Otoxil indications
Pharyngitis/Tonsillitis
Otoxil tablets USP are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes.
Limitations of Use
- The efficacy of Otoxil in the prevention of rheumatic fever was not established in clinical trials.
- The efficacy of Otoxil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.
Acute Bacterial Otitis Media
Otoxil tablets USP are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes.
Acute Bacterial Maxillary Sinusitis
Otoxil tablets USP are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β-lactamase–producing strains only).
Limitations of Use
The effectiveness of Otoxil for sinus infections caused by β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials.
Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis
Otoxil tablets USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (β-lactamase–negative strains), or Haemophilus parainfluenzae (β-lactamase–negative strains).
Uncomplicated Skin and Skin-structure Infections
Otoxil tablets USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes.
Uncomplicated Urinary Tract Infections
Otoxil tablets USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae.
Uncomplicated Gonorrhea
Otoxil tablets USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase producing and non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing susceptible strains of Neisseria gonorrhoeae.
Early Lyme Disease (erythema migrans)
Otoxil tablets USP are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Otoxil and other antibacterial drugs, Otoxil 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Otoxil description
Tablet: Each 125-, 250- and 500-mg tablet contains cefuroxime axetil which is equivalent to cefuroxime 125-, 250- and 500 mg, respectively. It also contains the following excipients: Microcrystalline cellulose, type A croscarmellose sodium, sodium lauryl sulphate, hydrogenated vegetable oil, colloidal anhydrous silica, methylhydroxypropyl cellulose, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and Opaspray white M-1-7120J.
Suspension: Reconstitution of the multidose bottles, as directed, yields a suspension containing 125 mg of cefuroxime (as Otoxil) in each 5 mL.
Zinnat suspension contains the following excipients: Aspartame, xantham gum, potassium acesulfame, povidone K30, stearic acid, sucrose, tutti-frutti flavour.
Otoxil dosage
Important Administration Instructions
- Otoxil tablets USP and Otoxil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis.
- Administer Otoxil tablets USP tablets as described in the appropriate dosage guidelines.
- Administer Otoxil tablets USP with or without food.
- Pediatric patients (aged 13 years and older) who cannot swallow the Otoxil tablets USP whole should receive Otoxil for oral suspension because the tablet has a strong, persistent bitter taste when crushed.
Dosage for Otoxil tablets USP
Administer Otoxil tablets USP as described in the dosage guidelines table below with or without food.
| Infection | Dosage | Duration (Days) |
| Adults and Adolescents (13 years and older) | ||
| Pharyngitis/tonsillitis (mild to moderate) | 250 mg every 12 hours | 10 |
| Acute bacterial maxillary sinusitis (mild to moderate) | 250 mg every 12 hours | 10 |
| Acute bacterial exacerbations of chronic bronchitis (mild to moderate) | 250 or 500 mg every 12 hours | 10a |
| Secondary bacterial infections of acute bronchitis | 250 or 500 mg every 12 hours | 5 to 10 |
| Uncomplicated skin and skin-structure infections | 250 or 500 mg every 12 hours | 10 |
| Uncomplicated urinary tract infections | 250 mg every 12 hours | 7 to 10 |
| Uncomplicated gonorrhea | 1,000 mg | single dose |
| Early Lyme disease | 500 mg every 12 hours | 20 |
| Pediatric Patients younger than 13 years (who can swallow tablets whole)b | ||
| Acute bacterial otitis media | 250 mg every 12 hours | 10 |
| Acute bacterial maxillary sinusitis | 250 mg every 12 hours | 10 |
Dosage in Patients with Impaired Renal Function
A dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney.
| Creatinine Clearance (mL/min) | Recommended Dosage |
| ≥30 | No dosage adjustment |
| 10 to ˂30 | Standard individual dose given every 24 hours |
| ˂10 (without hemodialysis) | Standard individual dose given every 48 hours |
| Hemodialysis | A single additional standard dose should be given at the end of each dialysis |
Otoxil interactions
Concomitant administration of probenecid with Otoxil tablets increases the area under the serum concentration versus time curve by 50%. The peak serum cefuroxime concentration after 1.5-g single dose is greater when taken with probenecid 1 g than without probenecid. Drugs that reduce gastric acidity may result in a lower bioavailability of Otoxil compared with that of fasting state and tend to cancel the effect of postprandial absorption.
Otoxil side effects
The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label:
Anaphylactic Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Tablets
Multiple-dose Dosing Regimens with 7 to 10 Days' Duration: In multiple-dose clinical trials, 912 subjects were treated with Otoxil (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of subjects treated with Otoxil who discontinued study drug because of adverse reactions was similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse reactions increased with the higher recommended doses.
The adverse reactions in Table 5 are for subjects (n = 912) treated with Otoxil in multiple-dose clinical trials.
| Adverse Reaction | Otoxil Tablets (n = 912) |
| Blood and lymphatic system disorders | |
| Eosinophilia | 1% |
| Gastrointestinal disorders | |
| Diarrhea | 4% |
| Nausea/Vomiting | 3% |
| Investigations | |
| Transient elevation in AST | 2% |
| Transient elevation in ALT | 2% |
| Transient elevation in LDH | 1% |
The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with Otoxil in multiple-dose clinical trials.
Immune System Disorders: Hives, swollen tongue.
Metabolism and Nutrition Disorders: Anorexia.
Nervous System Disorders: Headache.
Cardiac Disorders: Chest pain.
Respiratory Disorders: Shortness of breath.
Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers.
Skin and Subcutaneous Tissue Disorders: Rash, itch
Renal and Urinary Disorders: Dysuria.
Reproductive System and Breast Disorders: Vaginitis, vulvar itch.
General Disorders and Administration Site Conditions: Chills, sleepiness, thirst.
Investigations: Positive Coombs' test.
5-Day Regimen: In clinical trials using Otoxil tablets 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 subjects were treated for 5 days and 402 subjects were treated for 10 days. No difference in the occurrence of adverse reactions was found between the 2 regimens.
Early Lyme Disease with 20-Day Regimen: Two multicenter trials assessed Otoxil tablets 500 mg twice daily for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days' dosing.
Single-dose Regimen for Uncomplicated Gonorrhea: In clinical trials using a single 1,000 mg dose of Otoxil tablets, 1,061 subjects were treated for uncomplicated gonorrhea.
The adverse reactions in Table 6 were for subjects treated with a single dose of 1,000 mg Otoxil tablets in US clinical trials.
| Adverse Reaction | Otoxil Tablets (n = 1,061) |
| Gastrointestinal disorders | |
| Nausea/Vomiting | 7% |
| Diarrhea | 4% |
The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of Otoxil tablets 1,000 mg for uncomplicated gonorrhea in US clinical trials.
Infections and Infestations: Vaginal candidiasis.
Nervous System Disorders: Headache, dizziness, somnolence.
Cardiac Disorders: Tightness/pain in chest, tachycardia.
Gastrointestinal Disorders: Abdominal pain, dyspepsia.
Skin and Subcutaneous Tissue Disorders: Erythema, rash, pruritus.
Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction.
Renal and Urinary Disorders: Bleeding/pain in urethra, kidney pain.
Reproductive System and Breast Disorders: Vaginal itch, vaginal discharge.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Otoxil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders
Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia.
Gastrointestinal Disorders
Pseudomembranous colitis.
Hepatobiliary Disorders
Hepatic impairment including hepatitis and cholestasis, jaundice.
Immune System Disorders
Anaphylaxis, serum sickness-like reaction.
Investigations
Increased prothrombin time.
Nervous System Disorders
Seizure, encephalopathy.
Renal and Urinary Disorders
Renal dysfunction.
Skin and Subcutaneous Tissue Disorders
Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Otoxil contraindications
Otoxil is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to Otoxil or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Active ingredient matches for Otoxil:
Cefuroxime axetil in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| OTOXIL tab 500 mg x 10's (Shinto Biotec (TNT)) | $ 5.78 |
List of Otoxil substitutes (brand and generic names): | |
| Ocef CV | |
| Ocef CV 500 mg/125 mg Tablet (Gujarat Terce Laboratories Ltd.) | $ 0.53 |
| OXIZIM (India) | |
| 250 mg x 10's (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 3.00 |
| 500 mg x 10's (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 5.30 |
| Oxizim 250mg TAB / 10 (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 3.00 |
| Oxizim 500mg TAB / 10 (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 5.30 |
| Oxizim 250 mg Tablet (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 0.30 |
| Oxizim 500 mg Tablet (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 0.53 |
| OXIZIM tab 250 mg x 10's (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 3.00 |
| OXIZIM tab 500 mg x 10's (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 5.30 |
| Oxizim 250mg TAB / 10 (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 3.00 |
| Oxizim 500mg TAB / 10 (Novamed (Biochemix Healthcare Pvt Ltd)) | $ 5.30 |
| Penturox (Vietnam) | |
| Penturox 250 mg x 1 Blister x 10 Tablet | |
| Pluscef (Portugal) | |
| Reetac (Vietnam) | |
| Reetac 250 mg x 3 Blister x 10 Tablet | |
| Reetac 500 mg x 3 Blister x 10 Tablet | |
| REOX (India) | |
| REOX tab 250 mg x 10's (Rezicure) | |
| REOX tab 500 mg x 10's (Rezicure) | |
| Rifurox 250 (Vietnam) | |
| Rifurox 250 250 mg x 10 Blister x 10 Tablet | |
| Robcenat (Vietnam) | |
| Robcenat 250 mg x 2 Blister x 5 Tablet | |
| Romicef Tab (Philippines) | |
| Romicef Tab 250 mg x 100's | |
| ROXCEFA (India) | |
| ROXCEFA tab 250 mg x 10's (Wonder (Asrox)) | $ 1.01 |
| ROXCEFA tab 500 mg x 10's (Wonder (Asrox)) | $ 1.95 |
| Roxetil 500 (Philippines) | |
| Roxetil 500 500 mg x 10's | |
| Roxime 500 (Philippines) | |
| Roxime 500 tab 500 mg 10's (Steinbach) | |
| Sanfocef 500 (Vietnam) | |
| Sanfocef 500 500 mg x 1 Blister x 10 Tablet | |
| SECROX (India) | |
| SECROX tab 250 mg x 10's (MNW) | $ 2.17 |
| SECROX tab 500 mg x 10's (MNW) | $ 4.47 |
| Seem | |
| Seem 250 mg Tablet (Klokter Life Sciences) | $ 0.30 |
| Seem 500 mg Tablet (Klokter Life Sciences) | $ 0.58 |
| SEEROXIM (India) | |
| SEEROXIM tab 500 mg x 6's (Xieon (Stadia)) | $ 3.47 |
| Sefil Kid | |
| Sefil Kid 125 mg Tablet (Elikem Pharmaceuticals Pvt. Ltd.) | $ 0.22 |
| Shaltil | |
| Shaltil 250 mg Tablet (Shalman Pharmaceuticals Pvt. Ltd.) | $ 0.36 |
| Shaltil 500 mg Tablet (Shalman Pharmaceuticals Pvt. Ltd.) | $ 0.69 |
| Shatil | |
| Shatil 500 mg Tablet (Shalman Pharmaceuticals Pvt. Ltd.) | $ 0.69 |
| Sofa LB | |
| Sofa LB 250+LB Tablet (Omenta Pharma Pvt Ltd) | $ 0.19 |
| Sofa LB 500+LB Tablet (Omenta Pharma Pvt Ltd) | $ 0.36 |
| SORTUM (India) | |
| 500 mg x 10's (Gopal Life Sciences (Sovia Altis)) | $ 4.99 |
| Sortum 500 mg Tablet (Gopal Life Sciences (Sovia Altis)) | $ 0.50 |
| Sortum 500mg TAB / 10 (Gopal Life Sciences (Sovia Altis)) | $ 4.99 |
| SORTUM tab 500 mg x 10's (Gopal Life Sciences (Sovia Altis)) | $ 4.99 |
| Sortum 500mg TAB / 10 (Gopal Life Sciences (Sovia Altis)) | $ 4.99 |
| SOZIFUR (India) | |
| 250 mg x 100's (Sozin Flora Pharma) | $ 30.12 |
See 440 substitutes for Otoxil | |
Reviews
The results of a survey conducted on ndrugs.com for Otoxil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Otoxil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
