Ixime

Ixime

cefixime

Manufacturer:

Lupin

Distributor:

Multicare
Full Prescribing Info
Contents
Cefixime.
Description
Cefixime 100 mg Chewable Tablet (Ixime): Each chewable tablet contains Cefixime anhydrous equivalent to Cefixime 100 mg.
Action
Pharmacology: Pharmacodynamics: As with other cephalosporins, bactericidal action of cefixime results from inhibition of cell-wall synthesis. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. Cefixime has been shown to be active against most strains of the following organisms both in vitro and in clinical infections.
Gram-positive Organisms: Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative Organisms: Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are beta-lactamase positive), Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase- and non-penicillinase-producing strains).
Pharmacokinetics: Cefixime chewable tablets are bioequivalent to oral suspension.
Cefixime chewable tablets, given orally, is about 40%-50% absorbed whether administered with or without food; however time to maximal absorption is increased approximately 0.8 hours when administered with food. Cefixime chewable tablets produce average peak concentrations approximately 25%-50% higher than the tablets, when tested in normal adult volunteers. Two hundred mg dose of cefixime chewable tablets produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL), when tested in normal adult volunteers. The area under the time versus concentration after curve is greater by approximately 10%-25% with the cefixime chewable tablets than with the tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. This increased absorption should be taken into consideration if the cefixime chewable tablet is to be substituted for the tablet. Because of the lack of bioequivalence, tablets should not be substituted for cefixime chewable tablets in the treatment of otitis media. Cross-over studies of tablet versus chewable tablets have not been performed in children.
Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of chewable tablets.

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Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. Serum protein binding is concentration independent with a bound fraction of approximately 65%. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3-4 hours but may range up to 9 hours in some normal volunteers.
In subjects with half moderate impairment of renal function (20 to 40 mL/min creatinine clearance), the average serum half-life of cefixime is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis or peritoneal dialysis.
Indications/Uses
To reduce the development of drug resistant bacteria and maintain the effectiveness of Cefixime Chewable Tablets and other antibacterial drugs, Cefixime 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefixime is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms.
Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae (beta lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis, (most of which are beta-lactamase positive and S. pyogenes*.
Pharyngitis and Tonsillitis, caused by S. pyogenes.
Acute Bronchitis and Acute Exacerbations of Chronic Bronchitis, caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral), caused by Neisseria gonorrhoeae (penicillinase and non-penicillinase-producing strains).
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Dosage/Direction for Use
CEFIXIME CHEWABLE TABLETS SHOULD BE CHEWED BEFORE SWALLOWING.
Adults: The recommended dose is 400 mg daily.
Children: The recommended dose is 8 mg/kg/day of the cefixime. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours.
Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
In the treatment of infections due to S. pyogenes, a therapeutic dosage of Cefixime should be administered for at least 10 days.
Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Patients whose clearance is between 21 and 60 mL/min or patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval (i.e., 300 mg daily). Patients whose clearance is < 20 mL/min, or patients who are on continuous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval (i.e. 200 mg daily). Neither hemodialysis nor peritoneal dialysis remove significant amounts of drug from the body.
Overdosage
Gastric lavage may be indicated, otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of cefixime did not differ from the profile seen in patients treated at the recommended doses.
Contraindications
Cefixime is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Warnings
Before therapy with Cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product 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 Cefixime 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.
Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.
Special Precautions
Prescribing Cefixime Chewable Tablets in the absence of a proven or strongly suspected bacterial infection of a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The possibility of the emergence of resistant organisms which might result in overgrowth should be kept in mind, particularly during prolonged treatment. In such use, careful observation of the patient is essential. If super infection occurs during therapy, appropriate measures should be taken.
The dose of Cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully.
Cefixime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
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 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test. In rats, fertility and reproductive performance were not affected by cefixime at doses up to 125 time the adult therapeutic dose.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category B.
Reproduction studies have been performed in mice and rates at doses up to 400 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. 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.
Use in Lactation: It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
Adverse Reactions
Abdominal pain, nausea, dyspepsia, flatulence, hypersensitivity reactions, headaches, dizziness, seizures.
Drug Interactions
Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.
Storage
Store at temperatures below 25°C. Protect from light and moisture.
Shelf Life: 2 years.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Chewable tab 100 mg x 100's.
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