Novatex

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 Novatex 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.

Novatex 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

How Novatex works

The bactericidal activity of cefotaxime results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Novatex shows high affinity for penicillin-binding proteins in the cell wall including PBP Ib and PBP III.

Dosage

Novatex 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 Novatex 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

Novatex 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 Novatex 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 Novatex. 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.

Toxicity

Adverse effects following overdosage include nausea, vomiting, epigastric distress, diarrhea, and convulsions. Oral rat LD₅₀ is over 20,000 mg/kg while intravenous rat LD₅₀ is over 7,000 mg/kg.

Precaution

Novatex 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 Novatex 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

Novatex Hypertension interaction

[Moderate] Parenteral cefotaxime sodium contains approximately 51 mg (2.2 mEq) of sodium per each gram of cefotaxime activity.

The frozen solutions of cefotaxime sodium are additionally formulated with sodium citrate hydrous as a buffer.

The sodium content should be considered in patients with conditions that may require sodium restriction, such as congestive heart failure, hypertension, and fluid retention.

Novatex Drug Interaction

Unknown: aspirin, aspirin, amoxicillin / clavulanate, amoxicillin / clavulanate, sulfamethoxazole / trimethoprim, sulfamethoxazole / trimethoprim, albuterol / ipratropium, albuterol / ipratropium, acetaminophen, acetaminophen, valproic acid, valproic acid, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, phytonadione, phytonadione, phytonadione, phytonadione

Novatex Disease Interaction

Major: colitisModerate: renal dysfunction, sodium, dialysis, liver disease, seizure disorders

Elimination Route

Rapidly absorbed following intramuscular injection.

Half Life

Approximately 1 hour.

Elimination Route

Approximately 20-36% of an intravenously administered dose of 14C-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15-25% as the desacetyl derivative, the major metabolite.

Pregnancy & Breastfeeding use

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

Contraindication

Novatex 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 Novatex 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 Novatex 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

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