AX-3 Capsule, Powder For Suspension
AX-3 is a semi-synthetic, broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. AX-3 is highly stable in the presence of beta-lactamase enzymes. AX-3 has marked in -vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers.
Clinical efficacy of AX-3 has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes, Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.
AX-3 is used for the following infectious diseases -
Respiratory Tract Infections:
Pharyngitis and Tonsillitis
Acute Bronchitis and Acute Exacerbations of Chronic
Urinary Tract Infections
Uncomplicated gonorrhea (cervical/urethral)
AX-3 is also used to associated treatment for these conditions: Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae, Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae, Bacterial Sinusitis, Community Acquired Pneumonia (CAP), Gonorrhea of anus, Lyme Disease, Salmonella Infections, Salmonella Typhi Infection, Shigella Infection, Streptococcal Pharyngitis, Streptococcal tonsillitis, Uncomplicated Urinary Tract Infections, Bacterial otitis media, Bacterial rhinosinusitis, Uncomplicated Gonorrhea
|Other Names||Cefixim, Cefixima, Céfixime, Cefixime, Cefiximum|
|Type||Capsule, Powder For Suspension|
65% (concentration independent)
|Therapeutic Class||Third generation Cephalosporins|
|Manufacturer||Apollo Pharmaceutical Laboratories Ltd|
|Last Updated:||June 23, 2021 at 11:17 am|
Table Of contents
The usual treatment of AX-3 is 7 days. This may be continued for up to 14 days according to the severity of infection.
Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.
Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses
Direction for Reconstitution of Suspension
• To prepare 50 ml suspension, 25 ml boiled and cooled water is required.
• To prepare 40 ml suspension, 20 ml boiled and cooled water is required.
• To prepare 30 ml suspension, 15 ml boiled and cooled water is required.
• To prepare 50 ml DS suspension, 25 ml boiled and cooled water is required.
Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.
Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.
AX-3 is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.
Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, AX-3 should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. CNS disturbances: Headache, dizziness.
Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.
AX-3 should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)
Increased prothrombin time (with or withot bleeding) with anticoagulants (e.g. warfarin). Increased plasma carbamazepine concentrations with concomitant use. Increased bioavailability with nifedipine. Increased serum concentration with probenecid.
- Take with or without food.
3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.
Pregnancy & Breastfeeding use
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.
Lactation: It is not known whether AX-3 is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.
Use in Elderly
No special precautions are necessary. No dosage adjustment is required for elderly
Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.
Use in Children: Safety and effectiveness of cefixime in children aged less than 6 months have not been established. For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.
Use in elderly: No special precautions are necessary. Old age is not an indication for dose adjustment.
Dosage in renal impairment:
- Creatinine clearance: 20 ml/min or greater: normal dose
- Creatinine clearance: <20 ml/min or chronic ambulatory peritoneal dialysis
- Haemodialysis: daily dose should not exceed 200 mg.
Gastric lavage may be indicated; otherwise, no specific antidote exists. AX-3 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 AX-3 did not differ from the profile seen in patients treated at the recommended doses.
Interaction with other Medicine
Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience when AX-3 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.
Store in a cool and dry place below 30ºC