Celex

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Celex uses

• Indications & usage
• Dosage & administration
• Dosage forms & strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Overdosage
• Description
• Clinical pharmacology
• Nonclinical toxicology
• References
• How supplied/storage and handling
• Patient counseling information
• Celex reviews

1 INDICATIONS & USAGE

Celex is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:

• Respiratory tract infection
  

• Otitis media ( 1.2)
  

• Skin and skin structure infections ( 1.3)
  

• Bone infections ( 1. 4 )
  

• Genitourinary tract infections ( 1.5)
  

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Celex and other antibacterial drugs, Celex should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)

1.1 Respiratory Tract Infections

Celex is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes.

1.2 Otitis Media

Celex is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes, and Mo raxella catarrhalis.

1.3 Skin and Skin Structure Infections

Celex is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.

1.4 Bone Infections

Celex is indicated for the treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis.

1.5 Genitourinary Tract Infections

Celex is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escheric hia c oli, Proteus mirabilis, and Klebsiella pneumonia e.

1.6 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Celex and other antibacterial drugs, Celex should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.

2 DOSAGE & ADMINISTRATION

• Duration of therapy ranges from 7 to14 days depending on the infection type and severity. ( 2)
• Dosage adjustment is required in patients with severe and end stage renal disease (ESRD) defined as creatinine clearance below 30 mL/min. ( 2. 3 )
  

2.1 Adults and Pediatric Patients at Least 15 Years of Age

The usual dose of oral Celex capsule, USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.

For more severe infections larger doses of oral Celex capsules, USP may be needed, up to 4 grams daily in two to four equally divided doses.

2.2 Pediatric Patients

The recommended total daily doseof oral Celex capsules, USP for pediatric patients is 25 to 50 mg/kg givenin equally divided doses for 7 to 14 days. In the treatment of β-hemolyticstreptococcal infections, duration of at least 10 days is recommended. Insevere infections, a total daily dose of 50 to 100 mg/kg may be administered inequally divided doses.

For thetreatment of otitis media, the recommended daily dose is 75 to 100 mg/kg givenin equally divided doses.

2.3 Dosage Adjustments in Adult and Pediatric Patients at Least 15 Years of Age With Renal Impairment

Administer the following dosing regimens for Celex capsules, USP to patients with impaired renal function [see War nin gsand Precautions (5.4) and Use inSpecific Populations (8.6 ) ].

Table 1. Recommended Dose Regimen for Patients with Renal Impairment

*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

3 DOSAGE FORMS & STRENGTHS

250 mg capsules: a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink.

500 mg capsules: a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink.

333 mg capsules: a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink.

750 mg capsules: a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink.

Capsules: 250 m g, 333mg, 500 mg and 750 mg ( 3)

4 CONTRAINDICATIONS

Celex is contraindicated in patients with known hypersensitivity to Celex or other members of the cephalosporin class of antibacterial drugs.

Patients with known hypersensitivity to Celex or other members of the cephalosporin class of antibacterial drugs. ( 4)

5 WARNINGS AND PRECAUTIONS

• Serious hypersensitivity reactions: Prior to use, inquire regarding history of hypersensitivity to beta-lactam antibacterial drugs. Discontinue the drug if signs or symptoms of an allergic reaction occur and institute supportive measures. ( 5.1)
• Clostridium difficile-associated diarrhea (CDAD): Evaluate if diarrhea occurs. ( 5. 2)
  

• Direct Coomb’s Test Seroconversion: If anemia develops during or after Celex therapy, evaluate for drug-induced hemolytic anemia. ( 5. 3 )
  

• Seizure Potential: Use lower dose in patients with renal impairment. ( 5.4)
  

5.1 Hypersensitivity Reactions

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens- Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of Celex. Before therapy with Celex is instituted, inquire whether the patient has a history of hypersensitivity reactions to Celex, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.

If an allergic reaction to Celex occurs, discontinue the drug and institute appropriate treatment.

5.2 Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Celex, 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.

5.3 Direct Coombs’ Test Seroconversion

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including Celex. Acute intravascular hemolysis induced by Celex therapy has been reported. If anemia develops during or after Celex therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue Celex and institute appropriate therapy.

5.4 Seizure Potential

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue Celex. Anticonvulsant therapy can be given if clinically indicated.

5.5 Prolonged Prothrombin Time

Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.

5.6 Development of Drug-Resistant Bacteria

Prescribing Celex in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Prolonged use of Celex 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.

6 ADVERSE REACTIONS

The following serious events are described in greater detail in the Warning and Precautions section:

• Hypersensitivity reactions [ see Warning and Precautions ]
• Clostridium difficile-associated diarrhea [ see Warnings and Precautions ( 5.2 ) ]
  

• Direct Coombs’ Test Seroconversion [ see Warnings and Precautions ( 5.3 ) ]
  

• Seizure Potential [ see Warnings and Precautions ( 5.4 ) ]
  

• Effect on Prothrombin Activity [ see Warnings and Precautions ( 5.5 ) ]
  

• Development of Drug-Resistant Bacteria [ see Warnings and Precautions ( 5.6 ) ]
  

The most common adverse reactions associated with Celex include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice

In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.

Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported.

In addition to the adverse reactions listed above that have been observed in patients treated with Celex, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs:

Other Adverse Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.

Altered Laboratory Tests:Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.

7 DRUG INTERACTIONS

• Metformin: increased metformin concentrations. Monitor for hypoglycemia.
• Probenecid- The renal excretion of Celex is inhibited by probenecid. Co-administration of probenecid with Celex is not recommended. ( 7.2)
  

• Administration of Celex may result in a false-positive reaction for glucose in the urine. ( 7.3)

7.1 Metformin

Administration of Celex with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin.

Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking Celex and metformin [ see Clinical Pharmacology (12.2) ].

7.2 Probenecid

The renal excretion of Celex is inhibited by probenecid. Co-administration of probenecid with Celex is not recommended.

7.3 Interaction With Laboratory or Diagnostic Testing

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

There are 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.

Reproduction studies have been performed on mice and rats using oral doses of Celex monohydrate 0.6 and 1.5 times the maximum daily human dose based upon body surface area basis, and have revealed no evidence of impaired fertility or harm to the fetus.

8.3 Nursing Mothers

Celex is excreted in human milk. Caution should be exercised when Celex is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of Celex in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see Dosage and Administration ] .

8.5 Geriatric Use

Of the 701 subjects in 3 published clinical studies of Celex, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [ see Warnings and Precautions ( 5.4 ) ].

8.6 Renal Impairment

Celex should be administered with caution in the presence of impaired renal function (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended .

10 OVERDOSAGE

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of Celex.

11 DESCRIPTION

Celex capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Celex has the molecular formula C ₁₆ H ₁₇ N ₃O ₄S-H ₂Oand the molecular weight is 365.41.

Celex has the following structural formula:

Each capsule contains Celex monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of Celex. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.

cephalexin-str

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Celex is a cephalosporin antibacterial drug [seeMicrobiology ] .

12.3 Pharmacokinetics

Absorption:

Celex is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL).

Distribution:

Celex is approximately 10% to 15% bound to plasma proteins.

Excretion:

Celex is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.

Drug Interactions

In healthy subjects given single 500 mg doses of Celex and metformin, plasma metformin mean Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of Celex and metformin following multiple doses of either drug.

12.4 Microbiology

Mechanism of Action

Celex is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.

Resistance

Methicillin-resistant staphylococci and most isolates of enterococci are resistant to Celex. Celex is not active against most isolates of Enterobacter spp., Morganella morganii, and Proteus vulgaris. Celex has no activity against Pseudomonas spp., or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.

Antimicrobial Activity

Celex has been shown to be active against most isolates of the following bacteria both in vitro and in clinical infections [ see Indications and Usage (1) ].

Gram-positive bacteria

Staphylococcus aureus (methicillin-susceptible isolates only)

Streptococcus pneumoniae (penicillin-susceptible isolates)

Streptococcus pyogenes

Gram-negative bacteria

Escheric h ia coli

Haemophilusinfl uenzae

Klebsiellapneumoniae

Moraxella catarrhalis

Proteusmi rabilis

Susceptibility Tests Methods

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.

In cases of uncomplicated urinary tract infection only, susceptibility of E. coli, K. pneumoniae, and P. mirabilis to Celex may be inferred by testing cefazolin2.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test methods (broth or agar)1,2.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method2,3.

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

Qualit y Co n t r ol

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test ^{1 ,2,3},.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of Celex. Tests to determine the mutagenic potential of Celex have not been performed. In male and female rats, fertility and reproductive peLifetime studies in animals have not been performed to evaluate the carcinogenic potential of Celex. Tests to determine the mutagenic potential of Celex have not been performed. In male and female rats, fertility and reproductive performance were not affected by Celex oral doses up to 1.5 times the highest recommended human dose based upon body surface area.rformance were not affected by Celex oral doses up to 1.5 times the highest recommended human dose based upon mg/m2.

15 REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobials Susceptibility Tests; Twenty-Fifth Informational Supplement. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

16 HOW SUPPLIED/STORAGE AND HANDLING

Celex capsules, USP, are supplied as follows:

The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows:

Bottles of 4, 6, 8, 9, 10, 14, 20, 21, 24, 28, 30, 40 and 56 capsules.

Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F).

17 PATIENT COUNSELING INFORMATION

• Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to Celex, other beta-lactams (including cephalosporins) or other allergens (5.1)
• Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider
  

• Counsel patients that antibacterial drugs including Celex, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Celex is prescribed to treat a bacterial infection, tell patients 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 Celex or other antibacterial drugs in the future.
  

Manufactured by:

Alkem Laboratories ltd.

Mumbai - 400 013, India

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: July 2016

PT 1199-08

Different Celex products with other ingredients:

• Celex (Cephradine)
• Celex (Clarithromycin)
• Celex (Clonixin Lysine)

Celex pharmaceutical active ingredients containing related brand and generic drugs:

• Cephalexin

Celex available forms, composition, doses:

• Capsules; Oral; Cephalexin 250 mg
• Capsules; Oral; Cephalexin 500 mg
• Syrup; Oral; Cephalexin 125 mg / 5 ml

Celex destination | category:

• Human:
• Cephalosporins first-generation

Celex Anatomical Therapeutic Chemical codes:

• J01DB01 - Cefalexin

Celex pharmaceutical companies:

• Millimed

References

1. Dailymed."CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."CEPHALEXIN: 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/dailym... (accessed August 28, 2018).
3. "cephalexin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Celex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Celex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology