Cefditoren Pivoxil Tablets 200mg
Each film coated tablet contains:
Cefditoren Pivoxil Eqv. to Cefditoren……... 200 mg
Excipients…………………………………...……. q.s.
Colours: Iron Oxide USP-NF (Red) & Titanium Dioxide IP
Dosage form – Film coated Tablets
Strength: Tablets 200 mg
Cefditoren pivoxil tablet is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.
| Type of Infection | Dosage | Duration (Days) |
|---|---|---|
| Community-Acquired Pneumonia | 400 mg BID | 14 |
| Acute Bacterial Exacerbation of Chronic Bronchitis | 400 mg BID | 10 |
| Pharyngitis/Tonsillitis | 200mg BID | 10 |
| Uncomplicated Skin and Skin Structure Infections | 200mg BID | 10 |
BID-two times daily
It is recommended to take dose with the meal.
Patients with Renal Insufficiency
No dose adjustment is necessary for patients with mild renal impairment (CLcr: 50-80 mL/min/1.73 m2). It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (CLcr: 30-49 mL/min/1.73 m2) and 200 mg QD be administered to patients with severe renal impairment (CLcr: <30 mL/min/1.73 m2). The appropriate dose in patients with end-stage renal disease has not been determined.
Patients with Hepatic Disease
No dose adjustments are necessary for patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).
Zortorin Tablet is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components.
Zortorin Tablet is contraindicated in patients with carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency, because use of Zortorin Tablet causes renal excretion of carnitine.
Warnings
Before therapy with cefditoren pivoxil is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefditoren pivoxil, other cephalosporins, penicillins, or other drugs. If cefditoren pivoxil is to be given to penicillin- sensitive patients, caution should be exercised because cross- hypersensitivity 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 cefditoren pivoxil occurs, the drug should be discontinued. 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.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefditoren pivoxil, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile (C. difficile) is a primary cause of antibiotic-associated colitis.
After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Precautions
Prescribing Zortorin tablets 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.
Zortorin tablets are not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months. No clinical effects of carnitine decrease have been associated with short-term treatment. The effects on carnitine concentrations of repeat short-term courses of Cefditoren pivoxil are not known.
With other antibiotics prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. It should be taken with meals to enhance absorption. It may be taken concomitantly with oral contraceptives. It is not recommended when taken concomitantly with antacids or other drugs taken to reduce stomach acids.
As with other antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. In clinical trials, there was no difference between cefditoren and comparator cephalosporins in the incidence of increased prothrombin time.
Oral Contraceptives
Multiple doses of cefditoren pivoxil had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.
Antacids
Co-administration of a single dose of an antacid which contained both magnesium (800 mg) and aluminum (900 mg) hydroxides reduced the oral absorption of a single 400 mg dose of cefditoren pivoxil administered following a meal, as evidenced by a 14% decrease in mean Cmax and an 11% decrease in mean AUC. Although the clinical significance is not known, it is not recommended that cefditoren pivoxil be taken concomitantly with antacids.
H2-Receptor Antagonists
Co-administration of a single dose of intravenously administered famotidine (20 mg) reduced the oral absorption of a single 400 mg dose of cefditoren pivoxil administered following a meal, as evidenced by a 27% decrease in mean Cmax and a 22% decrease in mean AUC. Although the clinical significance is not known, it is not recommended that cefditoren pivoxil be taken concomitantly with H2 receptor antagonists.
Probenecid
As with other ß-lactam antibiotics, co-administration of probenecid with cefditoren pivoxil resulted in an increase in the plasma exposure of cefditoren, with a 49% increase in mean Cmax, a 122% increase in mean AUC, and a 53% increase in t1/2.
Drug/Laboratory Test Interactions
Cephalosporins are known to occasionally induce a positive direct Coombs' test. A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution or with CLINITEST® tablets), but not with enzyme-based tests for glycosuria (e.g., CLINISTIX®, TES-TAPE®). As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefditoren pivoxil.
Pregnancy
Pregnancy Category B
Cefditoren pivoxil was not teratogenic up to the highest doses tested in rats and rabbits. In rats, this dose was 1000 mg/kg/day, which is approximately 24 times a human dose of 200 mg BID based on mg/m2/day. In rabbits, the highest dose tested was 90 mg/kg/day, which is approximately four times a human dose of 200 mg BID based on mg/m2/day. This dose produced severe maternal toxicity and resulted in fetal toxicity and abortions.
In a postnatal development study in rats, cefditoren pivoxil produced no adverse effects on postnatal survival, physical and behavioral development, learning abilities, and reproductive capability at sexual maturity when tested at doses of up to 750 mg/kg/day, the highest dose tested. This is approximately 18 times a human dose of 200 mg BID based on mg/m2/day.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation
Cefditoren was detected in the breast milk of lactating rats. Because many drugs are excreted in human breast milk, caution should be exercised when cefditoren pivoxil is administered to nursing women.
Geriatric use:
No clinically significant differences in effectiveness or safety were observed between older and younger patients. No dose adjustments are necessary in geriatric patients with normal (for their age) renal function.
No studies on the effect on the ability to drive and use machines have been performed. Zortorin tablet is not expected to have any effect on the ability to drive and use machines.
In clinical trials, 4834 adult and adolescent patients have been treated with the recommended doses of cefditoren pivoxil tablets (200 mg or 400 mg BID). Most adverse events were mild and self-limiting. No deaths or permanent disabilities have been attributed to cefditoren.
Treatment-Related Adverse Events in Trials in Adults and Adolescent Patients ≥ 12 Years of age
Incidence > 1%
| Name | Cefditoren 200mg | Cefditoren 400mg | Comparators* |
|---|---|---|---|
| Diarrhea | 11% | 15% | 8% |
| Nausea | 4% | 6% | 5% |
| Headache | 3% | 2% | 2% |
| Abdominal Pain | 2% | 2% | 1% |
| Vaginal Moniliasis | 3%c | 6%c | 6%d |
| Dyspepsia | 1% | 2% | 2% |
| Vomiting | 1% | 1% | 2% |
*includes amoxicillin/clavulanate, cefadroxil monohydrate, cefuroxime axetil, cefpodoxime proxetil, clarithromycin, and penicillin
The overall incidence of adverse events, and in particular diarrhea, increased with the higher recommended dose of cefditoren.
Treatment related adverse events experienced by <1% but >0.1% of patients who received 200 mg or 400 mg BID of cefditoren pivoxil were abnormal dreams, allergic reaction, anorexia, asthenia, asthma, coagulation time increased, constipation, dizziness, dry mouth, eructation, face edema, fever, flatulence, fungal infection, gastrointestinal disorder, hyperglycemia, increased appetite, insomnia, leukopenia, leukorrhea, liver function test abnormal, myalgia, nervousness, oral moniliasis, pain, peripheral edema, pharyngitis, pseudomembranous colitis, pruritus, rash, rhinitis, sinusitis, somnolence, stomatitis, sweating, taste perversion, thirst, thrombocythemia, urticaria, and vaginitis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment.
Sixty-one of 2675 (2%) patients who received 200 mg BID and 69 of 2159 (3%) patients who received 400 mg BID of cefditoren pivoxil discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with cefditoren therapy. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea. Diarrhea was the reason for discontinuation in 19 of 2675 (0.7%) patients who received 200 mg BID and in 31 of 2159 (1.4%) patients who received 400 mg BID of cefditoren pivoxil.
Changes in laboratory parameters of possible clinical significance, without regard to drug relationship and which occurred in ≥1% of patients who received cefditoren pivoxil 200 mg or 400 mg BID, were hematuria (3.0% and 3.1%), increased urine white blood cells (2.3% and 2.3%), decreased hematocrit (2.1% and 2.2%), and increased glucose (1.8% and 1.1%). Those events which occurred in <1% but >0.1% of patients included the following: increased/decreased white blood cells, increased eosinophils, decreased neutrophils, increased lymphocytes, increased platelet count, decreased hemoglobin, decreased sodium, increased potassium, decreased chloride, decreased inorganic phosphorus, decreased calcium, increased SGPT/ALT, increased SGOT/AST, increased cholesterol, decreased albumin, proteinuria, and increased BUN. It is not known if these abnormalities were caused by the drug or the underlying condition being treated.
Cephalosporin Class Adverse Reactions
In addition to the adverse reactions listed above which have been observed in patients treated with cefditoren pivoxil, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:
Adverse Reactions: Allergic reactions, anaphylaxis, drug fever, Stevens-Johnson syndrome, serum sickness-like reaction, erythema multiforme, toxic epidermal necrolysis, colitis, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and superinfection.
Altered Laboratory Tests: Prolonged prothrombin time, positive direct Coombs' test, false-positive test for urinary glucose, elevated alkaline phosphatase, elevated bilirubin, elevated LDH, increased creatinine, pancytopenia, neutropenia, and agranulocytosis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Postmarketing Experience
The following adverse experiences, regardless of their relationship to cefditoren pivoxil, have been reported during extensive postmarketing experience, beginning with approval in Japan in 1994: pneumonia interstitial, eosinophilic pneumonia acute, acute renal failure, arthralgia, thrombocytopenia, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
Information on cefditoren pivoxil overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of cefditoren from the body, particularly if renal function is compromised (30% reduction of plasma concentrations following 4 hours of hemodialysis). Treat overdosage symptomatically and institute supportive measures as required.
In acute animal toxicity studies, cefditoren pivoxil when tested at the limit oral doses of 5100 mg/kg in rats and up to 2000 mg/kg in dogs did not exhibit any health effects of concern. Certain effects, such as diarrhea and soft stool lasting for a few days were observed in some animals as expected with most oral antibiotics due to inhibition of intestinal microflora.
Cefditoren is a bactericidal cephalosporin antibiotic that exerts its antimicrobial effect by inhibiting bacterial cell wall synthesis. This action is mediated through its strong affinity for penicillin binding proteins (PBPs), leading to disruption of peptidoglycan cross linking and subsequent bacterial cell lysis. Cefditoren demonstrates high binding affinity for PBPs in a wide range of susceptible bacterial species.
Antibacterial Activity
Cefditoren pivoxil is an orally administered prodrug that is hydrolyzed to its active form, cefditoren, during absorption in the intestinal wall. Cefditoren exhibits broad spectrum antibacterial activity in vitro against both Gram positive and Gram-negative organisms. It demonstrates particularly strong activity against Gram positive bacteria, including Staphylococcus spp., Streptococcus spp., and Streptococcus pneumoniae. Among Gram negative pathogens, cefditoren is active against Escherichia coli, Moraxella (Branhamella) catarrhalis, Klebsiella spp., Proteus spp., and Haemophilus influenzae. In addition, cefditoren shows activity against anaerobic bacteria such as Peptostreptococcus spp., Propionibacterium acnes, Bacteroides spp., and Prevotella spp. Notably, cefditoren is active against β lactamase–non producing ampicillin resistant (BLNAR) H. influenzae and is stable in vitro against β lactamase–producing strains.
Absorption & Bioavailability
Cefditoren pivoxil is an oral prodrug that is absorbed from the gastrointestinal tract and hydrolyzed to active cefditoren. Under fasting conditions, a single 200 mg dose produces a mean Cmax of ~1.8 µg/mL within 1.5–3 hours. Absolute bioavailability is approximately 14% when fasted and ~16% with a low fat meal. Exposure increases less than proportionally at doses ≥400 mg, and no accumulation occurs with twice daily dosing in subjects with normal renal function.
Food Effect
Food markedly enhances absorption. A high fat or moderate fat meal increases AUC by ~70% and Cmax by ~50% compared with fasting, supporting administration with food to optimize systemic exposure.
Distribution
Cefditoren has a small volume of distribution (Vss ~9.3 L) and is highly protein bound (~88%), mainly to albumin. Protein binding is concentration independent, reduced in hypoalbuminemia, and penetration into red blood cells is negligible.
Tissue Penetration
Cefditoren achieves measurable concentrations in skin blister fluid (AUC ~56% of plasma) and tonsil tissue (~12% of serum concentrations). Data on cerebrospinal fluid penetration are unavailable.
Metabolism & Excretion
Cefditoren is not significantly metabolized and is primarily eliminated unchanged in urine via glomerular filtration and tubular secretion. The mean elimination half life is ~1.6 hours in healthy adults. Renal clearance is reduced in renal impairment.
Hydrolysis of the prodrug releases pivalate, which is largely excreted as pivaloylcarnitine. Repeated dosing causes a reversible reduction in plasma carnitine levels, which return to normal within 7–10 days after discontinuation.
Special Populations
• Elderly: Increased exposure and prolonged half life due to reduced renal clearance; no dose adjustment needed with age appropriate renal function.
• Gender: Slightly higher exposure in females; no dose adjustment required.
• Renal Impairment: Exposure increases with declining renal function. Dose reduction is recommended for moderate and severe impairment.
• Hemodialysis: Approximately 30% of cefditoren is removed during dialysis; dosing recommendations are not established.
• Hepatic Impairment: Mild to moderate impairment has minimal effect; no dose adjustment required. Severe hepatic impairment has not been studied.
Microbiology
Cefditoren is a cephalosporin with antibacterial activity against gram-positive and gram-negative pathogens. The bactericidal activity of cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Cefditoren is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases. Cefditoren has been shown to be active against most strains of the following bacteria, both in vitro and in clinical infections, as described in the indications section.
Aerobic Gram-Positive Microorganisms
Staphylococcus aureus (methicillin-susceptible strains, including ß-lactamase-producing strains)
Note: Cefditoren is inactive against methicillin-resistant Staphylococcus aureus
Streptococcus pneumoniae (penicillin-susceptible strains only)
Streptococcus pyogenes
Aerobic Gram-Negative Microorganisms
Haemophilus influenzae (including ß-lactamase-producing strains)
Haemophilus parainfluenzae (including ß-lactamase-producing strains)
Moraxella catarrhalis (including ß-lactamase-producing strains)
The following in vitro data are available, but their clinical significance is unknown. Cefditoren exhibits in vitro minimum inhibitory concentrations (MICs) of ≤0.125 µg/mL against most (≥90%) strains of the following bacteria; however, the safety and effectiveness of cefditoren in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials.
Aerobic Gram-Positive Microorganisms
Streptococcus agalactiae
Streptococcus Groups C and G
Streptococcus, viridans group (penicillin-susceptible and -intermediate strains)
Not available
Zortorin tablets contain cefditoren pivoxil, a semi-synthetic cephalosporin antibiotic for oral administration. It is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active cefditoren.
Chemically, cefditoren pivoxil is (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-aminothiazol-4-yl)-2-methoxy-iminoacetamido]-3-[(Z)-2-(4-methylthiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
The empirical formula is C25H28N6O7S3 and the molecular weight is 620.73.
None.
Refer on pack.
10X10 Tablets
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
24th March 2026