DRUGS & SUPPLEMENTS
What are the side effects you encounter while taking this medicine?
Novocral (ceftazidime for injection, USP) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Novocral (ceftazidime for injection, USP) may be used alone in cases of confirmed or suspected sepsis. Novocral has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibiotics have been used.
Novocral may also be used concomitantly with other antibiotics, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibiotics should be followed. The dose depends on the severity of the infection and the patient’s condition.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Novocral (ceftazidime) and other antibacterial drugs, Novocral (ceftazidime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Novocral is contraindicated in patients who have shown hypersensitivity to Novocral or the cephalosporin group of antibiotics.
BEFORE THERAPY WITH Novocral IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO Novocral, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC REACTION TO Novocral OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Novocral, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Elevated levels of Novocral in patients with renal insufficiency can lead to seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see PRECAUTIONS ).
High and prolonged serum Novocral concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency.
The total daily dosage should be reduced when Novocral is administered to patients with renal insufficiency. Elevated levels of Novocral in these patients can lead to seizures, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms.
As with other antibiotics, prolonged use of Novocral (ceftazidime for injection, USP) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Inducible type I beta-lactamase resistance has been noted with some organisms (e.g., Enterobacter spp., Pseudomonas spp., and Serratia spp.). As with other extended-spectrum beta-lactam antibiotics, resistance can develop during therapy, leading to clinical failure in some cases. When treating infections caused by these organisms, periodic susceptibility testing should be performed when clinically appropriate. If patients fail to respond to monotherapy, an aminoglycoside or similar agent should be considered.
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.
Novocral should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of Novocral.
Prescribing Novocral (ceftazidime) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Patients should be counseled that antibacterial drugs, including Novocral (ceftazidime), should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Novocral (ceftazidime) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Novocral (ceftazidime) or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibiotics or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity and ototoxicity were not noted when Novocral was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibiotics, including Novocral, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibiotics, Novocral may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
The administration of Novocral may result in a false-positive reaction for glucose in the urine when using CLINITEST® tablets, Benedict's solution, or Fehling's solution.
It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
Long-term studies in animals have not been performed to evaluate carcinogenic potential. However, a mouse micronucleus test and an Ames test were both negative for mutagenic effects.
Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Novocral. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Novocral is excreted in human milk in low concentrations. Caution should be exercised when Novocral is administered to a nursing woman.
Of the 2,221 subjects who received Novocral in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see DOSAGE AND ADMINISTRATION ).
Novocral is generally well tolerated. The incidence of adverse reactions associated with the administration of Novocral was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.
The following adverse effects from clinical trials were considered to be either related to Novocral therapy or were of uncertain etiology:
Local Effects, reported in fewer than 2% of patients, were phlebitis and inflammation at the site of injection (1 in 69 patients).
Hypersensitivity Reactions, reported in 2% of patients, were pruritus, rash, and fever. Immediate reactions, generally manifested by rash and/or pruritus, occurred in 1 in 285 patients. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibiotics, including Novocral. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported very rarely.
Gastrointestinal Symptoms, reported in fewer than 2% of patients, were diarrhea (1 in 78), nausea (1 in 156), vomiting (1 in 500), and abdominal pain (1 in 416). The onset of pseudomembranous colitis symptoms may occur during or after treatment (see WARNINGS ).
Central Nervous System Reactions (fewer than 1%) included headache, dizziness, and paresthesia. Seizures have been reported with several cephalosporins, including Novocral. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of Novocral (see PRECAUTIONS: General ).
Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.
Rare cases of hemolytic anemia have been reported.
Laboratory Test Changes noted during clinical trials with Novocral (ceftazidime for injection, USP) were transient and included: eosinophilia (1 in 13), positive Coombs test without hemolysis (1 in 23), thrombocytosis (1 in 45), and slight elevations in one or more of the hepatic enzymes, aspartate aminotransferase (AST, SGOT) (1 in 16), alanine aminotransferase (ALT, SGPT) (1 in 15), LDH (1 in 18), GGT (1 in 19), and alkaline phosphatase (1 in 23). As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen, and/or serum creatinine were observed occasionally. Transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia, and lymphocytosis were seen very rarely.
Postmarketing Experience with Novocral (ceftazidime for injection, USP) Products
In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Novocral and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.
Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site.
Renal and Genitourinary
Cephalosporin-Class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with Novocral, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.
Altered Laboratory Tests
Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia.
Novocral overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis may aid in the removal of Novocral from the body.
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
NOTE: The Pharmacy Bulk Package is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or intravenous injection and intraperitoneal use are for informational purposes only.
Dosage: The usual adult dosage is 1 gram administered intravenously every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.
The guidelines for dosage of Novocral (ceftazidime for injection, USP) are listed in Table 5. The following dosage schedule is recommended.
Usual recommended dosage
1 gram IV or IM
Uncomplicated urinary tract infections
250 mg IV or IM
Bone and joint infections
2 grams IV
Complicated urinary tract infections
500 mg IV or IM
Uncomplicated pneumonia; mild skin and
500 mg to 1 gram
IV or IM
Serious gynecologic and
2 grams IV
2 grams IV
Very severe life-threatening infections,
especially in immunocompromised patients
2 grams IV
Lung infections caused by Pseudomonas
spp. in patients with cystic fibrosis with
normal renal function
30 to 50 mg/kg IV
to a maximum
of 6 grams per day
Neonates (0 – 4 weeks)
30 mg/kg IV
Infants and children
(1 month – 12 years)
30 to 50 mg/kg IV
to a maximum
of 6 grams per day
Impaired Hepatic Function
No adjustment in dosage is required for patients with hepatic dysfunction.
Impaired Renal Function
Novocral is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <50 mL/min), it is recommended that the dosage of Novocral be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Novocral may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 6.
NOTE: IF THE DOSE RECOMMENDED IN TABLE 5
Unit Dose of
50 to 31
30 to 16
15 to 6
When only serum creatinine is available, the following formula (Cockcroft’s equation)4 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:
[Weight (kg) x (140 - age)]
Males: Creatinine clearance (mL/min) = ––––––––––––––––––––––––––
[72 x serum creatinine (mg/dL)]
Females: 0.85 x male value
In patients with severe infections who would normally receive 6 grams of Novocral daily were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.
In pediatric patients as for adults, the creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency.
In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period.
Novocral (ceftazidime for injection, USP) can also be used in patients undergoing intra-peritoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of Novocral may be given, followed by 500 mg every 24 hours. In addition to IV use, Novocral can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.
Note: Generally Novocral should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.
Pharmacy Bulk Package is for use in a pharmacy admixture service only. Refer to Table 7. See above NOTE concerning the proper use of Pharmacy Bulk Packages.
The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or pending.
Intermittent IV infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing Novocral, it is desirable to discontinue the other solution.
All vials of Novocral as supplied are under reduced pressure. When Novocral is dissolved, carbon dioxide is released and a positive pressure develops.
Solutions of Novocral, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.
However, if concurrent therapy with Novocral and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.
Directions for Use of Pharmacy Bulk Packages:
Reconstitute with Sterile Water for Injection according to Table 7.
Diluent to Be Added
Approx. Avail. Volume
Approx. Avg. Concentration
1 gram/5 mL
1 gram/10 mL
Note: The Pharmacy Bulk Package is for use in a pharmacy admixture service only. Using aseptic technique, the closure should be penetrated only 1 time after reconstitution using a sterile dispensing set which allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. THE ENTIRE CONTENTS OF THE VIAL SHOULD BE DISPENSED WITHIN 4 HOURS OF INITIAL ENTRY.
A plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing in the pharmacy.
Reconstitute with Sterile Water for Injection according to Table 7.
The vacuum may assist entry of the diluent. SHAKE WELL.
Insert a gas relief needle through the vial closure to relieve the internal pressure. Remove the gas relief needle before extracting any solution.
IMPORTANT: The following chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.
Intravenous: Novocral (ceftazidime for injection, USP) when reconstituted as directed with Sterile Water for Injection, should be used within 4 hours. Solutions in Sterile Water for Injection in the original container or in 0.9% Sodium Chloride Injection in VIAFLEX® small-volume containers that are frozen immediately after reconstitution are stable for 3 months when stored at -20°C. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 24 hours at room temperature or for 7 days in a refrigerator. More concentrated solutions in Sterile Water for Injection in the original container that are frozen immediately after reconstitution are stable for 3 months when stored at -20°C. Once thawed, solutions should not be refrozen. Thawed solutions may be stored for up to 8 hours at room temperature or for 4 days in a refrigerator.
Novocral (ceftazidime for injection, USP) is compatible with the more commonly used IV infusion fluids. Solutions at concentrations between 1 mg/mL and 40 mg/mL in 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; 5% Dextrose Injection; 5% Dextrose and 0.225% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 10% Dextrose Injection; Ringer’s Injection, USP; Lactated Ringer’s Injection, USP 10% Invert Sugar in Water for Injection; and NORMOSOL®-M in 5% Dextrose Injection may be stored for up to 24 hours at room temperature or for 7 days if refrigerated.
Novocral is less stable in Sodium Bicarbonate Injection than in other IV fluids. It is not recommended as a diluent. Solutions of Novocral in 5% Dextrose Injection and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers and volume control devices of common IV infusion sets.
Novocral at a concentration of 4 mg/mL has been found compatible for 24 hours at room temperature or for 7 days under refrigeration in 0.9% Sodium Chloride Injection or 5% Dextrose Injection when admixed with cefuroxime sodium (ZINACEF®) 3 mg/mL, heparin 10 U/mL or 50 U/mL, or potassium chloride 10 mEq/L or 40 mEq/L.
Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including Novocral. The likelihood of precipitation with Novocral is dependent on the concentrations of vancomycin and Novocral present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with 1 of the compatible IV fluids) between the administration of these 2 agents.
Note: Parenteral drug products should be inspected visually for particulate matter before administration whenever solution and container permit.
As with other cephalosporins, Novocral (ceftazidime for injection, USP) powder, as well as solutions, tend to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.
Novocral in the dry state should be stored at 20° to 25°C (68° to 77°F) and protected from light. Novocral (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in vials as follows:
Pharmacy Bulk Package Bottles: equivalent to 6 grams of Novocral.
6 gram (tray of 10) NDC 0409-5086-11
Also available as:
Vials: equivalent to 1 gram and 2 grams of Novocral.
1 gram (tray of 25) NDC 0409-5082-16
2 gram (tray of 10) NDC 0409-5084-11
ADD-Vantage® Vials: equivalent to 1 gram and 2 grams of Novocral.
1 gram: NDC 0409-5092-16
2 gram: NDC 0409-5093-11
Manufactured by Sandoz GmbH for
Hospira Worldwide, Inc., Lake Forest, IL 60045, USA
Made in Kundl, Austria.
Depending on the reaction of the Novocral after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Novocral not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Novocral addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology