Itcef O

Itcef O Uses, Dosage, Side Effects, Food Interaction and all others data.

Itcef O is a combination of two antibiotics: Cefixime and Ofloxacin that is used to treat various types of bacterial infections. It fights against the microorganisms to prevent their growth and further spread of the infection.

Cefixime works by preventing the formation of the bacterial protective covering which is essential for the survival of the bacteria in the human body.

Ofloxacin works by preventing the bacteria from reproducing and repairing themselves. Together, they treat your infection effectively. It also

Trade Name Itcef O
Generic Cefixime + Ofloxacin
Type Tablet
Therapeutic Class

cephalosporin antibiotics

Manufacturer Gopal Life Sciences Pvt Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Itcef O
Itcef O

How Itcef O works

Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.

Ofloxacin acts on DNA gyrase and toposiomerase IV, enzymes which, like human topoisomerase, prevents the excessive supercoiling of DNA during replication or transcription. By inhibiting their function, the drug thereby inhibits normal cell division.

Dosage

Itcef O dosage

The usual treatment of Cefixime is 7 days. This may be continued for up to 14 days according to the severity of infection.

Cefixime Capsule

Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.

Cefixime Suspension

Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses

Ofloxacin Eye: Instill 1 drop in the affected eye(s) every 2 to 4 hours for the first two days and then 4 times daily. The length of treatment should not exceed ten days.

Ofloxacin Ear: Instill 1-2 drops in the affected ear(s) twice daily or as needed.

Ofloxacin Intravenous (Adult):

  • Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
  • Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
  • Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.

Ofloxacin Oral (Adult):

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

  • Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
  • Shigellosis: 400 mg single dose.
  • Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
  • Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
  • Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
  • Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
  • Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
  • Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.

Children: Ofloxacin is usually not indicated for use in children or growing adolescents.

Elderly: No adjustment of dosage is required in the elderly.

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.

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.

Side Effects

Common side effects of Itcef O
Nausea, Vomiting, Diarrhea, Stomach pain, Indigestion, Flatulence

Toxicity

Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.

LD50=5450 mg/kg (orally in mice)

Precaution

Cefixime 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)

Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

Prolonged use of eye drops & ear drops may result in overgrowth of non-susceptible organisms and secondary infection respectively.

Interaction

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.

Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.

Elimination Route

About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.

Bioavailability of ofloxacin in the tablet formulation is approximately 98%

Half Life

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.

9 hours

Elimination Route

Ofloxacin is mainly eliminated by renal excretion, where between 65% and 80% of an administered oral dose of ofloxacin is excreted unchanged via urine within 48 hours of dosing. About 4-8% of an ofloxacin dose is excreted in the feces and the drug is minimally subject to biliary excretion.

Pregnancy & Breastfeeding use

Single dose of Cefixime is considered safe in pregnancy. Ofloxacin should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some authorities, use is contraindicated. So, Itcef O is unsafe to take this medicine in pregnancy.

  • Do not take Itcef O if you are pregnant, think you may be pregnant or are planning to have a baby
  • If you conceive while taking this medicine, stop taking this medicine immediately and inform your doctor

Contraindication

Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.

It is contraindicated in patients who are hypersensitive to Ofloxacin or any other component of Ofloxacin (Eye/Ear Drops).

Ofloxacin tablet injection should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

Special Warning

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.

Renal Impairment:

  • CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
  • CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.

Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily

Acute Overdose

Symptoms of overdose include confusion, dizziness, altered consciousness, fits, irregular heartbeat, nausea, confusion. In the case of an overdose, contact your doctor immediately or visit your nearest hospital

Storage Condition

Store in a cool and dry place away from sunlight.

Innovators Monograph

You find simplified version here Itcef O

FAQ

What is Itcef O used for?

Itcef O is used in the treatment of bacterial infections. Cefixime + Ofloxacin is a combination of two antibiotics: Cefixime and Ofloxacin. Cefixime works by preventing the formation of the bacterial protective covering which is essential for the survival of the bacteria in the human body.

How does Itcef O work?

This combination works by causing the death of the infection-causing bacteria.

Is Itcef O safe during pregnancy?

Single dose of Cefixime is considered safe in pregnancy. Ofloxacin should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some authorities, use is contraindicated.

Is Itcef O safe during breastfeeding?

Itcef O excreted into human milk. Use is considered acceptable with monitoring of the infant for possible effects on the gastrointestinal flora (e.g., diarrhea or candidiasis [thrush, diaper rash]); avoiding breastfeeding between 4 to 6 hours after maternal dosing should decrease the infant's exposure to this drug in breast milk.


*** Taking medicines without doctor's advice can cause long-term problems.
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