Omtax

Omtax Injection

Omtax is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Omtax is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.

Uses

• Cefotime is used for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below.

• Lower respiratory tract infections, including pneumonia, acute or chronic bronchitis, bronchiectasis, lung abscess and post-operative chest infections.

- Urinary tract infections, including acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.

- Obstetric & gynecological infections, including pelvic inflammatory disease.

- Septicemia / Bacteremia

- Skin and soft tissue infections, such as - cellulitis, wound infections.

- Intra-abdominal infections including peritonitis.

- Bone and joint infections, e.g. osteomyelitis, septic arthritis.

- Central nervous system infections, e.g. meningitis.

- Uncomplicated gonorrhea, particularly when penicillin has failed or is unsuitable.

- Surgical prophylaxis: The administration of Omtax prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.

Omtax is also used to associated treatment for these conditions: Animal bite, Bacteremia, Bacterial Infections, Bacterial Peritonitis, Bacterial Pneumonia, Bacterial Sepsis, Bacterial Sinusitis, Bacterial Urinary Tract Infections, Bone and Joint Infections, CNS ventriculitis, Central Nervous System Infections, Community Acquired Pneumonia (CAP), Endometritis, Gonococcal arthritis, Gonorrhea, Gynaecological infection, Intra-Abdominal Infections, Lower respiratory tract infection bacterial, Lyme Neuroborreliosis, Meningitis bacterial, Pelvic Inflammatory Disease (PID), Pelvic cellulitis, Postoperative Infections, Skin and Subcutaneous Tissue Bacterial Infections

Omtax

Trade Name Omtax
Generic Cefotaxime
Cefotaxime Other Names Cefotaxim, Cefotaxima, Céfotaxime, Cefotaxime, Cefotaximum, Cephotaxime
Type Injection
Formula C16H17N5O7S2
Weight Average: 455.465
Monoisotopic: 455.056939303
Therapeutic Class Third generation Cephalosporins
Manufacturer Om Biotech
Available Country India
Last Updated: June 23, 2021 at 9:00 am

Structure

Omtax
Cefotaxime Structure

Dosage

Omtax dosage

Adults:

The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required.

Children:

The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.

Neonates:

The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day in divided doses have been given.

Gonorrhoea:

A single injection of 1 gm may be administered intramuscularly or intravenously.

Surgical Prophylaxis:

Immediately prior to surgery, a single dose of 1 gm is suitable for most of the procedures. For procedures longer than 4 hours a dose of 2 gm is recommended.

Renal impairment:

Because of extra-renal elimination, it is only necessary to reduce the dosage of Omtax in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing.

 

Direction for reconstitution

For reconstitution purpose add water for injection BP as per the following chart:

Route 250 mg 500 mg 1 gm

IM 2 ml 2 ml 3 ml

IV 2-5 ml 2-10 ml 4-10 ml

 

Intravenous infusion

Omtax may be administered by intravenous infusion. 1-2 grams are dissolved in 40-100 ml of water for injection BP or 0.9% Sodium Chloride injection BP or 5% Dextrose injection BP. The prepared infusion should be administered over 20-60 minutes.

Intermittent IV: Add 10 ml of sterile water for inj to a vial containing 0.5 g, 1 g or 2 g to provide a soln containing approx 50 mg, 95 mg, or 180 mg per ml, respectively. 

Intermittent or continuous IV infusion: Add 50 ml or 100 ml of NaCl 0.9% inj or dextrose 5% inj to an infusion bottle containing 1 g or 2 g. Alternatively, reconstituted soln may be further diluted with 50-1,000 ml of a compatible soln. IM: Add 2 ml, 3 ml or 5 ml of sterile or bacteriostatic water for inj to a vial containing 0.5 g, 1 g or 2 g to provide a soln containing approx 230 mg, 300 mg or 330 mg per ml, respectively.

Side Effects

Adverse reactions to Omtax have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs, the drug should be stopped and specific treatment instituted. As with other cephalosporins, changes in renal function have been rarely observed with high doses of Omtax. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.

Precaution

Omtax should be prescribed with caution in patients with a history of colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Omtax is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms.

Interaction

Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Food Interaction

No interactions found.

Half Life

Approximately 1 hour.

Pregnancy & Breastfeeding use

Omtax is pregnancy category B drug. Although animal studies have not shown any adverse effect on the developing fetus, the safety of Omtax in human pregnancy has not been established. So, Omtax should not be administered during pregnancy especially during the first trimester, without carefully weighing the expected benefits against the possible risks. As Omtax is excreted in human milk, either breast feeding or treatment of the mother should be stopped.

Contraindication

Omtax is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.

Special Warning

Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Omtax in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.

Acute Overdose

Most cases of Omtax Sodium overdosage have shown no over toxicity. The most frequent reactions were elevations of BUN and creatinine. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

Storage Condition

Store below 25° C, protected from light and moisture. Use reconstituted solution immediately. Reconstituted solution is stable for up to 24 h if stored between 2° to 8° C.

Innovators Monograph

Omtax contains Cefotaxime see full prescribing information from innovator Monograph

FAQ

What is Omtax used for?

Omtax is an antibiotic used to treat a number of bacterial infections. Specifically it is used to treat joint infections, pelvic inflammatory disease, meningitis, pneumonia, urinary tract infections, sepsis, gonorrhea, and cellulitis. Omtax is also used to prevent infection in people having certain types of surgery

How does Omtax work?

Omtax  works by interfering with the ability of bacteria to form cell walls.

What are the common side effects of Omtax?

Common side effects of Omtax are include:

  • injection site reactions (pain, irritation, a hard lump, or inflammation),
  • rash,
  • itching,
  • hives,
  • fever,
  • nausea,
  • vomiting,
  • stomach pain,
  • headache,
  • diarrhea,
  • vaginal itching or discharge, and
  • colitis.

Is Omtax safe during pregnancy?

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

Is Omtax safe during breastfeeding?

Omtax passes into human breast milk in small amounts and is usually compatible with breast feeding, but careful monitoring of the infant is recommended.

Can I drink alcohol with Omtax?

Omtax does not interact with alcohol, but some of its side effects are similar to the effects of alcohol.

Can I drive after taking Omtax?

Patients should be advised not to drive or operate machinery if any such symptoms occur.

When should be taken of Omtax?

To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IV administered 30 to 90 minutes prior to start of surgery.

Where should Omtax be injected?

Omtax should be administered by deep intra-gluteal injection, preferably the ventrogluteal muscle. It is recommended to use a 21 gauge, 1.5″ needle with a 3cc syringe.

How is Omtax eliminated ?

The elimination half-life of Omtax is about one hour, with the total body clearance being approximately twice that of the renal clearance.

How long can Omtax be used?

As a general rule Omtax is administered for a further 3 to 4 days after improvement/regression of the symptoms. Adults and children over 12 years in general receive 1 g Omtax every 12 hours.

Who should not take Omtax?

You should not use Omtax if you are allergic to Omtax or another cephalosporin antibiotic (cefdinir, cefalexin, Keflex, Omnicef, and others).

What happen If I missed dose of Omtax?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.If you are receiving this medicine at a clinic, call your doctor if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention .Overdose symptoms may include weakness, cold feeling, pale skin, blue lips, or seizure.

Can Omtax affects my kidney?

None of the patients treated with cefotaxime alone showed any signs of renal damage.

Is Omtax safe in renal failure?

Omtax can be safely used to treat patients with infections in the presence of renal dysfunction.

Does Omtax affect the liver?

Omtax  is a second-generation cephalosporin known to very rarely cause drug-induced liver injury.