Thico Uses

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Thico indications

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Pharyngitis/Tonsillitis

Thico 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

Acute Bacterial Otitis Media

Thico 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

Thico 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 Thico 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

Thico 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

Thico 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

Thico 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

Thico 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)

Thico 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 Thico and other antibacterial drugs, Thico 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.

Thico description

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Tablet: Each 125-, 250- and 500-mg tablet contains Cefuroxime Axetil which is equivalent to Thico 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 Thico (as Thico) in each 5 mL.

Zinnat suspension contains the following excipients: Aspartame, xantham gum, potassium acesulfame, povidone K30, stearic acid, sucrose, tutti-frutti flavour.

Thico dosage

Important Administration Instructions

Dosage for Thico tablets USP

Administer Thico tablets USP as described in the dosage guidelines table below with or without food.

Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Thico Tablets USP
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 Thico is eliminated primarily by the kidney.

Table 4. Dosing in Adults with Renal Impairment
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

Thico interactions

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Concomitant administration of probenecid with Thico tablets increases the area under the serum concentration versus time curve by 50%. The peak serum Thico 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 Thico compared with that of fasting state and tend to cancel the effect of postprandial absorption.

Thico 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 Thico (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 Thico 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 Thico in multiple-dose clinical trials.

Table 5. Adverse Reactions (≥1%) after Multiple-dose Regimens with Thico Tablets
Adverse Reaction

Thico 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 Thico 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 Thico 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 Thico 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 Thico 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 Thico tablets in US clinical trials.

Table 6. Adverse Reactions (≥1%) after Single-dose Regimen with 1,000-mg Thico Tablets for Uncomplicated Gonorrhea
Adverse Reaction

Thico 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 Thico 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 Thico. 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.

Thico contraindications

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Thico is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to Thico or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

Active ingredient matches for Thico:

Cefuroxime Axetil

Cefuroxime


Unit description / dosage (Manufacturer)Price, USD
Thico 250 mg Tablet$ 0.30
Thico 500 mg Tablet$ 0.54
THICO 250MG TABLET 1 strip / 10 tablets each (Dr. Johns Laboratories Pvt Ltd)$ 2.99
THICO 500MG TABLET 1 strip / 10 tablets each (Dr. Johns Laboratories Pvt Ltd)$ 5.38
Thico 250mg Tablet (Dr. Johns Laboratories Pvt Ltd)$ 0.30
Thico 500mg Tablet (Dr. Johns Laboratories Pvt Ltd)$ 0.54

List of Thico substitutes (brand and generic names):

THEOCEF tab 500 mg x 10's (Theo Pharma)$ 2.18
Ticef-AX 500mg TAB / 10 (Merion)$ 5.78
TICEF-AX tab 500 mg x 10's (Merion)$ 5.78
Topoxime 125 mg x 3 Blister x 10 Tablet
Topoxime 250 mg x 3 Blister x 10 Tablet
Topoxime 500 mg x 3 Blister x 10 Tablet
Topxime 250mg TAB / 100 (CureMax (Solitaire Pharmacia Pvt Ltd))$ 40.96
Topxime 500mg TAB / 100 (CureMax (Solitaire Pharmacia Pvt Ltd))$ 71.08
Topxime 750mg INJ / 1 (CureMax (Solitaire Pharmacia Pvt Ltd))$ 1.55
Topxime 1500mg INJ / 1 (CureMax (Solitaire Pharmacia Pvt Ltd))$ 3.01
250 mg x 100's (CureMax (Solitaire Pharmacia Pvt Ltd))$ 40.96
500 mg x 100's (CureMax (Solitaire Pharmacia Pvt Ltd))$ 71.08
750 mg x 1's (CureMax (Solitaire Pharmacia Pvt Ltd))$ 1.55
1500 mg x 1's (CureMax (Solitaire Pharmacia Pvt Ltd))$ 3.01
Topxime 500 mg Tablet (CureMax (Solitaire Pharmacia Pvt Ltd))$ 0.71
Topxime 250 mg Tablet (CureMax (Solitaire Pharmacia Pvt Ltd))$ 0.41
Topxime 1500 mg Injection (CureMax (Solitaire Pharmacia Pvt Ltd))$ 3.01
Topxime 750 mg Injection (CureMax (Solitaire Pharmacia Pvt Ltd))$ 1.55
TOPXIME tab 250 mg x 10's (CureMax (Solitaire Pharmacia Pvt Ltd))$ 4.10
TOPXIME tab 500 mg x 10's (CureMax (Solitaire Pharmacia Pvt Ltd))$ 7.11
Torcef 250 mg Tablet (Totem Biotech Pvt. Ltd.)$ 0.35
Torfur 250mg TAB / 10 (Torrent (Vista))$ 1.57
Torfur 500mg TAB / 10 (Torrent (Vista))$ 2.98
Torfur 750mg VIAL / 1 (Torrent (Vista))$ 1.20
TORFUR 250 MG TABLET 1 strip / 10 tablets each (Torrent (Vista))$ 1.75
TORFUR 500 MG TABLET 1 strip / 10 tablets each (Torrent (Vista))$ 3.55
TORFUR tab 250 mg x 10's (Torrent (Vista))$ 1.57
TORFUR tab 500 mg x 10's (Torrent (Vista))$ 2.98
Tozep 125 mg x 10 Packs
Tpoxim 250mg TAB / 10 (Allen Dale)$ 2.40
TPOXIM tab 250 mg x 10's (Allen Dale)$ 2.40
Travexel 250mg TAB / 6 (Goldline Pharmaceuticals)$ 1.73
Travexel 500mg TAB / 6 (Goldline Pharmaceuticals)$ 3.47
250 mg x 6's (Goldline Pharmaceuticals)$ 1.73
500 mg x 6's (Goldline Pharmaceuticals)$ 3.47
Travexel 250 mg Tablet (Goldline Pharmaceuticals)$ 0.29
Travexel 500 mg Tablet (Goldline Pharmaceuticals)$ 0.79
TRAVEXEL 1.5GM INJECTION 1 vial / 1 ML injection each (Goldline Pharmaceuticals)$ 1.66
TRAVEXEL 250MG TABLET 1 strip / 6 tablets each (Goldline Pharmaceuticals)$ 3.13

References

  1. PubChem. "cefuroxime". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "cefuroxime". http://www.drugbank.ca/drugs/DB01112 (accessed September 17, 2018).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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