|---|---|
| < 1 | 2 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
