Sozifur indications
Pharyngitis/Tonsillitis
Sozifur 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 Sozifur in the prevention of rheumatic fever was not established in clinical trials.
- The efficacy of Sozifur in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials.
Acute Bacterial Otitis Media
Sozifur 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
Sozifur 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 Sozifur 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
Sozifur 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
Sozifur 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
Sozifur 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
Sozifur 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)
Sozifur 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 Sozifur and other antibacterial drugs, Sozifur 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.
Sozifur description
Tablet: Each 125-, 250- and 500-mg tablet contains cefuroxime axetil which is equivalent to Sozifur 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 Sozifur (as Sozifur) in each 5 mL.
Zinnat suspension contains the following excipients: Aspartame, xantham gum, potassium acesulfame, povidone K30, stearic acid, sucrose, tutti-frutti flavour.
Sozifur dosage
Important Administration Instructions
- Sozifur tablets USP and Sozifur for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis.
- Administer Sozifur tablets USP tablets as described in the appropriate dosage guidelines.
- Administer Sozifur tablets USP with or without food.
- Pediatric patients (aged 13 years and older) who cannot swallow the Sozifur tablets USP whole should receive Sozifur for oral suspension because the tablet has a strong, persistent bitter taste when crushed.
Dosage for Sozifur tablets USP
Administer Sozifur 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 Sozifur 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 |
Sozifur interactions
Concomitant administration of probenecid with Sozifur tablets increases the area under the serum concentration versus time curve by 50%. The peak serum Sozifur 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 Sozifur compared with that of fasting state and tend to cancel the effect of postprandial absorption.
Sozifur 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 Sozifur (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 Sozifur 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 Sozifur in multiple-dose clinical trials.
| Adverse Reaction | Sozifur 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 Sozifur 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 Sozifur 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 Sozifur 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 Sozifur 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 Sozifur tablets in US clinical trials.
| Adverse Reaction | Sozifur 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 Sozifur 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 Sozifur. 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.
Sozifur contraindications
Sozifur is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to Sozifur or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Active ingredient matches for Sozifur:
Cefuroxime axetil in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| 250 mg x 100's | $ 30.12 |
| 500 mg x 100's | $ 47.59 |
| Sozifur 250 mg Tablet | $ 0.30 |
| Sozifur 500 mg Tablet | $ 0.48 |
| Sozifur 250mg TAB / 100 | $ 30.12 |
| Sozifur 500mg TAB / 100 | $ 47.59 |
| SOZIFUR tab 250 mg x 10's (Sozin Pharma) | $ 3.01 |
| SOZIFUR tab 500 mg x 10's (Sozin Pharma) | $ 4.76 |
| Sozifur 250mg TAB / 100 | $ 30.12 |
| Sozifur 500mg TAB / 100 | $ 47.59 |
List of Sozifur substitutes (brand and generic names): | |
| Soxime (Indonesia) | |
| Soxime 500 mg x 2 x 10's | $ 47.12 |
| Sozofur | |
| Sozofur 250mg TAB / 100 | $ 30.12 |
| Sozofur 500mg TAB / 100 | $ 47.59 |
| SPECTRAXIME (India) | |
| SPECTRAXIME Injection / 750mg / 1 units (Apex Laboratories Limited) | $ 1.08 |
| SPECTRAXIME Capsule/ Tablet / 250mg / 4 units (Apex Laboratories Limited) | $ 1.17 |
| SPECTRAXIME Injection / 1.5gm / 1 units (Apex Laboratories Limited) | $ 2.06 |
| SPECTRAXIME Capsule/ Tablet / 125mg / 4 units (Apex Laboratories Limited) | $ 0.63 |
| SPECTRAXIME Capsule/ Tablet / 500mg / 4 units (Apex Laboratories Limited) | $ 2.24 |
| SPECTRAXIME Injection / 250mg / 1 units (Apex Laboratories Limited) | $ 0.54 |
| Spectraxime 125mg TAB / 4 (Apex Laboratories Limited) | $ 0.86 |
| Spectraxime 250mg TAB / 4 (Apex Laboratories Limited) | $ 1.58 |
| Spectraxime 500mg TAB / 4 (Apex Laboratories Limited) | $ 2.89 |
| Spectraxime 125mg SUSP / 30ml (Apex Laboratories Limited) | $ 1.18 |
| Spectraxime 1.5g VIAL / 1 (Apex Laboratories Limited) | $ 2.06 |
| Spectraxime 250mg VIAL / 1 (Apex Laboratories Limited) | $ 0.54 |
| Spectraxime 750mg VIAL / 1 (Apex Laboratories Limited) | $ 1.08 |
| 125 mg x 4's (Apex Laboratories Limited) | $ 0.86 |
| 250 mg x 4's (Apex Laboratories Limited) | $ 1.58 |
| 500 mg x 4's (Apex Laboratories Limited) | $ 2.89 |
| 125 mg x 30ml (Apex Laboratories Limited) | $ 1.18 |
| 1.5 g x 1's (Apex Laboratories Limited) | $ 2.06 |
| 250 mg x 1's (Apex Laboratories Limited) | $ 0.54 |
| 750 mg x 1's (Apex Laboratories Limited) | $ 1.08 |
| Spectraxime 750 mg Injection (Apex Laboratories Limited) | $ 1.08 |
| Spectraxime 30 ml Suspension (Apex Laboratories Limited) | $ 0.20 |
| Spectraxime 500 mg Tablet (Apex Laboratories Limited) | $ 0.72 |
| Spectraxime 125 mg Tablet (Apex Laboratories Limited) | $ 0.21 |
| Spectraxime 250 mg Injection (Apex Laboratories Limited) | $ 0.54 |
| Spectraxime 1500 mg Injection (Apex Laboratories Limited) | $ 2.06 |
| SPECTRAXIME 1.5GM INJECTION 1 vial / 2 ML injection each (Apex Laboratories Limited) | $ 2.32 |
| SPECTRAXIME 250MG INJECTION 1 vial / 2 ML injection each (Apex Laboratories Limited) | $ 0.64 |
| SPECTRAXIME 250MG TABLET 1 strip / 10 tablets each (Apex Laboratories Limited) | $ 1.71 |
| SPECTRAXIME 500 MG TABLET 1 strip / 6 tablets each (Apex Laboratories Limited) | $ 1.73 |
| SPECTRAXIME 500 MG TABLET 1 strip / 10 tablets each (Apex Laboratories Limited) | $ 1.73 |
| SPECTRAXIME 750MG INJECTION 1 vial / 10 ML injection each (Apex Laboratories Limited) | $ 1.22 |
| SPECTRAXIME tab 125 mg x 4's (Apex Laboratories Limited) | $ 0.86 |
| SPECTRAXIME tab 250 mg x 4's (Apex Laboratories Limited) | $ 1.58 |
| SPECTRAXIME tab 500 mg x 4's (Apex Laboratories Limited) | $ 2.89 |
| SPECTRAXIME oral susp 125 mg x 30ml (Apex Laboratories Limited) | $ 1.18 |
| Spectraxime 125mg TAB / 4 (Apex Laboratories Limited) | $ 0.86 |
| Spectraxime 250mg TAB / 4 (Apex Laboratories Limited) | $ 1.58 |
| Spectraxime 500mg TAB / 4 (Apex Laboratories Limited) | $ 2.89 |
| Spectraxime 125mg SUSP / 30ml (Apex Laboratories Limited) | $ 1.18 |
| Spectraxime 1.5g VIAL / 1 (Apex Laboratories Limited) | $ 2.06 |
| Spectraxime 250mg VIAL / 1 (Apex Laboratories Limited) | $ 0.54 |
| Spectraxime 750mg VIAL / 1 (Apex Laboratories Limited) | $ 1.08 |
| Spectraxime 1.5gm Injection (Apex Laboratories Limited) | $ 1.16 |
| Spectraxime 250mg Injection (Apex Laboratories Limited) | $ 0.32 |
| Spectraxime 250mg Tablet (Apex Laboratories Limited) | $ 0.17 |
| Spectraxime 500mg Tablet (Apex Laboratories Limited) | $ 0.17 |
| Spectraxime 750mg Injection (Apex Laboratories Limited) | $ 0.12 |
| Spectraxime Tab | |
| Spectraxime Tab 250 mg Tablet (Apex Laboratories Limited) | $ 0.41 |
| Spectrazol (New Zealand, South Africa) | |
| Spectrazol Milking Cow (New Zealand) | |
| Spizef Tab | |
| Spizef Tab 250 mg Tablet (Cardiovascular (Orchid Chemicals & Pharmaceuticals Ltd.)) | $ 0.39 |
| Stacey (India) | |
| Stacey 250mg TAB / 1 (Argil) | |
| Stacey 500mg TAB / 1 (Argil) | |
| 250 mg x 1's (Argil) | |
| 500 mg x 1's (Argil) | |
| STACEY tab 250 mg x 10's (Argil) | |
| STACEY tab 500 mg x 10's (Argil) | |
| Stafcure (India) | |
| Stafcure 1.5g VIAL / 1 (Macleods Pharmaceuticals Pvt Ltd.) | $ 2.25 |
| Stafcure 750mg VIAL / 1 (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.20 |
| Stafcure 250mg TAB / 10 (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.42 |
| Stafcure 500mg TAB / 6 (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.63 |
| Stafcure 250 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.13 |
| Stafcure 500 mg Tablet (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.25 |
| STAFCURE 1.5 GM INJECTION 1 vial / 10 ML injection each (Macleods Pharmaceuticals Pvt Ltd.) | $ 2.48 |
| STAFCURE 250 MG TABLET 1 strip / 10 tablets each (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.88 |
| STAFCURE 500 MG TABLET 1 strip / 6 tablets each (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.96 |
| STAFCURE 750 MG INJECTION 1 vial / 10 ML injection each (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.44 |
| STAFCURE tab 250 mg x 10's (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.56 |
| STAFCURE tab 500 mg x 6's (Macleods Pharmaceuticals Pvt Ltd.) | $ 1.79 |
| Stafcure 1.5gm Injection (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.25 |
| Stafcure 250mg Tablet (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.19 |
| Stafcure 500mg Tablet (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.36 |
| Stafcure 750mg Injection (Macleods Pharmaceuticals Pvt Ltd.) | $ 0.14 |
| Starox DS | |
| Starox DS 30 ml Syrup (Sanify Healthcare Pvt. Ltd.) | $ 0.20 |
See 5192 substitutes for Sozifur | |
References
- PubChem. "cefuroxime". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "cefuroxime". http://www.drugbank.ca/drugs/DB01112 (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Sozifur 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 Sozifur. 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
