Taxim-O/Taxim-O 400/Taxim-O Forte

Taxim-O/Taxim-O 400/Taxim-O Forte

cefixime

Manufacturer:

Alkem Lab

Distributor:

Getz Bros
Full Prescribing Info
Contents
Cefixime trihydrate.
Description
Taxim-O: Tablet: Each film coated tablet contains: Cefixime USP as Trihydrate equivalent to anhydrous Cefixime 200 mg.
Taxim-O 400: Each orodispersible tablet contains: Cefixime (as trihydrate) USP 400 mg.
Colour: FD & C Yellow No. 6.
CEFIXIME (TAXIM-O 400) 400 mg dispersible tablet is a semisynthetic, cephalosporin antibiotic for oral administration. Chemically, it is (6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0] oct-2-ene-2-carboxylic acid, 72-(Z)-[O-(carboxymethyl) oxime] trihydrate. Molecular weight = 507.50 as the trihydrate.
Chemical Formula is C16H15N5O7S2•3H2O.
Excipients/Inactive Ingredients: In addition the tablet contains the following inactive ingredients: maize starch, microcrystalline cellulose, purified talc, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, tulsion 339, aspartame, sunset yellow FCF.
Action
Taxim-O: Tablet: Pharmacology: Pharmacodynamics: Pharmacological effects/mode of action: Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. It is highly stable in the presence of beta-lactamase enzymes.
Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime.
Pharmacokinetics: The absolute oral bioavailability of Cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard to meals.
From in vitro studies, serum or urine concentrations of 1 mcg/mL or greater were considered to be adequate for most common pathogens against which cefixime is active. Typically, the peak serum levels following the recommended adult or paediatric doses are between 1.5 and 3 mcg/mL. Little or no accumulation of cefixime occurs following multiple dosing.
The pharmacokinetics of cefixime in healthy elderly (age >64 years) and young volunteers (11-35) compared the administration of 400 mg doses once daily for 5 days. Mean Cmax and AUC values were slightly greater in the elderly. Elderly patients may be given the same dose as the general population.
Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. Metabolites of cefixime have not been isolated from human serum or urine.
Serum protein binding is well characterised for human and animal sera; cefixime is almost exclusively bound to the albumin fraction, the mean free fraction being approximately 30%. Protein binding of Cefixime is only concentration dependent in human serum at very high concentrations which are not seen following clinical dosing.
Transfer of 14C-labelled Cefixime from lactating rats to their nursing offspring through breast milk was quantitatively small (approximately 1.5% of the mothers' body content of cefixime in the pup). No data are available on secretion of Cefixime in human breast milk. Placental transfer of Cefixime was small in pregnant rats dosed with labelled Cefixime.
Taxim-O 400: Pharmacology: Pharmacokinetics: CEFIXIME (TAXIM-O 400) dispersible tablets, given orally, are about 40%-50% absorbed from gastrointestinal tract whether administered with or without food; although the rate of absorption may be decreased in the presence of food. Absorption is fairly slow; peak plasma concentrations of 2 to 3 micrograms/mL and 3.7 to 4.6 micrograms/mL have been reported between 2 and 6 hours after single doses of 200 and 400 mg, respectively. About 65% of cefixime is bound to plasma proteins. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. Information on the distribution of cefixime in body tissues and fluids is limited. It crosses the placenta. Relatively high concentrations may be achieved in bile and urine. About 20% of an oral dose (or 50% of an absorbed dose) is excreted unchanged in the urine within 24 hours. Up to 60% may be eliminated by non-renal mechanisms; there is no evidence of metabolism but some is probably excreted into the faeces from bile. It is not substantially removed by dialysis.
Microbiology: Antimicrobial Action: 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-lactamase may be susceptible to cefixime. Cefixime has been shown to be active against many strains of the gram-positive and gram negative both in vitro and in clinical infections. It has a mode of action and spectrum of activity similar to those of the third generation cephalosporin cefotaxime, but some Enterobacteriaceae are less susceptible to cefixime. Haemophilus influenzae, Moraxella catarrhalis (Branhamella catarrhalis), and Neisseria gonorrhoeae are sensitive, including penicillinase-producing strains. Of the Gram positive bacteria, streptococci are sensitive to cefixime but most strains of Staphylococci, Enterococci, and Listeria spp. are not. Enterobacter spp., Pseudomonas aeruginosa, and Bacteroides spp. are resistant to cefixime.
Indications/Uses
Taxim-O: Tablet: Cefixime is used as an alternative treatment of urinary tract infections, otitis media, respiratory infections caused by susceptible organisms including penicillin-susceptible S. pneumoniae, S. pyogenes, H. influenzae, and Enterobacteriaceae with documented poor compliance or poor response to conventional oral antibiotics. It is used as an outpatient therapy of serious soft tissue or skeletal infection due to susceptible organisms and as a single dose oral treatment of uncomplicated cervical/urethral gonorrhea.
Taxim-O 400: To reduce the development of drug resistant bacteria and maintain the effectiveness 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 (TAXIM-O 400) dispersible tablets are 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.
Uncomplicated gonorrhea caused by N. gonorrhoeae. 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).
Dosage/Direction for Use
Taxim-O: Tablet: Absorption of Cefixime is not significantly modified by the presence of food. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
Adults and Children over 10 Years: The recommended adult dosage is 200-400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.
The Elderly: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.
Children weighing more than 50 kg or older than 10 years should be treated with the recommended adult dose (200-400 mg daily depending on the severity of infection).
The safety and efficacy of cefixime has not been established in children less than 6 months.
Dosage in Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 mL/min or greater. In patients whose creatinine clearance is less than 20 mL/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 mL/min.
Taxim-O 400: Adults: It is given orally 200 to 400 mg daily as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended.
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. Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
Renal Impairment: Cefixime tablets may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearance 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 (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 (200 mg daily).
Overdosage
Taxim-O: Tablet: There is no experience with overdoses with Cefixime.
Adverse reactions seen at dose levels up to 2 g Cefixime in normal subjects did not differ from the profile seen in patients treated at the recommended doses. Gastric lavage may be indicated in overdosage. No specific antidote exists. Cefixime is not removed from the circulation in significant quantities by dialysis.
Taxim-O 400: 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 effects 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
Taxim-O: Tablet: Cefixime is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.
Taxim-O 400: CEFIXIME (TAXIM-O 400) dispersible tablets are contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Anaphylactic/anaphylactoid reactions have been reported with the use of cefixime. Antibiotics, including cefixime, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to treatment with broad spectrum antibiotics, including cefixime tablets, alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of severe antibiotic-associated diarrhea including pseudomembranous colitis. Pseudomembranous colitis has been reported with the use of cefixime chewable tablets and other broad spectrum antibiotics; therefore, it is important to consider this diagnosis in patients who develop diarrhea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment and may range in severity from mild to life-threatening. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, management should include fluids, electrolytes, and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.
Warnings
Taxim-O 400: This product contains aspartame which may cause allergic type of reaction including anaphylactic symptoms and life threatening episodes in certain susceptible persons.
Special Precautions
Taxim-O: Tablet: Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporins should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins and patients who have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary.
Cefixime should be administered with caution in patients with markedly impaired renal function.
Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment.
Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.
Taxim-O 400: General: CEFIXIME (TAXIM-O 400) dispersible 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 superinfection 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 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.
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 times the adult therapeutic dose.
Use in Children: Safety and effectiveness of cefixime in children aged less than six months old have not been established.
Use In Pregnancy & Lactation
Taxim-O: Tablet: Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.
Taxim-O 400: Usage in Pregnancy: Reproduction studies have been performed in mice and rats 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.
Nursing Mothers: 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
Taxim-O: Tablet: Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.
Gastrointestinal Disturbances: The most frequent side effects seen with Cefixime are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarrhoea occurs. Other gastrointestinal side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has also been reported.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus, drug fever and arthralgia have been observed, including rare cases of urticaria or angioedema. These reactions usually subsided upon discontinuation of therapy. Rarely, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Haematological and Clinical Chemistry: Thrombocytosis, thrombocytopenia, leucopenia, hypereosinophilia, neutropenia and agranulocytosis have been reported. These reactions were infrequent and reversible. Mild transient changes in liver and renal function tests have been observed.
Hepatic Disorders: Transient rises in liver transaminases, alkaline phosphatase and jaundice can also occur.
Miscellaneous: Other possible reactions include genital pruritus and vaginitis.
Taxim-O 400: Most of adverse effects observed in clinical trials were of a mild and transient nature. Five percent (5%) of patients discontinued therapy because of drug-related adverse effects. The most commonly seen adverse effects were gastrointestinal events, which were reported in 30% of adult patients on either the BID or the QD regimen. Clinically mild gastrointestinal symptoms occurred in 20% of all patients, moderate events occurred in 9% of all patients and severe adverse effects occurred in 2% of all patients. Individual event rates included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. These symptoms usually responded to symptomatic therapy or ceased when cefixime was discontinued. Several patients developed severe diarrhea and/or documented pseudomembranous colitis, and a few required hospitalization.
The following adverse effects have been reported following the use of cefixime. Incidence rates were less than 1 in 50 (less than 2%), excepts as noted previously for gastrointestinal events.
Gastrointestinal: Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting. Several cases of documented pseudomembranous colitis were identified during the studies. The onset of pseudomembranous colitis symptoms may occur during or after therapy.
Hypersensitivity Reactions: Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness like reactions have been reported.
Hepatic: Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.
Renal: Transient elevations in BUN or creatinine, acute renal failure.
Central Nervous System: Headaches, dizziness, seizures.
Hemic and Lymphatic Systems: Transient thrombocytopenia, leukopenia, neutropenia, and eosinophilia. Prolongation in prothrombin time was seen rarely.
Abnormal Laboratory Tests: Hyperbilirubinemia.
Other: Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.
Drug Interactions
Taxim-O: Tablet: A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.
A false positive direct Coombs' test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognised that a positive Coombs' test may be due to the drug.
As common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulation therapy.
Taxim-O 400: 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.
Drug/Laboratory Test Interactions: A false-positive reactions for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide. The administration of cefixime may result in a false-positive reaction for glucose in the urine using Clinitest, Benedict's solution, or Fehling's solution. A false-positive direct Coomb's test has been reported during treatment with other cephalosporin antibiotics; therefore, it should be recognized that a positive Coomb's test may be due to the drug.
Storage
Taxim-O: Tablet: Store at temperatures not exceeding 30°C.
Store in a dry place and protect from light.
Taxim-O 400: Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Taxim-O: FC tab 200 mg x 10's, 50's. Powd for oral susp 50 mg/5 mL x 60 mL.
Taxim-O 400: Orodispersible tab 400 mg x 30's.
Taxim-O Forte: Powd for oral susp 100 mg/5 mL x 60 mL.
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