Tizime250 mg/vial

Lower Respiratory Tract Infections

Tizime is an established, guideline-supported treatment for lower respiratory tract infections, including hospital-acquired pneumonia (including ventilator-associated pneumonia) caused by susceptible organisms such as Pseudomonas aeruginosa, Klebsiella pneumoniae, and other susceptible gram-negative bacteria, administered under medical or hospital supervision.

Urinary Tract Infections

Tizime is an established treatment for complicated and uncomplicated urinary tract infections caused by susceptible organisms, including infections due to Pseudomonas aeruginosa and other susceptible gram-negative pathogens.

Intra-Abdominal Infections

Tizime is established therapy for complicated intra-abdominal infections (including peritonitis) caused by susceptible organisms, generally used in combination with an agent active against anaerobic bacteria, since Tizime itself has little activity against anaerobes.

Skin and Skin-Structure Infections

Tizime is an established treatment for skin and skin-structure infections caused by susceptible organisms.

Bone and Joint Infections

Tizime is an established treatment for bone and joint infections caused by susceptible organisms.

Gynecologic Infections

Tizime is an established treatment for gynecologic infections caused by susceptible organisms.

Bacterial Septicemia

Tizime is an established treatment for bacteremia/septicemia caused by susceptible organisms.

Central Nervous System Infections

Tizime is an established treatment for meningitis and other central nervous system infections caused by susceptible organisms, reflecting its ability to penetrate the blood-brain barrier, particularly when the meninges are inflamed; it is used under specialist/hospital direction.

Pseudomonas aeruginosa Infections (Notable Antipseudomonal Activity)

Tizime has notable antipseudomonal activity and is a guideline-recognized option for serious infections caused by Pseudomonas aeruginosa, including in patients with cystic fibrosis or febrile neutropenia, often as part of combination regimens for the most severe presentations.

Empiric Therapy in Febrile Neutropenia (Guideline-Supported/Adjunct Use)

Tizime is a guideline-recognized option for empiric monotherapy or combination therapy in febrile neutropenic patients at risk of serious gram-negative infection, used under specialist oncology/infectious-disease direction.

Tizime is administered only by or under the supervision of a qualified healthcare professional in a hospital or clinical setting, as it is given by intravenous or intramuscular injection.

Ceftazidime Pentahydrate is supplied as a sterile powder for injection, available in strengths equivalent to 250 mg, 500 mg, 1 gram, and 2 grams of ceftazidime base per vial (the pentahydrate salt form provides the labeled amount of active ceftazidime). Exact strengths, pack sizes, and the presence of added sodium carbonate (used to aid dissolution) vary by manufacturer; some presentations are combined with dextrose for premixed intravenous infusion.

Antibiotic — Third-generation Cephalosporin (beta-lactam antibiotic class) with antipseudomonal activity

Ceftazidime Pentahydrate is a bactericidal, third-generation cephalosporin that exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) within the bacterial cell wall, inhibiting the final transpeptidation (cross-linking) step of peptidoglycan synthesis. This action weakens the bacterial cell wall and leads to cell lysis and death. Ceftazidime Pentahydrate is stable to hydrolysis by many bacterial beta-lactamases, which contributes to its broad gram-negative spectrum, including notable activity against Pseudomonas aeruginosa.

Ceftazidime Pentahydrate is not appreciably absorbed after oral administration and is therefore given by the intravenous or intramuscular route. Following intravenous or intramuscular administration, Ceftazidime Pentahydrate is widely distributed into body tissues and fluids, including cerebrospinal fluid when the meninges are inflamed, bile, sputum, and bone. Ceftazidime Pentahydrate is minimally protein-bound (approximately 10%) and is not significantly metabolized; it is eliminated largely unchanged by the kidneys via glomerular filtration, with an elimination half-life of approximately 1.5 to 2 hours in patients with normal renal function. Renal impairment substantially prolongs the half-life of Ceftazidime Pentahydrate and requires dose or interval adjustment.

• Tizime is given only by intravenous (IV) infusion/injection or intramuscular (IM) injection; it is not taken by mouth.
• Tizime is administered by, or under the direct supervision of, a qualified healthcare professional, typically in a hospital or clinical setting.
• For IV use, Tizime is reconstituted and further diluted as directed, then given by slow intravenous injection (over 3–5 minutes) or by intermittent infusion (over approximately 15–30 minutes); see Reconstitution below.
• For IM use, Tizime is reconstituted with an appropriate diluent (e.g., sterile water for injection or 1% lidocaine hydrochloride, where locally appropriate) and injected deep into a large muscle mass.
• Avoid intra-arterial injection or accidental injection into or near nerve tissue.
• Take Tizime exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice, and complete the full prescribed course even if symptoms improve early.

• Aminoglycosides (e.g., gentamicin, amikacin): concurrent use with Tizime may increase the risk of nephrotoxicity; renal function should be monitored closely when these agents are combined, even though the combination is sometimes used intentionally for synergy against Pseudomonas aeruginosa.
• Loop diuretics (e.g., furosemide): concurrent use with Tizime and other cephalosporins may increase the risk of nephrotoxicity, particularly in patients with renal impairment.
• Chloramphenicol: in vitro antagonism has been demonstrated between chloramphenicol and Tizime; concurrent use should be avoided when possible.
• Other nephrotoxic drugs: caution is advised when Tizime is combined with other agents known to impair renal function, as combined effects on the kidney may be additive.
• Vancomycin and other drugs (physical/Y-site incompatibility): Tizime is physically incompatible with vancomycin and certain other drugs when mixed in the same intravenous line or container; lines should be flushed thoroughly between infusions of incompatible drugs.
• Live bacterial vaccines (e.g., oral typhoid vaccine): antibiotics including Tizime may reduce the effectiveness of live bacterial vaccines; vaccination should generally be deferred until after completing a course of Tizime.

Common Side Effects

• Local reactions at the injection site, such as pain, phlebitis, or inflammation following IV administration
• Diarrhea, nausea, or vomiting
• Skin rash, itching (pruritus), or urticaria
• Positive Coombs' test (without hemolysis) in some patients

Serious Side Effects (Seek Medical Attention)

• Signs of a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, difficulty breathing, or anaphylaxis (see Contraindications and Precautions and Warnings)
• Severe, persistent, or bloody diarrhea, which may indicate Clostridioides difficile-associated diarrhea or colitis, and can occur even weeks after stopping Tizime
• New or worsening seizures, myoclonus, confusion, or reduced consciousness, particularly with high doses or in patients with renal impairment (see Precautions and Warnings)
• Severe skin reactions such as blistering, peeling skin, or widespread rash
• Signs of a blood disorder, such as unusual bruising, bleeding, or persistent sore throat/fever
• Yellowing of the skin or eyes, dark urine, or unusual tiredness, which may indicate liver injury

Pregnancy

Tizime crosses the placenta. Reproduction studies have not shown evidence of harm to the fetus, and Tizime is generally considered acceptable for use in pregnancy when a serious susceptible infection clearly requires treatment; however, Tizime should be used only if clearly needed, and the potential benefit should justify the potential risk to the fetus. Use of Tizime in pregnancy should always be directed by a qualified physician.

Breastfeeding

Tizime is excreted into human breast milk in low concentrations. Tizime should be used with caution during breastfeeding, and only if clearly needed, since the potential benefit to the mother should be weighed against the potential effects on the nursing infant, such as disturbance of gut flora, diarrhea, or allergic sensitization; consult a physician before using Tizime while breastfeeding.

• Hypersensitivity and anaphylaxis: serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with Tizime and other cephalosporins, more often in patients with a history of allergies. Before starting Tizime, patients should be questioned about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibiotics.
• Cross-reactivity with penicillin allergy: a history of penicillin allergy increases the risk of a hypersensitivity reaction to Tizime; Tizime should be given with caution to penicillin-allergic patients and only if clearly needed, with appropriate monitoring.
• Clostridioides difficile-associated diarrhea (CDAD): as with nearly all antibiotics, Tizime can disturb normal gut flora and permit overgrowth of C. difficile, ranging from mild diarrhea to severe, life-threatening colitis; this should be considered in any patient who develops diarrhea during or after treatment with Tizime.
• Seizures and neurotoxicity: high doses of Tizime, particularly in patients with renal impairment whose dose has not been appropriately reduced, have been associated with seizures, encephalopathy, tremor, myoclonus, and confusion; the dose of Tizime must be reduced according to renal function to minimize this risk.
• Renal impairment: since Tizime is eliminated primarily by the kidneys, patients with reduced renal function require dose and/or interval adjustment, with close monitoring of renal function during prolonged therapy.
• Superinfection: prolonged use of Tizime may result in overgrowth of non-susceptible organisms, including fungi and resistant bacteria; clinical response should be monitored, and appropriate measures taken if superinfection occurs.
• Antibiotic stewardship: take Tizime exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice. Misuse or incomplete courses of Tizime can promote antibiotic-resistant bacteria and reduce the future effectiveness of Tizime and other antibiotics.
• Administered under medical supervision: Tizime is an injectable antibiotic given intravenously or intramuscularly and is administered by, or under the direct supervision of, a qualified healthcare professional in a hospital or clinical setting.

Overdose or excessively high blood levels of Tizime, particularly in patients with renal impairment whose dose has not been reduced appropriately, may cause neurological effects including seizures, encephalopathy, tremor, myoclonus, confusion, and reduced consciousness.

If an overdose of Tizime is suspected, seek immediate medical attention or contact emergency services/a poison control center right away. Management is supportive and symptomatic; because Tizime is administered in a hospital or clinical setting, overdose is typically identified and managed promptly by healthcare staff. Tizime can be removed from the circulation by hemodialysis or peritoneal dialysis in cases of severe overdose or accumulation due to renal impairment. Do not attempt to manage a suspected overdose at home without professional medical guidance.

Store unreconstituted Tizime powder for injection at room temperature (below 30°C/86°F), protected from light and moisture, in the original container, and out of the reach and sight of children. After reconstitution, solutions of Tizime should generally be used promptly; if not used immediately, follow the manufacturer's specific storage instructions (reconstituted solutions are typically stable for a limited period at room temperature and for a longer period under refrigeration at 2–8°C). Do not freeze reconstituted solutions unless the manufacturer's labeling specifically permits it, and do not use Tizime beyond its expiry date or if the solution shows particulate matter or discoloration.

Children

Tizime is approved for use in neonates, infants, and children, with dosing based on body weight and age; see Dosage and Pediatric Uses for details. Safety and efficacy in premature neonates have not been as extensively established as in term neonates and older infants.

Elderly

No specific dose reduction of Tizime is required in elderly patients based on age alone, provided renal function is normal. Because renal function commonly declines with age, elderly patients should have renal function assessed, and the dose/interval of Tizime adjusted accordingly if impairment is present.

Renal Impairment

Because Tizime is eliminated primarily by the kidneys, patients with reduced creatinine clearance require a reduced dose and/or extended dosing interval to avoid drug accumulation and reduce the risk of neurotoxicity, including seizures; consult a nephrology or pharmacy dosing reference for precise adjustment based on the degree of impairment (see Dosage table above).

Hepatic Impairment

Tizime is eliminated primarily by the kidneys rather than the liver, and formal dose adjustment for hepatic impairment alone is not well established; Tizime can generally be used at standard doses in patients with hepatic impairment and normal renal function, under medical supervision.

Pregnant and Breastfeeding Women

See the Pregnancy and Lactation section above for detailed guidance on the use of Tizime in this population.

Tizime powder for injection must be reconstituted before use.

• For IM injection or IV bolus: reconstitute with the diluent and volume specified on the manufacturer's label (commonly sterile water for injection); carbon dioxide is released during dissolution, and gentle swirling (not vigorous shaking) is recommended. Allow any froth to settle before withdrawing the dose.
• For intermittent IV infusion: reconstitute as above, then further dilute in a compatible intravenous fluid (e.g., 0.9% sodium chloride or 5% dextrose) to the volume directed for infusion.
• Inspect the reconstituted solution of Tizime visually for particulate matter and discoloration before administration; the solution should not be used if either is present.
• Use reconstituted or diluted Tizime solutions promptly, or store as directed by the manufacturer; follow local hospital protocols for storage time and temperature after reconstitution.
• Do not mix Tizime with other drugs in the same syringe or infusion container unless compatibility has been confirmed, since Tizime is physically incompatible with certain drugs (e.g., vancomycin).

Antibiotics > Beta-lactam antibiotics > Cephalosporins > Third-generation cephalosporins (antipseudomonal)

Ceftazidime Pentahydrate exerts its bactericidal effect by binding to penicillin-binding proteins (PBPs) located within the bacterial cell wall, inhibiting the transpeptidation (cross-linking) step of peptidoglycan biosynthesis that is essential for cell-wall structure and integrity. This interference, together with continued activity of bacterial autolytic enzymes, leads to lysis and death of actively dividing, susceptible bacteria. Ceftazidime Pentahydrate is notably stable against hydrolysis by many bacterial beta-lactamases, which underlies its broad gram-negative spectrum and its distinctive activity against Pseudomonas aeruginosa compared with many other cephalosporins.

B (FDA legacy pregnancy category, as previously assigned prior to the current Pregnancy and Lactation Labeling Rule; see Pregnancy and Lactation section for current, narrative-based guidance)

Tizime is approved for use in neonates, infants, and children for the same categories of susceptible bacterial infections as in adults, including serious infections such as meningitis, septicemia, and infections caused by Pseudomonas aeruginosa, with dosing based on body weight and age. In infants and children aged 1 month to 12 years, the usual dose of Tizime is 30–50 mg/kg given intravenously every 8 hours, not to exceed 6 grams per day. In neonates from birth to 4 weeks of age, the usual dose of Tizime is 30 mg/kg given intravenously every 12 hours, reflecting immature renal function and drug clearance in this age group.

Safety and efficacy of Tizime in premature neonates have not been as extensively established as in term neonates and older infants, and dosing in this population should be directed by a neonatologist or pediatric specialist. As in adults, the dose of Tizime should be adjusted in children with renal impairment.