Bactolox

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BACTOLOX (BACTOLOX)

Composition:

Active substance: ceftazidime;

1 vial contains ceftazidime pentahydrate equivalent to ceftazidime 0.5 g or 1.0 g;

Excipient: sodium carbonate anhydrous.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: crystalline powder, white to light yellow in color.

Pharmacotherapeutic group.

Antibacterial agent for systemic use. Third-generation cephalosporins.

ATC code J01D D02.

Pharmacological properties.

Pharmacodynamics.

Ceftazidime is a bactericidal cephalosporin antibiotic whose mechanism of action is related to inhibition of bacterial cell wall synthesis.

Acquired resistance to the antibiotic varies across different regions and may change over time, with significant differences possible among individual strains. It is advisable to use local data on antibiotic susceptibility and prevalence of beta-lactamase-producing microorganisms with extended-spectrum activity, especially when treating severe infections.

Susceptible microorganisms

Gram-positive aerobes: Streptococcus pyogenes, Streptococcus agalactiae.

Gram-negative aerobes: Citrobacter koseri, Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitidis, Proteus mirabilis, Proteus spp., Providencia spp., Pasteurella multocida.

Strains with possible acquired resistance

Gram-negative aerobes: Acinetobacter baumannii, Burkholderia cepacia, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Klebsiella spp., Pseudomonas aeruginosa, Serratia spp., Morganella morganii.

Gram-positive aerobes: Staphylococcus aureus, Streptococcus pneumoniae, Viridans group streptococci.

Gram-positive anaerobes: Clostridium perfringens, Peptococcus spp., Peptostreptococcus spp.

Gram-negative anaerobes: Fusobacterium spp.

Resistant microorganisms

Gram-positive aerobes: Enterococcus spp., including E. faecalis and E. faecium, Listeria spp.

Gram-positive anaerobes: Clostridium difficile.

Gram-negative anaerobes: Bacteroides spp., including B. fragilis.

Others: Chlamydia spp., Mycoplasma spp., Legionella spp.

Pharmacokinetics.

After intramuscular injection of 500 mg and 1 g, mean peak serum concentrations of 18 mg/L and 37 mg/L, respectively, are rapidly achieved in patients. Within 5 minutes after intravenous bolus administration of 500 mg, 1 g, or 2 g, mean serum concentrations reach 46 mg/L, 87 mg/L, or 170 mg/L, respectively. Therapeutically effective concentrations persist in serum for up to 8–12 hours after both intravenous and intramuscular administration. Plasma protein binding is approximately 10%. Concentrations exceeding the minimum inhibitory concentration (MIC) for most common pathogenic microorganisms are achieved in tissues and body 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.

Ceftazidime is not metabolized in the body. After parenteral administration, high and sustained serum concentrations are achieved. The elimination half-life is approximately 2 hours. The drug is excreted unchanged and in active form via the urine by glomerular filtration; approximately 80–90% of the administered dose is recovered in urine within 24 hours. In patients with impaired renal function, ceftazidime elimination is reduced, and dosage adjustment is required. Less than 1% of the drug is excreted in bile, significantly limiting the amount reaching the intestinal tract.

Clinical characteristics.

Indications.

Treatment of the following infections in adults and children, including newborns:

• 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.

Treatment of bacteremia arising in patients as a result of any of the above infections.

The medicinal product Bactolox may be used for the treatment of patients with neutropenia and fever due to bacterial infection.

The medicinal product Bactolox may be used for prophylaxis of urinary tract infections during urological surgery (transurethral resection of the prostate).

When prescribing this medicinal product, its antibacterial spectrum directed primarily against Gram-negative aerobes should be taken into account (see sections "Pharmacological properties" and "Special instructions").

Bactolox should be used in combination with other antibacterial agents if it is expected that some of the microorganisms causing the infection are not covered by the spectrum of activity of ceftazidime.

The drug should be prescribed in accordance with current official guidelines for the use of antibacterial agents.

Contraindications.

Hypersensitivity to ceftazidime or to any of the excipients of the drug.

Hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g., anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams, and carbapenems).

Interaction with other medicinal products and other types of interactions.

Concomitant administration of high doses of the drug with nephrotoxic medicinal products may adversely affect renal function (see section "Special instructions").

Chloramphenicol is an in vitro antagonist of ceftazidime and other cephalosporins. The clinical significance of this phenomenon is unknown; however, if concomitant use of Bactolox and chloramphenicol is considered, antagonism should be taken into account.

Like other antibiotics, Bactolox may affect intestinal flora, leading to reduced reabsorption of estrogens and decreased efficacy of combined oral contraceptives.

Bactolox does not interfere with enzymatic methods for determining glucosuria; however, a minor interference may occur when using copper reduction methods (Benedict, Fehling, Clinitest).

Ceftazidime does not interfere with the alkaline picrate method for creatinine determination.

Special precautions for use.

As with other beta-lactam antibiotics, severe and occasionally fatal hypersensitivity reactions have been reported. If severe hypersensitivity reactions occur, ceftazidime therapy must be discontinued immediately and appropriate emergency measures initiated.

Before initiating treatment, patients should be questioned about previous hypersensitivity reactions to ceftazidime, cephalosporin antibiotics, or other beta-lactam antibiotics. The drug should be administered with caution to patients who have experienced mild hypersensitivity reactions to other beta-lactam antibiotics.

The medicinal product Bactolox has a limited antibacterial spectrum. It is not an appropriate agent for monotherapy of certain types of infections unless the causative pathogen is unknown and known to be susceptible to this drug, or there is a high likelihood that the probable pathogen will be susceptible to ceftazidime treatment. This is particularly important when considering treatment of patients with bacteremia, bacterial meningitis, skin and soft tissue infections, and bone and joint infections. Furthermore, ceftazidime is susceptible to hydrolysis by certain extended-spectrum beta-lactamases. Therefore, when selecting ceftazidime for treatment, information regarding the prevalence of microorganisms producing extended-spectrum beta-lactamases should be taken into account.

Serious skin adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with ceftazidime. These reactions may be life-threatening or fatal (frequency unknown).

Patients should be informed about the signs and symptoms of these reactions, and careful monitoring for skin reactions is required.

If symptoms suggesting these reactions occur, ceftazidime should be discontinued immediately and alternative therapy considered.

If a serious reaction such as SJS, TEN, DRESS syndrome, or AGEP develops during ceftazidime treatment, re-administration of this drug is absolutely contraindicated.

Concomitant treatment with high doses of cephalosporins and nephrotoxic drugs, such as aminoglycosides or potent diuretics (e.g., furosemide), may adversely affect renal function. Clinical experience with ceftazidime has shown that this is unlikely when recommended dosages are followed. There are no data indicating that ceftazidime adversely affects renal function at usual therapeutic doses.

Ceftazidime is eliminated by the kidneys; therefore, the dose should be reduced according to the degree of renal impairment. Cases of neurological complications have been reported when the dose was not appropriately reduced (see sections "Dosage and administration" and "Adverse reactions").

As with other broad-spectrum antibiotics, prolonged treatment with ceftazidime may result in overgrowth of non-susceptible microorganisms (e.g., Candida, Enterococci); in such cases, discontinuation of therapy or other necessary measures may be required. Close monitoring of the patient is essential.

Cases of pseudomembranous colitis, ranging from mild to life-threatening, have been reported with antibiotic use. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic therapy. If prolonged or significant diarrhea occurs, or if abdominal cramps develop, treatment should be discontinued immediately, further investigations performed, and specific therapy for Clostridium difficile initiated if necessary. Medicinal products that inhibit intestinal motility should not be administered.

As with other broad-spectrum cephalosporins and penicillins, some previously susceptible strains of Enterobacter spp. and Serratia spp. may become resistant during ceftazidime therapy. Therefore, periodic susceptibility testing should be performed.

The medicinal product Bactolox contains sodium (one vial with 500 mg ceftazidime contains 26 mg sodium; one vial with 1 g ceftazidime contains 52 mg sodium), which should be considered when treating patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

Data on ceftazidime use in pregnant women are limited. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal or fetal development, or postnatal development. The drug should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ceftazidime is excreted in human milk in small amounts, but no effects on the breastfed infant are expected with therapeutic doses. The medicinal product Bactolox may be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No specific studies have been conducted. However, adverse reactions such as dizziness may affect the ability to drive or operate machinery (see section "Adverse reactions").

Dosage and Administration.

Table 1

Adults and children with body weight ≥ 40 kg

Intermittent administration
Infection	Dose administered
respiratory tract infections in patients with cystic fibrosis	100–150 mg/kg body weight per day every 8 hours, maximum up to 9 g per day1
febrile neutropenia	2 g every 8 hours
hospital-acquired pneumonia
bacterial meningitis
bacteremia*
bone and joint infections	1–2 g every 8 hours
complicated skin and soft tissue infections
complicated intra-abdominal infections
peritonitis associated with continuous ambulatory peritoneal dialysis
complicated urinary tract infections	1–2 g every 8 or 12 hours
prophylaxis of infectious complications during prostate surgery (transurethral resection)	1 g at the time of anesthesia induction, 1 g at the time of catheter removal
chronic otitis media	1–2 g every 8 hours
malignant external otitis
Continuous infusion
Infection	Dose administered
febrile neutropenia	Administer a loading dose of 2 g followed by continuous infusion of 4 to 6 g every 24 hours1
hospital-acquired pneumonia
respiratory tract infections in patients with cystic fibrosis
bacterial meningitis
bacteremia*
bone and joint infections
complicated skin and soft tissue infections
complicated intra-abdominal infections
peritonitis associated with continuous ambulatory peritoneal dialysis
1 In adult patients with normal renal function, no adverse reactions were observed when administering 9 g per day.

*If this is associated or suspected to be associated with infections listed in the section "Indications".

Table 2

Infants and children older than 2 months of age and body weight < 40 kg

Intermittent administration
complicated urinary tract infections	100–150 mg/kg body weight/day in 3 doses, maximum dose – 6 g per day
chronic otitis media
malignant external otitis
neutropenia in children	150 mg/kg body weight/day in 3 doses, maximum dose – 6 g per day
respiratory tract infections in patients with cystic fibrosis
bacterial meningitis
bacteremia*
bone and joint infections	100–150 mg/kg body weight/day in 3 doses, maximum dose – 6 g per day
complicated skin and soft tissue infections
complicated intra-abdominal infections
peritonitis associated with continuous ambulatory peritoneal dialysis
Continuous infusion
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 – up to 6 g per day
hospital-acquired pneumonia
respiratory tract infections in patients with cystic fibrosis
bacterial meningitis
bacteremia*
bone and joint infections
complicated skin and soft tissue infections
complicated intra-abdominal infections
peritonitis associated with continuous ambulatory peritoneal dialysis

Table 3

Infants and children aged ≤ 2 months

Intermittent administration
Most infections	25–60 mg/kg body weight per day in 2 divided doses1
1In neonates and children aged ≤ 2 months, the serum half-life may be 2–3 times longer than in adults

*If this is associated or there is suspicion of association with infections listed in the section "Indications".

Children

The safety and efficacy of administering the medicinal product Bactolox by continuous intravenous infusion to infants and children ≤ 2 months of age have not been established.

Geriatric patients

Due to reduced ceftazidime clearance, in elderly patients with acute infections, the daily dose 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. Close clinical monitoring of the efficacy and safety of this medicinal product is recommended.

Renal impairment

Ceftazidime is excreted 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 creatinine clearance.

Recommended maintenance doses of ceftazidime in renal impairment – intermittent administration.

Table 4

Adults and children ≥ 40 kg body weight

Creatinine clearance, mL/min	Approximate serum creatinine level, µmol/L (mg/dL)	Recommended single dose of ceftazidime, g	Dosing frequency, hours
50–31	150–200 (1.7–2.3)	1	12
30–16	200–350 (2.3–4)	1	24
15–6	350–500 (4–5.6)	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. In such patients, monitoring of serum ceftazidime levels is recommended.

In children, creatinine clearance should be adjusted according to body surface area or body weight.

Table 5

Children < 40 kg

Creatinine clearance, ml/min**	Approximate serum creatinine* level, µmol/L (mg/dL)	Recommended individual dose, mg/kg body weight	Dosing frequency, 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

*Serum creatinine levels calculated according to recommendations 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 directly.

Careful clinical monitoring of the efficacy and safety of Bactolox is recommended.

Recommended maintenance doses of ceftazidime in renal insufficiency – continuous infusion.

Table 6

Adults and children ≥ 40 kg body weight

Creatinine clearance, mL/min	Approximate serum creatinine level, µmol/L (mg/dL)	Dosing frequency, hours
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)	A loading dose of 2 g is administered, followed by continuous infusion of 1 g every 24 hours
≤ 15	> 350 (>4)	Not studied

Dose selection should be cautious. Careful clinical monitoring of the efficacy and safety of the drug is recommended.

Children < 40 kg

The safety and efficacy of the intravenous continuous infusion of Bactolox in children with impaired renal function and body weight < 40 kg have not been established. Careful clinical monitoring of efficacy and safety of use is recommended.

If continuous intravenous infusion of the drug is required in children with impaired renal function, creatinine clearance should be adjusted according to the child's body surface area or body weight.

Hemodialysis

The serum half-life of ceftazidime during hemodialysis is 3 to 5 hours.

A maintenance dose of ceftazidime, as recommended in Table 7, should be administered after each hemodialysis session.

Peritoneal dialysis

The drug Bactolox can be used during peritoneal dialysis, including continuous ambulatory peritoneal dialysis.

In addition to intravenous administration, ceftazidime can be added to the dialysis fluid (usually 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 in divided doses. For low-flux hemofiltration, doses should be as for impaired renal function.

For patients undergoing venovenous hemofiltration and venovenous hemodialysis, dosage recommendations are provided in Tables 7 and 8.

Dosing recommendations for ceftazidime in patients undergoing prolonged venovenous hemofiltration

Table 7

Residual renal function (creatinine clearance, ml/min)	Maintenance dose (mg) according to ultrafiltration rate (ml/min)a
	5	16.7	33.3	50
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.

Dosage recommendations for ceftazidime in patients undergoing prolonged venovenous hemodialysis

Table 8

Residual renal function (creatinine clearance, mL/min)	Supplemental dose (mg) for dialysate at flow rate (mL/min)a
	1 L/h			2 L/h
	Ultrafiltration rate (L/h)			Ultrafiltration rate (L/h)
	0.5	1	2	0.5	1	2
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

The medicinal product Bactolox 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 aspect 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.

The dose depends on the severity of the disease, sensitivity, location and type of infection, as well as on the patient's age and renal function.

Instructions for Preparation of Solutions

The medicinal product Bactolox is compatible with most intravenous infusion solutions. However, sodium bicarbonate for injections should not be used as a solvent (see section "Incompatibilities").

All vial sizes are manufactured under reduced pressure. During reconstitution, carbon dioxide is released and pressure in the vial increases. Small bubbles of carbon dioxide in the reconstituted solution can be disregarded.

Table 9

Dose administered		Required amount of solvent (ml)	Approximate concentration (mg/ml)
250 mg	Intramuscular Intravenous bolus	1 2.5	210 90
500 mg	Intramuscular Intravenous bolus	1.5 5	260 90
1 g	Intramuscular Intravenous bolus Intravenous infusion	3 10 50*	260 90 20
2 g	Intravenous bolus Intravenous infusion	10 50*	170 40

* Reconstitution should be performed in two steps (see text).

The solution color varies from pale yellow to amber depending on concentration, diluent, and storage conditions. Provided 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% glucose 40 and 0.9% sodium chloride solution; 10% glucose 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 to 0.25 mg/mL is compatible with peritoneal dialysis fluid (lactate).

For intramuscular administration, ceftazidime may be dissolved in 0.5% or 1% lidocaine hydrochloride solution.

The stability of both drugs is maintained when ceftazidime at a concentration of 4 mg/mL is mixed with the following substances: hydrocortisone (hydrocortisone sodium phosphate) 1 mg/mL in 0.9% sodium chloride injection or 0.5% glucose solution; cefuroxime (cefuroxime sodium) 3 mg/mL in 0.9% sodium chloride injection; cloxacillin (cloxacillin sodium) 4 mg/mL in 0.9% sodium chloride injection; heparin 10 IU/mL or 50 IU/mL in 0.9% sodium chloride injection; potassium chloride 10 mEq/L or 40 mEq/L in 0.9% sodium chloride injection.

The contents of a 500 mg BacTolox vial, reconstituted with 1.5 mL of water for injection, can be added to a metronidazole solution (500 mg in 100 mL), and both drugs retain their activity.

Preparation of solutions for intramuscular or intravenous bolus injection

1. Insert the needle of the syringe through the vial cap and add the recommended volume of diluent.
2. Remove the syringe needle and shake the vial until a clear solution is obtained.
3. 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. Small bubbles of carbon dioxide gas may be disregarded.

Preparation of solutions for intravenous infusion (1 g vial)

1. Insert the needle of the syringe through the vial cap and add 10 mL of diluent.
2. Remove the syringe needle and shake the vial until a clear solution is obtained.
3. Do not insert an air vent needle through the cap until the drug is completely dissolved. Insert an air vent needle through the cap into the vial to relieve internal pressure.
4. Add the resulting solution to an intravenous infusion system to achieve a total solution volume of at least 50 mL and administer by intravenous infusion over 15–30 minutes.

To ensure sterility of the product, it is essential not to insert an air vent needle through the cap before the drug is fully dissolved.

After reconstitution:

After reconstitution, the medicinal product maintains chemical and physical stability for up to 6 days at 4 °C and for up to 9 hours at 25 °C.

From a microbiological standpoint, the solution should be used immediately. If not used immediately, responsibility for the duration and conditions of storage prior to use rests with the user. If reconstitution was not carried out under controlled and validated aseptic conditions, the solution should be stored for no longer than 24 hours at a temperature of 2 °C to 8 °C.

After dilution:

After dilution, the medicinal product maintains chemical and physical stability for up to 6 days at 4 °C and for up to 9 hours at 25 °C.

From a microbiological standpoint, the solution should be used immediately after reconstitution and dilution. If not used immediately, responsibility for the duration and conditions of storage prior to use rests with the user. If dilution was not carried out under controlled and validated aseptic conditions, the solution should be stored for no longer than 24 hours at a temperature of 2 °C to 8 °C.

Children.

Can be used in children from the first days of life.

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 "Method of administration and dosage" and "Special precautions"). Serum ceftazidime concentrations can be reduced by hemodialysis or peritoneal dialysis.

Adverse Reactions

Adverse reactions have been classified by frequency of occurrence from very common to uncommon: very common (≥ 1/10); common (≥ 1/100 and < 1/10); uncommon (≥ 1/1000 and < 1/100); rare (≥ 1/10,000 and < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data), and also by organ systems:

Infections and infestations

Uncommon – candidiasis (including vaginitis and candidal stomatitis).

Blood and lymphatic system disorders

Common – eosinophilia and thrombocytosis.
Uncommon – leukopenia, neutropenia, and thrombocytopenia.
Frequency not known – lymphocytosis, hemolytic anemia, and agranulocytosis.

Immune system disorders

Frequency not known – anaphylaxis (including bronchospasm and/or hypotension).

Nervous system disorders

Uncommon – dizziness, headache.
Frequency not known – paresthesia.

Neurological complications such as tremor, myoclonia, seizures, encephalopathy, and coma have been reported in patients with renal impairment who did not receive appropriate dose reduction of ceftazidime.

Vascular disorders

Common – phlebitis or thrombophlebitis at the injection site.

Gastrointestinal disorders

Common – diarrhea.
Uncommon – nausea, vomiting, abdominal pain, and colitis.

As with other cephalosporins, colitis may be Clostridium difficile-associated and may present as pseudomembranous colitis (see section "Special precautions").

Frequency not known – taste disturbances.

Renal and urinary disorders

Uncommon – transient increase in blood urea nitrogen.
Very rare – interstitial nephritis, acute renal failure.

Hepatobiliary disorders

Common – transient increase in one or more liver enzymes (ALT, AST, LDH, GGT, alkaline phosphatase).
Frequency not known – jaundice.

Skin and subcutaneous tissue disorders

Common – maculopapular rash or urticaria.
Uncommon – pruritus.
Frequency not known – angioedema, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, acute generalized exanthematous pustulosis.

General disorders and administration site conditions

Common – pain and/or inflammation at the site of intramuscular injection.
Uncommon – fever.

Investigations

Common – positive Coombs test.
Uncommon – as with some other cephalosporins, transient increases in blood urea, blood urea nitrogen, and/or serum creatinine have occasionally been observed.

A positive Coombs test occurs in approximately 5% of patients and may interfere with blood grouping.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Incompatibilities.

Bactolox is less stable in sodium bicarbonate injection solution than in other intravenous diluents and therefore is not recommended as a solvent.

Bactolox and aminoglycosides should not be mixed in the same infusion system or syringe.

Instances of precipitate formation have been observed when vancomycin was added to a ceftazidime solution. Therefore, it is recommended to flush infusion systems and intravenous catheters between administration of these two drugs.

Packaging.

0.5 g or 1.0 g of the drug in a glass vial stoppered with a rubber plug and sealed with an aluminum crimp cap fitted with a flip-off cap providing a tamper-evident seal.

1 vial per cardboard pack.

Prescription status.

Prescription only.

Manufacturer.

Astral SteriTech Private Limited
astral steritech Private Limited

Manufacturer's address.

911, G.I.D.C., Makarpura, Vadodara, Gujarat, 390 010, India
911, Gidc, Makarpura, Vadodara, Gujarat 390 010, India (IND)

Marketing Authorisation Holder.

M. Biotech Limited
M. Biotech Limited

Address.

Gladstone House, 77-79 High Street, Egham TW20 9HY, Surrey, United Kingdom