What are the possible side effects of Ceftazidime ACS Dobfar?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
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diarrhea that is watery or bloody;
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swelling, pain, or irritation where the injection was given;
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cold feeling, discoloration, or skin changes in your fingers;
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seizure (black-out or convulsions);
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white patches or sores inside your mouth or on your lip;
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jaundice (yellowing of the eyes or skin); or
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severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
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nausea, vomiting, diarrhea, stomach pain;
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headache, dizziness;
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numbness or tingly feeling; or
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vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Ceftazidime ACS Dobfar in details
Ceftazidime ACS Dobfar is generally well tolerated. The incidence of adverse reactions associated with the administration of Ceftazidime ACS Dobfar 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 Ceftazidime ACS Dobfar 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 Ceftazidime ACS Dobfar. 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.
Central Nervous System Reactions (fewer than 1%) included headache, dizziness, and paresthesia.
Seizures have been reported with several cephalosporins, including Ceftazidime ACS Dobfar. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in renally impaired patients treated with unadjusted dosing regimens of Ceftazidime ACS Dobfar.
Less Frequent Adverse Events (fewer than 1%) were candidiasis (including oral thrush) and vaginitis.
Hematologic
Rare cases of hemolytic anemia have been reported.
Laboratory Test Changes noted during clinical trials with Ceftazidime ACS Dobfar (Ceftazidime ACS Dobfar 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 Ceftazidime ACS Dobfar (Ceftazidime ACS Dobfar 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 Ceftazidime ACS Dobfar and were reported spontaneously. For some of these events, data are insufficient to allow an estimate of incidence or to establish causation.
General
Anaphylaxis; allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest); urticaria; pain at injection site.
Hepatobiliary Tract
Hyperbilirubinemia, jaundice.
Renal and Genitourinary
Renal impairment.
Cephalosporin-Class Adverse Reactions
In addition to the adverse reactions listed above that have been observed in patients treated with Ceftazidime ACS Dobfar, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
Adverse Reactions
Colitis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage.
Altered Laboratory Tests
Prolonged prothrombin time, false-positive test for urinary glucose, pancytopenia.
What is the most important information I should know about Ceftazidime ACS Dobfar?
- Ceftazidime ACS Dobfar may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ceftazidime ACS Dobfar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Ceftazidime ACS Dobfar only works against bacteria; it does not treat viral infections (eg, the common cold).
- Be sure to use Ceftazidime ACS Dobfar for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Ceftazidime ACS Dobfar may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur during treatment or within several months after treatment with Ceftazidime ACS Dobfar. Do not treat diarrhea without first checking with your doctor.
- Ceftazidime ACS Dobfar may reduce the ability of your blood to clot. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Diabetes patients-Ceftazidime ACS Dobfar may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Ceftazidime ACS Dobfar. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Ceftazidime ACS Dobfar may affect certain lab test results. Make sure your doctor and lab personnel know you are using Ceftazidime ACS Dobfar.
- Lab tests, including kidney or liver tests or blood cell counts, may be performed while you use Ceftazidime ACS Dobfar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Ceftazidime ACS Dobfar with caution in the ELDERLY; they may be more sensitive to its effects.
- Use Ceftazidime ACS Dobfar with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this while you are pregnant. Ceftazidime ACS Dobfar is found in breast milk. If you are or will be breast-feeding while you use Ceftazidime ACS Dobfar, check with your doctor. Discuss any possible risks to your baby.
Ceftazidime ACS Dobfar contraindications
Hypersensitivity Reactions to Ceftazidime ACS Dobfar or the Cephalosporin Class of Antibiotics, Penicillins, or Other Beta-lactam Antibiotics
Ceftazidime ACS Dobfar for Injection USP and Dextrose Injection USP is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to Ceftazidime ACS Dobfar or the cephalosporin class of antibiotics, penicillins, or other beta-lactam antibiotics.
References
- DailyMed. "CEFTAZIDIME: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "(6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-(1-hydroxy-2-methyl-1-oxopropan-2-yl)oxyiminoacetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate pentahydrate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- NCIt. "Ceftazidime Anhydrous: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ceftazidime ACS Dobfar are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ceftazidime ACS Dobfar. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology