Nitipime

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

Nitipime Hydrochloride is a preparation of Nitipime. It is a fourth generation broad-spectrum cephalosporin antibiotic. Nitipime acts by inhibition of bacterial cell wall synthesis. It is highly resistant to hydrolysis by most beta-lactamases and exhibits rapid penetration into gram-negative bacterial cells.

Nitipime has been shown to be active against most strains of the following microorganisms:

Gram-Positive Microorganisms:

Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Viridans group streptococci, Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus hominis, Streptococcus agalactiae.

Gram-Negative Microorganisms:

Enterobacter, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Acinetobacter calcoaceticus, Citrobacter diversus, Citrobacter freundii, Enterobacter spp., Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (including beta-lactamase producing strains), Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens, Neisseria meningitidis.

Anaerobes:

Trade Name Nitipime
Availability Prescription only
Generic Cefepime
Cefepime Other Names Cefepima, Cefepime, Cefepimum
Related Drugs amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, Augmentin
Type Injection
Formula C19H24N6O5S2
Weight Average: 480.561
Monoisotopic: 480.124959288
Protein binding

The serum protein binding of cefepime is approximately 20% and is independent of its concentration in serum.

Groups Approved, Investigational
Therapeutic Class Fourth generation Cephalosporins
Manufacturer Nitin Pharmaceuticals Pvt Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Nitipime
Nitipime

Uses

Nitipime Hydrochloride is used for the treatment of the following infections:

• Pneumonia (moderate to severe)

• Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis)

• Uncomplicated Skin and Skin Structure Infections

• Complicated Intra-abdominal Infections

• Empiric Therapy for Febrile Neutropenic Patients.

Nitipime is also used to associated treatment for these conditions: Bacterial Infections, Complicated Intra-Abdominal Infections, Complicated Urinary Tract Infection, Febrile Neutropenia, Meningitis, Bacterial, Pyelonephritis, Severe Pneumonia, Uncomplicated Urinary Tract Infections, Moderate Pneumonia, Uncomplicated skin and subcutaneous tissue bacterial infections

How Nitipime works

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

Dosage

Nitipime dosage

Recommended dosage schedule for adults with normal renal function

Type of Infection Dose Frequency Duration (Days)

Moderate to severe Pneumonia 1-2 g IV q12h 10

Empiric Therapy for Febrile Neutropenic Patients 2 g IV q8h 7

Mild to moderate Uncomplicated or Complicated Urinary 0.5-1 g IV/IM q12h 7-10

Tract Infections (including pyelonephritis)

Severe Uncomplicated or Complicated Urinary 2 g IV q12h 10

Tract Infections (including pyelonephritis)

Moderate to severe Uncomplicated Skin and Skin Structure 2 g IV q12h 10

Infections

Complicated Intra-abdominal Infections 2 g IV q12h 7-10

Pediatric Patients (2 months up to 16 years)

The maximum dose for pediatric patients should not exceed the recommended adult dose.

Type of Infection Pediatric patients up to 40 kg in weight

Dose Frequency Duration

(Days)

Uncomplicated and Complicated Urinary Tract Infections 50 mg/kg q12h 7-10

(including pyelonephritis)

Uncomplicated Skin and Skin Structure Infections 50 mg/kg q12h 10

Pneumonia 50 mg/kg q12h 10

Febrile Neutropenic Patients 50 mg/kg q8h 7

Impaired Hepatic Function - No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function - In patients with impaired renal function (creatinine clearance <60 ml/min), the dose of Nitipime should be adjusted. The recommended initial dose of Nitipime should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of Nitipime in patients with renal insufficiency are presented in the following table:

Creatinine Clearance Recommended Maintenance Schedule

(ml/min)

>60 500 mg q12h 1g q12h 2g q12h 2g q8h

Normal recommended

dosing schedule

30-60 500 mg q24h 1g q24h 2g q24h 2g q12h

11-29 500 mg q24h 500 mg q24h 1g q24h 2g q24h

<11 250 mg q24h 250 mg q24h 500 mg q24h 1g q24h

CAPD 500 mg q48h 1g q48h 2g q48h 2g q48h

Hemodialysis 1g on day 1, then 500 mg q24h thereafter 1g q24h

Preparation of Solutions of Nitipime Hydrochloride

Single-dose vial Administration Amount of diluent to be added

500 mg IM 1.3 ml

500 mg IV 5 ml

1 gm IM 2.4 ml

1 gm IV 10 ml

These solutions may be stored up to 24 hours at room temperature or 7 days in a refrigerator.

Nitipime Hydrochloride is compatible at concentrations between 1 and 40 mg/ml with the following IV infusion fluids: (1) 0.9% Sodium chloride, (2) 5% and 10% Dextrose.

IV infusion: Add 5 mL, 10 mL, or 10 mL of a compatible IV soln to a vial labeled as containing 500 mg, 1 g, or 2 g, respectively, to provide soln containing approx 100 mg/mL, 100 mg/mL, or 160 mg/mL of the drug, respectively. The appropriate dose of the drug should then be added to a compatible IV soln.

IM inj: Add 1.3 mL or 2.4 mL of an appropriate diluent (e.g. sterile water for inj, NaCl 0.9%) to a vial labeled as containing 500 mg or 1 g respectively, to provide a soln containing approx 280 mg/mL.

Side Effects

Generally Nitipime is well tolerated. However, few side-effects including rash, pruritus, urticaria, fever, headache, nausea, vomiting, diarrhea, dizziness, oral moniliasis may occur.

Toxicity

Symptoms of overdose include seizures, encephalopathy, and neuromuscular excitability.

Precaution

In patients with impaired renal function (creatinine clearance <60 ml/min), the dose of Nitipime should be adjusted. Nitipime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis.

Interaction

Increased potential for nephrotoxicity and ototoxicity of aminoglycosides. Increased risk of nephrotoxicity with potent diuretics (e.g. furosemide).

Food Interaction

No interactions found.

Volume of Distribution

  • 18.0 ±2.0 L
  • 0.3 ±0.1 L/kg [Pediatric]

Elimination Route

The absolute bioavailability of cefepime after an IM dose of 50 mg/kg was 82.3 (±15)% in eight patients.

Half Life

2.0 (± 0.3) hours in normal patients. The average half-life in patients requiring hemodialysis was 13.5 (± 2.7) hours and in patients requiring continuous peritoneal dialysis was 19.0 (± 2.0) hours.

Clearance

  • 120 mL/min [Healthy adult male receiving a single 30-minute IV infusions of cefepime]
  • 3.3 +/-1.0 mL/min/kg [Petriatic patients (2 months – 11 years of age) receiving a single IV dose]

Elimination Route

Elimination of cefepime is principally via renal excretion with an average (±SD) half-life of 2 (±0.3) hours and total body clearance of 120 (±8) mL/min in healthy volunteers. Nitipime is excreted in human milk.

Pregnancy & Breastfeeding use

Pregnancy: There are no adequate and well-controlled studies of Nitipime use in pregnant women. Nitipime should be used during pregnancy only if clearly needed.

Lactation: Nitipime is excreted in human breast milk in very low concentrations. Caution should be exercised when Nitipime is administered to a nursing woman.

Contraindication

Hypersensitivity to cefepime or other cephalosporins.

Acute Overdose

Patients who receive an overdose should be carefully observed and given supportive treatment. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

Interaction with other Medicine

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Nitipime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Storage Condition

Nitipime Hydrochloride should be stored in a cool & dry place and protected from light.

Innovators Monograph

You find simplified version here Nitipime

Nitipime contains Cefepime see full prescribing information from innovator Nitipime Monograph, Nitipime MSDS, Nitipime FDA label

FAQ

What is Nitipime used for?

Nitipime is a fourth-generation cephalosporin antibiotic. Nitipime has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both types of organism than third-generation agents. Nitipime also used in the treatment of various bacterial infections caused by susceptible bacteria, such as pneumonia, urinary tract infections, and skin infections.

How safe is Nitipime?

The safety profile of Nitipime is excellent and comparable to that of Nitipime and those reported for other cephalosporins.

How does Nitipime work?

Nitipime works by killing bacteria or preventing their growth.

What are the common side effects of Nitipime?

Common side effects of Nitipime are include:

  • Abdominal or stomach cramps
  • back, leg, or stomach pains
  • bleeding gums, nosebleeds
  • confusion
  • convulsions
  • dark urine
  • difficulty with breathing
  • fever, chills
  • general body swelling
  • headache
  • irregular heartbeats
  • loss of appetite
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • nausea or vomiting
  • numbness and tingling around the mouth, fingertips, or feet
  • tremor
  • yellowing of the eyes or skin

Is Nitipime safe during pregnancy?

Nitipime should be used during pregnancy only if clearly needed. The Nitipime group is generally considered safe for use during pregnancy, but each drug is slightly different and may have different side effects.

Is Nitipime safe during breastfeeding?

Nitipime is acceptable in nursing mothers.

Can I drink alcohol with Nitipime?

Using alcohol with certain medicines may also cause interactions to occur.

Can I drive after taking Nitipime?

Nitipime generally does not cause any problems with your ability to drive a car or operate machinery.

When should be best taken of Nitipime?

Nitipime are supposed to be taken on an empty stomach should be taken about an hour before a meal, or 2 hours after a meal.

How should be taken of Nitipime ?

Nitipime injection can also be given intramuscularly. It is usually given every 8 or 12 hours for 7 to 10 days. A healthcare provider can teach you how to properly use the medication by yourself.

How long does Nitipime take to work?

Nitipime takes about six to eight hours for food to pass through your stomach and small intestine.

What is the half-life of Nitipime?

The half-life of Nitipime was approximately 2.3 hours.

Can Nitipime cause kidney failure?

Patients with renal failure who are treated with Nitipime has been reported sporadically.

Who should not take Nitipime ?

You should not use this Nitipime if you are allergic to Nitipime or other cephalosporin antibiotic.

What happens if I miss a dose?

Use the Nitipime 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.

Can I take Nitipime for a long time?

Continue to use this Nitipime for the full time prescribed, even if symptoms disappear after a few days. Stopping the Nitipime too early may result in a return of the infection.


Is Nitipime bad for liver?

Nitipime is considered well-tolerated and is associated with few adverse reactions. Although Nitipime -induced neurotoxicity and nephrotoxicity have been reported in recent years, there are currently no formal reports of hepatic injury caused by this Nitipime.

How long can I take Nitipime?

Use this Nitipime for the full prescribed length of time, even if your symptoms quickly improve. Some infections must be treated for up to 6 weeks.

Can I overdose on Nitipime?

Nitipime related neurological toxicity has been associated with overdosing due to severe renal dysfunction.

How often can I take Nitipime?

Nitipime is usually given every 8 or 12 hours for 7 to 10 days.

What happens if I miss a dose?

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.

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