| Active Ingredient | CEFIXIME (Capsule) |
|---|
| Drug Name | FDA Application No. | Company | Dosage Form;Route | Strength | RLD Strength | Original Approval or Tentative Approval Date |
Exclusivity Expiration (NCE) |
Exclusivity Expiration (ODE) |
Chemical Type |
Review Classification |
Marketing Status |
TE Code |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SUPRAX | NDA# 203195 | LUPIN LTD | CAPSULE;ORAL | 400MG | 400MG (RS) | June 1, 2012 | - | - | Type 3 - New Dosage Form | STANDARD | Prescription | None |
| Parameters | Details |
|---|---|
| Structural Formula |
/Structural_Formula.jpg) |
| Chemical Name | (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-(carboxy methyl) oxime] trihydrate |
| CAS No | 79350-37-1 |
| Molecular Formula | C16H15N5O7S2.3H2O |
| Molecular Weight | 507.50 as the trihydrate |
| Appearance | A white or almost white powder |
| Solubility | Soluble in methanol, slightly soluble in water and ethanol and practically insoluble in ethyl acetate. |
| Water Solubility | 55.11 mg/L |
| Polymorphism | - |
| pKa (Strongest Acidic) | 3.45 |
| pKa (Strongest Basic) | 2.92 |
| Log P | -0.4 |
| Identification | - |
| Degradation | - |
| Hygroscopic | slightly hygroscopic |
| Photostability study | - |
| Melting Point | 218-225 °C |
| BCS Class | - |
| Manufacture of API | - |
| Parameters | Details |
|---|---|
| Indications and Usage | For Uncomplicated Urinary Tract Infections, Otitis Media, Pharyngitis and Tonsillitis, Acute Exacerbations of Chronic Bronchitis, Uncomplicated Gonorrhea (cervical/urethral). |
| Dosage and Administration |
Adult: The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400mg is recommended. The capsule and tablet may be administered without regard to food. In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days. Pediatric Patients (6 months or older) :The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours. |
| Mechanism of action |
Cefixime is a semisynthetic cephalosporin antibacterial drug. As with other cephalosporins, the bactericidal action of cefixime results from inhibition of cell wall synthesis. Cefixime is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of betalactamases may be susceptible to cefixime. |
| Absorption |
The 400 mg capsule is bioequivalent to the 400 mg tablet under fasting conditions. Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg tablet or 400 mg of cefixime suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule. |
| Food Effect | Food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on Cmax. |
| Distribution | Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of cefixime are not available. |
| Metabolism | There is no evidence of metabolism of cefixime in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. |
| Elimination | In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers. |
| Peak plasma time (Tmax) | 2-6 hours |
| Half life | 3-4 hours |
| Bioavailability | - |
| Age, gender | Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. |
| DMF | Status | Type | Submit Date | Holder |
|---|---|---|---|---|
| 13687 | I | II | September 1, 1998 | LEDERLE LABORATORIES |
| 15996 | A | II | May 20, 2002 | LUPIN LTD |
| 16313 | I | II | December 17, 2002 | SANDOZ PRIVATE LTD |
| 17655 | I | II | September 7, 2004 | ORCHID CHEMICALS AND PHARMACEUTICALS LTD |
| 19307 | A | II | March 28, 2006 | NECTAR LIFESCIENCES LTD |
| 19960 | A | II | November 14, 2006 | ORCHID PHARMA LTD |
| 23474 | A | II | January 18, 2010 | PARABOLIC DRUGS LTD |
| 25390 | I | II | September 30, 2011 | CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD |
| 26047 | A | II | June 8, 2012 | UNIMARK REMEDIES LTD |
| 26369 | A | II | September 10, 2012 | AUROBINDO PHARMA LTD |
| 27033 | A | II | April 3, 2013 | KYONGBO PHARMACEUTICAL CO LTD |
| 27121 | A | II | April 29, 2013 | COVALENT LABORATORIES PRIVATE LTD |
| 27527 | A | II | September 27, 2013 | SANDOZ GMBH |
| 9478 | I | II | December 31, 1991 | ASTELLAS PHARMA INC |
| Parameters | Details |
|---|---|
| Strength | 400mg |
| Excipients used | colloidal silicon dioxide, crospovidone, low substituted hydroxy propyl cellulose, magnesium stearate, and mannitol |
| Composition of coating material | - |
| Composition of caspule shell | ferric oxide black, ferric oxide red, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide |
| Pharmaceutical Development | - |
| Manufacture of the product | - |
| Tablet / Capsule Image |
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|
| Appearance | size “00EL” capsules with pink opaque cap and pink opaque body with “LU” on the cap and “U43” on the body in black ink. Capsules contain white to yellowish white granular powder. |
| Imprint code / Engraving / Debossment | “LU” on the cap and “U43” on the body in black ink. |
| Score | - |
| Color | Pink opaque |
| Shape | Capsule |
| Dimension | Size "00el" (26mm) |
| Mfg by | Lupin Pharma (US) |
| Mfg for | Lupin Pharma (US) |
| Marketed by | - |
| Distributed by | - |
| Application No. | Prod No | Patent No | Patent Expiration | Drug Substance Claim | Drug Product Claim | Patent Use Code | Delist Requested | Link |
|---|---|---|---|---|---|---|---|---|
| There are no unexpired patents for this product in the Orange Book Database. | ||||||||
| USP Apparatus | Speed (RPMs) | Medium | Volume (mL) | Recommended Sampling Times (minutes) | Date Updated |
|---|---|---|---|---|---|
| I (Basket) | 100 | 0.05 M Phosphate Buffer, pH 7.2 | 900 | 10, 20, 30, 45 and 60 | August 15, 2013 |
| Market | EU | US |
|---|---|---|
| Strength | Packaging System | |
| 400MG | - | Bottle of 50 capsules Unit Dose Package of 10 (1 blister of 10 capsules) |
| Storage | Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. | |
| Label | Link |
|---|---|
| FDA label | Download |
| FDA chemistry review | Download |
| FDA Pharmacology Review(s) | Download |
| FDA Clinical Pharmacology Biopharmaceutics Review(s) | Download |
| FDA BE Recommendation | Download |
| European Public Assessment Report |
| - |
| www.accessdata.fda.gov, www.drugbank.ca, www.ema.europa.eu, www.medicines.org.uk, dailymed.nlm.nih.gov |
