DRUGS & SUPPLEMENTS
1 INDICATIONS & USAGE
Cefalen is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefalen and other antibacterial drugs, Cefalen 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
Cefalen is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes.
1.2 Otitis Media
Cefalen 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
Cefalen 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
Cefalen is indicated for the treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis.
1.5 Genitourinary Tract Infections
Cefalen 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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefalen and other antibacterial drugs, Cefalen 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
2.1 Adults and Pediatric Patients at Least 15 Years of Age
The usual dose of oral Cefalen 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 Cefalen 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 Cefalen 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 Cefalen 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)
Cefalen is contraindicated in patients with known hypersensitivity to Cefalen or other members of the cephalosporin class of antibacterial drugs.
Patients with known hypersensitivity to Cefalen or other members of the cephalosporin class of antibacterial drugs. ( 4)
5 WARNINGS AND PRECAUTIONS
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 Cefalen. Before therapy with Cefalen is instituted, inquire whether the patient has a history of hypersensitivity reactions to Cefalen, 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 Cefalen 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 Cefalen, 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 Cefalen. Acute intravascular hemolysis induced by Cefalen therapy has been reported. If anemia develops during or after Cefalen therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue Cefalen 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 Cefalen. 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 Cefalen 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 Cefalen 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:
The most common adverse reactions associated with Cefalen 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 Cefalen, 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
Administration of Cefalen 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 Cefalen and metformin [ see Clinical Pharmacology (12.2) ].
The renal excretion of Cefalen is inhibited by probenecid. Co-administration of probenecid with Cefalen 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
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 Cefalen 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
Cefalen is excreted in human milk. Caution should be exercised when Cefalen is administered to a nursing woman.
8.4 Pediatric Use
The safety and effectiveness of Cefalen 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 Cefalen, 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
Cefalen 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 .
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 Cefalen.
Cefalen 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. Cefalen has the molecular formula C 16 H 17 N 3O 4S-H 2Oand the molecular weight is 365.41.
Cefalen has the following structural formula:
Each capsule contains Cefalen monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of Cefalen. 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Cefalen is a cephalosporin antibacterial drug [seeMicrobiology ] .
Cefalen 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).
Cefalen is approximately 10% to 15% bound to plasma proteins.
Cefalen 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.
In healthy subjects given single 500 mg doses of Cefalen 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 Cefalen and metformin following multiple doses of either drug.
Mechanism of Action
Cefalen is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.
Methicillin-resistant staphylococci and most isolates of enterococci are resistant to Cefalen. Cefalen is not active against most isolates of Enterobacter spp., Morganella morganii, and Proteus vulgaris. Cefalen has no activity against Pseudomonas spp., or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.
Cefalen 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) ].
Staphylococcus aureus (methicillin-susceptible isolates only)
Streptococcus pneumoniae (penicillin-susceptible isolates)
Escheric h ia coli
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 Cefalen may be inferred by testing cefazolin2.
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.
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 Cefalen. Tests to determine the mutagenic potential of Cefalen 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 Cefalen. Tests to determine the mutagenic potential of Cefalen have not been performed. In male and female rats, fertility and reproductive performance were not affected by Cefalen oral doses up to 1.5 times the highest recommended human dose based upon body surface area.rformance were not affected by Cefalen oral doses up to 1.5 times the highest recommended human dose based upon mg/m2.
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
Cefalen 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
Alkem Laboratories ltd.
Mumbai - 400 013, India
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: July 2016
Cefalen pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Cefalen available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Cefalen destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Cefalen Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Cefalen pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Cefalen?
Depending on the reaction of the Cefalen after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cefalen 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.Is Cefalen addictive or habit forming?
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.
Reviewsdrugs.com conducted a study on Cefalen, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cefalen consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
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The information was verified by Dr. Arunabha Ray, MD Pharmacology