Fthazid 1000 mg
UkraineTable of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FTAZID 1000 mg (FTAZID 1000 mg)
Composition:
Active substance: ceftazidime;
One vial contains ceftazidime equivalent to anhydrous ceftazidime (a sterile mixture of ceftazidime pentahydrate and sodium carbonate) 1000 mg.
Pharmaceutical form. Powder for solution for injection.
Main physicochemical properties: white or almost white crystalline powder.
Pharmacotherapeutic group.
Antibacterial agents for systemic use. Other beta-lactam antibiotics. Third-generation cephalosporins. Ceftazidime. ATC code J01DD02.
Pharmacological properties.
Pharmacodynamics.
Ceftazidime is a bactericidal cephalosporin antibiotic whose mechanism of action is related to inhibition of bacterial cell wall synthesis. It has high activity against a broad spectrum of gram-positive and gram-negative bacteria, including strains resistant to gentamicin and other aminoglycosides. It is highly stable against the action of most beta-lactamases produced by both gram-positive and gram-negative microorganisms. Ceftazidime demonstrates high in vitro activity and acts within a narrow range of MIC (minimum inhibitory concentration) against most infectious agents. In vitro studies have shown that when the drug is used in combination with aminoglycoside antibiotics, an additive effect is observed, and in some experiments with certain strains, synergism has also been documented.
The prevalence of acquired resistance among isolated species may vary depending on geographical region and time; therefore, local information on resistance patterns is necessary, especially when treating severe infections. If local resistance prevalence is such that the drug's efficacy in treating at least some types of infections is questionable, this should be taken into account.
In vitro studies have demonstrated that ceftazidime is active against the microorganisms listed below.
| Usually susceptible species |
| Gram-positive aerobes: Streptococcus pyogenes Streptococcus agalactiae |
| Gram-negative aerobes: Citrobacter koseri Haemophilus influenzae Moraxella catarrhalis Neisseria meningitidis Pasteurella multocida Proteus mirabilis Proteus spp (other) Providencia spp. |
| Species that may develop resistance |
| Gram-negative aerobes: Acinetobacter baumannii+ Burkholderia cepacia Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Klebsiella spp (other) Pseudomonas aeruginosa Serratia spp Morganella morganii |
| Gram-positive aerobes: Staphylococcus aureus* Staphylococcus pneumoniae** Viridans group streptococcus |
| Gram-positive anaerobes: Clostridium perfringens Peptostreptococcus spp. |
| Gram-negative anaerobes: Fusobacterium spp. |
| Resistant organisms |
| Gram-positive aerobes: Enterococcus spp including Enterococcus faecalis, Enterococcus faecium Listeria spp |
| Gram-positive anaerobes: Clostridium difficile |
| Gram-negative anaerobes: Bacteroides spp. (many strains of Bacteroides fragilis are resistant). |
| Others: Chlamydia spp Mycoplasma spp Legionella spp |
| *S. aureus methicillin-susceptible strains are considered to have low susceptibility to ceftazidime. All methicillin-resistant S. aureus are resistant to ceftazidime. **S. pneumoniae strains with intermediate or penicillin-resistant susceptibility may be expected to have reduced susceptibility to ceftazidime. + High resistance rates are observed in one or more EU countries/regions. |
Pharmacokinetics.
Absorption.
In patients, after intramuscular injection of 500 mg and 1 g, mean peak concentrations of 18 and 37 mg/L are rapidly achieved, respectively. Within 5 minutes after intravenous bolus administration of 500 mg, 1 g, or 2 g, serum concentrations reach mean levels of 46, 87, or 170 mg/L, respectively. The pharmacokinetics of ceftazidime are linear within the single dose range of 0.5–2 g following intravenous or intramuscular administration.
Distribution.
Plasma protein binding is approximately 10%. Ceftazidime concentrations exceeding the MIC for most common pathogenic microorganisms are achieved in tissues and fluids such as bone, heart, bile, sputum, intraocular fluid, synovial fluid, pleural fluid, and peritoneal fluid. Ceftazidime rapidly crosses the placenta and is excreted into breast milk. The drug poorly penetrates the intact blood-brain barrier; in the absence of inflammation, concentrations in the central nervous system (CNS) are low. However, during meningitis, CNS concentrations of ceftazidime reach 4–20 mg/L or higher, which corresponds to therapeutic levels.
Biotransformation.
Ceftazidime is not metabolized in the body.
Elimination.
After parenteral administration, high and sustained serum concentrations of ceftazidime are achieved. The elimination half-life is approximately 2 hours. The drug is excreted unchanged in active form in urine via glomerular filtration; about 80–90% of the dose is recovered in urine within 24 hours. Less than 1% is excreted in bile, significantly limiting the amount of drug reaching the intestine.
Renal impairment.
In patients with impaired renal function, elimination of ceftazidime is reduced; therefore, dosage adjustment is required (see section «Dosage and administration»).
Hepatic impairment.
Mild to moderate hepatic dysfunction, in the absence of renal impairment, did not affect the pharmacokinetics of ceftazidime in patients receiving the drug at a dose of 2 g intravenously every 8 hours for 5 days (see section «Dosage and administration»).
Elderly patients.
The reduced clearance of ceftazidime observed in elderly patients is primarily related to age-related decline in renal function. The mean elimination half-life in elderly patients (aged 80 years) is 3.5–4 hours, both after single-dose administration and after prolonged administration (over 7 days) at a dose of 2 g twice daily intravenously (bolus).
Children.
The elimination half-life of ceftazidime is prolonged in full-term and preterm neonates, ranging from 4.5 to 7.5 hours after administration of a 25–30 mg/kg dose. However, in patients aged 2 months and older, the elimination half-life is similar to that in adults.
Clinical characteristics.
Indications.
The medicinal product is indicated for the treatment of infections in adults and children, including newborns:
- nosocomial (hospital-acquired) pneumonia;
- respiratory tract infections in patients with cystic fibrosis;
- bacterial meningitis;
- chronic suppurative otitis media;
- malignant external otitis;
- complicated urinary tract infections;
- complicated skin and soft tissue infections;
- complicated intra-abdominal infections;
- bone and joint infections;
- peritonitis associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis;
- bacteremia associated or potentially associated with any of the aforementioned infections;
- infections in febrile neutropenic patients suspected to be due to bacterial infection.
The medicinal product may be used for prophylaxis of infectious complications during prostate surgery (transurethral resection).
When prescribing ceftazidime, consideration should be given to its antibacterial spectrum, which primarily includes Gram-negative aerobes (see sections "Special precautions for use" and "Pharmacological properties").
The medicinal product should be used in combination with other antibacterial agents if microorganisms causing the infection are expected to be outside the spectrum of ceftazidime activity.
The medicinal product should be prescribed in accordance with official recommendations for the use of antibacterial agents.
Contraindications.
Hypersensitivity to cephalosporin antibiotics.
Hypersensitivity to ceftazidime or to any of the excipients of the medicinal product.
History of severe hypersensitivity (e.g., anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams, and carbapenems).
Interaction with other medicinal products and other forms of interaction.
Interaction studies have been conducted only with probenecid and furosemide.
Concomitant administration of high doses of the medicinal product with nephrotoxic medicinal products may adversely affect renal function (see section "Special precautions for use").
Chloramphenicol is an in vitro antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon is unknown; however, if concomitant use of the medicinal product with chloramphenicol is proposed, the possibility of antagonism should be considered.
Special precautions for use.
Hypersensitivity reactions.
As with other beta-lactam antibiotics, severe and sometimes fatal hypersensitivity reactions have been reported. If severe hypersensitivity reactions occur, ceftazidime therapy must be discontinued immediately and appropriate emergency measures should be initiated.
Prior to starting treatment, it is necessary to determine whether the patient has previously experienced severe hypersensitivity reactions to ceftazidime, cephalosporin antibiotics, or other beta-lactam antibiotics.
Ceftazidime should be administered with particular caution to patients with a history of mild allergic reactions to other beta-lactam antibiotics.
Antimicrobial spectrum.
Ceftazidime has a limited antibacterial spectrum. It is not an appropriate agent for monotherapy of certain types of infections, except when the causative pathogen is known to be susceptible to this drug or when there is a high probability that the pathogen will be susceptible to ceftazidime. This is particularly important when considering treatment of patients with bacteremia, bacterial meningitis, skin and soft tissue infections, or bone and joint infections. Furthermore, ceftazidime is susceptible to hydrolysis by certain extended-spectrum beta-lactamases (ESBLs). Therefore, when selecting ceftazidime for therapy, local data on the prevalence of microorganisms producing extended-spectrum beta-lactamases should be taken into account.
Pseudomembranous colitis.
Cases of pseudomembranous colitis, ranging from mild to life-threatening, have been reported during antibiotic therapy. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic use. If diarrhea is persistent and severe, or if abdominal cramps occur, therapy should be discontinued immediately, further diagnostic evaluation should be performed, and specific treatment for Clostridium difficile should be initiated if necessary. Medicinal products that inhibit intestinal peristalsis should not be prescribed.
Renal function.
Concomitant administration of high doses of cephalosporins and nephrotoxic medicinal products, such as aminoglycosides or potent diuretics (e.g., furosemide), may adversely affect renal function.
Ceftazidime is eliminated via the kidneys; therefore, the dose should be reduced according to the degree of renal impairment. Patients with impaired renal function require careful monitoring of the safety and efficacy of the drug. Cases of neurological complications have been reported when the dose was not appropriately reduced in patients with renal impairment (see sections "Dosage and administration" and "Side effects").
Overgrowth of non-susceptible microorganisms.
As with other broad-spectrum antibiotics, prolonged use of this medicinal product may result in overgrowth of non-susceptible microorganisms (e.g., Enterococci, fungi); in such cases, discontinuation of therapy or other interventions may be necessary. Continuous monitoring of the patient's condition is essential.
Effect on laboratory parameters.
Ceftazidime does not interfere with enzymatic methods for detecting glucosuria but may slightly interfere with copper reduction methods (Benedict's, Fehling's, "Clinitest"), potentially yielding false-positive results.
Ceftazidime does not interfere with creatinine measurement using the alkaline picrate method.
A positive Coombs test has occurred in approximately 5% of patients receiving ceftazidime. This phenomenon may interfere with blood cross-matching tests.
Sodium content.
The medicinal product contains sodium. One vial containing 1000 mg of ceftazidime contains 52 mg (2.3 mmol) of sodium, which should be taken into account when treating patients on a sodium-restricted diet.
Use during pregnancy or breastfeeding.
Pregnancy.
Data on the use of ceftazidime during pregnancy are limited. Animal studies do not indicate any direct or indirect harmful effects on pregnancy, labor, or embryonic and postnatal development. The use of this medicinal product during pregnancy is possible only if the expected benefit outweighs the potential risk to the mother and fetus.
Breastfeeding.
Ceftazidime passes into breast milk in small amounts, but when used at therapeutic doses, no effect on the breastfed infant is expected. The medicinal product may be used during breastfeeding.
Fertility.
No data available.
Ability to affect reaction rate when driving or operating machinery.
No specific studies have been conducted. However, the occurrence of adverse reactions such as dizziness may affect the ability to drive or operate machinery (see section "Side effects").
Method of administration and dosage.
Adults and children weighing ≥ 40 kg.
| Intermittent (periodic) administration |
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| Infection: |
Dose administered: |
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100–150 mg/kg body weight per day every 8 hours, maximum dose 9 g per day1 |
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2 g every 8 hours |
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1–2 g every 8 hours |
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1–2 g every 8 or 12 hours |
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1 g at induction of anesthesia, 1 g at the time of catheter removal |
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1–2 g every 8 hours |
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| Continuous (prolonged) infusion |
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| Infection: |
Dose administered: |
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A loading dose of 2 g is administered, followed by continuous infusion of 4 to 6 g every 24 hours1 |
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| 1 In adult patients with normal renal function, administration of 9 g per day did not cause adverse reactions. *When associated or suspected to be associated with infections listed in the section "Indications". |
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Children weighing <40 kg
| Infants and children > 2 months of age and weighing < 40 kg. |
Infection |
Usual dose |
| Intermittent (periodic) administration |
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| Complicated urinary tract infections |
100–150 mg/kg body weight per day in 3 divided doses, maximum dose – 6 g per day |
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| Chronic otitis media |
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| Malignant external otitis |
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| Neutropenia in children |
150 mg/kg body weight per day in 3 divided doses, maximum dose – 6 g per day |
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| Respiratory tract infections in patients with cystic fibrosis |
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| Bacterial meningitis |
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| Bacteremia* |
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| Bone and joint infections |
100–150 mg/kg body weight per day in 3 divided doses, maximum dose – 6 g per day |
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| Complicated skin and soft tissue infections |
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| Complicated intra-abdominal infections |
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| Peritonitis associated with continuous ambulatory peritoneal dialysis |
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| Continuous infusion. |
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| Febrile neutropenia |
A loading dose of 60–100 mg/kg body weight is administered, followed by continuous infusion of 100–200 mg/kg body weight per day, maximum dose 6 g per day |
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| Hospital-acquired pneumonia |
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| Respiratory tract infections in patients with cystic fibrosis |
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| Bacterial meningitis |
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| Bacteremia* |
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| Bone and joint infections |
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| Complicated skin and soft tissue infections |
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| Complicated intra-abdominal infections |
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| Peritonitis associated with continuous ambulatory peritoneal dialysis |
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| Infants and children ≤ 2 months of age. |
Infection |
Usual dose |
| Intermittent (periodic) administration. |
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| Most infections |
25–60 mg/kg body weight/day in 2 divided doses1 |
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| 1In infants and children ≤ 2 months of age, the serum half-life may be 3–4 times longer than in adults. *If associated or suspected to be associated with the infections listed in the section "Indications". |
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Children.
The safety and efficacy of the medicinal product administered by continuous intravenous infusion in infants and children aged ≤ 2 months have not been established.
Geriatric patients.
Due to the reduced clearance of ceftazidime with age, for geriatric patients with acute infections, the daily dose generally should not exceed 3 g, particularly in patients aged 80 years and older.
Hepatic impairment.
Dosage adjustment is not required in patients with mild to moderate hepatic impairment. Clinical studies in patients with severe hepatic impairment have not been conducted. Careful clinical monitoring of efficacy and safety of the medicinal product is recommended.
Renal impairment.
Ceftazidime is eliminated unchanged by the kidneys. Therefore, the dose should be reduced in patients with impaired renal function.
The initial dose should be 1 g. The maintenance dose should be based on glomerular filtration rate.
Recommended maintenance doses of ceftazidime in renal impairment: intermittent (periodic) administration.
Adults and children with body weight ≥ 40 kg.
| Creatinine clearance, mL/min |
Approximate serum creatinine level, µmol/L (mg/dL) |
Recommended single dose of ceftazidime, g |
Dosing interval, hours |
| 50–31 |
150–200 (1.7–2.3) |
1 |
12 |
| 30–16 |
200–350 (2.3–4.0) |
1 |
24 |
| 15–6 |
350–500 (4.0–5.6) |
0.5 |
24 |
| < 5 |
> 500 (> 5.6) |
0.5 |
48 |
For patients with severe infections, the single dose may be increased by 50% or the frequency of administration correspondingly increased. For such patients, monitoring of ceftazidime serum levels is recommended.
For children, creatinine clearance should be calculated according to body surface area or body weight.
Children with body weight < 40 kg.
| Creatinine clearance, mL/min** |
Approximate serum creatinine level*, µmol/L (mg/dL) |
Recommended individual dose, mg/kg body weight |
Dosing interval, hours |
| 50–31 |
150–200 (1.7–2.3) |
25 |
12 |
| 30–16 |
200–350 (2.3–4.0) |
25 |
24 |
| 15–6 |
350–500 (4.0–5.6) |
12.5 |
24 |
| < 5 |
> 500 (> 5.6) |
12.5 |
48 |
*This serum creatinine level is calculated according to recommendations and may not precisely reflect the degree of renal function impairment in all patients with renal insufficiency.
** Creatinine clearance calculated based on body surface area, or measured.
Careful clinical monitoring of efficacy and safety of administration is recommended.
Recommended maintenance doses of ceftazidime in renal insufficiency – continuous (prolonged) infusion.
Adults and children with body weight ≥ 40 kg.
| Creatinine clearance, mL/min |
Approximate serum creatinine level, µmol/L (mg/dL) |
Dose |
| 50–31 |
150–200 (1.7–2.3) |
A loading dose of 2 g is administered, followed by continuous infusion of 1 to 3 g every 24 hours |
| 30–16 |
200–350 (2.3–4.0) |
A loading dose of 2 g is administered, followed by continuous infusion of 1 g every 24 hours |
| ≤15 |
>350 (>4.0) |
Not studied |
Dose selection should be cautious. Careful clinical monitoring of the efficacy and safety of the drug is recommended.
Children with body weight < 40 kg.
The safety and efficacy of administering the drug by continuous intravenous infusion in children with body weight < 40 kg and impaired renal function have not been established. Careful clinical monitoring of the efficacy and safety of its use is recommended.
If administration of the drug by continuous intravenous infusion is required in children with impaired renal function, creatinine clearance should be calculated according to the child's body surface area or body weight.
Hemodialysis.
The serum half-life of ceftazidime during hemodialysis ranges from 3 to 5 hours.
A supplemental dose of ceftazidime, as recommended in the table below, should be administered after each hemodialysis session.
Peritoneal dialysis.
Ceftazidime can be used during peritoneal dialysis, including standard regimens and continuous ambulatory peritoneal dialysis.
In addition to intravenous administration, ceftazidime may be added to the dialysis fluid (typically 125 to 250 mg per 2 L of dialysis solution).
For patients with renal insufficiency undergoing prolonged arteriovenous hemodialysis or high-flux hemofiltration in intensive care units, the recommended dose is 1 g daily as a single dose or divided doses. For low-flux hemofiltration, doses should be adjusted as in renal impairment. Dosing recommendations for patients undergoing venovenous hemofiltration and venovenous hemodialysis are provided in the tables below.
Dosing recommendations for ceftazidime in patients undergoing prolonged venovenous hemofiltration
| Residual renal function (creatinine clearance, ml/min) |
Maintenance dose (mg) according to ultrafiltration rate (ml/min)a |
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| 5 |
16.7 |
33.3 |
50 |
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| 0 |
250 |
250 |
500 |
500 |
| 5 |
250 |
250 |
500 |
500 |
| 10 |
250 |
500 |
500 |
750 |
| 15 |
250 |
500 |
500 |
750 |
| 20 |
500 |
500 |
500 |
750 |
The maintenance dose should be administered every 12 hours.
Dosing recommendations for ceftazidime in patients undergoing prolonged venovenous hemodialysis
| Residual renal function (creatinine clearance, ml/min) |
Replacement dose (mg) for dialysate at flow rate (ml/min)a |
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| 1.0 l/h |
2.0 l/h |
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| Ultrafiltration rate, (l/h) |
Ultrafiltration rate, (l/h) |
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| 0.5 |
1.0 |
2.0 |
0.5 |
1.0 |
2.0 |
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| 0 |
500 |
500 |
500 |
500 |
500 |
750 |
| 5 |
500 |
500 |
750 |
500 |
500 |
750 |
| 10 |
500 |
500 |
750 |
500 |
750 |
1000 |
| 15 |
500 |
750 |
750 |
750 |
750 |
1000 |
| 20 |
750 |
750 |
1000 |
750 |
750 |
1000 |
The maintenance dose should be administered every 12 hours.
Administration method.
The medicinal product is administered intravenously by injection or infusion, or by deep intramuscular injection. Recommended sites for intramuscular administration are the upper outer quadrant of the gluteus maximus muscle or the lateral part of the thigh.
Ceftazidime solutions may be administered directly into the vein or into an intravenous infusion system, if the patient is receiving parenteral fluids.
Standard recommended methods are intermittent (periodic) intravenous administration or continuous intravenous infusion.
Intramuscular administration should be used only when the intravenous route is not feasible or less suitable for the patient.
The dose depends on the severity of the disease, sensitivity, site and type of infection, as well as the patient's age and renal function.
Acquired resistance to the antibiotic varies in different regions and may change over time, and may differ substantially between individual strains. It is advisable to use local data on antibiotic susceptibility, especially when treating severe infections.
Preparation of injection solution.
The medicinal product is compatible with most commonly used intravenous infusion solutions. However, sodium bicarbonate for injection should not be used as a solvent (see « Incompatibility*»* ).
| Dose administered |
Route of administration |
Required amount of diluent (ml) |
Approximate concentration (mg/ml) |
| 1 g |
Intramuscular Intravenous bolus Intravenous infusion |
3 10 50 |
260 90 20 |
The color of the solution varies from pale yellow to amber depending on the concentration, solvent, and storage conditions. When the recommendations are followed, the drug's efficacy is not affected by variations in its coloration.
Ceftazidime at concentrations from 1 mg/mL to 40 mg/mL is compatible with the following solutions:
0.9% sodium chloride solution;
M/6 sodium lactate solution;
Hartmann's solution;
5% glucose solution;
0.225% sodium chloride and 5% glucose solution;
0.45% sodium chloride and 5% glucose solution;
0.9% sodium chloride and 5% glucose solution;
0.18% sodium chloride and 4% glucose solution;
10% glucose solution;
10% dextran 40 and 0.9% sodium chloride solution;
10% dextran 40 and 5% glucose solution;
6% dextran 70 and 0.9% sodium chloride solution;
6% dextran 70 and 5% glucose solution.
Ceftazidime at concentrations from 0.05 mg/mL to 0.25 mg/mL is compatible with peritoneal dialysis fluid (lactate).
Ceftazidime at the concentrations listed in the table above may be administered intramuscularly with 0.5% or 1% lidocaine hydrochloride solution.
Preparation of solutions for intramuscular or intravenous bolus injection:
- Insert the needle of the syringe through the vial stopper and add the recommended volume of diluent.
- Remove the syringe needle and shake the vial until a clear solution is obtained.
- Invert the vial. With the syringe plunger fully depressed, insert the needle into the vial. Withdraw the entire solution into the syringe, keeping the needle tip submerged in the solution at all times. The solution may be administered directly into the vein or, if necessary, via an infusion line if the patient is receiving parenteral fluids.
Preparation of solutions for intravenous infusion:
- Insert the needle of the syringe through the vial stopper and add the recommended volume of diluent.
- Remove the syringe needle and shake the vial until a clear solution is obtained.
- Invert the vial. With the syringe plunger fully depressed, insert the needle into the vial. Withdraw the entire solution into the syringe, keeping the needle tip submerged in the solution at all times. The withdrawn solution should be further diluted with diluent to a total volume of 50 mL and administered via an infusion set as usual.
The medicinal product is intended for single use; therefore, any unused solution should be discarded.
Children. The drug is indicated for use in children, including newborns.
Overdose.
Overdose may lead to neurological complications such as encephalopathy, seizures, and coma. Symptoms of overdose may occur in patients with renal impairment if the dose is not appropriately reduced (see sections "Dosage and Administration" and "Special Warnings and Precautions for Use"). Serum concentrations of ceftazidime can be reduced by hemodialysis or peritoneal dialysis.
Adverse Reactions.
The most commonly observed adverse effects are eosinophilia, thrombocytosis, phlebitis or thrombophlebitis at the site of intravenous administration, diarrhea, transient elevation of liver enzymes, maculopapular rash or urticaria, pain and/or inflammation following intramuscular injection, and positive Coombs test.
Infections and infestations: Candidiasis (including vaginitis and aphthous stomatitis).
Blood and lymphatic system disorders: Eosinophilia, thrombocytosis, neutropenia, leukopenia, thrombocytopenia, lymphocytosis, hemolytic anemia, and agranulocytosis.
Immune system disorders: Anaphylaxis (including bronchospasm and/or arterial hypotension).
Nervous system disorders: Dizziness, headache; neurological complications*, paresthesia.
*Cases of neurological complications such as tremor, myoclonia, seizures, encephalopathy, and coma have been reported in patients with renal impairment in whom the dose of ceftazidime was not appropriately reduced.
Vascular disorders: Phlebitis or thrombophlebitis at the site of intravenous administration.
Gastrointestinal disorders: Diarrhea, antibiotic-associated diarrhea and colitis**, nausea, vomiting, abdominal pain, taste disturbances.
**As with other cephalosporins, colitis may be Clostridium difficile-associated and may present as pseudomembranous colitis.
Renal and urinary system disorders: Uncommon – prolonged elevation of blood urea, blood urea nitrogen, and/or serum creatinine; very rare – interstitial nephritis, acute renal failure.
Hepatobiliary disorders: Transient elevation in levels of one or more liver enzymes (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma-glutamyl transferase, alkaline phosphatase), jaundice.
Skin and subcutaneous tissue disorders: Maculopapular rash or urticaria, pruritus, angioneurotic edema, polymorphic erythema, Stevens-Johnson syndrome, and toxic epidermal necrolysis, risk of drug reaction with eosinophilia and systemic symptoms (DRESS).
General disorders and administration site conditions: Pain and/or inflammation at the site of intramuscular injection, fever.
Investigations: Positive Coombs test.***
***A positive Coombs test is observed in approximately 5% of patients, which may interfere with blood grouping.
If any adverse events, side effects, or lack of therapeutic effect occur, they should be reported to the regulatory authority.
Shelf life.
2 years.
Storage conditions.
Store in the original packaging, protected from light, at a temperature not exceeding 25°C.
Keep out of reach of children.
Incompatibilities.
The medicinal product is less stable in sodium bicarbonate injection solution than in other intravenous infusion solutions. Therefore, sodium bicarbonate solution is not recommended as a solvent.
Ceftazidime and aminoglycosides should not be mixed in the same infusion system or syringe.
Cases of precipitate formation have been observed when vancomycin was added to ceftazidime solution. Therefore, it is recommended to flush infusion systems and intravenous catheters between administration of these two medicinal products.
Packaging.
1000 mg of powder in a glass vial, 1 vial per carton.
Prescription status. Prescription only.
Manufacturer.
Nitin Lifesciences Ltd. / Nitin Lifesciencеs Ltd.
Manufacturer's address.
Village-Rampur Road, Paonta Sahib, District Sirmour, Himachal Pradesh, India.
Marketing Authorization Holder.
Ochoa Impex / Ochoa Impex.
Address of the Marketing Authorization Holder.
E-360, Greater Kailash part-II, New Delhi-110048, India.